ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - PUBLIC MEETING - - - Tuesday, July 5, 1994 The Committee met in the Ballroom of the Vista Hotel, 1400 M Street, N.W., Washington, D.C., at 11:00 a.m., Ruth Faden, Chairperson, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H. Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA KING, J.D. SUSAN LEDERER, Ph.D LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. HENRY D. ROYAL, M.D. PHILIP K. RUSSELL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. STAFF: DAN GUTTMAN, L.L.B. JEFF KAHN, Ph.D., M.P.H. STEPHEN KLAIDMAN ANNA MASTROIANNI, J.D. JONATHAN MORENO, Ph.D. ALSO PRESENT: PHILIP CAPLAN WITNESSES: COOPER BROWN SENATOR TONY deBRUM AMBASSADOR WILFRED KENDALL JONATHAN WEISGALL I-N-D-E-X PAGE Welcome and Orientation to Meeting 4 Report on Ethics Committee 12 Reports from the Ethics Subcommittee 25 Endorsements Discussion 40 Report from the Scope Subcommittee 94 Report from the Cold War Subcommittee 141 Report from the Outreach Subcommittee 152 Staff Introductions and Project Assignments 177 Public Comment Ambassador Kendall 196 Senator deBrume 196 Mr. Weisgall 210 Mr. Brown 228 P-R-O-C-E-E-D-I-N-G-S 11:00 A.M. CHAIRPERSON FADEN: Good morning. Will the Committee members please come to the table, please? We have everyone here. Would you like to sit Phil, for a minute. MR. CAPLAN: I'll sit for a moment here. CHAIRPERSON FADEN: Okay. I think we have everyone. Good morning. I guess we're ready to start. Phil, can you open us up without knocking over -- thank you so much. MR. CAPLAN: Good morning. My name is Philip Caplan, Special Assistant to the Cabinet Secretary from the White House, and as a designated federal official for this meeting of the Independent Advisory Committee on Human Radiation Experiments, I now declare it open. CHAIRPERSON FADEN: Thank you. Thanks, Phil. I think people are happier to see you when you're doing your other job? MR. CAPLAN: Closing remarks? CHAIRPERSON FADEN: Which is closing us, but nevertheless, we're always happy to see you. Thank you very much. Welcome to our fourth meeting. We have air conditioning, which is really a step forward. And we hope to have air conditioning throughout the entire meeting. It's actually not exactly cool in here, so if anybody listening knows how to make the air conditioning more powerful, that would be welcome. That would be welcome. We have a very packed agenda. Let me just announce if you see some empty spaces around the table, this is really duty beyond duty to have a meeting the day after July Fourth. Some people are flying in from parts of the country. The reason the meeting started at 11:00 was to allow people to be with their families on July Fourth and leave this morning. So a few people will kind of be filtering in between 11:00 and 12:00. That's to accommodate traffic and flight and stuff like that. So we should have a full complement with the exception of Ruth Macklin, who is still doing her international travels. She wanted me to communicate her regrets and her embarrassment at missing two meetings in a row, and she absolutely says she can make every single meeting after this. So, that's it. She will be here to every one thereafter, but we will miss Ruth today. In terms of what we're going to try to accomplish, as always I have my little overview of the objectives for the next two days, and let me just run them by you very briefly and then we'll commence. I see forming objectives for today's meeting. The first is to review and provide further guidance to the staff's work with respect to both data collection and synthesis of data. With respect to data collection efforts on the part of the staff, today Jonathan is going to brief us as to progress with respect to data collection about ethics, policies and practices. And tomorrow, we will have reports, first reports, on data collection efforts in collaboration with NASA and the CIA, as well as updates on data collection efforts collaboratively with HHS, DOE, DOD and the VA. That happens tomorrow. Also tomorrow we're going to be spending about an hour looking at efforts that staff has made in the area of data synthesis. This is going now beyond data collection to trying to put all this stuff together. And so we'll have a short presentation from staff about an information management system that we're implementing and then some initial discussion of proposed draft way of trying to group the various experiments and events that are of interest to us to see whether that's a fruitful way to proceed. So we'll be doing that tomorrow. So our first objective is to, as always, review the efforts of staff and to continue to provide guidance to staff so that staff can be working hard in between meetings. Our second objective is to further this mutual education process that we've embarked on together and this meeting we will have one presentation by Jay Katz. That will be tomorrow morning and he's going to give a presentation of the history of human experimentation and there are some readings in the briefing book that orient us to that topic. Our third objective, as always for every meeting, is to have input from the public. We have an hour set aside today, as we do at every meeting. It happens that it's the first day today, to hear I believe from three speakers, Anna? Do we have three? We have three speakers who have indicated an interest in speaking with us this afternoon. And finally, our fourth objective, and I'm actually very excited to be able to say that we're at a point to be able to do this, is to move the work of the Committee itself forward. That is, to move our work, Committee members' work, forward and to begin to give more formal shape to our collaborative efforts as a group. And here I see two parts. First, we will be hearing reports, and that's today, from our four subcommittees. All four subcommittees have been actively working away since the last meeting, and we have everywhere from a general report of how things are going to some very specific proposals depending on the subcommittee, which we as a whole committee now need to deliberate and either endorse or modify. We'll hear from two subcommittees before lunch and then two subcommittees after lunch; and then finally in this area of moving the work of the committee forward, that is the committee itself. You may remember that last time that Dan and I got charged with what we were terming by the end of the meeting as the vision thing, that we were supposed to come up with some sort of vision document for the committee, either by this meeting if possible or by our second meeting in July at the very latest. Well, we sort of skipped over the vision thing, I think. It may be that Dan and I are not very visionary, but we did come up first with a statement of what I would call goals and objectives and then from that, actually have at this point a preliminary, and I underscore very preliminary, draft of a final outline, and it's an outline for the final report. We put final in the right place. It's a draft outline of the final report. And this product is a result of the work not only of Dan and myself, but many members of the staff, and also Duncan sent us a draft of an outline for the final report, which was very helpful and kind of inspired us to go further. So this pulls together some of what Duncan provided with some of the stuff that was in this goals and objectives document that I had come up with, and then Dan came up with something and then other members of the staff came up with something. In any event, we have a something now, which is a document that might function to pull us together. If it's bad, we'll know it and we'll be able to react to it. Where it's good, we'll hopefully pull around it and be able to really give direction to the staff and to our own efforts from now on. You do not -- if you are thinking what is she talking about? I haven't seen this. This is correct. You have not seen it yet. It was worked on until the last minute. What we are going to do is distribute it today, and I will walk everybody through it today. Because standing by itself, it sort of isn't terribly meaningful, so I'll try to explain kind of what it's intended to accomplish. It will take maybe 45 minutes to do that today, and then we've set aside about an hour and a half tomorrow afternoon to revisit the document. You'll have had a chance to digest it, think about it, talk about it and come to your own sense of how useful you think it is. And we will spend a good chunk of tomorrow afternoon then critiquing that document, seeing whether it's in good enough shape that we can kind of go with it for now or whether you want to make revisions in it, which we will then prepare for the next meeting. So that's basically what will happen over the next two days. We start at 11:00. We started at 11:01 I understand, and we go to 5:00 today, not to 5:30. And then we pick up again tomorrow morning at 9:00 and go until 3:00 in full session. There are some subcommittees that may be meeting after 3:00, but as a full committee we conclude at 3:00. At this point, let me turn the agenda over to Jonathan, who's going to give us a quick update on the ethics data collection. Let me just mention for those of you who find this room arrangement as unpleasant as I do, I can't -- I didn't realize that Jay was even sitting there because I couldn't see him through Anna. Apparently at lunch, we are going to magically have the room rearranged so that we can see each other. The people in the corners will become more incorporated. Jonathan? MR. MORENO: Thank you, Ruth. Perhaps I'll begin by just saying a word about process in terms of the ethics data collection. Essentially we have now in place a staff of brilliant, post-baccalaureate readers who comb through every page of every document that we receive including experimental protocols, which for those of you who sit on IRB's and have done this sort of thing, a grim business. They have been briefed by members of the Ethics Group, the more senior people in the Ethics Group, to look for certain kinds of documents or notations or memoranda or letters concerning certain specific sorts of issues. For example, of course, informed consent, what kind of consent? Is there a consent form? Is there a note in the medical record from the physician? Is there an exchange about risk benefit issues between the investigator and the colleague at another institution? So on and so forth. So those are the kinds of -- and very broadly, they're instructed to be very liberal in the material that they bring to us so that we can then assess it and decide whether it fits into a bigger story. And if so, which of the many stories that we're following? That sounds more rational in description than it is in practice. Usually what happens is one of us is sitting in an office, somebody runs in with something, a hot document, and we run to their office and see what else is in the file with them. And we, together, try to piece the story together. In your, I believe it's Tab I in the briefing book, or Tab -- I'm losing track of my tabs, Tab I -- Tab L, we've included quite a bit of material this time and it's sort of interesting. Three days before the deadline for this briefing book, I turned to my colleague, Kathy Taylor, and said I don't think we have anything. I think we'll just have to tell Dan and Ruth that we don't have anything this week. And then some boxes came in and we started working furiously for the next day and a half. And there were sort of three stories that I want to highlight for you, one rather involved one having to do with the Department of Defense in the early 50's; the other having to do with the Atomic Energy Commission, the other two having to do with AEC. I'll begin with the DOD story. You'll recall that a couple of months ago, for the last couple of months, we've been talking about the now-famous, for those of us who are interested in this sort of thing, Wilson Memorandum from February of '53 in which the new Secretary of Defense, Charles Wilson, signed off on an Armed Forces Medical Policy Council recommendation for the DOD essentially to adopt the Nuremberg Code with one addition, the 11th Commandment, namely that prisoners of war should not be used in research. We were interested in knowing more about the background to the adoption of the Nuremberg Code, and the documents that we received the last couple of weeks have really told, I think, a very interesting story, one in which it becomes clear that there was a great concern that there was no -- and I'm going to use the following phrase carefully because the lawyers have warned me about it. There seemed to be a regulatory vacuum in the Department in 1951 and '52 with respect to the use of human volunteers. There seemed to be no code, no regulation, that enabled the Department to use human volunteers in the early 50's. I take that, as a matter of fact, from a statement that's on page four in Tab L which is underlined. There is no DOD policy on the books which permits this type of research, and that documentation is provided for you. It was also the case, and it becomes quite clear in the documents that were received from late '51 and during '52, that there was great concern in the Department about Soviet activity in the area of biochemical warfare, biological warfare, BW and chemical warfare, CW. And there was concern that the Soviets, in effect, were getting ahead of us, might be getting ahead of us in these areas. And so there was a worry about what I started to call a couple of weeks ago the Biochem Gap, thinking about the missile gap in 1960, the alleged missile gap. Gradually also to BW and CW, there was added along the way during '52 in the discussions it seems RW, radiological warfare, as well. And there was at the same time the impression that Nuremberg Code, the consequence of the Nuremberg trials, and the Holocaust, these were important things to remember. Those considerations came together in a series of interesting discussions, it's clear now, in the Department from late '51 through the year 1952, in which different entities within the Department made different kinds of recommendations. The Armed Forces Medical Policy Council's recommendation to the Secretary of Defense that there should be, in effect, an adoption of a Nuremberg-like standard was not, it is quite clear, universally accepted at first by entities within the Department. The memoranda that we have indicate that at least some other advisory groups thought either that there should be no written policy at all, because it becomes legalistic and so forth, or that there should be policies with different kinds of elements than a Nuremberg-like policy. And indeed apparently, right around the time that the new Secretary of Defense was taking over in early 1953, the Service Secretaries and the Undersecretary got together to try to resolve this controversy within the Pentagon about what kind of standard to adopt for the use of human subjects. And they couldn't agree, and they essentially turfed it to the incoming Secretary of Defense on the ground that it was going to be his headache anyway. He was going to have to apply the new policy, so let him make the decision about what kind of policy the Department should have. I commend that reading to you at several pages, single-spaced, but nevertheless, I think it really is a quite fascinating story. Finally, as we now know, the new Secretary of Defense did indeed sign off on the document that established the Nuremberg Code as essentially the policy of the Department of Defense. With respect to the Atomic Energy Commission, there's another story of debate and disagreement it seems, but one the yielded in a way an even more interesting result. We'd reported before that earlier in 1947, AEC officials established a consent policy, but one that essentially seemed to give discretion to the investigator, to the scientist, to the physician, to decide whether or not this was truly a voluntary arrangement on the part of the subject. But later on in 1947, the Advisory Committee on Biology and Medicine on the AEC adopted a much stricter standard, and I think perhaps a standard that even today we would regard as quite strict, at least with respect to certain of its major features, requiring not only that the patient give his complete and informed consent in writing, but also that the "responsible next of kin give in writing a similarly complete and informed consent revocable at any time during the course of such treatment". A formidable consent standard indeed, one that required not only the individual's written consent, but also a next of kin's consent. The philosophers of medical ethics can debate the confidentiality issue that emerges from that kind of a requirement if we're talking about allegedly therapeutic treatment. In any case, there again in the AEC we see a debate about how strict a standard to have and gradually, as in the Department of Defense, a relatively more strict standard emerges as the one that is finally adopted. Finally, the staff notes without extended comment the denial on the part of the Chief of the AEC's public information service in December 1950 that the Agency has ever sponsored a medical research project where human beings are used for experimental purposes. That's my report. CHAIRPERSON FADEN: Thank you, Jonathan. Are there questions? Jonathan, the reports in the briefing book obviously -- and let me just pick up on one point. This was a point that Jay made at our last meeting. Again, this is of more interest to some of us than to other of us. When I had forgotten who has used the term "informed consent" prior to '57, and Jay rightly said the term really wasn't introduced until '57 and I had actually whispered that to Dan just at that moment saying the same thing. And I said, "See, Jay says the same thing I say, so it must be right." It was really quite interesting now to see in this document that, in fact, the term "informed consent" is used. Now it clearly didn't take on the -- it would be wrong to -- MR. MORENO: Implications. CHAIRPERSON FADEN: -- give it the same meaning, but the term "informed consent" is the term that is used in this '50 -- what is the date on that document, '51? MR. MORENO: Fifty-one. CHAIRPERSON FADEN: Fifty-one, yes. MR. MORENO: It refers to a '47 letter. CHAIRPERSON FADEN: Right, so it's really quite interesting. They used the term "voluntary" and "informed consent" which is probably just a way in which language is phrased, but nevertheless, now it introduces an interesting way of crediting Scalli. I'm not quite sure what we will say after this. DR. KATZ: It's very interesting. I did, for many years, search with all kinds of people of finding in case law the use of "informed consent" prior to 1957. It is not there to be found. It may exist. It was used for the first time in 1957. It has also an interesting history, but this is not for today. But people often overlook that informed consent in law does not mean what the general way in which informed consent is used in these documents, meaning that the consent should be informed; that the patient or whoever should know also in his own mind what he is consenting to. In law, informed consent is a hybrid term in which informed refers to the disclosure obligations by the physician and consent goes to consent, and of course that's even today in law is a very ill-defined kind of term. CHAIRPERSON FADEN: You may have noticed with your briefing book this time, we provided a triaging document, a bidding guide. We had gotten some reports that we were overwhelming people with material, so we worked out this triaging document which allows you to work your way through the briefing book according to the priorities that we've set as opposed to your own. But some of the documents that we put in the attachment category, really they're just the ones Jonathan references, are really quite interesting when you get into them. So this is the staff report, by way of a teaser, to suggest that if you really want to look at the exact wording on precisely how the exchange went, the material is there. Thank you, Jonathan. The denial is an interesting part of the story too, which we will -- that is, the claim that there was no AEC- supported work involving human subjects. We will keep a pace here, and there is clearly much to do. We are now going to turn to reports from subcommittees. I'm going to do the ethics report, report of the Ethics Subcommittee first. If possible -- Anna, will Reed be here in time to do his before lunch? SPEAKER: Once he's checked in -- CHAIRPERSON FADEN: Okay. He was coming in this morning, so we'll have to wing it and see. The plan was to do the Ethics and Outreach Subcommittee reports before lunch and the Scope and Cold War Subcommittee reports after lunch. We'll just have to see who's around. We may move lunch around a little bit. I guess that's another -- we can't move lunch around. We can't move lunch around? It's amazing how little control we have over our lives when these committee things start. Because Mary Ann isn't here either. She's coming in late, so it will be hard to do the Cold War. All right, we'll see. We're just going to wing it. Ruth Macklin, as I've already mentioned, is not here. She's asked me for the last time to give the Ethics Subcommittee report. Now she did share in our Ethics Subcommittee meeting and is very much in leadership of that subcommittee, but she did ask me to walk us through our subcommittee report to the full committee which I will do now, and we will bring her up to date. The members of the subcommittee that are here that can help me are Eli, Phil, Susan and that's everybody except Ruth, and that's staff for the subcommittee, many of whom are here as well. So we can supplement this. Basically, where the Ethics Subcommittee has focused in the interim between the last meeting and this meeting is on the issue of continuing with data gathering and what kinds of data gathering efforts do we need to undertake that are different from those that the staff currently have underway. And there are two areas. Well let me step back. The area where the subcommittee immediately feels a need for more information is in the area of practices; that is to say what are the practices and what have the practices been with respect to the involvement of human subjects in biomedical research, in ionizing radiation specifically, but in biomedical research generally as well. So the focus of the Ethics Subcommittee has been first on practices, and then within practices, in two time frames basically: first, oral histories. Let me step back. The first area is what have the historical practices been, where there is a scholarly controversy in fact about the extent to which the sorts of documents that Jonathan made reference to: the Nuremberg Code, the 1953 Defense Department memo on policy, and so on, the extent to which those policy statements and those codes of ethics actually affected the practice of investigators and their work with human subjects. And if you look at the Scalli literature, there's some disagreement and debate about exactly the extent to which people conducted their research in line with the principles enunciated in something like, for example, the Nuremberg document. In line with our charge to provide criteria for evaluating studies that had been conducted in past decades as well as the present, the subcommittee feels strongly the need to learn more about this debate and to augment the general understanding of this question by some original research. And with that -- we mentioned this at the last subcommittee meeting -- we are now proposing, as a stand-alone project, an oral history project. If you recall last time we had talked about aggregating -- putting an oral history project together with a project intended to elucidate contemporary practices. For a complex of reasons, the subcommittee now thinks that a disaggregation of these two projects would be preferable and I can go through that. But our current proposal is first that we endorse the conduct of a stand-alone oral history project, the intent of which is to elucidate the standard, the actual practices of investigators in research involving human subjects from the 1940's until the present, but with a concentration really on the decades prior to our own lived experience: the 40's, 50's, 60's, and 70's especially. The proposal here is to identify approximately 15 to perhaps 20 investigators, ten of whom have been involved hopefully for a career lifetime in research involving ionizing radiation, and another five or ten whose work has been in other arenas of biomedical investigation, and essentially to interview them about their understandings of how they practiced their work with human subjects across the decades. The project would be conducted by people who are experienced oral historians, and would be guided by an expert panel of people who are experts in the history of human experimentation and the ethics of human experimentation as well as people who are experts in oral history. Susan Lederer and Ruth Macklin and others have been able to recommend names for the expert panel, and we are trying to pull this together. The work would be done obviously only if it could be done well, and we would conduct it according to the high standards of research in the oral history tradition. We are fortunate to have access to people who have that expertise, both on the committee membership and in the staff, and we can reach out where we don't have it. So I'm commending this on behalf of the subcommittee to the full committee so that we can have a better empirical base for understanding essentially what life was like as we try to situate the studies that are of interest to us as we proceed. Maybe I should go through the other two and then have discussion. We are also concerned about our being able to fulfill that part of our mandate that speaks to the current situation; that is to say the contemporary setting of research involving human subjects. It is certainly my felt belief that if we were to write a report that looked to the past and spoke not at all to the present and to the future, the value of the report would be considerably limited. And in particular from the perspective of the American public, it will of course be of interest to learn about what happened in the past and to provide a vision onto that past through out contemporary moral standards. But it is also important to say something about what the current practice is with respect to human subjects. Does the American public still need to be concerned or are things under control? And that's a rather cryptic way of pointing to our mandate with respect to the present and the future. Here again, there is an absence of adequate information. There are really not very good empirical bases for drawing any conclusions about the current situation with respect to research involving human subjects generally and certainly not adequate data with respect to research involving human subjects and ionizing radiation. We have proposed as a subcommittee now two projects to attempt to at least, in part, fill that gap. There's no way that within the time frame that we have we can do the definitive work on the current situation, but we can at least gather the sorts of information that, bolstered with information from secondary sources already available, we would be in a better base to make recommendations about current policies and procedures and needs for the future. Let me describe both of these. And I just realized that I did something really dumb, which is there's a memo in your folder which you should have been looking at as I have been speaking. And it's from the Ethics Subcommittee to the members of the whole committee, and if you want to pull it out now, it's available and it basically summarizes what I'm saying to you. It's what I'm looking at, so you might as well be looking at it as well. I apologize. I forgot that it wasn't in the briefing book. First we are proposing that we review a sample of protocols currently implemented involving both ionizing radiation and another arena of biomedical research. Basically what we had in mind here is that we get a denominator from the relevant funding agencies and oversight agencies with which we are working, principally DHHS, DOE, DOD and the VA, but perhaps all of the agencies. We would like to know what their current portfolio is with respect to research involving human subjects, current and ionizing radiation. That is, what are the 8,000, 80, 22, whatever the situation is, studies currently being implemented that have been funded and approved? We would have to think carefully, and this fits as well with issues on the Scope Committee about whether certain sorts of studies involving ionizing radiation would be excluded. For example, what we have debated is whether we would want to toss out from the denominator studies in which subjects are exposed to ionizing radiation but for incidental purposes, for example where it's a matter of establishing eligibility criteria for other studies, if somebody has a chest x-ray, in order to get into another trial. And it might show up in a search as someone being exposed to ionizing radiation, but the ionizing radiation is not itself a subject of the research. Or it's a brain cancer chemotherapy trial, and brain scans are being done to monitor an end point. We will have to make judgements about whether that sort of study goes in or out of the denominator. But bracketing that, we would have a denominator of studies involving ionizing radiation currently being conducted. We would draw a sample of those studies, and then we would ask the funding agencies to provide us with the grand proposal based on which that work was awarded support. And that grand proposal will include the human subject section as all grand proposals currently are required to include, as well as the consent form that is submitted for review by the study section. This material then would be reviewed by us, and "us" would be defined as a subgroup of committee members and staff members. Jay Katz has indicated an interest in leading this effort and I personally would be delighted to have him do that. We would need to articulate some very specific objectives for this review, but presumably at minimum, the review would be directed at answering the following questions: To what extent, if at all, are human beings currently being exposed to -- we'd have to come up with a label that we would like, but more than minimal risk of harm, research involving ionizing radiation. Where there is such exposure, is there offsetting benefit or not? And then a second question is, to what extent, if at all, is there any indication that the consent procedure is being proposed. And we might remember all we would have is the written documentation which is clearly not what you would like in an ideal circumstance. To what extent do the consent procedures, as explained in the grand proposal, adequate in terms of contemporary standards? So we would have at least those two questions and presumably also we would be able to address the question of is there any indication or to what extent is there any indication that particular communities or subgroups of communities are disproportionately or inappropriately being involved as subjects in such studies? Those would be the minimal objectives of the study. Clearly we would draw on different members of the committee and different expertise on the staff for different parts of this review, some of which obviously requires technical expertise with respect to radiation risks. Others require expertise with respect to consent standards and procedures and still others, sensitivity and expertise with respect to selection of subjects. But that would be the meat of this project. Because all we would have available to us would be the dry documents, we would be missing any information that you could learn from talking to people who have been or are involved in research involving in the subjects as subjects, which you're not hearing at all, to use a trendy term, are the voices of the people who are subjects in research when you get your information in this fashion. And so the third project that we're proposing, and this is a refinement of the project that we briefly mentioned at the last committee meeting, is a study in which we would interview patients who may be involved in research. And what's proposed at this point is something like the following: we would identify ten institutions, roughly five academic institutions and five federal government institutions. The institutions would be selected because they are the recipients of the highest volume of federal research funds. So essentially you get selected because you're in that elite club which all institutions like to be in. So it's not an affront to be in this group. It's a privilege and something, of course, all institutions and medicines strive to join, but with it comes a certain burden of responsibility. We would acknowledge, of course, that we would have a skewed sample in the sense that there's no reason to think that practices in institutions in which there's much less research being conducted necessarily have the same experience. But in selecting high volume institutions, we would at least be speaking to the experience of their many people who were involved as research subjects. We would use a parallel criterion for selecting federal facilities as well: high volume locations. And the proposal as it stands right now is to focus on medical oncology and radiation oncology for conflicts of pragmatic reasons and research design reasons. But the notion would be that we would identify co- investigators in radiation oncology and medical oncology at each of these institutions who would be willing to work with us. And we would again use only very highly experienced interviewers in this area of research and conduct a qualitative research study in which we would blanket an institution for perhaps two to four days with our professional interviewers who would approach people in waiting rooms in medical oncology and radiation oncology out- patient facilities after it's been made plain to the people in the waiting room that the institution is cooperating with a National Advisory Committee and the conduct of such a study, you may be approached by such a person and it's okay. We think it's fine if you want to be in it. We think it's fine if you don't want to be in it, but we want you to know that it's a legitimate activity, that kind of thing, so people wouldn't be approached cold. And in order to protect the privacy of the people who are sitting in the waiting room, we would not ask to be told in advance who is a patient, who is a family, an accompanying friend. We would simply approach someone saying we are doing this project, the purpose of which is to understand better how people appreciate and experience being -- receiving medical care in this institution, which a great deal of experimental and research work is being done. We are interested in talking to people who are currently patients. Here's how long it would take, blah, blah, blah. Would you be interested in learning more about the study? And if a person says no, I wouldn't, we won't know if it's because they're not a patient and not eligible or because they're a patient and they just don't want to bother. I mean, if somebody volunteers and says I'm not a patient, it's my wife, that's fine. But the point is, we don't screen people in advance, basically themselves out. Anybody willing to be interviewed, we would interview for about an hour using a qualitative methodology and we would essentially begin by ascertaining whether that person believes they are a part of any research protocol. So we would start from ground zero. We would not know at the time the interview was being conducted in fact whether they are or are not participants in a research project. We would pick sites where there's a high probability that many of them indeed are, but we would not know. We would get the patient's permission to review all their relevant records, so we would then be able to establish whether in fact their understanding of whether or not they're involved in research squares with the institution's understanding of whether they are involved with research. And we would also seek their permission to verify that information with whoever is their primary care provider in the context of that setting. So we're not talking about their family physician or general practitioner or internist, but whoever it is in that center that is their primary oncologist or radiation physician. So that's the proposal. We would do this both for radiation oncology and medical oncology because we would not want to conclude by just the structure of the study that there would be anything particularly different or unique in radiation oncology that would not be true for a similar situation in which patients are enrolled as research subjects, but not in projects involving ionizing radiation. And I should mention that with respect to the protocol review study I mentioned earlier, there would also be a comparison group, some other group besides ionizing radiation from whom we would also draw a sample of proposals and expose those proposals to the same review. I think I should stop at this point. What we're asking for obviously is for the full committee to endorse the proposal of the subcommittee. We have thought hard about whether we can get this done in the time frame and the answer is maybe, depending on how quickly we can reach a conclusion and how quickly we can get approvals from all of the various levels of government and institutional review that would be required. Pat? MS. KING: If this goes over the ground that was discussed at the last meeting, again that could be, and this may have been discussed before. First I have just a brief question and then I want to express my concerns. Will the research projects we undertake be in this protocol and subject to the Institutional Review Board? CHAIRPERSON FADEN: Yes. MS. KING: Okay. The thing that concerns me about the datagathering project in the totality is that I don't sense, with the possible exception of oral histories, that we will learn much out of historical information or current information on selection of subject procedures, something that I'm very much interested in. In fact, I'm very concerned that it means we are doing here what we've always done in the past, which has spent much more time with one set than we spend actually on the selection subject. And I know that the write up of the Research Protocol Review, for example, did not mention selection subjects, although you were quite eloquent in talking about why we're going to get to those issues and trying to do that project, and that's an oversight. With the possible exception of the oral history, because investigators can give very good information about why it is they selected certain subjects, it concerns me that what we get after that is nothing real except on paper about selection of subjects, itself. Most of the radiation research in the past has involved the vulnerable groups. We've targeted groups that we think of as not being empowered in relation to perhaps investigators -- because of race, class, ethnicity -- CHAIRPERSON FADEN: Gender. MS. KING: -- gender. I can think of a whole list of them. I don't see a way for pulling that information out in terms of what actual practices were. I don't suspect we will find a lot of it on paper, which is why oral history project -- CHAIRPERSON FADEN: That's a very important amendment. And as you're talking, I'm thinking, reaching back to some other work that I've done recently, with respect to the historical situation, I'm not sure. And the oral histories, we can certainly make sure that we focus on that in our discussions, in our interviews, with the respondents, but we might want to think hard about who we select with an eye towards that. And I apologize for it, that dimension, the justice dimension not being elucidated enough clearly in the write-ups. With respect to the contemporary situation, in particular the protocol review, since at least HHS now records information about the characteristics of the subjects involved in the research that it supports, it's conceivable that we could look at that, not only for a sample, but indeed for either a large sample or perhaps even for all, for the entire denominator, just to get a slice into what the subject pools look like in the current situation, the 1994 situation, with respect to questions of relative powerlessness. MS. KING: The other concern, and this is a different way of getting at it, and I'm not a historian, but so maybe this is not important. But there is nothing that allows a relatively contemporary matching of what I consider the investigated institution side with the subject side, except in the current period where I'm sure all of our data is much better than it is historically. For example, oral histories are going to look at investigators. They're not going to look at anybody who is a subject, although we get public testimony. That is not the same as a carefully conducted oral interview. Similarly with the patient interviews, we are not, for example, going to correlate, it doesn't seem from here, the investigators and their understandings of the project in any kind of contemporary fashion with the patient interviews. So that's my second concern. That's a question because maybe the historians can tell me whether it's an important question. Is it important to have that kind of contemporaneous matching to some extent so that you understand what the investigators and the subjects see roughly in the same period. Is it unimportant and just to underscore the selection of subjects again? DR. LEDERER: It's interesting to hear you raise that concern because I have that same concern, particularly in the oral history component that we're not hearing from the subjects, we're hearing from the investigators. But I think there are many practical problems that arise in first identifying subjects who might be useful sources of information for us. I think that those problems perhaps override exploiting them, in this sense, as a useful source of data in this sense. I think we certainly would want to discuss comparing subjects and the investigators when we talk about the oncology portion of this. That was something that, for instance, you hear a lot about. CHAIRPERSON FADEN: I think we did talk a little bit about that. The historical subject is the problem that Susan has identified. It would be wonderful if we could do a systematic study of people who participated in studies in the past. The concern we have is in the time frame. How would we do that? So maybe if you want the subcommittee to work a little bit harder in thinking about is there a way to do that creatively, responsibly, and validly, we can continue to struggle with that. We kind of gave up on that issue. The contemporary situation, one of the things hearing you talk -- I guess I personally would not be in favor of the complementing of the patient interview study that's proposed here for the 1994 situation with the investigators of those very same protocols. But we could have a parallel oral history project, interviewing project of 15 investigators, 20 investigators currently involved in research; more like a comparison of the people who started their careers in the 80's, late 70's, 80's and 90's, interviewing them and interviewing people who began their careers in the late 40's and 50's and hearing the differences there. That, I think, is eminently doable and that may be a very welcome amendment to the proposal as we have envisioned. MS. KING: One final question. CHAIRPERSON FADEN: Sure. MS. KING: The final question is has the subcommittee considered the practices of institutional review boards, which are our first line of protection and, after all no matter what we do, it is what they do and what they say that ultimately determines what subjects are exposed to. CHAIRPERSON FADEN: We have talked in the subcommittee about the IRB situation and reached the following ten conclusions. We will gather all and every available secondary source of information about the functioning of IRB's. There is an IRB study that -- I don't know exactly how to phrase it -- launched, on the way to be launched, implemented, a large one, then we couldn't possibly hope to duplicate or approach in our own time frame. So we thought what can we do around the fact that we can't do a large IRB function study? But we will certainly draw on all the available secondary information on how well IRBs are or are not functioning and think about the sorts of things that an IRB study wouldn't address, which we could fill in with our specific focus on ionizing radiation. I mean if, for example, on our protocol review, our own internal protocol review, we discover problems, that's strong inferential evidence that the IRB system isn't working as well as it should because all of these proposals have been approved by IRB's or they wouldn't be funded by the federal government. So we would be doing kind of a different attack on that problem. Instead of looking directly at how the IRB's are doing, we would be looking at the products of IRB-approved processes and seeing well, things look pretty good or they don't look pretty good from the perspective of an Ethics Committee, which in fact is what we are. Eli? DR. GLATSTEIN: I have a few comments here. One is that with respect to radiation, most major institutions at least that investigate for radiation not only have to go through an IRB, but also have to get the approval of Radiation Safety. CHAIRPERSON FADEN: That's right. DR. GLATSTEIN: And approval of one without the other is not good enough. Secondly, with respect to the issue of how patients are selected, in general, at least to get federal support, you are proposing to study a specific problem over a finite period of time. First thing you have to do is show that you have enough patient material that makes that a practical thing to fund. It's understood that not every single patient who's eligible will go on study for a variety of reasons. First of all, a patient has to give an informed consent. If he chooses not to, he doesn't go on. But secondly, while you're studying patients, you have to careful about the quality of data that you're going to get. If we know that we're dealing with drug addicts, we don't use them. If we know that we're dealing with people who move around on an annual basis, moving from one city to another of a distance away about every 18 months, they're not appropriate for us to be using for investigation purposes. We need a certain degree of reliability here. And there is just a variety of factors here which make it generally hard to get more than about half the patients who are eligible on the study, and that's in major institutions. In minor institutions, it's much less than that. The number of patients that go on study over the country as a whole with cancer is something like one or two percent of the patients that have cancer. It's a very small proportion even in diseases where there's no established treatment of value, so that it's a complicated subject. With respect to the issue of race, for example, there are data in most institutions on Caucasian versus black, but if you want to get into other minorities, Spanish-speaking and so forth, it's very hard to get that information. It's only recently been required by the Feds, and as a consequence those data are now being generated. But prior to the last few years, you'd have to go through every single chart to get that information. You won't have it tabulated on the computer. At one point, it was thought not to be appropriate to list that kind of issue so that it's complicated to now retrieve. CHAIRPERSON FADEN: Yes, I think that your points are well-taken, Eli. One of the interesting questions as we conduct both contemporaneous projects, the patient interview one and the proposal review one, is because of the fact that radiation proposals go through two levels of review. Will we be seeing, in fact, that indeed those proposals are "better in some sense" from an ethics point of view? We don't know. It's an interesting question. We hope next, at the second meeting, to have a colleague of Henry's come and give us a detailed update on all the levels of review that contemporary projects involving ionizing radiation must satisfy so we can all be on board in that area. Eli? DR. GLATSTEIN: The other issue had to deal with trying to tabulate total radiation exposures from a variety of things that are not considered part of the study. For example, if you have a number of chest x-rays or brain scans and so forth -- when you get to low-dose radiation, it is not easy to show biological impact. The chest x-ray, you can't show it. When you talk about the multiple rad exposures, you can show something. But when you get down to something under a few rad of exposure, which is several hundred chest x-rays, we usually extrapolate a number of studies that get done on a routine basis, not studying or not investigational, is highly variable depending upon who is doing the study and who is the doctor. But you are required in most of these things to outline what studies are going to be done how frequently and that is being seriously modified by who's paying for it these days because anything that's considered excessive is usually not being paid for by third-party carriers. So we have no standard at this point. I guess that's what I'm trying to say. It's not going to be easy to -- CHAIRPERSON FADEN: No. DR. GLATSTEIN: -- to focus on that, and I think that's a bag of worms for purposes of this committee. CHAIRPERSON FADEN: If I turn it around, Eli, though, given all of the technical problems and the absence of consensus about how to understand the meaning of risk in the context of low-dose radiation, how -- I mean, we need to say something to the American public about whether they should be worrying or how much they should be worrying about -- DR. GLATSTEIN: Well, I appreciate that, but when you talk about the cancer patient, particularly one who is getting a radiation treatment, who is getting several thousand rad to some specific part of the body, the impact of an additional chest x- ray or a brain scan is trivial. I mean, it's a manifestation of the old adage that you have to fight fire with fire. CHAIRPERSON FADEN: Right, and that's -- I think if we talk about the two projects, the review of the proposal's project would be not limited to oncology patients, but would be across the board. And in any instance in which there was a judgement by whatever review group that we constitute that there was some level of risk that was of any moment, there would be an immediate assessment of the prospect of assessing direct benefits that would have to go in. It's really essentially to put a thermometer into the pool and pull it out and say to the American public, you have a lot to worry about, you have a little bit to worry about, you have nothing to worry about, somewhere on that continuum with respect to the ongoing activity of research involving human subjects and ionizing radiation, one concern being risk, another concern being inequity in selection of subjects, and another concern being consent procedures. They would be the three that we would -- what a thoughtful committee member. We are struggling with a personnel staff committee problem. The plan was to have Reed do the Outreach Committee before lunch. Reed isn't here, and so we don't know what to do about that. And Duncan had planned to give the Scope Committee report after lunch, and he's kindly sending a note saying he could cope with it, and Henry is saying he can cope with it. And I don't know who else is on the Scope Committee, but it would be very helpful, Ken, if we could cope, we could all cope with our shifting schedule here. Mary Ann also is not yet here, although her plane has landed and she is dropping her child off at day care and will be here momentarily. But we have to deal with the exigencies of the -- at least there are no thunderstorms. So we could go forward. I'm sorry, Phil, did you want to say something? DR. RUSSELL: Yes. I'd like to express some level of concern about the patient part of this datagathering. I'm concerned that the science of the study and the nature of the study is made to produce very skewed data from small samples or very small samples, that because of the selection of the institutions, it won't be broad enough to give us a lot of confidence in using it as a thermometer of what the temperature of the whole pool is. I'm also quite concerned that this is a very subjective approach. Not necessarily so, of course, but the semi-structured interview is not a validated instrument to -- or without validation I should say -- is apt to give us a bias that's quite dependent on the interviewers, rather than the subject. So while recognizing the true importance of getting to the issue of how informed is the informed consent really from a subject's point of view, I have to express some level of concern. Do we have the resources and time to pursue this type of patient-level investigation? CHAIRPERSON FADEN: We may not. I mean, I think one of the things we have to acknowledge that if we do what is called the patient interview study here, we are adopting and endorsing a totally different methodology, a qualitative methodology in which the validation of the instrument is not the criterion against which you judge the quality of the data you obtain. We would be in a different arena. We would be talking more the methodology of the ethnographer in some respects than that of the quantitative social scientist. So all of that goes out the window. So we'd have to adjust and we'd have to be comfortable as a committee with that field of research that's owned by the qualitative social scientist rather than the quantitative social scientist. I am personally, but this would be something that the whole committee would have to accept. I think there's a huge contribution of people on the qualitative social sciences make to our understanding of the human experience that you can't get from standardized instruments where you have reliability coefficients and validity measures and things of that sort. But you're right, we'd have to all be comfortable with that. We'd have to be comfortable that within that style of research, we are conducting the study according to the high standards internal to that approach, that methodology, which is different. But still you want it to be as good as it can be of the kind that it is, and then you raise the real question of can we pull it off in the time frame, if we only want to do it if we can do it well. And I have reservations about that myself. I worry less about general questions to other kinds of institutions. And you just would say, well, we just can't. I mean, we won't say whether you go to a drug company or you go to a small institution -- DR. GLATSTEIN: -- evaluate danger of the former. CHAIRPERSON FADEN: There is, and I think the other thing we would have to say about this area is that we would not be looking for a fine point of understanding of the disclosed information. That would be unfair. I mean, there's going to be a time gap which we won't know about between when the person was approached about being enrolled in the study and when we would interview them. And so we're not going to be sitting there and saying what are the rare complications or remote side effects that they told you could happen. But we're looking for more gross indications like do you know you're a research subject and how did you come to be one? Not, did you -- please tell me what they told you about the fine points of the risks and benefits, because that really would be an inappropriate kind of a question in a design in which you have no control over time. But you would hope that even if a person has been in a study for 18 months, that they know that they're in a study. They would be kind of at that level since cardinal to all of this is the notion that people can withdraw from those research subjects at any time. So at minimum, they should still be knowing that they're a research subject, or they should understand that the treatment that they're getting is experimental in some relevant respect. Maybe that's not a good enough outcome to warrant the effort. Maybe that's not important enough. I think that in the interest of time, if it's agreed -- if the members of the Scope Committee feel brave enough to proceed without caucusing, we can continue it. Perhaps what we can do is get the sense of the whole committee on each of these separately and then we could proceed if that's okay, so that the Ethics Subcommittee could continue to do its work. On the oral history, the proposal is for the endorsement of the oral history project with the possible friendly amendment that we may also include respondents whose careers began say in the 70's through the 90's to complement those respondents whose careers began in the late 40's, early 50's and continued onward to enrich that sense of how practices have evolved. DR. KATZ: One question. Of course, you know once we get into data, we assume the life of their own -- this also goes to the subject interview, but staying now with the oral histories. How challenging will these oral histories be conducted? Will be just obtain sort of the views on the way they conducted human research ten, 15, 20, 30, 40 years ago or will as part of the oral history, somebody say to them, the interviewers say to them, what possessed you Dr. So-and-so to do this research with mentally incompetent youngsters without their consent? By what authority, by what God-given authority, did you do this? Is the interview going to do that? And for our purposes, it might be very important, but we may not wish to do that. So I'm concerned about all these oral histories just I think as some of the things that you're concerned about is what are we letting ourselves in for? And how far -- and to what depths are we going to pursue for obtaining these oral histories? DR. LEDERER: Are you suggesting that we shouldn't ask the hard questions? DR. KATZ: No, I would love it. I would love it, yes, from what you know about me. But are we willing to do that? DR. LEDERER: I think we have to be willing to ask the questions. I think we certainly have to be prepared for the very real possibility that the respondents will be either unwilling or unable to answer that question. DR. KATZ: Or walk out. DR. LEDERER: Yes. And I think that it will be important for us not to approach this in an adversarial -- I mean, we're not putting them on a witness stand, although they will be witnessing, in a sense, to history. DR. KATZ: But that's an important issue, you know? To what extent will we have to be, you know, not -- will we also have to be somewhat "adversarial" in this kind of interview. And I don't mean in the -- sense, but be adversarial. DR. LEDERER: Well, perhaps this is where historians would differ in their approach from lawyers. Maybe in the hope of getting more information, maybe asking the questions differently and framing them. I mean, that's certainly not our only purpose. I guess the one proviso that I would about our interest in doing the oral history is that these respondents would be informative not only about the evolution of human subjects' practices, but about the Cold War ethos. And certainly, there would be coordination with that aspect of the discovery process because we would want to understand them in the context of how they made these decisions, but to also to ask the hard questions, but be prepared for somebody to leave the room or not to respond or to be unable to respond or unwilling to respond. CHAIRPERSON FADEN: I think it would be a mistake to adopt an adversarial stance. I think that would be inappropriate. At the same time, we're looking for an honest reflection. And part of it goes to your experience and my experience has been not overwhelming in numbers, but quite compelling in meaning in talking to people who conducted research in the 40's and 50's a great candor and searching examination of what they did then that they wouldn't do now, that they did then that they're happy about. I mean, people I think are not in all cases concerned solely with reconstructing their experiences so that it sounds good today. And you have an ear that is sympathetic to the context and the times, but allowing for people to acknowledge that what perhaps happened in the past is not something that today would be considered appropriate. DR. KATZ: No, you used the right word in the searching rather than adversarial. But then how far one searches becomes very, very important. Our reason is that the physician, what happened to be by law, was somewhat adversarial, but this instance he was searching a member of an IRB that was under investigation. And he asked the person about the Belmont report and he seemed to be getting some inadequate answers, so he pulled further, further and further. Then the doctor said, "Look, I've never worked at Belmont before. Does it have anything to do with horseracing?" So he finally got a response, you know? But it took some searching. CHAIRPERSON FADEN: Well if we take it that we conduct the oral histories in a searching fashion, and remember, these will be guided by the appropriate criteria for the conduct of all histories. We are having professional historians conduct the interviews. We are not -- I'm not going to do them. Yes, Pat? MS. KING: Whenever somebody raises a question, it always generates four or five others. CHAIRPERSON FADEN: I know. MS. KING: But I take your methodological point, but the second question is -- my understanding is that oral histories don't usually take place in the context that these will be taking place. So what did the committee decide about -- they're not going to go in some library, you know, to be opened 25, 50 years from now. This is in the context of a national publicity, etc. CHAIRPERSON FADEN: That's a good point. MS. KING: So what has the committee considered about what we are telling the people we will interview, because it seems -- you don't have to answer this, but if you've considered it -- it seems to me it goes to the question of candor, if the names are going to be released, if any of the comments that they make are going to become data from which we can extrapolate conclusions or implications. These are the kinds of questions that even the method -- forget it -- cannot answer. That's what I'm trying to say. And so I'm concerned about whether the committee has considered some of these possibilities in terms of whether this is a worthwhile effort. CHAIRPERSON FADEN: The answer is we haven't in that level of detail. The notion is that that would be the charge put to the consultants that would come in, that these are all issues clearly that would have to be worked out. Again, let me just hold that as a criterion. We would not conduct any project if the people who are the experts within that methodology tell us you can't do it validly. And if one of the reasons why it can't be done validly is the context of our being a Presidentially-appointed advisory committee as opposed to a private historian who's doing this for a project, a book that's going to come out 20 years from now, we will have to rethink it. I'm operating on the assumption that there is a way to do it validly within the context of our being an advisory committee, but if it turns out that the view from the experts that we convene is that you can't do it, people are going to be too thrown by the larger context, we would abandon the project. Nancy? DR. OLEINICK: Just one other question that was also raised by a previous question in terms of the tenor of the interview as to whether it should be more neutral or more adversarial. We've added the more recent investigators, those whose careers began in the last decade or so. They, in a sense, serve as a control group. Now if the interview is conducted in a different manner for that group than for the other group, the kinds of information that will be obtained will differ because of the atmosphere of the interview. That's another reason to again decide for a more neutral language. CHAIRPERSON FADEN: Well, presumably the methodology would be the same. You know, if we were to do this, it would be an interesting experience, but both groups reporting perhaps research in the 70's which would be kind of interesting, both groups, one starting their career in the 70's and the other kind of concluding their careers in the 70's and see whether there's any agreement about how the 70's were experienced. It will be interesting. Can I just take it? I have a feeling that the Scope people are off the hook, that we're not going to get to Scope until after lunch after all. But can I take it that -- can the subcommittee take it that the full committee has endorsed the oral history project with the understanding that if the expert oral historians tell us it cannot be done validly, we will not do it? Is that all right? We just need the authorization to then - - okay. If we go on, I want to save the patient interviews for last since it's my suspicion is that that may be where there is the least agreement. Can we go to -- Research Protocol Review is not really the right way to describe it. This would be a review of a sample of currently-funded projects in ionizing radiation and to some other area of investigation or areas of investigation involving human subjects which has not yet been stipulated, but which we can get wiseheads together and come up with some reason for picking them as a comparison group. We don't have a document detailing this, but the notion is that we would draw a sample in a genuine sense of a sample from a denominator of research currently being supported by the relevant agencies of the Federal Government, and we would create review teams that would look at the three issues of selection of subjects, consent procedures and benefits with these threshold questions that we're intending to address. This is the dipping of thermometer into the pool and being able to say something to the American public about the current characteristic of research involving human subjects in this area and a comparison area. We are now entertaining the notion that we may want to look at the subject composition for the universe, if not -- and not only the sample if that data is, in fact, automated as I understand it's supposed to be now, right? We went through this on another project where at the time we were looking at it, the data as you point out Eli, was not available. The data were not available in a way that you could look at it in a handy fashion. But presumably for 1994, current ongoing projects patient characteristics, sample subject characteristics are available in a computerized form. Nancy? DR. OLEINICK: I'll just ask the question and maybe Eli or Henry would have some insight into this as to whether -- what fraction of the patients on protocols are on protocols funded by federal agencies as opposed to pharmaceutical houses or internal funds? Are we sampling the universe by sampling the federal agencies? DR. GLATSTEIN: Well, it's very -- institution to -- I'm mean that's the only honest answer I can give you. I mean, in some places it will be an 80 to 90 percent fit and in other instances, it will be exactly the opposite. CHAIRPERSON FADEN: We have to make it very clear that we would always be looking at work funded by the federal government, work that was supported by direct companies or done by investigators without external support, we couldn't speak -- it's very important, very important. DR. OLEINICK: Because it might be rather different now. CHAIRPERSON FADEN: That's very important and we would have to very much -- DR. GLATSTEIN: If you go to the waiting room to be with the patients, the chances are less than 50/50 that any one patient is on a study. CHAIRPERSON FADEN: Right. We'll come to -- can we get the full committee's endorsement of the review -- I'm sorry, Duncan? DR. THOMAS: I was just was wondering whether the subcommittee ever considered whether there was any merit in trying to find out about protocols which either were submitted and not assigned or were refused IRB approval? CHAIRPERSON FADEN: It would be wonderful if we could figure out a way to do that. I mean, I'm happy to take it on as a challenge to the Ethics Subcommittee to see if there's anything meaningful that could be done with either of those categories. We can certainly get information about the number, the particular proposals that have raised issues at the study section at above level on ethics grounds and whether any have involved ionized radiation in recent years I'm sure, but the more searching questions -- DR. THOMAS: Every pink sheet has got a line there for human subjects' consents. CHAIRPERSON FADEN: Right, right. So that's a doable project. We can certainly add that. Are we okay then as a full committee? Phil? DR. RUSSELL: Just one question. Are we going to have any difficulty with the fact that most of the material that we've been dealing with in the 50's or 60's were a one-of-a-kind investigator-driven kinds of projects and to compare those with these broad, national protocols that have gone through months and years of review and layer on layer of evaluation is going to be kind of apples and oranges. CHAIRPERSON FADEN: I think we're hoping to say it's apples and oranges. I mean, the goal is not really just to -- DR. RUSSELL: Well, there's also a class of studies going on currently that are not radiation oncology, but in other fields where there are one-of-a-kind investigator-initiated different types of things. There are a lot more comparable in terms of procedure and regulatory issues and so forth -- CHAIRPERSON FADEN: I see. DR. RUSSELL: -- than the big, national protocols. CHAIRPERSON FADEN: We would presumably not only -- I mean, are you saying that almost all the work going on in ionizing radiation today are part of national protocols? DR. RUSSELL: In oncology, for example, there's a lot of things -- CHAIRPERSON FADEN: We would not be doing this on oncology. DR. RUSSELL: -- initial protocol would work. DR. GLATSTEIN: Well, I think we're talking about two kinds of study here. There are national studies that go through, as you say, layer upon layer of review and take literally years to get underway. But there are still individual institutional studies, and that I think is where the most attention should be paid. CHAIRPERSON FADEN: Okay. DR. GLATSTEIN: The institutional studies sponsored by federal funds. CHAIRPERSON FADEN: Well, we can certainly -- when we draw this sample, we can draw -- I'm looking at Duncan because whenever the word "sample" comes up, certain people get implicated. But we can think about how to draw the sample and we can do a stratified -- I mean, these are all -- like in any other research project, there will be 100,000 decisions that will have to be made from now on once we get the endorsement of the full committee to go forward, and we may create -- hate to raise the specter of yet another committee, but we may create different groupings of committee members to attack different parts of this project because we obviously need different expertise than the expertise that is on the Ethics Subcommittee to do this part of the project correctly. So we will clearly be reconfiguring people around this project. But can I call the committee on the question of whether we should proceed? Does the Ethics Subcommittee have the endorsement of the full committee for this review of contemporary proposals? Thank you. That leaves us with the patient interview part of the project, part of the proposal, excuse me. Pat? MS. KING: Well, I'm quite comfortable in trying to do some qualitative research. As a person who's comfortable with that approach, it's very important that it be done well however because the field already has a bad name, and I don't want to contribute -- in some quarters, I don't want to contribute to -- on those grounds some of the sufferings. So I actually like the idea of doing qualitative research. I want to be comforted that it will be done well. I would also say that if it cannot be done, because that may be some of the judgements of the experts given the outline here, it can't be done well, to ask the committee to think about something that maybe we wouldn't dignify with the term "research". I was struck by the fact that in the Massachusetts report, the narratives of the subject had a power all of their own. Nobody called them research. Nobody said, you know, you have to be able to extrapolate findings, etc. So I'm interested in two things: whether we could really do it in terms of qualitative research, and if we couldn't do it, is there some way to incorporate in our own work what I call narrative? In fact, I rather suspect that it might be more interesting. We might find out how patients/subjects really feel about how they're being treated as patients/subjects in their understanding if we were less focused on our study instruments; if they could sort of just explain things in their own terms and ways and just let it come out. So I want to make a plea for both, that if we get to the point where we just can't justify it as research, that we not abandon totally the idea of getting the perspective of the patient because I think it's important. CHAIRPERSON FADEN: The Outreach Committee has a particular -- has taken that in part on as a charge, and part of what the Outreach Committee will be telling us, as I understand, includes a discussion of continuing efforts to encourage people who want to talk to the committee in one fashion or another to do so. This is a sort of central part of our outreach. What you're suggesting goes beyond that to something more systematic and -- MS. KING: I suspect -- now maybe I'm wrong because I thought the Outreach Committee would be talking to people or encouraging people to talk who considered themselves subjects in the past or have something to say about the past. CHAIRPERSON FADEN: We want the present too. MS. KING: I really think that it's as equally valuable to get the perspective of subjects, patients/subjects today, and it may not be possible to do it in any really good research fashion. And I just make a strong plea that if that's not possible, that we ought not end the discussion of can we get something I think that might relate to what we're getting about the past. CHAIRPERSON FADEN: Henry? DR. ROYAL: I'd like to have some help about the ethics of the patient interview. One of the reasons why some of the experiments that we're looking into have been criticized is that there's been no benefit to patients and that there's possible harm. Could someone make the same argument about the patient interviews? What exactly is the benefit to the patient and are there some potential harms of the interview process? CHAIRPERSON FADEN: I think that's a relevant question. The Ethics Subcommittee was very driving on this point at our last call. We have to make sure that any study that we conduct, all of us obviously, but clearly this committee, must be very mindful that any study that we conduct is conducted only in the most ethically-acceptable fashion. I've done some work of this sort myself, not as much as others, but I have done some. And I think it's clearly inappropriate to claim that there's any potential for benefit to the people who take the time to talk to you. It is the case that some people enjoy this kind of an interview. They like having somebody listen to them and they like being valued, having their opinions and experiences validated and being paid attention to. So there's a sense in which many people enjoy this kind of interview. You can call it a benefit if you want, but I'm quite comfortable saying this is a study. What we would propose would offer no prospect of benefit or certainly no prospect of significant benefit except the possibility that some people would enjoy the hour, would feel valued and perhaps feel as if they're making a contribution. I also think though that we could argue that there is no risk. We would not be -- it would be hard to conceive of a way in which we would putting people who would be talking to us at any risk if we follow the confidentiality procedures that we have envisioned following correctly. We would certainly insulate the person's responses from the people providing care to them at their institution so that they could feel free to share with us whatever thoughts they had about their experience without fear that that information would be available to the people who are providing care to them and might -- to their disadvantage, even unconsciously, in the future. So we would obviously have to take great care to insulate the people who would be taking the time to talk to us from any prospect that anything that they would share with us could then be used against them in some fashion in the context in which they're receiving their medical care. But there are pretty good procedures in place for being able to insulate data in that context. I think we can be okay there. So you basically I think can argue that this isn't so much -- there's no benefit, but there's no real risk of harm either. There's no harm that has to be offset or risk of harm. I may be wrong. Jay? DR. KATZ: But if, for the first time in these interviews, we were to find out that there were -- CHAIRPERSON FADEN: We won't know. We won't know. In other words, when we conduct the interview -- here's an area where I do feel confident. I don't think that I would have the time to do it, but these are the sorts of interviews that I can do. I would not know if that person was a research subject or not when I'm interviewing. Our interviewers wouldn't know the status of that person while we're discussing it with them. We would ask them about -- you have a very detailed interview guide which makes sure you cover the topics that you cover. But the interviewer isn't there knowing that the person is a research subject and trying to see, did you get it right? You're basically having a conversation with them about when their care started and have they ever been asked to be in a research project and what they decided and are they in any now and how did it go, and things of that sort. We would later establish whether, in fact, their understanding of their medical care, how much of it is standard care, how much of it is on protocol, is accurate. But we would not then use it. We would then, as researchers, not go back and say you're wrong. You're actually not on a protocol that you thought you were on. So there would be no way in the context of that interview that we could correct that person's understanding of their experience. It would not be that type of interview. It would be the kind of thing Pat is talking about, basically letting the people that we interview tell us about their experiences in receiving care in an institution and in a setting in which a high volume of research funded by the federal government is being conducted. Nancy, did you -- or Lois, I'm sorry. MS. NORRIS: Just a brief question. Do you anticipate offering the same shield of confidentiality to the institutions who agree to cooperate as well as to the researchers or physicians who might be -- CHAIRPERSON FADEN: We would offer the following, and Lois, I have to apologize. One of these things I hate about this table is I can't -- that's why we're going to correct it. I can't see Lois or Jay without sort of making Dan and Anna go like this. What we can offer to the institutions is that the data all are reported in the aggregate for all the institutions. We would say that the institutions were Institutions A, B, C, D and E. But we would report the data in the aggregate so if everybody looks good, everybody looks good. If everybody looks bad, everybody looks bad. Or 50 percent look good and -- we wouldn't do it by institution. We would do it sort of overall. The institutions will have to know that there is no way that you could write this up without naming the institutions in which the interviews were conducted. We also don't need to identify the protocols that the subjects were on. That's really not of interest. But we would distinguish between ionizing radiation and medical oncology if, indeed, there are any differences. I mean if it turns out that because of the extra layer of review in ionizing radiation protocols that is evidenced in what the patients are hearing or saying, that would be reported. You couldn't not name the institutions in which the interviews were conducted. Henry? DR. ROYAL: When I read the narratives from Fernald, it seemed like the narratives were more about what it was like to be institutionalized than it was to participate in a radiation experiment. So one of our concerns about patient interviews is whether or not it's going to have to do with participating in an experiment or whether it's going to have to do with what do you think of our health care system? What's it like to be in a hospital? Are people nice to you? CHAIRPERSON FADEN: Body of care? DR. ROYAL: Yes. I mean, it really -- well, as I said, the Fernald narrative in this interview has the potential not to focus on what it is the committee should be focusing on. The second thing is we, all investigators, tend to underestimate the harms of what they're doing. I was struck when I read the Fernald narratives that one of the individuals, it was sort of part of his hidden past that he had been in the school and that all became public knowledge. CHAIRPERSON FADEN: Yes, it's quite compelling. DR. ROYAL: And there's clearly a lot of anxiety that has been brought about by the Fernald investigation and we need to be careful to avoid doing that same sort of thing. CHAIRPERSON FADEN: Well, your points are well-taken. On the first, that would be a function of how you structure the interview guide. I mean, clearly we are not doing a quality of care study or a study that's generally addressed at how people are proceeding, the extent to which they're being treated respectfully by the medical community. We would be focusing on their sense to which they see themselves involved in research. And if they say they're not, we would then continue with them in a discussion of how would you feel about it and what would you think about it and things of that sort? On the issue of whether, indeed, there are some potential opportunities for harm that I've glossed over, you're right. You know, it's a mistake to say that there's no conceivable way in which someone might come away from an interview like this feeling bad, for example. There's a higher likelihood in my experience that they would come away feeling good, but they could come away feeling disturbed as a result of the process of being asked to reflect about when they were asked -- you know, now that I think about it, I really didn't get a chance to talk to my family members before I said yes and you could stir up feelings of retrospective anxiety, guilt, whatever. So you're right, that could happen. MS. KING: I can't help but take note of Henry's concerns, but with one caveat. And that is, often we learn a great deal if we learn about the context in which patients exist. For example, prisoners often consent, not because we take them through all these informed consent processes, but because they're bored, which tells us a great deal. But we can only find that out by spending time, I think, talking to them about how boring their existence is. And one of the things that was so powerful about -- that is, that you could see how both parents and members of the school might react to being treated in what they thought was a respectful way given the conditions that existed. It cuts both ways. CHAIRPERSON FADEN: It does cut both ways and the -- constructed and interviewed that allows you to understand the experience and the context in which the experience is being lived. So you wouldn't go immediately to "Tell me, are you a research subject?". You'd have to start with, "Tell me something about how long you've been ill and what brings you here? And how you go to Osh Kosh Tertiary Medical Care Facility? And most of that data, that becomes not data that we report, but data that is useful in understanding what we then hear later, and also to get the person comfortable to start talking. You have to begin a process. It's a dialogue and trust has to be established to get the information that's valid. We're going to need to call it quickly, but Eli and Duncan, I think -- DR. GLATSTEIN: Well, I just want to ask you how many research subjects do you expect to interview? CHAIRPERSON FADEN: The fantasy is that we would have 200 patients interviewed. DR. GLATSTEIN: How many research subjects? CHAIRPERSON FADEN: Well, my guess would be that half of them might be research subjects. DR. GLATSTEIN: I think you're overestimating by a factor of ten. I think you're talking about -- if you just take people at random in the waiting room, the chance of hitting a research subject in a busy institution that does a lot of research is probably in the neighborhood of five percent. Now if you're prepared to deal with that number -- CHAIRPERSON FADEN: Well, that's certainly worth checking out, Eli. I mean, that's not my intuition, but you're more experienced than I am. So we need to go back and take a look at that. It's certainly of interest to me to talk to people who are not research subjects to see if they rightly understand that they're not research subjects. So I certainly don't think it's a loss. DR. GLATSTEIN: But I have a problem with -- CHAIRPERSON FADEN: But you're right, you must have a certain -- DR. GLATSTEIN: -- just a quantitative issue as far as I'm concerned. Are you going to get the kind of yield that you're expecting? I think you're going to have a problem. CHAIRPERSON FADEN: Well what we can do is we can pursue that one and we can establish with the centers that we would be -- see whose cooperation we were seeking, indeed what proportion of their out-patients in radiology/oncology are on protocol. And if it turns out that it's two percent five percent or eight percent, that would be problematic. It would be devastating. In fact, there would be no point in proceeding. I think it's fine if half the people, in fact, are off protocol because it would be interesting to talk to them to see if they thing just because they're Osh Kosh famous tertiary medical care facility that they must be on protocol. But you're right. It would not do it all if they only talked to ten people who are actually on protocol. That would be no good. DR. GLATSTEIN: Well, the only institution in the country that would have a high proportion of research patients is the NCI because they fill about 80 or 90 percent, but nobody else does because people are sent there specifically for research. CHAIRPERSON FADEN: Yes, yes. Well let's do this. It sounds as if we need to do more homework on this particular one. So if I'm going to take it that we've already approved the oral histories, providing the experts tell us that the oral histories can be done validly; we have approved the review of the current proposals. Those are major steps forward. That gives the Ethics Subcommittee and the staff working on those topics lots to do. We will investigate further the kind of issue that Eli has raised and all the other technical and not-so-technical questions with respect to the patient interviews, and revisit that at the end of the -- at our second July meeting, and we reach closure then. We can't hang on beyond that and actually have a prayer of doing it. So if that's all right with the committee, we'll revisit that one and decide for sure in our second July meeting we're going to try to try to make it happen or we're going to bag it. Is that all right? With that, we can stop for lunch. The Scope Committee then can come in after lunch and we will rearrange -- we will now furiously try to rearrange the agenda so that we can get three subcommittee reports in after lunch. (Whereupon, the proceedings went off the record for a lunch break at 12:35 p.m. and resumed at 1:47 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1:47 P.M. CHAIRPERSON FADEN: I think we have almost everyone. Reed is still not here. Ken is in the hallway. Come, Ken. Okay. We're going to start. We're going to try to get -- we're going to redo it. All right, we have a realigned agenda which Anna and I worked at on at the end of the session which is gone. So we have to reconstruct it. But the room is rearranged nicely. I think this is, from my point of view, much better. Isn't this better? This makes you feel more connected. Pardon? DR. OLEINICK: Is there more significance for the -- CHAIRPERSON FADEN: I don't know. All right. We are going to rearrange the agenda a bit to try to get three subcommittee reports in this afternoon. The time devoted to my walking us through the draft outline, which is for your consideration, will be shortened. We are going to revisit it tomorrow, so it is basically I'm going to walk you through the document in a much shorter compass of time. You can go home, go to your hotel rooms, and look at it some more. And then we have about an hour and half tomorrow to really debate it and work with it, so I think that should be all right. We're going to try to get the three subcommittees in in the following order: Scope, Cold War and Outreach. We still haven't figured out where Reed is, but we're trying. So we have a fall-back position I think if Reed is not here as to who will present the report on the Outreach Committee. But if I could just turn to Duncan and if you could start the report on the Scope Committee, that would be great. DR. THOMAS: The subcommittee met three times since our last meeting, once face to face at the last meeting in collaboration with the Cold War committee, and then again in collaboration with the Cold War Committee, we had a second telephone conversation. And then the Scope Committee met by itself by telephone conference last week. While we were talking with the Cold War Subcommittee, the focus of our discussion was on the medical experiments and so Mary Ann and I have worked out that she would describe our joint thinking on the medical experiments when she gets her turn. So I'm going to try to be brief here and just simply talk, focus my remarks on the intentional releases. First of all, most of our discussion has been focused on trying to draw the limits as to what we should consider and what we would not consider. In the process, it might have gotten lost in the shuffle that there is a list of things that we're supposed to talk about as inter-related in the executive order. And we wanted to reinforce that that's, in fact, our first priority and staff is encouraged to go ahead and continue to explore Green Run and all of the other examples that are listed there. Nevertheless, as an immediate priority, we thought that it was worth pushing ahead with further documentation on some of these things that we're calling borderline incidents in order to help us get an early reading as to what our priorities should be for the extent to which we wish to pursue each of these. We have at least a working definition of what we mean by an experiment and why don't I read it to you? "An environmental release should be designated as 'experimental' if it was done for the primary purpose of testing human health effects or the extent of human exposures." And that's wording that's taken pretty much right out of the executive order with the exception of the insertion of the "primary". And whether we want to continue to keep that word "primary purpose" in there as part of our definition of an experimental release is something that we might wish to discuss some more. I suggest the use of a different word and I'd suggest we call it a study. The observation of human health effects potentially resulting from environmental exposures. These exposures might be further subdivided into intentional or accidental or even natural. These are terms which await further, more vigorous definition, but I think we have a pretty clear idea in our heads as to what we mean by them. And I think I speak for the subcommittee when I say that the extent to which we consider some studies at all, we might limit consideration to just that subgroup of intentional exposures, setting aside the accidental or natural exposures. But that too is a point that I think we should continue to debate. Now that then leads us to the question of criteria for prioritizing the various options. In our last discussion, Ken came up with four criteria which are particularly important. First of all, was it experimental? Are there likely to have been medical consequences? Were there "bad government activities" and do issues of liability arise from them? And do there remain unanswered questions? Of course, foremost in our minds with regard to the last ones are secrecy aspects and there's a general consensus that we really do need to focus on the secrecy aspects of these things. Let me just add a couple of additional points from another list which I compiled. There's some overlap here: the level of risk, that's implicit in Ken's second criteria. Were there further secret aspects, the story remained to be told? What information was provided to the subjects at the time, especially whether intentionally misleading information was provided, but also whether the information was subsequently proved to be wrong. That is in light of what we now know of radiation risks. The extent to which the purpose of the exposure was to study adverse health effects, that's touched on in our definition. Were there potentially beneficial treatments or exposure remediation was denied? And these issues come up in any number of circumstances. And finally, whether the subjects had the option to refuse to participate in either the exposure or in the subsequent medical follow-up. So those are some of the issues which we think we need to think about in the context of each one of these instances. Now we still have some trepidation about passing judgement on each of these borderline cases at this preliminary stage of our deliberations. In particular we feel like we would really like to hear more from the various groups that are directly affected, who are intensely asking us questions like "is our situation going to be included or not?" So there is some temptation simply not to give any clue at this point as to what we're thinking, but I think for the purpose of moving the debate along, it would probably be useful to give some indications as to the general line of our thinking on each of the borderline cases that we've discussed in the past. Let me make clear at this point that the purpose is not to make an absolute in or out recommendation. It's, I think, our view to some extent, everything is in, but that there will be distinctions made in terms of the depth to which we decide to pursue things. But each of the examples, which I'm going to go through in a moment, are all part of the Cold War story and need to be told to some extent, whether we actually go into the details of them or not. I say this because the staff has received numerable requests from various organizations saying are you going to consider our particular circumstance? And I think we'd like to be able to tell them that yes, to at least some extent we are going to be thinking about your issues and we would like to hear from you. For that disclaimer, let me read through a brief list of items that we have been talking about and give you some of our preliminary thoughts about them. Let me begin with the Marshall Islanders. I understand we're going to be hearing from a delegation of them later this afternoon. CHAIRPERSON FADEN: That's correct. DR. THOMAS: So the purpose is, of course, not to prejudge whatever it is they may say to us. I think there's abundant evidence that Marshall Islanders were exposed to some substantial doses of fall-out, and there's some well-documented evidence of the facts. The crux of the issue that we need to think about is whether this constituted an experiment in any sense of the word. They were probably not adequately informed about the risks at the time. There is a possibility that they may have been deliberately misinformed, although I have yet to see the documentation of that claim. And I don't know what kinds of options they might have had to refuse. So the crux of the question regarding the Marshall Islanders is to whether or not there was an experimental purpose and their relocation back into a contaminated homelands. And I think the Marshall Islanders themselves may be one of the best leads in terms of whatever documentary evidence they've uncovered in the latest boxes of material that was just released by DOE. The Atomic Veterans are the next group of concern. Here there seems to me to be a division between two types of exposures. There is the clean-up activities of contaminated ships, for example, at the Bikini Atolls and elsewhere, where there was considerable concern about the radiation safety activity of it and of this activity. And in my view, this represents an occupational hazard, but not anything that has -- in any sense that I can see, a clear, experimental purpose involved. Then there are other activities where it was felt that it's important to understand something or other about the performance of soldiers on a nuclear battlefield where it's very difficult for me to see how this can be construed as anything other than experimental in nature. Now in this regard, we have recently uncovered a document which has now been circulated, I believe, to all of the committee members. And it's worth just saying a few words about this document, and I think there will probably be more extensive discussion on this tomorrow when we have the briefing on the document retrieval process from DOD. This document consists of a series of minutes and background documents from the working group on military requirements for observation of human volunteers. Let me take you through this document and highlight a few things that you ought to be looking at and thinking about. Mine looks a little bit thicker than what other propel are referring to, so I may have a few things that not all the committee has. The first document that I have is the Joint Panel on Medical Aspects of Atomic Warfare, dated February 15, 1950, the report of a working group on military requirements for observation of human volunteers. Eli, do you have that? Is that the same thing? Okay. Probably the thing to do is flip down to page four of this document. CHAIRPERSON FADEN: Duncan, there is a bit of a problem because you do have a thicker document. MR. GUTTMAN: The committee has the agenda eight meeting with the except. Duncan, I've given as the scopechairman -- we got these documents last Friday -- the surrounding context so he could make sense. So you all, when you get to the eighth meeting agenda, that's when you can have the same documentation Duncan has. DR. THOMAS: Okay. Well I think nevertheless, I'm going to read just two short excerpts from this first document the rest of you haven't yet received which helped put into context what now appears to be a really rather extensive debate as to whether or not the military should be undertaking some program of experimentation on humans. Rather than try to organize these comments in any logical sequence, I'm simply going to go through them in the order in which I have them here. The first quote is as follows: "Many individuals feel that we have sufficient data on humans to give these answers." This was preceded by an extensive discussion as to what the various questions were that were of military importance. "Others feel that they do not", do not have adequate information, "and therefore, some human experimentation should be done on military volunteers to whom the effects of ionizing radiation have been explained in detail." A little further down the page it says, "The Advisory Panel then had a long discussion of the problem of human experimentation, and it was the consensus of this group that human experimentation was probably not the answer at this time due to the fact that in order to obtain significant results, several thousand people would have to be exposed to ionizing radiation." "Dr. Shields Warren expressed his opinion that sufficient data was already at hand." Well this begins to give you a little bit of the sense of the discussion, that there really was quite compelling need to answer a number of important questions about how soldiers would perform on a nuclear battlefield, and other questions relating to defense aspects of how we should protect ourselves in the event of a nuclear attack. And the Army had a real dilemma on their hands as to how they could get this information in any other means other than by human experimentation. I'm flipping down now to the agenda for the eighth meeting of this Joint Panel on the Medical Aspects of Atomic Warfare. And is this something -- CHAIRPERSON FADEN: This is the document everybody should have, Duncan. DR. THOMAS: Okay. Let me read just into the record the second paragraph of item one on the front page of this document. "It is therefore requested that the Joint Panel on Medical Aspects of Atomic Warfare be requested to submit for approval jointly by the Committee on Medical Sciences and Committee on Atomic Energy a statement of the medical and enviro- medical information they consider essential for the Department of Defense to obtain through participation in atomic weapons tests conducted in the future without regard to a specific type or location of a test." So what this is saying is at this point, we have not yet undertaken any human experimentation. We were asking this panel to put together a research program. And a little further down in the document, we begin to get some more details as to what this program might consist of. I direct your attention down to page five. Now there's really quite a lot of things that are outlined in this shopping list of thing of potential interest. I've just highlighted a few of these which sound to me like it would be difficult to get this information in any other way than by human experimentation. Item nine: "Internal contamination of survivors of a contaminating burst." Item 11: "Effects of exposure to the eye in an atomic flash." Item 16: "Measurements of the concentration of radioactive particles within pressurized aircraft." Item 21: "Studies of the inhalation and ingestion of radioactive materials in a fall-out cell." Item 22: "The retention of inhaled radioactive materials." Item 24: "Measurement of radioactive isotopes in the body fluids of atomic weapons test personnel." Item 29: "Psychophysiological changes after exposure to nuclear explosions." So here we have laid out something of a shopping list of experiments that were considered by this panel as providing information that the military needed to have. What we don't have here is any evidence yet that any of these studies were undertaken. But scattered throughout here, and I think Dan might want to comment some more if not now, tomorrow. The -- leads to further documentation that must have resulted from the deliberations of this panel and I think it gives us some leads now to pursue this story a little bit further and find out whether or not the military did, in fact, carry out human experiments for military purposes. CHAIRPERSON FADEN: Jay, did you want to -- DR. KATZ: Can I just add something to this? DR. THOMAS: Yes. DR. KATZ: It's wonderful of you because it struck me in reading it a few minutes ago that it says on page two towards the end, "Any such detonation should be the occasion of a carefully-planned bio-medical program. To be methodologically discouraged, however, is the type of thinking that leads to the inclusion of animals at the test merely because they are test -- to which to please the" -- and then it goes on about animals. It doesn't say the same things about human beings, and in the sense saying, look, you'd better be careful with human beings also, and not just include them. At least, I didn't say anything of the document that specifically refers to human beings. It did so with respect to animals. DR. THOMAS: Yes, I would agree with that. It's clear there was a lively debate about these issues at the time. CHAIRPERSON FADEN: Henry wanted to get in, Duncan. I have a better angle of vision than you do. DR. ROYAL: There's a handwritten note on all the pages. Is this when it was declassified, June 23, '94? When was this document declassified? MR. GUTTMAN: I can't tell for sure. This is one that we -- if I can give the context of this for two seconds. Duncan did an excellent job of overview. Jim David, our staff person, about several weeks ago had noted there was this joint panel of the Defense Department which was created in 1949. Your briefing books, in Tab O, has the charter for the panel. After Jim discovered it, we asked the Defense Department to go get us as much as they could of further documentation, and we received that from the Defense Department last week. And June 23rd is, I guess, when they pulled it out of the archives, not necessarily when it was declassified. It's not clear when it was declassified. DR. RUSSELL: It was declassified. The declassified stamp is dated 23 June. MR. GUTTMAN: I'm not an expert and Jim's not here, but he can tell you -- I've gone through this with Jim before. The dates here are not necessarily -- what the Archives do when they give it out -- I mean, there's a technical Archive -- here. If I can -- can I make just a couple of other comments that I think may provide context? One, of course we're looking at fragments of the story that may or may not have been buried for a long period. The first point Duncan referred to in the documents which he has, and you all of course can get copies of, is a contextual debate about whether or not there should be human experimentation. And what's odd is that it seems while that debate is ongoing, simultaneously there is some level of experimentation. So that for example, there are certain things that we know to be experiments of the human nature, like Medical College of Virginia, whether it was bad or good or radiation or not, appears to be a human experiment that was ongoing. And we see a similar pattern in the case of the AEC where there's this constant debate about whether or not it should be done, but at some level it's going on. The second point is to where this document lies. As I said, Jim discovered that there was this panel. And of course, we've asked for everything related to it and DOD was very good in giving us at least the beginning, the fragmentary meeting minutes and so forth. After this eighth meeting, which you all have, the only other documentation we have is a tenth and 11th meeting where it appears that, in fact, there were discussions of the biomedical plans for particular tests. In addition, there were further items on human experimentation on the agenda. We don't have the substance of those discussions. We suspect that by the time it got to the 11th meeting in 1953, there was a reorganization of DOD, the Defense Department, so that this became a different group. And of course, we're interested in it. But the long and the short of it is the present trail is that it looks like it in some form. Of course they went ahead with biomedical research related to atomic testing. The question is what, if anything, did it have to do with human beings. That is a question. CHAIRPERSON FADEN: Thank you, Dan. Duncan, do you want to continue? DR. THOMAS: Yes, I just want to say one more thing about the veterans before moving on to the other groups. One of the issues which we'll have to address is whether or not the fact of any of the veterans were indeed harmed by their exposures. As I suspect most of you are probably aware, there have been a series of studies of the health of the atomic veterans and these studies have come in for some criticism. We heard that message from Pat Broudy at the last public comment period. Without wanting to prejudge this issue, there's one news item which I wanted to alert this committee to, that there is, at the moment, a National Academy committee which is reviewing these studies, and they're expecting to have a report out in the matter of a few weeks or perhaps a few months. So I think we can do nothing more than simply wait to see what they come up with. CHAIRPERSON FADEN: Henry, did you want to make a comment? I'm sorry, Duncan go right ahead. No, it's fine. DR. THOMAS: Okay. Well, let me move on then to the next group, which we've had some discussion about which are the uranium miners. Now in my view, the uranium miners represent a very sad chapter in the history of public health. These miners were exposed to enormous levels of radon and they have suffered a terrible burden in terms of their lung cancer incidence. The latest estimates that there's probably something like about 250 preventable deaths that occurred in this group. I'm going to have some more to say about this at some later point when I give the briefing on radiation risks. The question that we have to address now is whether there's any experimental purpose involved. I, for one, find it very difficult to see an experimental purpose, but Jay has raised concerns that whether experimental or not, that there are serious ethical issues in terms of the behavior of the U.S. Public Health Service in addressing these concerns. This is, I think, a deep and important ethical issue which we need to talk about as a committee and I suggest we make it an agenda item for one of our future meetings and pursue this to some level. Anyway, that's my take on it at the moment. There is not a clear experimental purpose. It's hard for us to see how this is part of our mandate as described in our charter. There are, nevertheless -- it's an important of the Cold War story. There are some interesting ethical issues to be debated. I should also mention at this point a potential conflict of interest in that I have been, myself, involved in some re-analysis of the data from the miner data, from the miner study, and I think you've now circulated to the panel one of my publications on that subject. And I'll just let you people read it and judge for yourself and I'd be happy to defer to what the committee decides about whether I have a serious conflict. The next group is the down-winders. Again, I need to announce a conflict of interest. In this case, I think it's a more substantial one inasmuch as I was one of the senior investigators of people down wind of the Nevada test site. And again, two of my publications on this subject have been circulated to the committee which you can decide upon. Here's one where I think I probably should step back and let someone else carry the ball. And I'm giving now the committee the entre into this literature and you can pursue it yourself. Many of the same questions arise. It's hard again to see an experimental purpose in the down-winders. There were, nevertheless, ethical concerns about the quality of the information that was provided to the population, indeed actual, conscious misrepresentations of the truth. And the main thing which I think this committee might want to address is the extent to which the Radiation Exposure Compensation Act both for the down-winders as well as the uranium miners and the atomic veterans has been effective in providing a reasonable response to these issues. Then finally, there's a number of groups which I think we don't want to consider, but I should mention for the record. Worker studies of the DOE facilities, of DOE workers, to me, this is just clearly occupational hygiene and there's no real experimental purpose involved. It seems to me we should set them aside, and I don't think there's been anyone who has seriously proposed that we ought to consider the workers. The one exception here is we have every now and then stumbled upon examples where laboratory workers were involved as study subjects and were asked to drink or be injected with various radionuclides. And it's these instances -- I think we simply handled them along with all of the other medical experiments, so we don't need to make a particular distinction. There are, of course, some slightly different ethical concerns that arise in the use of workers as study subjects. In particular, some ones which I recently stumbled upon relating to the children of the workers being involved as study subjects. This is something that I think we'll probably want to comment on. Routine releases from DOE facilities is another one where, with the exception of intentional releases like Green Run, it's hard to see any experimental purpose. We need to say something rather about them to help put into context the intentional releases to say, for example, that the releases from Green Run as one example would be just a very small portion of the overall releases from Hanford for which there might indeed have been some demonstrable health effects. And there is a major study underway now to address just that question. So I think that wraps it up. CHAIRPERSON FADEN: The floor is open for discussion on questions to the Scope Committee, members of the Scope Committee, subcommittee. Ken? MR. FEINBERG: Let me start off by concurring in what Duncan has said as a member of the subcommittee. I think that it is a mistake if we draw too many crystallized conclusions yet, as Duncan points out, as to what is in and out of the report. The way I would evaluate the next few months for the committee based on the subcommittee's report, it would be first we have looked at various aids to assist us in getting the facts, even on some that would appear to be outside the scope as being clearly non-experimental. The subcommittee has talked to the staff about taking advantage of reams of Congressional testimony and outside historian research and other short-cut aids to try and see whether there is a certain sort of jurisdictional prerequisite that can be met that somehow certain activities would fall within the mandate of this committee's charter. So I do think that Duncan is absolutely right when he recommends on behalf of the entire subcommittee that we not write off anybody yet. And if anybody believes that they fall within the scope of our charter, we should hear what they have to say before making any final decision. That's sort of a methodological point. Put another way, there are some activities that clearly fall within our charter, some that may fall within our charter, and some that apparently don't fall within our charter, but we haven't drawn any conclusions yet. The second thing I would say is that insofar as we tell in our report the whole picture, even if there may be activities that are tangential or even outside the mandate of the committee's charter, it may be in telling the whole story that reference to certain activities is perfectly appropriate. Without getting into any great detail or getting to the bottom line, it may be that a full and fair and accurate picture, it may be worthwhile to make reference to certain activities that may not be part of our charter and may not be within our scope, but are part of the story. That gets to the next point, which to me is in terms of drafting or recommending any remedies, again it's premature to talk about how we will articulate those remedies, how much detail we will want to get into, whether that falls beyond the scope of our charter even as to known experiments. How much in the way -- are we talking in the remedy area in terms of guidelines, recommendations for generic remedies or are we talking about "X" should get "Y" dollars, or "Z" should get "T" dollars or whatever? I think it's premature, but the reason I lay out this point, picking up on Duncan's point, just as it may be possible a) for us not to exclude anybody yet pending more discovery, and b) just as it may be possible in telling the whole story to make reference to certain events that may be outside of our charter, but can referred to, so too depending on what our recommendations look like, it may be a relatively simple task to say, for example, that generically if we are recommending that a certain process be established to assure ethical peer review in the future, if we are recommending that compensation not be discussed, by guidelines for compensation or for remedies being established for certain experiments, it may be that similar guidelines, the same guidelines, can apply to any number of government activities assuming that the guidelines themselves have been met. So I guess the way I come out on this, and it's premature, but the way I lean at the present time, I think is consistent with what Duncan is saying, and consistent with what Henry and the rest of the subcommittee was thinking, Jay and others, it is that a) it is premature to draw any conclusions yet; b) certain government activities are more clearly within our mandate, the charter, than others; but that c) we have to discover what there is using various methodological mechanisms that are out there: Congressional testimony on the Marshall Islanders, there's a library full of materials there, for example; uranium miners, the same; atomic veterans, the same. And then decide in the next few months, are there any of these government activities that are clearly out for all purposes? Are there some clearly in for all purposes? And is there this gray area where, well, it's a stretch? But in terms of prospective remedy and prospective recommendation, we might as well include them because there's no good reason not to include them in terms of generic or guidelines-types of recommendations concerning remedies. Final point, I am concerned about the danger of making what we think are reasonable distinctions as to certain activities being included and some being excluded that will be perceived by some to be invidious discrimination and divisive. And I'm not sure that's necessary. I don't know yet. It all depends, I think, on what the facts demonstrate and how we decide as a stylistic matter to fashion the remedies or the prospective recommendations because that may help us avoid a perception that we're being unfair. So I think that's just -- I'm just trying to build on what Duncan says in the way of going step by step by step, shutting the door on nobody raising concerns which we will address in time I think. CHAIRPERSON FADEN: Henry? DR. ROYAL: I feel reasonably comfortable about the work of the Scope Committee in terms of defining the scope of what this committee is supposed to be doing, the Scope Subcommittee, because I think it's impossible if you're going to tell the Cold War story, for example, not to be pretty much all- inclusive. What troubles me is the priorities part of the scope. It seems to me that we're gathering a lot of information and we're not thinking about how we're going to use that information. For example, let's take informed consent. What are the rules going to be about informed consent? Are investigators going to be innocent until proven guilty or is the lack of finding a piece of paper that has written informed consent going to be an indication that informed consent was not obtained? And on the other hand, if we find a piece of paper, are we going to assume that adequate, informed consent was obtained? It seems to me there are a lot of issues related to informed consent, these in and out criteria in the remedies that are going to take an awful lot of work to agree upon. And we haven't given that task the priority that I think it should get. Maybe we haven't given it the priority because intrinsically we realize how difficult it's going to be. But it's not going to get any easier by putting it off. CHAIRPERSON FADEN: Are you suggesting that we specifically ask the Scope Subcommittee to take that issues on, those sets of issues on, under the heading of "Priorities" which you already have as part of your territory? DR. ROYAL: Yes. It's not clear to me that the people who are on the Scope Subcommittee are necessarily the best people to decide about each of those issues, but I think they're important issues to address. CHAIRPERSON FADEN: As a practical matter, let me suggest that it would be very helpful if you could articulate in some specifics the questions you've just described. We can take them back and reapportion in terms of thinking about who should be doing some preliminary cuts on those questions. The only way that work is going to get done, I think, is if we identify it, flag it, and make it somebody's responsibility. So it would be very helpful, Henry. DR. KATZ: Ruth, I can't be very articulate about it as yet. I will refer to it from maybe a different perspective, a little bit more articulately tomorrow. But it all depends on what questions we're going to ask with respect to what Ken said and also what Henry just said. It seems to me there's an overall question that goes beyond informed consent, is here we do know that people were misused, people were deceived, people were used by others in all kinds of ways. And how was this possible in a democratic society that really aspires to certain values of self-determination, autonomy, relative openness? How did these people get the authority and how did they assume the authority in doing what they were doing? I think that is very inarticulately put at the moment a question we have to ask ourselves and to wrestle with a bit. And primarily for the purpose, what can we ultimately recommend that these kinds of things will not happen in the way in which they happened in the 40's, 50's and 60's? There probably will be in the future secret experiments. There probably will be studies of course of "national emergencies" that we had in the 40's, 50's and 60's, but who should authorize them? Because as I read these documents, many of these things just happen in thoughtless fashion, without really thinking through what the issues were to the extent to which it was possible to think them through. And this is, I hope, will be one of the contributions that we can make to the future. CHAIRPERSON FADEN: We've got Pat and Ken on that subject, or others. MS. KING: Well, if Jay pleads the fear of being articulate, I can do the same thing. DR. ROYAL: Do it in the microphone. (Laughter) CHAIRPERSON FADEN: -- and articulate in a respect. MS. KING: When I was listening to the report of the subcommittee, the phrase that gave me trouble -- there's some other things, but other people have spoken to them. I won't repeat them. The phrase that gave me trouble was "experimental purpose". And the reason that the phrase "experimental purpose" gave me trouble is because it gets to answering things when the questions should still be open. Let me see if I can articulate that. When the National Commission whom -- because it understood that it was making recommendations that might be federal recommendations, debated what should be considered research, we adopted a formulation that I understood, and I think those of us that worked on it understood, but it wasn't a formulation that worked for every purpose, every conceivable purpose. It worked for a very narrow purpose of regulation. At that time, the debate was if you were Patient Subject A and you were over at Hospital A and you are Subject B and you're in Hospital B, did it matter to you as subjects whether the person who manipulated your body did so after having a written protocol that told what the method was going to be and what hypothesis it was with the hope that it would generalize knowledge, and over in Hospital B, you had somebody that said, "Gee, it would be a good idea to see how this subject would react if I did exactly the same intervention"? Now the National Commission called the first one -- that was a very simplistic description -- called the first one "research". It called the second one sort of nothing, if you understand what I mean. It was innovative therapy, it was banned research, it was a whole range of things. What always struck me was that from the perspective of the subject, they didn't really care. The same thing was done to exactly the same -- same thing to two different people calling one research and something else. It made absolutely no difference to them if they were both equally injured. Part of what I think I hear today -- the reason I got troubled with the term "experimental purpose" was it seems to me that if we look at current research, we operate implicitly with an understanding of what research is, and that understanding does not take account of opportunity. When we look at the history, we get more confused because for one, the idea of what is research and what was research is not as explicit, I think, or as clear as it is today. But more importantly, and to keep running across areas where it was hard to say they are necessarily protocols and things weren't done, and all the i's dotted and the t's crossed, but where people said, "Great opportunity." You know, sort of like Tuskegee, "Great opportunity". Let us see what now we can find out and even not always putting it in a protocol. This goes back a little bit to what Ken says. I don't know if I'm being articulate, but I'd love to see the subcommittee try to give a range of definitions that it is using or at least to define more appropriately its term "experimental purpose". "Experimental purpose" to me says gee, everything turns on whatever intent those who were in charge of the manipulation had in mind. And that's a funny way to make scope fall, that it is the intent of the people who did the funding or the intent of the people who were doing the research. That may be an appropriate definition for some purposes. It may not be for others. The reason I say that is because in explaining this story, it may be very important that the public, which will operate on different understandings of what is research, understands the range of understandings that may operate. It may even be important to point out that scientists have certain things in mind, but if you're not a scientist, you may look at other things and consider that experimentation or research. So I think what I heard Ken alluding to, and maybe he'll correct me I'm sure if I misjudged him, is that lawyers often understand that where you want to end up may have a lot to do with how you define things. And what I'm pleading for, because we're in this big, open area, is that we think now about a range of ways -- range, with no conclusion -- a range of ways of defining, and maybe that's a bad term -- defining what it is that we're talking about. An experimental purpose, when you say something did not have an experimental purpose, doesn't always do it for me because there may be situations where I can't identify that "experimental purpose" that I think for all other relevant reasons might be virtually identical to one that you might describe as having an experimental purpose. That is really inarticulate, but I'm hoping that I'm getting to what I think we need to think about in trying to think about scope. CHAIRPERSON FADEN: I would only wish I was as inarticulate as all of our committee members who protest about the inarticulateness -- it would do well. Ken, did you still have a comment? MR. FEINBERG: Just in response to Henry and to Patricia. I don't think that the priorities concern that Henry expressed is as serious as Henry might think because all I'm suggesting is that as a methodological matter in terms of staff, man hours, person hours, for purposes of doing the research and ganging what's out there, I pick up on Duncan's point. And that is that there are certain mass exposures that are in a range going from the Marshall Islanders all the way to the uranium miners or the atomic veterans or the Nagasaki survivors or what have you, there is a range. And that for these mass exposures, this committee doesn't have the time, the resources to reinvent the wheel. That's all I think the Scope Subcommittee was suggesting that the door was open, but that in terms of these mass exposures, call them experiments, call them experiments plus, call them probably not experiments. Even under a liberal definition that Patricia talks about, the staff ought to be directed to focus on the readily available research that's been done for years on these people rather than begin anew. It can't be done. The Marshall Islanders, the Congressional testimony takes up a library. The same with the atomic veterans, the same with others it seems. And I want to make it clear, all I'm suggesting as a methodological point is that we should, on the mass exposure side, rely on what we know or what's out there already supplemented by public comment or interview or anybody that will give us additional leads, historians or what have you, leading to a conclusion, sooner rather than later, that we know enough. I mean, we could continue to get every last bit of information. But in terms of a decision and remedy that will allow us either directly or indirectly to include certain groups, certain exposures, in a recommendation, we have enough corroboration so that we can go forward absent the type of comprehensive global search that may be required by staff in areas specifically mentioned in the charter that Duncan refers to. So I really think that this discussion that I've had with Duncan and with Henry and with Patricia, there is no real disagreement, at least not yet. There may be at some point, but all I'm suggesting is that we have a limited number of staff, a limited amount of time, and we have to focus that time and staff as best we can. CHAIRPERSON FADEN: Let me pick up on your -- oh, I'm sorry, Pat. Go ahead. MS. KING: I was just going to say that there was no disagreement with me because I was not making a method point. I actually was making an education point that we start thinking about early; that it is clear to me that we are going to come out with something at the end that will be a scope area that the committee is comfortable with. What I'm trying to suggest is that it may not be so easily understood, that that was the only -- we don't want to project that was the only way of resolving the scope question. Now what we want to be able to say is something that educates and explains that there are lots of ways of making this cut. We will have reasons, in the end I hope, for doing it our way, but I think that we should start thinking now, because I think we do have enough data now to start thinking about the multiple ways in which you could take these cuts. That does not go to what the staff should be directed to doing. So I agree with what Ken was saying about that. MR. FEINBERG: You should be aware that Duncan, and I think others -- and Duncan can speak for himself -- but we've thought about that. Experimental purpose, when Duncan on the subcommittee uses the term "primarily experimental purpose" or a "primary purpose", we did discuss at the subcommittee level certain exposures initiated with experimentation in mind or after the fact of evaluation of experimental subjects resulting from an accidental or a negligent or a reckless exposure. So again, I think we're agreeing that how we define the universe may require, for reasons of fairness and equity, a broad view of what constitutes "experimental." MS. KING: I don't know. CHAIRPERSON FADEN: As a procedural matter, we need to move onto two more subcommittees. At the same time, this is clearly a very central debate that we're having. Duncan, did you want to have a word as the chair of the subcommittee before we conclude? DR. THOMAS: I guess I just want to clarify what motivates this discussion, and I, for one, am very sensitive to a concern which Ken raised at one of our earlier meetings about the political ramifications of runaway commissions getting way beyond the terms of their mandate. And I think that's what's motivating the search to find some dividing line that would help us make a decision whether or not we are to pursue things that a strict reading of the charter would say are none of our business. CHAIRPERSON FADEN: I'm going to take it that as I heard it, the subcommittee isn't coming to the full committee for endorsement of any particular anything yet. So in some ways, this discussion is at a different stage than say the Ethics Subcommittee. MR. FEINBERG: With just one exception. CHAIRPERSON FADEN: Okay. MR. FEINBERG: I hope that the full committee and the Chair and the staff will endorse what I think has been implicit the last couple of months, which is that the staff's role in uncovering information concerning these mass exposures that are referred to in subcommittee reports will -- that the staff will take advantage of all that's gone before and will not try and reinvent the wheel on us. CHAIRPERSON FADEN: That goes without saying. I mean, we clearly were responding to the same set of constraints that you are articulating, Ken. There is only so much time, so many people, and so many jobs that can be done. But I think what you said about at some point you know enough, speaks to Jay's point as well. You don't have to uncover every relevant piece of evidence before you can reach a conclusion that's sufficient, that has the power to speak to either issues of remedies or issues of procedural authority. I mean, there's a point at which you can say we know enough to know that something went awry and something needs to be done about it. And hopefully, we can do that in some cases without much in the way of original work. Did you want to say something, Dan, before we go on? MR. GUTTMAN: Just I think -- just to go back to Henry's point. It's clear we have to keep our eye on the ball and look at the hundreds of the biomedical experiments. It's clear we have to be efficient in respect to the other. And I think you all will be. The one new development, if it's a new development, is with this kind of document that Duncan is referring to. We have a trail where the word "experiment" -- you know, it's nice that the word "experiment" is used because then you know you're in the ballpark, right -- is used in relation to the most serious, potential kind of event that we're dealing with. And the question is whether in terms of efficiency, and I've been struggling with this since we've had it and talked to the atomic vets people out there, is this news? Is this something that's been in all these billions of hearings. Or are we now, because of declassification -- it may be this was just declassified last week and because of our particular vantage -- we're the only weird characters that worry about experiments in connection with an atomic bomb as opposed to everything else you could worry about. We may be looking at this afresh and we may actually be onto a trail that hasn't been looked on, and that's the interesting question here, and obviously pursue it as efficiently as possible. CHAIRPERSON FADEN: So that remains to be seen. MR. GUTTMAN: Yes. CHAIRPERSON FADEN: I hate to do this, but we have so much to do that I want to move on. And Mary Ann, can you take us through the Cold War? Thank you. Mary Ann is going to take us through the Cold War in ten minutes. (Laughter) CHAIRPERSON FADEN: A ten minute tour of the Cold War, the Cold War Subcommittee. To our jargon, our own shorthand, it sounds -- DR. STEVENSON: I'll be relatively brief because the details of what we discussed in the subcommittee meeting on the 21st are actually going to be covered in detail during tomorrow's late morning and afternoon sessions. And most of what I'm going to say is really going to address more methodology-type questions. But one of the first things that we discussed -- again, this was the joint Scope and Cold War Subcommittee meeting on June 21st -- was the development of this draft template for cataloging experiments that come to the attention of the committee, either through personal files, telephone, or agency documents, really any sorts of documents or information source. And Gil Whittemore on the staff had already begun doing this to some degree with a summary report form that I think everybody has received or did receive last meeting. And we discussed this. The members had time beforehand to discuss and add as they wished to this form. And what evolved from that discussion is that the form really is broken down, I think, roughly into two categories and then subcategories within that. And the first two items on that form -- and the new form is in Tab N of the briefing book. The first real item of substance is subjects and then protocol consent. And those I would sort of put in the general category of ethical issues and so those are the two descripters that fall into that ethical category of each of these experiments that come to be cataloged. And then, after much discussion, we tried to categorize scientific purpose, if you will, for lack of a better word. And what we ended up deciding on is that the experiments should be classified according to radiation research, and that being studies of human health effects and human exposure, either external beam or internal ingestion or inhalation of isotopes, injection, and including intentional releases. Then there's the Therapeutic or Diagnostic category and then Scientific, which is meant to include metabolism and dosimetry studies. And then finally Other, to include things that wouldn't fall into the previous categories. And we all felt fairly comfortable that once we had decided on these categories and decided to go ahead and let one of the staff members, Jonathan Engel, go ahead and do a pilot run with this form on the Markey experiments to see if it was usable and fairly consistent across the line of say 30, 40 experiments. And he's going to report on that tomorrow. But what we hope to achieve with this form, and again picking up on Ken and Duncan's comments, is that although it appears that our scope is going to be infinitely large, we do need within the committee and subcommittee to sharpen and define the criteria whereby the specific experiments are of interest to our committee and try to prioritize at some point. And I think this form or at least tabulation of the information onto this form should be helpful when we get to the point that we are making priority decisions. I think it's also important too, in light of experiments that are being released from various agencies, most recently from the DOE -- it's not clear to the members of the subcommittee what the criterion for inclusion in these releases necessarily are, and I think we have to put our own definition on them. And for instance, within that group that were recently released, there was something involving -- an experiment involving EMP or electromagnetic field radiation, which is clearly not in our purview. So it's very important for us to make our own cut because there may be things included in these public releases that are not at all in the scope of our committee. And again, the format of the form, with the consent and description of the subjects being more in the ethical arena and the scientific purpose being the secondary part of the form, I think will allow us to perhaps address those issues separately in different groups of experiments. There may be some experiments where both issues are of importance to the committee, but there may be some experiments where only the ethical or only the scientific are of interest. And I think that's another strength of the form. Maybe tomorrow the committee as a whole would want to make comments or they can make them now. I mean, it seems maybe more appropriate tomorrow after it's -- CHAIRPERSON FADEN: Yes. I think it may be better to have the critique of the form in the context of Jonathan's report on how it's worked -- DR. STEVENSON: Right. CHAIRPERSON FADEN: -- because he may have some thoughts as well, and I know members of the committee have thoughts about how the form could be changed. And he could respond to what it would mean if that had been in there, would it have changed anything. But it's a real step forward that we're working on a data collection common matrix here. DR. STEVENSON: Right. The other very practical advantage of this is that it can be then hopefully entered into a computer databank in a systematic form. So again, it's accessible. So unless there are any other comments, I'm just going to move to the second sort of methodological issue that we covered in our subcommittee meeting, and that is the grouping of experiments. And again, this is going to be covered in detail tomorrow. But again, in trying to keep up with this information that is being presented to the committee, it was felt that we should, even initially before we get into very detailed cataloging of the individual experiments, put them into larger groupings. And those have fallen out to be government purpose, whole body radiation, radiation warfare and intentional releases. And those are going to be spoken about in detail tomorrow. Again, there may be instances when experiments are placed in more than one category and we're aware of that. But it again is an attempt to try to organize this material so that it's not just sitting there and we have all of this to try and catalog at a later date. And it's as much for efficiency and also in helping us create and construct this map, this historical map, and again with the overlay of the ethics story on top of it. So again, these various subcategories are going to be presented tomorrow in detail. So unless there are any specific comments now, I think it's probably best to save that until the presentation. CHAIRPERSON FADEN: That's fine. Thank you. But Duncan's got a point or a question for you, Mary Ann, so let's not close it quite yet. DR. THOMAS: I just want to touch on the significance of this accomplishment that we have a classification -- at least a working classification scheme. And it's implications are for what we do for future data collection. We have been confronted with this problem of these great, long lists of undifferentiated exposures and Mary Ann might want to comment on another document she's drafted which provides a plan for sampling these experiments. The question in the back of my mind is where we go with the sampling scheme. At least we have some way of reading through this list and then deciding where in our classification scheme things fit. What I haven't heard much discussion of yet is what we do next, having drawn a sample by one means or another in terms of pursuing further information. I think it's meaningless simply to go and say, "Give us all you've got on this experiment." We need a much more focused approach and we haven't really begun to think about what that focused approach consists of. In the best of all worlds, it would consist of going and getting the research protocol and you would just phone up NIH and say, "I want the grant application for such-and-such" and that will have in it the consideration of human subjects and the types of radiation and all the other things we want to know about. Chances are they'll tell us they don't have the grant application anymore, and what do we do next? What plan do we have for going to institutions to get information? So that's I think where the committee needs to go next in terms of its datagathering plan. CHAIRPERSON FADEN: Did you want to respond, Mary Ann? DR. STEVENSON: I don't have any actually additional comments because we haven't discussed as a committee about going to the institutions. I mean, I think just as an aside probably most of the committee members did have time to read the Massachusetts report and that was very educational to me because they had a very confined question and a very confined and defined group of institutions. And even then, they had a very difficult time coming up with concrete facts, I mean mostly due to the poor state of documentation. And to me, it was just very humbling in terms of the task that's ahead of us and should, I think at some point, be discussed in terms of what we can really hope to achieve because that was a very defined task and yet it's full of caveats and disclaimers. CHAIRPERSON FADEN: Yes, I had the same reaction exactly. It's very sobering and it's good that it came out in some ways at the time that it did, lest we get carried away with what we think we can accomplish. DR. STEVENSON: Right. I think the other thing that was very educational about that is they did, at least in terms of the iodine experiments, in essence identify the problem, but felt comfortable to move that problem into someone else's arena or state that that particular episode needed the direct consideration of another committee. And that's not by way of passing the buck. I think they felt they could not do an adequate job by trying to cover it within the scope of their own committee. And I think that's something we're going to have to consider, that at least decide to what level or to what degree we're going to address these various topics and consider the possibility that certain things, although we recognize them as being necessary for us to address, we cannot, as a committee, do that. CHAIRPERSON FADEN: Well, we'll continue with some of this tomorrow, but it is not going to go away. Both Mary Ann and Duncan are right. We have lots of issues unresolved. But even when we reach the point that we're more or less comfortable with the groupings that we have identified, now what are we supposed to do? It certainly looms large for the staff, so we'll work on it. MR. GUTTMAN: We were impressed by how much information they had about the -- CHAIRPERSON FADEN: Relatively speaking, so it's two sides on. But let me just take this minute. I think I should have said this at the outset, so let me just say it now. There's an awful lot of very hard work clearly going on in the staff which we don't see because we get kind of cleaned product, but it's really quite impressive, and a lot of careful and hard planning and leadership -- there's also a lot of good work going on on the part of the subcommittees which we can sense from hearing each other's reports. But everybody is working really impressively hard on this committee, and we ought to feel good about that. Now the question is can we sustain it over the next eight or so months will be the issue and that's kind of the challenge before us. We should move on to Outreach. Reed is not here. Steve Klaidman, who is the main staff liaison for that committee, is going to give us an overview. And other members of the Outreach Committee that are here can help you, Steve, in ratifying your summary and calling for clarification. MR. KLAIDMAN: I'd like to begin just by saying that there is a substantial degree of time sensitivity to the issues that the Outreach Subcommittee is concerned with. We are planning -- thinking about meetings to be held outside the City of Washington, and the lead time is considerable to get these things done effectively. We have -- CHAIRPERSON FADEN: Steve, can I interrupt for one second? MR. KLAIDMAN: Sure. CHAIRPERSON FADEN: I should have directed everybody to Tab -- is it I? MR. KLAIDMAN: I. CHAIRPERSON FADEN: Okay. If everybody looks at Tab I, there is a report from the subcommittee and this is a very specific report so it will probably help Steve and all of us if we're looking at that. MR. KLAIDMAN: Yes, I'm going to stay as close to that report as I can because I think it represents the consensus of the subcommittee. And if I'm incorrect about that, Henry or Lois or Sue will correct me. But if we are going to have these meetings, decisions have to be made fairly quickly so that we can begin the planning process. There are three criteria on which i think the subcommittee has reached consensus as underlying principles for why we should do this: One is to make the committee available to concerned members of the public, people who want to meet with this committee who have things to say to this committee. Secondly, to make their information and perspectives available to the committee, and third, to help publicize the committee's work with the thought that the more the public knows about the work of this committee, the better it is likely to receive the final report of the committee. Specifically, the subcommittee would like to recommend that three full-scale committee meetings be held outside of Washington, and four meetings with small panels, probably three-member panels of the committee be held in various places around the country, again to make committee members available to the broadest and most diverse segment of the public that we can manage. And the three cities that the subcommittee recommends for full committee meetings were selected principally on a geographical basis and they are San Francisco, Atlanta and Chicago. The recommendations of the full committee during the last meeting about the considerations for the selection of cities were followed in the selection of these three cities with respect to things like weather and availability of good meeting sites and so forth. We also tried to select cities for full meetings which were not in communities where major experiments had been held so that it would not appear that the committee was going simply to hear testimony from people in those communities bout those issues. San Francisco, as you all are aware, is a city which had one of the plutonium injection subjects. But apart from that, nothing else took place in the city. But it is, as is a line-up -- of an area in which a great many experiments took place, and it would be easy, for example, for people from Hanford, from Oregon, from elsewhere in California to come and meet with the committee. Atlanta has the virtue of being a Southeastern airline hub. There are a great many experiments in the southeastern part of the United States ranging from Tulane in New Orleans to Nashville and so forth. In both cases, these cities are close to states which have had very, very heavy help-line responses: Florida, for reasons that are not entirely clear, and California are the two leading states in help-line telephone calls. The third city, Chicago, selected principally to represent the Midwest so that people who do not have an opportunity to easily reach the other two, might more readily be able to come to Chicago. The principle for the small panel meetings would be, in a sense, the opposite of that for the large group and it would be to go to the communities where there is the largest interest because they are communities in which experiments have occurred. And they could be places like Nashville, Albuquerque, a city like Spokane in Washington because it's near Hanford, also close to Walla Walla, Washington where prison experiments were conducted and Salem, Oregon and so forth. So that really, in a nutshell, is what the committee is recommending. We need two to three months lead time to make these meetings work. We would like to go out in advance of the committee, find people who could appear before the committee at these meetings and we would suggest as well that these meetings be structured a bit differently from the Washington meetings to provide more time for people to address the committee, more time for the committee to question these people so that at least a half day would be devoted to public comment at the meetings. I think that's all. CHAIRPERSON FADEN: So we all understand that the proposal is for the full committee to endorse the recommendation of the subcommittee and we can take them together or separately. Three of our already scheduled meetings, the dates you already have, that three of those would be held elsewhere, not in Washington, presumably the three cities that Steve has identified. And then in addition, some of us would go to four -- no one person would go to all four, but we would look for volunteers, committee members who would be willing to go to a one-day essentially a hearing-type format in a community to listen to what people have to say and then to report back to the full committee what was heard. We can disaggregate this package anyway that we like. Pat? MS. KING: I asked to go first I guess because if you're going to be against God and motherhood and apple pie, you might as well put your neck out and get going. But when I read this memo, the politician in me went out the door and the efficiency expert came in. And there is a fine way to balance between listening and hearing and doing the things for outreach and trying to efficient with scarce resources and staff time and committee time. And my initial reaction to this -- I'm not suggesting that it be scrapped. Just the numbers I find overwhelming. I think it's too much to have three full committee meetings and four panels of the committee around the country. I don't know how many other people have participated in these kinds of things. I certainly have for the other committees that I've served on. It's an incredible amount of time. It doesn't matter much to the committee people because you travel wherever you have to go to anyway, so that is not the big issue. It's an incredible amount of staff time and logistics and you remove the staff from its operating base and transport them. And there are many ways to hear the public, not all require face-to-face -- some require face-to-face interaction. But I don't think face-to-face interaction need be -- sort of become the sole focus. And let me explain what I mean. Ken said before that there's a lot of information already in records. There's testimony of people. There's been testimony before Congressional hearings. There's testimony before us here. I'm not saying that there's not additional testimony to be heard because I'm sure there probably is. I just don't see three full committee meetings and four small meetings, although I am in favor of the principle, lest people think I'm totally terrible. I am in favor of outreach. It's just to the extent to which you go. We're talking about fanning around the country, when I look at proposals like this. And it gives me a great deal of trouble when I look at the time limits that we have for this entire project. So if you push me, if I'm not the only person who is this kind of person, I can give you my recommendations about what I think a more reasonable kinds of meetings. CHAIRPERSON FADEN: I think that's appropriate. MS. KING: But I may be the only person that feels this way. CHAIRPERSON FADEN: Pat, trust me, you're not. Go ahead. (Laughter) CHAIRPERSON FADEN: Trust me, and this is a subcommittee report. It goes straight from the subcommittee. MS. KING: I actually favor sending out panels around the country and no full committee meetings away. To hear -- panels to do explicitly what is akin to Congressional panels going out and taking public testimony because that is what public outreach is. And I, for one, would be willing to do that, but I think that's clearly doing what we want to be able to do and focusing just on that. CHAIRPERSON FADEN: Jay? DR. KATZ: You were not there last time, Pat. I made the recommendation last time. MS. KING: Oh, I didn't know that. CHAIRPERSON FADEN: So there's a counter-proposal. Henry? DR. ROYAL: I'd like to hear from the staff about how disruptive having a full committee would be outside of Washington. CHAIRPERSON FADEN: Anna? Anna, do you want to -- Anna honchos the work to get -- MS. MASTROIANNI: It's actually something that Steve and I haven't had a chance to fully flesh out. We wanted to get the committee's sense of -- we would probably send out two to three -- I don't think you really want the details of how many people we'd send out to do the advance work and what kind of work it would involve for Steve, which he's perfectly willing and has the time to do. I really -- I guess -- we can work with whatever the committee comes up with, okay? We can. Dan may have some differing opinion. MR. GUTTMAN: Let me just say that as someone who is in a sufficiently elevated position to have no knowledge of what Anna's been doing, I can know that she's been going through amazing amounts of difficulties to get the briefing book out and, you know, there's a learning curve. At the risk of stepping on toes, obviously we're all in favor of outreach and I would go along on the outreach part, and less on moving the entire -- this session. Because the important thing is that, you know, we hear from people that can't come here. And given the time constraints, that would be the preference. CHAIRPERSON FADEN: Notice that they only gave us one mike up at this point. MS. MASTROIANNI: The only -- I do have one point and that is that if we do go off to off-site meetings, it does not permit the staff to come in and listen to the where the committee. They would have to rely on minutes and transcripts of the meetings. So we would probably take about eight staff members instead of the 30 or so that can come and go from the meeting sites, and that is a consideration. MS. KING: Not to mention the fact that you leave here and go work. MS. MASTROIANNI: That's right. CHAIRPERSON FADEN: Actually that's one of my deep concerns too. We obviously don't have the whole staff stay during the entire Advisory Committee meeting, but people come in and out particularly where their work is being discussed or where their area of expertise is most relevant. And we would lose that if the whole committee goes because we obviously can't, as Anna says, transport everybody. Anna is being accommodating. Dan and I are a projector. MR. GUTTMAN: We should also, as long as we're mentioning Anna, mention Jeanne and Jerry and the others out there that have been licking envelopes and doing these other important tasks. CHAIRPERSON FADEN: It's a big issue. Now at the same time, we should hear from people on the subcommittee. Reed isn't here as the Chair of that subcommittee to defend it and it puts Steve in a funny position, so I would particularly like to hear from the members of the subcommittee that presumably think this is the way to go. Henry? DR. ROYAL: Well the particular concern is the ultimate impact that this committee is going to have and whether or not by having full committee meetings, people would be more aware of this committee and therefore, the committee would likely have more impact because of the fact that we had full committee meetings. So I think an issue of whether or not full committee meetings would have more impact than hearings, but it has the potential to greatly affect out work. Because if no one knows about the committee, it's not going to have much effect. CHAIRPERSON FADEN: Pat? MS. KING: I have two thoughts: one I think that the real impact of the committee is how good a report it produces ultimately and so that becomes my first priority, how to be more efficient. But also I take Henry's point very seriously. I think in terms of -- and I may be wrong about this and Steve can correct me. But in terms of going out and taking testimony from people that come in and have narratives -- it's the sort of thing I was talking about this morning -- you will increase the awareness of the committee. That is what the press, the public will come in and hear. They don't want to hear us like we're talking now. CHAIRPERSON FADEN: It's kind of boring. MS. KING: It's pretty boring. (Laughter) MS. KING: Well, I think so. CHAIRPERSON FADEN: Yes, I think so too. MS. KING: So I think that there is an -- outreach is 1) important; 2) making sure that people who have not been able to be heard up until now are heard is very important, but I think that the thing to do is structure the way we can hear people, not having to come to Washington, but hear people, in a way that's the least disruptive and that's why again I propose that three committee members sitting someplace listening to people talk, I think will do just as well in those terms, in terms of increasing awareness, as will the presence of the full committee. And there's a marginal difference of us saying "the Committee comes to San Francisco" or "the Committee comes to Cincinnati", but I think in terms of hearing, in terms of making sure we have incorporated those stories here, I think we can accomplish that and accomplish some of our other purposes with having panels go take testimony. CHAIRPERSON FADEN: Nancy, did you want to say something? DR. OLEINICK: Did the committee at all consider the possibility of some kind of a compromise in terms of a teleconference at one of these outside sites? In other words, if the majority of the committee were meeting here and three members, for example, were in San Francisco, we could be communicating completely without this terrible disruption of moving the whole staff and the expense. MS. KING: Are you talking about those teleconferences where they have down-links in different places so that you can do interaction? DR. OLEINICK: Sure. I have no idea how one does that or what the cost is, but it's something that maybe could be looked into. CHAIRPERSON FADEN: Lois? MS. NORRIS: In answer to Nancy's question, no this has not been discussed by the subcommittee and I am going break ranks with the subcommittee and suggest that I think perhaps Pat is being practical. We have to consider the burden on the staff. I think they've done a wonderful job and I don't want to increase the burden and make you less efficient with limited resources. I was toying with that same idea as I was sitting here thinking about this. I don't know if that's practical, if it can be done. And I'd like to hear Steve comment on whether he thinks that would be effective. MR. KLAIDMAN: I think the teleconference is a good idea. In terms of regional press coverage, which can be very important, a full committee sitting in an area is likely to get vastly more than a panel. How you measure the impact of that, whether it is marginal as Pat suggests, and that may be, or whether it is genuinely significant and it is the kind of impact that will make people significantly more aware of the committee and its work and prepare the ground better for the report -- and I certainly agree with Pat that the report is finally the most important thing. But if that ground is not well-prepared, the report, no matter how good it is, may not be received in the best possible way. It may well be that three is too many in terms of staff disruption. I'm still frankly not totally convinced that there would be so much staff disruption that to do one or two of these would not be quite workable. I mean, Ruth is surely right, but it will make it impossible for the entire staff to participate in the way it does in the Washington meeting. Again, is that something that is marginal in its effect or should we consider that to be a significant effect? My own feeling is that there would be more to be gained by having a couple of meetings of the full committee outside of the city than none. CHAIRPERSON FADEN: Well, I'm hearing at this point three proposals and there are infinite variations in between. If not infinite, somebody could work out all the -- that we could have. But we have the proposal from the subcommittee as it was presented, three travelling subcommittees and four panels. We have Jay and Pat's proposal that we just scrap the whole committee going anywhere; that we retain, I don't know what the number is, three or four panels. And then we have this twist now that Nancy and Lois have introduced which is that we augment the panels with teleconferencing hook-up so that more than the three members of the committee could participate in an interactive way during the testimony process where we are hearing from people. I suppose it's even conceivable that we could have -- we'd strive for the whole committee to be available in three locations. I'm not sure. But in any event, we've got that and then we've got the proposal that Steve essentially suggested which was we cut back from three full committee meetings outside of Washington to two or one travelling committees. Now I don't know how to do this because you know, we can call for a vote on five different options. I think maybe the best would be to get a sense of the committee as between stark options. How many people are leaning towards which was of setting it up? And then try to come refine it. Jay, do you have a suggestion? DR. KATZ: Yes. Why don't you get a sense that just as each -- would as many as possible to give you a sense and then in the light of your discussions with staff, you then make a decision taking the sense of the committee into the town, but only taking -- and you will have the final line and make the final decision. CHAIRPERSON FADEN: I'd be happy to do that, but I'd like to fold the Outreach Subcommittee into that process. DR. KATZ: Sure, sure. CHAIRPERSON FADEN: Pat? DR. KATZ: There are two purposes that have been identified and actually everything on them be accomplished in terms of evaluation against two purposes. One is hearing from people who want to talk to us. That's purpose one. Purpose two is we want to get some press relations coverage outside of the national media, where to be quite frank, sometimes I wish they didn't cover us so well because there's lot of mistakes made sometimes. But we want to get more regional press coverage. I'm in an organization that just did exactly the teleconferencing around the country. Depending on how many down-links you have, you can involve as many people across the country as you want. It is an excellent vehicle for interacting with people who want to talk to us. So it ought to be evaluated against that purpose in terms of the multiple ways you can achieve that. And I think we ought to do the same thing with getting press coverage. I don't disagree with Steve that that's important. I was just de-emphasizing my strategic -- but I think it evaluating what we were talking about, we should be clear about what we want to accomplish and then whether those purposes can be accomplished separately or must they always be mixed? And we use one form to try to accomplish both because maybe we can magnify our impact without tying up our resources. Does that make sense? CHAIRPERSON FADEN: It's very helpful. We really do have two agendas and it is important that this outreach proposal is intended to accomplish. So we have to keep them both in mind. It's not clear that we have them prioritized or not, but I am looking for that sense that Jay suggested that we need to have. How many people are in favor of something, a cutting back from the proposal as it came from the subcommittee? So that's all but one, and of course, we don't have Reed here, which makes it -- or Ruth, but I'm thinking about the people on the subcommittee. Is Ruth on the subcommittee? MR. KLAIDMAN: Ruth is on the subcommittee. CHAIRPERSON FADEN: All right, so that is a problem. I'm not sure that we can go much further than to say that the full committee, those of us who are here, and of the full committee want something less ambitious than this report. But exactly how to pare it down, we're going to leave open until -- no, you want to go further than that, Jonathan? How much further did you want to go. DR. THOMAS: You don't have the lead time to defer this to subcommittee for very much longer. CHAIRPERSON FADEN: No, only to the next July meeting is all we would have and then the committee would have to -- we have another meeting scheduled in less than three weeks. So my thinking is that we can get this resolved, come back and then at the next July meeting, we just decide it. Or we send out a vote. Anna was pointing out before -- MS. MASTROIANNI: Is Reed still expected today? CHAIRPERSON FADEN: We don't know. Is Reed expected? It's quite confusing, this situation here. MS. MASTROIANNI: He apparently missed his flight. CHAIRPERSON FADEN: So we don't know. We don't know. DR. KATZ: We just want to get a sense of how many people are in favor of -- CHAIRPERSON FADEN: Sure, I'd be happy to do that, plus or minus augmenting it with teleconferencing, which would have to be investigated. So it's essentially the proposal that Jay had suggested and then Pat independently reintroduced that we scrap a travelling full committee and we have four testimony hearing-type sessions around the country, and open as to what cities. We don't have time to do that right now. How many of you are in favor of that proposal? So it's about six? I haven't voted. Seven, six or seven. So and the telecommunications, augmenting it right, would be pursued as a way of involving more of us. So there's at least a significant portion of the committee that is interested in dropping all travelling for full committee meetings. And we will work with that, go back to the Outreach Committee. Lois, is that okay? MS. NORRIS: You're just answering my question. CHAIRPERSON FADEN: And I'm looking at -- is it Lois and Henry are the two members of the Outreach Committee here. I didn't know you were on it, I'm sorry. I can't keep track. I'm so impressed with the people who are on more than one committee and almost everybody is on more than one committee, and I tend to think of you as on the one that I'm on and forget that you're on another one. So if the three of you can take that back, and I'd be happy to be on the call as well. We can try to work it out and come up with something. At the next committee meeting, we have to decide it. Is that still enough lead time? MS. MASTROIANNI: Yes, or we can send out -- CHAIRPERSON FADEN: Or, Anna reminds me, if we can do it more quickly, we will send out something for ratification by mail. All right, we know we want to do something different from the recommendation as it came to us for -- DR. STEVENSON: Just in terms of efficiency to maybe in the same communication, the exact times, if not places, could be specified. Because I think if we're actually going to try to get information and use it, we've got to get it sooner rather than later. CHAIRPERSON FADEN: Yes, that's a very good point, Mary Ann. DR. STEVENSON: Otherwise, it's just going to be gratuitous and -- CHAIRPERSON FADEN: We have your calendars which have probably since changed unfortunately, but we have your calendars for all of the months that the committee is in operation based on which we selected the committee meetings. We can try to work with those and quickly come up with some dates, certainly for these hearings that would be held, and especially if we're talking about augmenting it with hook-ups and teleconferencing and so on. The more people who can reserve a day or a part of a day, the better. Okay, thank you all very much for your hard work. And before we break, we have a quick report from Jeff Kahn on new staff members and how the staff is going and so on. And here I feel very awkward. I want to acknowledge every single member of the staff for all the wonderful work that's being done and Jeff's job of keeping track of all of it. It's no small piece of it. MR. KAHN: Okay, very quickly, since the last meeting, we have added three new members to the staff and we have a fourth who's pending. For their full bio-sketches, I just refer you to Tab C in the briefing book. They're in alphabetical order and you folks can identify yourselves by standing up so folks will know who you are: Ms. Barbara Birney. Ms. Birney comes to us from Boston University, where she directed a project evaluating health indicators in populations living near hazardous waste sites. She's trained in epidemiology primarily. The second is Noel Theodosiou. She's come to us as a recent honors graduate from Swarthmore College where she studied History, Political Science and Music. The third is Sandra Thomas. CHAIRPERSON FADEN: Is Sandra not here? MR. KAHN: She's right there behind the camera over here. Dr. Thomas recently competed a post fellowship in epidemiology at the University of North Carolina. She did her medical training at Ohio State University, where she also received a Masters in Preventive Medicine and for that degree, wrote her Masters thesis on diagnostic radiation exposure in neonatal intensive care units. Soon to be official is Dr. John Harbert who will be introduced formally at the next meeting. Dr. Harbert is a nuclear medicine specialist. Also in Tab C is a slightly updated current assignment sheet. I'll refer you to that. It's much the same as it was last time we met, with a couple of small changes. You'll notice on the first page under "Experiments, Mapping" what were formerly the University of Cincinnati experiment had the plutonium conjunction experiments, we renamed those total body irradiation and the Markey experiments, respectively, to give a clear indication of where we've come since the last time we talked about those particular areas of inquiry. This is a very general project assignment sheet. And as the subcommittees continue to do their work and give directions to the staff about how to proceed, as well a the picture in terms of the final work product, it gets fleshed out. This will change probably quite markedly. So not much new to report this time, but I think stay tuned is the bottom line. CHAIRPERSON FADEN: Questions for Jeff? Henry? DR. ROYAL: Shouldn't the experiments mapping reflect the four more? In other words, Green Run should be environmental releases and the Markey experiments is a whole collection of different kinds of experiments. It seems to me they should be -- CHAIRPERSON FADEN: It's going to be revised again. MR. GUTTMAN: That's tomorrow's discussion. CHAIRPERSON FADEN: That's tomorrow's discussion so the work -- MR. KAHN: I'm trying not to get ahead of you all. CHAIRPERSON FADEN: The goal is not to be behind, so as soon as the committee formally ratifies a new way of organizing it, the staff assignments are going to be relabelled. We probably should have mentioned that Henry, thank you. DR. ROYAL: Right. CHAIRPERSON FADEN: Which is the lead-in into the outline, okay? And it's this document called draft report outline in the loop holder. Let me emphasize that it is -- you always hear this, but this truly is as preliminary a draft as you can have. We ask that you not circulate it beyond the committee. We expect that it will bear only a family resemblance to the actual outline of the final report when it's done and would be concerned that too premature a distribution of this draft outline might generate unnecessary concern, wasted effort and otherwise cause problems. So we're asking you to just keep this close for right now and as we work with it and revise it and become more comfortable with it, we will, of course, make it widely available. I mentioned in my opening comments that this is an outgrowth of the charge that the committee gave Dan and me at the last meeting to go come up with a vision document that can kind of guide us together. And we quickly went from vision to particulars. In between that vision notion and this document, there does exist something called the goals and objectives document that has been played around with in staff and we may bring that up. This sort of makes that obsolete in some respects, but we can reintroduce it. And I did already mention that we had invited anyone who wanted to share thoughts about vision, purpose, goals or objectives on the committee to send it to Dan or to me or to Anna. Duncan took advantage of that offer and sent us a very nicely thought out, detailed outline for a final report. And Duncan, you'll recognize some of your words here. Now let me just say that this document, although it is preliminary in draft, has been much debated in some of the committee -- the staff committees that have looked at it. And so you have benefit here not just a few of -- they're thinking of actually a fairly large number of people on the staff. What I want to do now is just take from now to 3:45, just a few minutes, to kind of orient you to this document. And at the risk of giving people homework, which is always an unfair, cruel thing to do when you have a packed, two-day meeting, if you could take a chance tonight at your leisure or tomorrow morning at breakfast or tomorrow at lunch to take a look at it in more detail, then we will have in the afternoon tomorrow a more specific -- we will have a discussion. This is really not the time to discuss the document, but just to orient you to it. We will have a discussion of the draft outline where we can start to take it apart. And hopefully, that process will continue into the next July meeting, our second meeting in July. But basically, the draft outline here is divided into three parts with some preparatory material. As all good reports have, there will be an executive summary. And as all good reports have, there will be some introductory material that talks about our scope, our charter, our purpose, our methodology, our staffing and all that kind of stuff. So we've put the executive summary and the overview outside of the substantive part of the report. Just know that, of course, any good report would be that. Then we have divided the report into three sections, and each of those sections begins on a different page. Part One is "Foundations". Part Two we're calling "Focal Points, Experiments and Intentional Releases", and Part Three we're calling "Looking to the Future". Part One in Foundations, we've divided that again into three sections. And by the way, the headings and subheadings are not intended to indicate when a chapter begins or a chapter ends. We haven't yet figured out how many chapters, as it were, these topics would result in. But generally, there would be "X" number of chapters under the heading of Foundations, and in this proposal, oriented around three areas. The first subsection under Part One of Foundations I, is called "Ethical Principles, Historical Ethical Standards and Criteria for Judging Experiments". And you'll see here what would be included would be a discussion of the history of policy rules and procedures both with respect to the Federal Government from 1942 to the present, and also a history of policy rules and procedures governing research involving human subjects, as expressed in professional codes and standards. There would then a section discussing what we have learned; with respect to practices involving human subjects, a small section about the history prior to 1942, and the information we had gleaned about practices from secondary sources, from our own oral history, from the review of grand proposals that was approved this morning. And also if we go on to conduct an interview study, the data from the interview study would be reported here. There would in this section also be a discussion about the intersection of interests that are at the core of one dimension of the work of this report, and that is a review of thinking and reflection on the interaction of the interests that the nation has in defense and security with the interest that the nation has in securing human rights in a liberal democracy, and in all of that the role of secrecy and openness in that continuing balance of societal interests. So we would have some hopefully informed and well- crafted background discussion of how to put these sorts of issues together or how they have been put together in commentary on these complex topics. Similarly, we would have in this section hopefully a well-crafted discussion about questions of historical relativism and retrospective moral judgement. These are kind of the foundational, philosophical topics that provide the background against which we have to reach some very practical conclusions and hopefully make some very practical suggestions. And also in this report, we would lay out our own conclusions taking into account the discussion that would have preceded us with respect to national security and human rights and also the discussion that would have preceded with respect to historical relativism and retrospective moral judgement, our conclusions about whether and why and how to judge experiments and policies over time, leaving all of that open. Notice that the report outlined here does not say we are already taking a position, indeed that we will even judge experiments that occurred in the past, but that we will at least stake out our position as to whether we believe judgement is appropriate and if so, why, and if so, how to make judgements about the conduct of people who preceded us in the policies. So that would be a bid chunk of the report broken down into some unspecified number chapters. We would then move on to set a different context which is related obviously, and that is the socio-political context out of which our work comes. And here we have three topics: the culture of national security from the World War II, the Cold War and beyond, the culture of biomedical science and also the popular cultures shifting public perceptions of atomic energy, all of this by way of setting more background for our deliberations. And finally in Foundations, there would be a discussion of the science of radiation from 1942 to the present, which would include a careful review of how it is that people understood the risks of radiation over time, both within the scientific community and relating it to the previous discussion in the popular culture? Again, and this is just to walk you through it. If you wouldn't mind holding your comments until tomorrow. If you want to start scribbling, this is stupid, why did she set up this way? First of all, it's not just me. (Laughter) CHAIRPERSON FADEN: Secondly, you know, if it's not right, that's okay. There really is -- you hear this all the time, but there really is no ownership here except I walked by it furiously for being exactly like this. So we'll go on. Back to Part One. Part Two is an attempt to try to organize the overwhelming amount of data and information that this committee already has, let alone the amount of data and information that the committee will likely have by the time it's finished. So you see here, and this specifically will be discussed in somewhat more detail tomorrow, but you see here the notion that we would try to organize our discussion of the experiments and research projects and intentional releases which we wish to bring to the public's attention by putting them as already been discussed into categories. Those categories are not usually exclusive and exhaustive. They are categories which are put together because they're a loose fit and can help tell stories rather than categories that are air-tight in some conceptual, analytic sense of categories. You'll see here some suggested categories that Dan and the staff will walk you through why these categories a little bit more tomorrow. All of this is open for grabs. But right now, they're divided roughly into two categories, somewhat arbitrarily: scientific and medical theme groupings, and other kinds of groupings. You see in a box here for each grouping the kinds of questions that would be discussed. And this comes very heavily, Duncan, from your language, so you should -- if you don't like this part, say it's Duncan's fault. But the understanding would be for each grouping that we decide we want to say something about, we would pick a couple of illustrative or one or two illustrative examples, tell them in more detail, and then overall try to reach some conclusions for the grouping taken together for all the of the questions that are in that boxed group. And you'll note that they include considerations heavily dealing with questions of ethics, but other considerations as well. And finally, there's a section under Part Two called "Putting the Pieces Together" and here the concern is fine, now we've told in our report eight, 12, six different stories about different types of research projects or events like intentional releases that are of interest. But what do we have to say overall about what happened? So the notion would be in the Putting the Pieces Together Section, we would take three powerful themes that have animated the existence of this committee in the first place and see what we can say about those themes overall for the entire experience of research involving ionizing radiation, both military purpose and otherwise. And the three themes that are suggested here is first the theme of exploitation of power differentials. This is awkward language, but it's trying to replace the reference to vulnerable populations. We're all struggling for new language. But it's to what extent do we see a theme here evolving that people in positions of relative powerlessness have appeared or have they appeared disproportionately in the stories that we have been telling, yes or no, and where and why? A second theme that would have to do with openness, disclosure, consent, and voluntariness and a third thing that would have to do with level of risk. Overall, what has been the risk or potential for harm that we see in this experience? I don't know whether it's doable, but that was the thinking that there would be a final attempt to put this together. The third section, "Looking to the Future", which none of this I guess is particularly original when you look at the history of committee reports, but okay, it works. So, it's here. Looking to the Future is intended to answer the question what policies, practices and values are needed to protect the public's interest in the ethical conduct of science and openness in government and in national security? So putting this together, realizing that this committee is charged with the ethical conduct of science, charged with considering ethics of science, charged with considering openness in government and also mindful that there are legitimate interests in national security, what do we have to say about the current situation and what recommendations do we want to make for the future? And you'll see here from I to V the sorts of topics that at least this draft suggests we would need to come to grips with. And of course, remedies would be a central component of this Looking to the Future Section. It might seem odd to say the remedies of looking to the future, but in fact, I think that's where it fits. It's the current situation. What do we do about the past and the current situation, and what do we do in the current situation to minimize the chances of the sorts of things for which we think remedies are in order now, will not happen again? So this is the draft. Please rip it apart and we'll come back to it tomorrow afternoon. The idea would be if we can get enough of this ratified by tomorrow, we can start to organize or reorganize staff along the sections of this report. That would be terribly helpful. If we can do it, that would be really great. So if we can get enough of this endorsed with all the modifications people want to make so that it's good enough, to start saying it's good enough to start organizing staff around it, we can work out many more of the fine points at our second meeting in July. But if we could get enough of agreement to say this is more or less on track and start slicing the world up that way for purposes of work assignments, that would be a really valued outcome in terms of efficiency and productivity for us. So at the risk of being real dictatorial and saying let's not have any discussion now, let's not have any discussion now. (Laughter) CHAIRPERSON FADEN: Let's break and then we reconvene at 4:00 for our public comment period. (Whereupon, the proceedings went off the record at 3:41 p.m. and resumed at 4:05 p.m.) CHAIRPERSON FADEN: Would the members please come to the table so we can resume our deliberations, please? We have an hour. Anybody can survive an hour. Come, group. I am pleading. Committee members, would you please come to the table. There are cookies for the committee members who come in a timely fashion. (Laughter) CHAIRPERSON FADEN: But only people who come in a timely fashion can get cookies. There you go. All right, I think we should start. This is our public comment period. We are privileged to hear from three people this afternoon. The rules of the game remain as they always are, each speaker has five minutes. The committee then has an opportunity after each person presents to ask questions. We adjourn at 5:00 so we have roughly an hour to hear from our three presenters. Our first presenter is -- if we could ask Ambassador Wilfred Kendall, please, of the Marshall Islands, and Senator Tony deBrum of the Marshall Islands to come to the table, please? We're very privileged to have you come today and I understand Senator deBrum that you're going to make the presentation and then Mr. Ambassador that you'll be available for questions? Thank you. And if you could just keep your comments to five minutes, that would give the committee sufficient opportunity to engage in a dialogue with you. AMBASSADOR KENDALL: Members of the Committee, I want to thank you for this opportunity this afternoon to be here. Senator deBrum is going to present our statement this afternoon, so I'll defer to Senator deBrum to proceed, please. SENATOR deBRUM: I believe our show statement of documents have been distributed. I do want to join the Ambassador in thanking the committee for allowing us to participate today, to state our case before you and ask your help in continuing to find and help interpret for us information that we have sought for nearly 50 years, and are only beginning to get now. I am Tony deBrum. I am a Senator in the Parliament of the Marshalls. I have lived in the Marshalls all my life. I lived in Likiep, an island in the Northern Marshalls between 1945 and 1958 and as a young boy, from the time I was 13 years old, witnessed many of the atomic tests that were conducted in the Marshalls, including the infamous Bravo shot of 1954. As an adult, I have been involved in government service and I was directly involved in the rehabilitation of Bikini Atoll as well as Eniwetok Atoll. I was also the government official involved in the eventual evacuation of Bikini people after it was discovered that they had ingested too much cesium. I was the Vice Chairman of the Status Commission of the Marshall Islands, which was the agency charged with negotiating with the United States for the termination of the trust issue and the implementation of the Compact of Free Association, which now rules the relationship between our countries. All during this time, and I think especially because I was as a young boy, exposed to matters nuclear, we had tried to get the United States Government to release to us information regarding the tests themselves, exposure of the people, what they were to and with the people after exposure, explanations as to why weather reports and predictions that people would be exposed were not followed or why the military insisted on exploding these devices when it was clear that they would result in the exposure of civilian population in the Marshalls. There is no doubt in our minds that we have documents in the pile that we provided to prove that there was no accident that people were exposed. The weather changes that were used as the excuses before were really not the case. It was very clear from the beginning that blowing up some of these devices would result in human exposure. And then for many years following the exposure of populations in Utrik and Rongelap, for example, in the Marshalls, studies have been conducted on the people, on their bodies, that the government knew -- the government know the people themselves fully understand. Attempts to obtain records from the U.S. Government agencies involved have been futile. Recently, with the release of documents heretofore secret or classified, we have been able to piece together various pieces of evidence which lead us to believe that Marshall's populations, different groups, different times, were used for radiation experiments. I hasten to add that at this point in time, we have just gone through a very few of these documents. We have not had the chance to go through all of them. But from what we have seen so far, we can conclude that there were projects and programs conducted by various agencies of the United States which involved exposing people and studying them. There is a project called 4.1 Biomedical Studies, which is called a study of response of human being exposed to signa, beta and gamma radiation due to fallout from high yield weapons, which was first introduced, as far as the documents show, in 1953. After Bravo in 1954, the same study is now referred to after people were brought into -- for studies as the study of response of human being accidently exposed to significant data on gamma radiation, etc., etc., etc. We have evidence that people in the Marshalls were brought to laboratories and hospitals in the United States, including Argonne, Brookhaven, Cleveland General, Chicago, Serrow, military hospitals, and for what reasons we still have not been able to discern. The people themselves thought they were being brought up for medical care. In many cases, we find out they were not actually treated for any kind of medical condition, even though they seemed to have been part of some study tied in with other studies in the United States. Again, those documents are contained in the documents we presented earlier. We want to engage this committee in assisting us to acquire other documents. We have a list of those that we have been able to identify from studying the documents presented to us. But we want to say now that we are very grateful for the Government's position in releasing information that we could not get before. Throughout the negotiations for the Compact, we were told one thing about these tests and studies in the Marshalls when, in fact, more serious problems were known to exist in the Marshalls and known to the American negotiators who withheld it for one reason or another. We have reason to believe that not only was some of this information withheld from us, the Marshallese negotiators, but this information was also withheld from the United States Congress and the committees most directly involved with that process. And we would like to engage their help as well in trying to get this information released. We stand prepared to answer questions. CHAIRPERSON FADEN: Thank you very much, and thank you for providing us with this documentation which obviously will take us some while to go through. And you'll have to excuse the committee members. We have obviously not had a chance to go through the materials in advance of your presentation, but we all will. Are there questions for Senator deBrum or for the Ambassador? Yes, Duncan? DR. THOMAS: You referred in your presentation to a list of documents that you've become aware of as a result of plowing through this pile. I think that might be very helpful to us. SENATOR deBRUM: It's still in there. DR. THOMAS: Is that in there? SENATOR deBRUM: Yes. DR. THOMAS: Okay. In a similar vein, I notice the statement in your written document there that while DOE has been very forthcoming with documents, that you got very little from DOD. Would these be mainly in the category of things that you've requested so far without success from DOD? SENATOR deBRUM: Yes, yes. DOD has provided us a pile of documents maybe this thick compared to the boxes and boxes and boxes we've seen from DOE. But we would like to engage the Department of Defense also in this process and request that this information be provided. MR. GUTTMAN: You've obviously given the committee quite a few documents. But in your statement, you refer to the 4.1 and I just want to get clear for the record and focus the committee on what you're talking about. There's a document that's probably two-thirds of the way through that's got this 9/28 on the bottom, right-hand corner. If people can find it, I don't know how else to describe it. It's entitled -- actually there are so many markings on the front, it's not clear what it's entitled. But it's a listing or appears to be a listing. And the question, you had shown this to staff previously. People can find that. CHAIRPERSON FADEN: Just hold on a minute. It's going to be hard to find. MR. GUTTMAN: It's two before this document, "Marshall Islands Chronology". That's probably the easy way to find it -- or three before it. This appears to be, in some respects, related in document form to what we were discussing earlier, what Duncan was discussing earlier, that is to be a pre-detonation discussion of itemization of research protocol. And looking at page three under Program Four, I assume this is what you've been talking about in your testimony? It says here "Biomedical studies, Commander E.P. Cronkite, Project 4.1 Study of Response of Human Beings Exposed to Significant Beta and Gamma Radiation Due to Fall-out from High- Yield Weapons". Now obviously if you look at the document, this looks like this has been pasted on. And if you can talk about what you know about that. As I understand, you are saying this appears to be a document that was authored before the test at which this test item was then conducted. Is that -- SENATOR deBRUM: The first memo is referring to the Project 4.1 is dated 10 November 1953. The first human beings we know from the Marshalls brought in for examination/study after exposure were people from -- and Rongelap and Isaa Isaa brought in after the March 1, '54 Bravo detonation. CHAIRPERSON FADEN: So the chronology here is critical? SENATOR deBRUM: Yes. MR. GUTTMAN: But the question, this looks like it's obviously not part of the original. Do you know anymore about that document? SENATOR deBRUM: That document appears exactly as it was given to us. CHAIRPERSON FADEN: We could ask for the original. MR. GUTTMAN: I think Gil, our staff, has already maybe taken it up possibly with the Department of Energy. CHAIRPERSON FADEN: We'll see if we can't get the original. SENATOR deBRUM: We would like very much for the committee to check that out, yes. CHAIRPERSON FADEN: We'll see if we can get the original on that document. Well, there's clearly an awful lot of material here for the committee to digest and I hope you take the absence of questions as an indication of an absence on interest. It's more a matter of needing to absorb -- Jay, any question? DR. KATZ: Just to make sure that I understand it correctly, is it true that some of the Marshall Islanders, after they had been evacuated, of course wanted to return to their islands and returned to their island without being informed that there was still dangerous radioactivity levels present on the island? And they should carefully consider whether they wanted to exercise the option to return or not. SENATOR deBRUM: What you say is exactly true. Many populations will return without adequate warning as to what they will be subjected to when they returned to the islands that were already contaminated. Some islands were more contaminated than others. Rongelap, in the end, people actually asked to be removed because they were not sure they were safe where they were because of the presence of numerous cases of thyroid cancers and other problems normally related to exposure. People in the other islands of the Marshalls that were known to be exposed, that were known ahead of time would be exposed, were given no warning even. The people testing these bombs knew that the people of the Marshalls depend entirely on rain water for their drinking water. There are no rivers or well waters that you can drink in the Northern Marshalls. Yet no warning was given that rain water would become contaminated after these shots. They were washing ships that were rained on. They were washing barracks and tents that were gathering radioactive material from rain, but the people in the Marshalls were drinking this rain water and were never warned that this was dangerous. The food is the same way. Food grown in the Marshalls was subject to fall-out, but people were not ever warned about eating these materials. Fish, the same way. We have now documents included in your set which show that they knew that certain fish were already poisonous, but people were not told not to eat them. Also people of Bikini who were repatriated after it was declared safe, as you know were subsequently told to move back off Bikini because of the cesium in their bodies. The military and the DOE people at the time told us that they were adequately warned not to eat certain foods. We question that. We question that even today. In Rongelap, they were only told not to eat the coconut crab, which in the process of molting eats its own shell and therefore keeps whatever radioactive material it had before onto the next generation. And hoves, people were told not eat those, but not anything else. So people continued to become at least ingest radioactive material after that. DR. KATZ: Thank you. SENATOR deBRUM: In the case of Ailuk Island next to Utrik, it's also included in your documents, Ailuk was known to be exposed to a level where evacuation would have been advisable after Bravo, but the military upon learning that there were 400 people in Ailuk and another 42 or 87 in the other atolls decided not to move them purely for logistics purposes at the time we were told. Later studies indicated that Ailuk was, in fact, exposed to more radiation than had been originally determined, and yet no attempt was made to give treatment or any kind of examination or monitoring of that population. In the end we were told they may have been exposed to more radiation than the people of Utrik because they were kept on the island. People of Utrik were removed. CHAIRPERSON FADEN: Are there other questions? We clearly have a lot of material to absorb and I suspect that we may be coming back to you for clarification and for further cooperation. Thank you very much. SENATOR deBRUM: I failed to mention that this material that you have, I want to thank Holly Barker of the Embassy of the Marshall Islands and some of your staff people also who consented to putting it together. We are very much grateful for that. CHAIRPERSON FADEN: We are delighted to have the material. Thank you. If we can just take a minute, we'll get our next presenter. We obviously can't expect you to add, going through these materials, to your other things for this evening, but it certainly would be helpful if committee members could take a look at this in the near future and give us reaction. Our next presenter is Jonathan Weisgall, who is here. Mr. Weisgall? Please. MR. WEISGALL: Good afternoon. I'm Jonathan Weisgall. I have served as legal counsel to the people of Bikini since 1975. I wear another hat as well. I've written a book that has just come out on Operation Crossroads entitled "Operations Crossroads, the Atomic Tests at Bikini Atoll". I've worked in the Marshalls for some 20 years very closely with Senator deBrum by the way, who is an excellent spokesman for the Marshallese. I want to focus your attention in my five minutes. I've submitted about a 14-page statement, but let me hit some of the highlights as quickly as possible. And I want to focus specifically on two of the 23 atomic tests at Bikini, the 1946 Baker shot and I want to pick up on some of Senator deBrum's points on the 1954 Bravo shot. I don't want to go into too much detail on Baker. It's basically -- I've written it, but I think some of the highlights are important. I maintain in the book that men were routinely over-exposed to radiation hazards at the Baker shot. No warnings were given to any of the men. The anecdotal evidence of over-exposure at Baker, I submit, is overwhelming. And by the way, the tolerance dose, the maximum daily tolerance dose at the time was set by the Radiological Safety Director at the standard that was prevalent at the time at .1 Roentgen. There are experts here better than I. In general today we deal in REM. For the general public, the annual tolerance dose is .1 REM, which is close to what the daily maximum tolerance dose was at Bikini. I think a REM is about .78 Roentgens, so I'm off by a little bit. But order of magnitude, what was acceptable for daily tolerance of sailors at Bikini in 1946 has now been lowered by a factor of 365. And there were over-exposures at Bikini as high as 50 times the daily tolerance dose. Multiply that by 365, you've got daily over-exposures in an order of magnitude of 18,000 of what would be acceptable today. Work on certain target ships just had to be stopped due to over-exposures, different rad safe monitors wrote at the time -- and I tried to really limit myself to contemporaneous documents, not oral histories or recollections. But rad safe monitors wrote, for example, an attitude of indifference, I'm quoting, on the part of one of the ship's captains, the Prinz Eugen, where men were being exposed to 50 times the daily tolerance dose because the Captain thought that there was enough of a cushion. Another rad safe monitor wrote about what he called the "hairy-chested attitude" that he saw on the part of the Navy. There were a host of factors I think that led to this over- exposure: a huge amount of unexpected contamination due to the fact that this was an underwater shot that resulted in what was later called a base surge, a kind of rolling waves, almost like the mist at the bottom Niagara Falls, a lot of malfunctioning radiological safety equipment, shortage of monitors, failure to observe regulations, and an attitude of ignorance and indifference displayed by many of the people there. As far as this committee is concerned, I don't know if I hit every document that's available. You face the problem that a writer faces. You're getting more and more information. At some point, you've got to stop, you've got to do your work, and you've got to issue a report. Well, I had to do the same thing. There was a Medical-Legal Advisory Board set up at Crossroads. I touch on that a great deal in the book. There may be more information out there. It occurred to me today thinking about it that there may be other archives to hit. There were five or six or seven prominent physicians involved. The Chairman, a fellow named Robert Newell, and I don't know very much about him, wrote after the test that the Board, and I'm quoting, "initially served to reassure to Col. Warren" -- he was in charge of radiological safety -- "that the safety measures were such as to attract no justifiable criticism and to give what assurance was possible that no successful suits could be brought on account on the radiological hazards of Operation Crossroads". I find it interesting as well to tie this into some documents that your committee released at your June meeting, which was the establishment of this Secret Atomic Medicine Division at the Veterans Administration, staffed by the way by a lot of the doctors who were out at Bikini. And it was set up -- I say "secret" because the documents themselves say this was set up on a confidential basis. It was designed that no publicity should be given to this matter. And this was set up specifically to prepare for claims that might be brought be veterans. Well, what were the claims in 1947? I can only think of two: the Occupation Forces in Nagasaki/Hiroshima and Operation Crossroads. I know your staff is working at that. I think that's an important part of the Crossroads story. Let me turn briefly to Bravo and pick up both on some of the points raised by Duncan Thomas today and several weeks ago by Ken Feinberg in what he described as his Remedies 101 primer. It was more than a primer. In 1953, again timing chronology is absolutely important. Let's go one year before the Bravo shot. The Navy, having evacuated all the islanders for 200 miles south, west and east of Bikini, went to the other agencies of the Government in 1953, ten months before Bravo, and said, "Well, we have to establish a danger zone and we should probably move the people off of Rongelap and Ailinginae." The High Commissioner, the highest-ranking U.S. Government official was absolutely adamant in not moving more islanders off. The Bikinians had already been displaced now for eight years. They were very unhappy. And he wrote back to Washington. Again, this is February '53, 11 months before Bravo. "I urge you to do everything in your power to limit the boundaries of the danger zone to exclude any atolls or island in the Marshall Islands other than Bikini and Ailinginae." And he said, "If absolutely necessary, set the line three miles west of Ailinginae." I don't have a map here, but suffisive to say, it's very close to Rongelap. "This would avoid the necessity of informing the Marshallese of the expanded danger area and so protect them and the Administration from the results of what would be, at the very best, unsettling knowledge for them to have." I wanted to stress that because the factors that Duncan Thomas talked about, and I think you asked the right questions -- were people purposefully misled or has our knowledge changed? "This would avoid the necessity of informing the Marshallese." I want to hit briefly on this windshift you heard from Tony deBrum. After the midnight briefing, six hours before the shot, U.S. ships were told to move away from Bikini and to the south. So not only do we know that there was no windshift, measures were taken to protect some of the U.S. personnel. No measures were taken to help the Marshallese get out of harm's way. That directive for the ships to move, to me, is very telling. How did the Marshallese feel? Well again, I just want to pick a couple of documents. Late 1954, after Bravo -- this is a document I just got last week. One U.S. scientist compared some of the findings from the Bravo shot to Operation Sunshine, the test aborted fetuses in Chicago. He wrote, "I wonder whether our concepts of the sickness of the median lethal dose must be revised" and then says "the excessive fall-out from Bravo shot indicates to me that if anything, the Sunshine estimates of the strontium 90 uptakes by human beings is not exaggerated." Again, at some point, I think the line blurs between whether the Marshallese were victims of a deliberate design to be tested and what they ended up being. What they ended up being were subjects of an experiment. Another example, and your committee has the minutes of the 1956 AEC meeting with Dr. Merrill Eisenbud saying, and I'm quoting "Utrik is by far the most contaminated place in the world and it will be very interesting to go back and get some good environmental data." Professor Katz, I think this responds to your question of -- I mean, I think if the people from Utrik were told that this was the AEC view that their atoll is the most contaminated in the world and it would be a great place to do some studies, they might have thought twice about going back. My clients, the Bikinians, this is not limited to the 1940's, 1950's and 1960's. The Bikinians were back at Bikini in the 1970's. Lawrenceally to prepare for claims that might be brought be veterans. Well, what were the claims in 1947? I can only think of two: the Occupation Forces in Nagasaki/Hiroshima and Operation Crossroads. I know your staff is working at that. I think that's an important part of the Crossroads story. Let me turn briefly to Bravo and pick up both on some of the points raised by Duncan Thomas today and several weeks ago by Ken Feinberg in what he described as his Remedies 101 primer. It was more than a primer. In 1953, again timing chronology is absolutely important. Let's go one year before the Bravo shot. The Navy, having evacuated all the islanders for 200 miles south, west and east of Bikini, went to the other agencies of the Government in 1953, ten months before Bravo, and said, "Well, we have to establish a danger zone and we should probably move the people off of Rongelap and Ailinginae." The High Commissioner, the highest-ranking U.S. Government official was absolutely adamant in not moving more islanders off. The Bikinians had already been displaced now for eight years. They were very unhappy. And he wrote back to Washington. Again, this is February '53, 11 months before Bravo. "I urge you to do everything in your power to limit the boundaries of the danger zone to exclude any atolls or island in the Marshall Islands other than Bikini and Ailinginae." And he said, "If absolutely necessary, set the line three miles west of Ailinginae." I don't have a map here, but suffisive to say, it's very close to Rongelap. "This would avoid the necessity of informing the Marshallese of the expanded danger area and so protect them and the Administration from the results of what would be, at the very best, unsettling knowledge for them to have." I wanted to stress that because the factors that Duncan Thomas talked about, and I think you asked the right questions -- were people purposefully misled or has our knowledge changed? "This would avoid the necessity of informing the Marshallese." I want to hit briefly on this windshift you heard from Tony deBrum. After the midnight briefing, six hours before the shot, U.S. ships were told to move away from Bikini and to the south. So not only do we know that there was no windshift, measures were taken to protect some of the U.S. personnel. No measures were taken to help the Marshallese get out of harm's way. That directive for the ships to move, to me, is very telling. How did the Marshallese feel? Well again, I just want to pick a couple of documents. Late 1954, after Bravo -- this is a document I just got last week. One U.S. scientist compared some of the findings from the Bravo shot to Operation Sunshine, the test aborted fetuses in Chicago. He wrote, "I wonder whether our concepts of the sickness of the median lethal dose must be revised" and then says "the excessive fall-out from Bravo shot indicates to me that if anything, the Sunshine estimates of the strontium 90 uptakes by human beings is not exaggerated." Again, at some point, I think the line blurs between whether the Marshallese were victims of a deliberate design to be tested and what they ended up being. What they ended up being were subjects of an experiment. Another example, and your committee has the minutes of the 1956 AEC meeting with Dr. Merrill Eisenbud saying, and I'm quoting "Utrik is by far the most contaminated place in the world and it will be very interesting to go back and get some good environmental data." Professor Katz, I think this responds to your question of -- I mean, I think if the people from Utrik were told that this was the AEC view that their atoll is the most contaminated in the world and it would be a great place to do some studies, they might have thought twice about going back. My clients, the Bikinians, this is not limited to the 1940's, 1950's and 1960's. The Bikinians were back at Bikini in the 1970's. Lawrence Livermore writes in 1976 that Bikini Atoll may be, and I'm quoting, "the only global source of data on humans where intake via ingestion is thought to contribute the major fraction of plutonium body burden. It is possibly the best available source of data for evaluating the transfer of plutonium across the gut wall." That led the Bikinians themselves to find a lawyer and sue the U.S. Government and, of course, they had to be moved off. Let me in one minute -- CHAIRPERSON FADEN: One minute, thank you. What you're saying, of course, is of great interest to the committee. I'm just trying to follow the committee's rules and give the committee a chance to ask you some questions. MR. WEISGALL: Let me talk remedies. I talk a lot about the Bikinians and the other Marshallese. I think there's a need to have the Bikinians under Brookhaven. They were exposed in the 70's to low levels. They need more assistance on radiological clean-up matters. There are other problems at Rongelap and Eniwetok and Utrik. I think there's a very serious problem with the veterans. They now have to go through dose reconstructions. Those are very expensive tests. They are run by the Government. Less than 100 veterans have recovered using this particular method, and I believe less than 1,500 have actually recovered from the VA for radiation-related diseases. I think as you look at remedies, you ought to consider a recommendation to Congress to can the dose reconstruction issue altogether. It doesn't really do much and the radial -- even Stafford Warren said at Bikini at the time, "You can't say how much exposure any one sailor got at any one particular time. One guy could be sleeping three feet away from another and could have had a radically different amount of radioactive material absorbed because of the way those fission products acted." For the veterans, I think there's some other recommendations the committee can think about. They don't cost too much money. I think they're psychologically important. An apology from this country, much like we did with the Japanese internese, the thanks of this country, and perhaps even something like a monument to atomic veterans. Sometimes that means a lot more than dollars. The rest is in the written statement and I'd be prepared to answer any questions you have. CHAIRPERSON FADEN: Thank you very much. Have we questions? Questions for Mr. Weisgall? Eli? DR. GLATSTEIN: Let me just ask, you mentioned something about a tolerance dose. What was the figure you gave? MR. WEISGALL: At the time, .1 Roentgen. DR. GLATSTEIN: And what does tolerance mean? MR. WEISGALL: This was what was established by the Radiological Safety Head at Operation Crossroads for the maximum exposure for a sailor or anyone else at Bikini for one day, maximum daily tolerance dose was the way it was referred to. DR. GLATSTEIN: Can you get that baseline information for us, please? MR. WEISGALL: Absolutely. You can get it right out of the index of the book. I've provided that. DR. GLATSTEIN: Can you get the reference source for that, please? MR. WEISGALL: Yes. I believe that that actually came from what was the 1934 national -- the precursor maybe to the Bureau of Standards, but that was what was prevalent at the time. I don't know how good an index I've got here. I'll test it. Tolerance dose -- bear with me. DR. ROYAL: Eli, what I think that refers to is the occupational exposure limit that was in effect at the time. MR. WEISGALL: That's right. DR. GLATSTEIN: Occupational, not tolerance. MR. WEISGALL: Correct, yes. DR. ROYAL: Well, what we would call occupational exposure limit. MR. WEISGALL: Occupation exposure. This had been set in 1934 by the National Bureau of Standards for manufacturing plants in the United States. DR. GLATSTEIN: All right, but that does not have reference to some physiological limitation. MR. WEISGALL: No. DR. GLATSTEIN: Okay. MR. WEISGALL: In fact, the Roentgen was a different unit of measurement. CHAIRPERSON FADEN: We've got Henry and then Pat. DR. ROYAL: Could you give us some idea of the number of Marshall Islanders that may have been affected and also the number of veterans? MR. WEISGALL: Marshall Islanders, 239 I think represents the total from Rongelap and Utrik who were actually evacuated by Bravo. You heard from Senator deBrum, there were 420 people on Ailinginae who were not evacuated. The Bikinians today number nearly 2,000, but there were never more than about 140 at time living back on Bikini in the 1970's. So that's rough numbers. Veterans, it's very hard. There were 40,000 sailors and 42,000 men at Crossroads. By my count, there were as many as 16,000 sailors involved in the actual decontamination efforts of the ships after the Baker shot and that, to me, was the danger part, so as high as 16,000. CHAIRPERSON FADEN: Henry, one more and then to Pat. DR. ROYAL: Yes, the other question I have is the Government was very interested in the effects of radiation and I would have thought that if they had an operation that involved exposure of human beings to radiation that they would want to have accurate measurements of what their dose was so that they could learn something scientifically, that they would have regarded this as an experiment of opportunity, I think that's what we call it now. But you're suggesting that the information was not collected. MR. WEISGALL: They did have -- again, I'm flipping through as quickly as I can. I don't want to take your time. There were some badges at Operation Crossroads. I believe -- I think I'm right on this number, that there were never more than about 8,000 total badges used out of 42,000 participants and they were in their infancy at the time. I spent some time talking about the equipment used at Crossroads, much of which was criticized at the time for being faulty. But as many as 8,000 men may have been badged, although it is not clear that anyone was badged for the entire three-week period that was the most critical right after the Baker shot. CHAIRPERSON FADEN: Pat? MS. KING: I find very intriguing the idea that a monument, a national apology, could be placed in the rank of remedies. It has been something that I've thought about myself. When you reflect on the Vietnam War Memorial, for example, and what a healing role it plays. While it is difficult to advocate that as a part of a remedies package, as a lawyer I also know people think in terms of remedies as money. I would be very interested to know where we could find some support or where you get some support for the statements that some of these more intangible ideas, which I think carry great weight, might be of service to us other than your intuition which is very much like my own. MR. WEISGALL: Several come to mind. I believe that the legislation -- you've got it and Ken gave you an awfully good lecture a couple of weeks ago. MS. KING: I was not here. That's why -- MR. WEISGALL: But on the Japanese internees, I believe the legislation actually has a formal apology in it. MS. KING: Yes, it does. MR. WEISGALL: And I think it's either the Radiation Exposure Compensation Act or another one has similar language. I mean, the Congress apologizes. And yes, I mean look, this is me, private citizen, talking as a remedy. Sure, monuments don't do what money does, but I've been to the Vietnam Memorial enough times to see that the effect that has is extraordinary. And in talking to veterans -- and believe me, I get a call or a letter just about one or two a day now with this book, these people, they really want recognition and the widows, they want the facts. It's as if your husband died in an automobile accident in Belgium or something and you just want to know what happened. These widows want to know -- he flew through the cloud. I just want the information. I want to know what happened to him. CHAIRPERSON FADEN: Any other questions? We'll circulate your statement, Mr. Weisgall, to everybody on the committee. We don't all have it, but we appreciate it very much. MR. WEISGALL: My pleasure, thank you. CHAIRPERSON FADEN: Thank you. We have a third presenter, Mr. Cooper Brown, from the National Committee of Radiation Victims who has presented to us once before and is back again. MR. BROWN: Madame Chair, thank you for having me back again. I want to, on behalf of not just the National Committee for Radiation Victims, but also a recently-formed Citizen's Task Force that we were involved in helping set up that represents the experiment victims, those that we know of to date. I would like to make an appeal today to the Advisory Committee on their behalf to address the issue of remedies. And well I should add too, I have a couple of responses to a couple of the questions that were just asked, but perhaps I should get through the thrust of what I wanted to say first. With the exception of perhaps a couple of concluding comments on the Marshall Islands, the purpose of my then appearing before the Advisory Committee today is to stress what we see as the absolute need for an assessment, if not a judgement, from or by the Advisory Committee as to the remedy or remedies that would be considered just for the experiment victims. And before I get into the reasons for that, just briefly about myself. I have been involved in representing victims of the nuclear weapons testing before Congress and in the Courts since 1980, and I believe I know of what I speak when I get into this issue of remedies. And I don't want to discuss what types of remedies are necessary or should be considered at this point. I'd like to reserve that to a later date, but rather to discuss with you why the real need for this committee to get involved in this issue. Basically, we have two forms for providing relief to victims and their families. One is through the Courts and another is through either an existing or a to-be-established administrative agency. Now for either of those to serve as a meaningful forum, action by the Congress will be required. The flip side to that, of course, is -- and which I want to discuss in a little more detail here, is that Congress can and has in the past served as a useful impediment to access to justice. Based on my experience through the National Committee for Radiation Victims and also as a private practitioner for the last 12 years, I can tell you, and this is probably no surprise to most who are sitting here, is Congress has, on more than one occasion, succumbed to influences and forces who may and more often have not had the best interest of the victims at heart. And the examples: the forces or interests that -- these forces and interests have taken various forms and one obviously is the national security interest as defined by Government bodies. And when we knew that we were up against something most unusual was in 1981, Congress was on the verge of passing a relatively innocuous reform to VA health care provisions, the General Counsel to the Defense Department, at that time a Mr. William B. Taft IV, sent a letter to Sonny Montgomery in which he says -- they list a whole bunch of reasons why they're opposed to it, but at the end, "We are more concerned", and I'm quoting, "that Section III of the Senate Pass Bill creates the unmistakable impression that exposure to low level ionizing radiation is a significant health hazard. "This mistaken impression has the potential to be seriously damaging to every aspect to the Department of Defense's Nuclear Weapons and Nuclear Propulsion Programs. The legislation could adversely affect our relations with our European allies, impact upon the civilian nuclear power industry and raise questions regarding the use of radioactive substances in medical diagnosis and treatment." Right there in sum was the definition of the National Security interest that the atomic veterans then had to struggle through. Needless to say, the Health Care Bill passed and none of that came to fruition. Nevertheless, it's a concern that we're going to be up against here. Another interesting form of national security is one that is defined by powerful private industries and institutions, and most notorious was the 1984 passage of what has become known as the Warner Amendment, which I won't get into any detail here other than to say what it succeeded in doing was absolving the private contractors from liability in lawsuits brought by the atomic veterans. It's interesting that something like the Congress would feel compelled to pass something like that when the Courts have already created a defense for a contractor that's merely doing the bidding of the Government. Nevertheless, that bill was passed and another way that this will arise is that limitations will be imposed. This happened with the Radiation Exposure Compensation Act. Two categories of cancers or other identifiable medical problems -- this happened in RECA when the Senate succumbed to pressure from the nuclear industry to attach limiting factors to the list of cancers that were identified as compensable. You also have -- the radiation victims, the experiment victims may be up against what I refer to as the power of vested institutions. Part of this comes in the form of Congressional committees fighting over, trying to protect their turf and you also get into this problem where private institutions, who actually pretend to represent a category or group of victims, are seeking to protect their own interests. And this, for us, was most noticeable when the atomic veterans were seeking relief outside of the VA system and the powerful veterans groups were fighting to keep and contain the whole issue inside of the VA process. Interestingly, the Radiation Exposure Compensation Act has provisions for atomic veterans outside of the VA system. The only reason that happened was really thanks to AT&T and the University of California who snuck this through the House Armed Services Committees in conference as a way of preventing the Warner Amendment from being repealed. The veterans groups didn't know about it. The Administration didn't know about it. It just happened. And then you have an interesting phenomena which I call the power of the vocal constituent combined with the influence of the well-timed amendment. I don't know if anybody has looked at the list of cancers that are, for example, in PL 100-321, but it sort of departs from -- and other standards, acceptable scientific standards, about what is and what is not a radiation-related cancer. And the reason for that, quite frankly, is the squeaky wheel gets the grease. And then, of course, there are the budget constraints, and this was most noticeable in the $50,000 awarded to the Utah Fall-out victims. There's a lot of nice reasons and rationales that have been extended as to why folks only got $50,000 for a cancer death under RECA. The reality is they were up against the budget and they had to do something. And the other limitation and concern is that when you strive for a limited -- like a global award and you're looking for a limitation, as was the case in the Marshall Islands, which leads to a final example and a concern. That is, there will be the desire, both institutionally and just simply I think a matter of human response to an issue like this, to bring closure to this kind of an issue. This happened in the Marshall Islands settlement. The end result was unfortunately not enough money provided. The extent of the damage was far greater than anybody had ever anticipated. And so whereas statutorily a leukemia death might be entitled to $100,000 compensation award, folks in the Marshall Islands are getting less than 50 cents on the dollar. In any event, that sort of -- quickly, I'll try to put this together in writing and present it for further consideration. But basically the bottom line on all of this is that if the experiment victims and their families are left to the benevolence of the Congress without the assistance of this Advisory Committee, I fear for what they're going to see in the end. CHAIRPERSON FADEN: Thank you. MR. BROWN: I want to just make a couple of comments about the Marshall Islands. CHAIRPERSON FADEN: We have a problem because we're past the time limit. So maybe we can see if anybody would like to ask you a question about that. MR. BROWN: Okay, thank you. CHAIRPERSON FADEN: But thank you, Mr. Brown. Are there questions? DR. KATZ: One question or request if it's possible. In the light of your great experience in these matters, could you give us sort of an estimate when you write to us about how many persons might, in your opinion, qualify for compensation? How much compensation for general kinds of categories and an estimate as to what the total cost might be? Might that be possible? MR. BROWN: You're question is something that I've studiously tried to avoid because I feel it's too early in the process to know. And also, I feel that it would be presumptive on my part to speak on behalf of the victims community when they have yet wrestled this issue to the ground themselves. So with all due respect, I would like to dodge that question for the time being, but at some point, certainly we will be in the position to I think at least provide two cents worth on the matter. CHAIRPERSON FADEN: Are there other questions? Henry? DR. ROYAL: What was the size of the Marshall Islands settlement? MR. BROWN: The Marshall Islands settlement, they set up a $150 million trust fund, which was then charged with accumulating $18 million a year in interest, which it never has made on the $150,000. They pay out $18 million a year in awards over a 15-year lifespan. So you've got a $270 million pay-out. The remainder of the principal then reverts to the Marshall Islands Government to be used as they see fit. The projections are that there will be less than $30 million in the account at the end of 15 years because they've been drawing down more -- they've been basically having to tap into principal in order to meet that $18 million a year pay-out. So it's a little complicated, but from Congress' perspective, it was $150 million and supposedly the end of discussion. Just one comment, if I may. This ties in with something that Ken Feinberg had said earlier with this mass exposures. CHAIRPERSON FADEN: We need to close in one minute, so if you can do it one minute, that would be great. MR. BROWN: I'll try and list. The comment was made on the need to focus on readily available documents and information in the mass exposures. I'm really afraid that that does not and will not work in the Marshall Islands context because a lot of the information is sitting up at Brookhaven, formerly NRDL, and there has been no access to those medical records. The few that we've seen, at one time, were classified. I know that in the -- when I was representing some of the folks before the Nuclear Claims Tribunal, we made -- since we knew they were doing chromosome testing on the people, some of the clients made requests for that information. They were directed by one of the judges at the Nuclear Claims Tribunal who used to be in the General Counsel's Office at the NRC not to get into that stuff, so they intentionally avoided it. And there's some other questions about chelating experiments and other things that were going on, being conducted by Brookhaven. And none of that stuff has been seen. So if you say, "We're only going to look at what is already out there", we've missed the whole point with the Marshall Islands. CHAIRPERSON FADEN: It would be helpful if you would include those observations in what you send us subsequently. That would be very helpful. MR. BROWN: Thank you again. CHAIRPERSON FADEN: Well, thank you, Mr. Brown. We're done, folks, but only until tomorrow morning. (Whereupon, the public meeting was adjourned for the day at 4:58 p.m., to be resumed at 9:00 a.m., the following morning, Wednesday, July 6, 1994.) ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + PUBLIC MEETING + + + + WEDNESDAY, JULY 6, 1994 + + + + The Committee met in Ballroom A, Vista Hotel, 1400 M Street, N.W., Washington, D.C. at 9:00 a.m., RUTH FADEN, Chair, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H., Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. SUSAN E. LEDERER, Ph.D. LOIS L. NORRIS NAld said "That was good, Mom" and he pulls up his sleeve. We had the reaction of the rest of the American public. This is really lively stuff. But, in any event, it was kind of nice. We have a really packed day. And so I think it behooves us to get started efficiently. APPROVAL OF MINUTES OF JUNE 13-14 MEETING CHAIRPERSON FADEN: The first thing on the agenda is a call for approval of the minutes. I hope you had better luck than I did. The minutes were in your blue packets. Let me just ask if there are any -- a little short-cutting of Robert's Rules here. Are there any amendments, corrections, additions, changes to the minutes? Nancy? DR. OLEINICK: I have just an extremely small point. Steve Klaidman gave a very nice presentation. Are we calling that risk assessment or risk communication? Communication. Okay. CHAIRPERSON FADEN: We should change that. DR. OLEINICK: That's what I thought. You weren't really assessing the risk, but talking about how the public perceives it. CHAIRPERSON FADEN: I assume that Nancy's correction, recommended correction, to change the title of Steve's talk is acceptable. It's certainly correct. Okay. Thank you, Nancy. I'm always impressed when people actually read minutes. This was restful? Oh, really? It's like: Who reads minutes? Only I have to read them because I have to sign off on them. I'm delighted if any of my colleagues read them as well. That's great. Any other corrections, amendments, changes? Usually people note if they've been marked absent when they've been present. Those are the sorts of things that you generally hear from when you ask for corrections to the minutes, "I really was here. You put me down as absent." All right. I will take it that the minutes of the June 13th and 14th meeting are approved. We are going to have the next in our series of continuing education presentations this morning. And Jay is going to educate us about the history of human experimentation. Thank you. Can you get over the obstacle course? DR. KATZ: Yes. Thank you, Ruth. BRIEFING: HISTORY OF HUMAN EXPERIMENTATION (TAB F) DR. KATZ: I've assigned myself three tasks. I'll try to, of course, be as brief as possible. One is to present to you with some commentary the more significant dates in the history of the regulation of human experimentation; two, to make some comments on the inherent tension in the conduct of research; and, finally, to share with you, albeit most briefly, some of the lessons that I have learned during my 30 years' reflection on this history and the implications for the future regulation of human research. So first the dates. In my prepared comments, which I hope will be eventually distributed to the Committee, I made some more extensive commentaries on the wonderful presentation of Susan Lederer's. And here because of the constraints of time, I only want to highlight one of the things that she told us during her presentation, namely, and I quote, "that many physicians believe that introducing an explicit requirement for consent would interfere not only with the practice of medicine, but also with the progress of medical science," end quote. I think in a few words and with an economy of words, she captured one of the most important problems inherent in human research, to which I will come back again and again during this talk, because Susan alerts us here to the fact that investigators' concern that an abiding commitment to informed consent has far-reaching implications for the physician-patient relationship as well as for the conduct of research. And I believe that to this date, these concerns still pervade what is going on in human experimentation. Now to the dates: first, 1803. Thomas Percival at the request of the Manchester Infirmary of England published his code of medical ethics which with minor modifications became in 1947 the American Medical Association's first code of medical ethics. Percival appreciated that medicine must develop innovative therapies in order to advance medical practice and admonish physicians only that in doing so, quote, "The gentlemen of the faculty should be scrupulously and conscientiously governed by sound reason, just analogy, or well-authenticated fact," end quote. He said nothing about consent. Indeed, he commanded patients that, quote, "their obedience to the prescriptions of their physicians should be prompt and implicit. They should never permit their own crude opinions as to their fitness to influence the attention to them," end quote. The AMA's code incorporated these instructions to patients. It omitted any reference to the ethics of innovative treatment or to human experimentation. Eighteen thirty-three, William Beaumont's code, which Susan did discuss. Three, 1865, Claude Bernard laid down his principles for the ethical pursuits of human experimentation. He enjoined the medical profession from doing anything that may be harmful to patients. Bernard limited his focus to situations in which patient care, innovative therapy, and therapeutic experimentation become merged, excluding from consideration non-therapeutic research. Throughout he said nothing about patient subject consent. Four, 1900. The Prussian Minister of Religious, Educational, and Medical Affairs' directive on human experimentation may be the first regulatory action that specifically addressed human experimentation. It set forth that research is prohibited unless, quote, "the person concerned has been clear unequivocally that he consents to the intervention," end quote. In 1931 the German Reich Minister of the Interior promulgated regulations which were even more stringent and comprehensive than the Nuremberg Code. And I will not say more about these interesting historical events except they demonstrate to my satisfactions that we shouldn't pay too much attention to codes of ethics. They are largely being regarded. Codes of ethics are written to the stars and to the heavens, and they only require meaning if they are surrounded by detailed commentary. Remember what Rabbi Hillel said when a pagan said, "If you can tell me the essence of Judaism while standing on one leg, then I will join your religion." Rabbi Hillel thought for a moment, stood on one leg, and said, "Do unto others as you do unto yourself. The rest is just commentary. Go and learn it." It's the going and learning it which is the important issue, not the prescription. And let me here only observe in passing because Susan talked about it at some length that, really, these kinds of principles were disregarded by the European and American research profession. In the mid-Nineteenth Century, to add just one example, a famous investigator wrote this in an article published in a major scientific journal, quote, "Perhaps others will not be restrained from making further experiments often leading to the complete wrecking of the lives of the persons subjected to them. "It would add considerably to my peace of mind in respect to the victims' state if these experiments were to spread the conviction" -- that's his experiments -- "that the secondary stage is contagious if they lead to the establishing of such an important truth, the suffering of a few individuals were not too high a price to be paid by mankind," by mankind, mind you, "for the attainment of such a truly beneficial and practical result," end quote. Nineteen forty-seven, the Nuremberg Code. Since many of you have read my article on -- I hope that some of you have read my article on the consent principle of the Nuremberg Code. Therefore, I shall limit myself to the briefest of observations. Never before in the history of human experimentation, again, of course, except for the 1900 and 1931-1930 German regulations, and never since has any code or regulation put it so uncompromisingly, quote, "The voluntary consent of the human subject is absolutely essential," end quote. But there is more. Principally one of the codes then immediately goes on to emphasize not the subjects' capacities to understand, but the investigators' obligation to desist from introducing into the consent process, quote, "any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraints or coercion," end quote. The judges of the Allied military tribunal, thus, placed the emphasis where it first belongs, on the physician investigator, and not on the patient subjects, who are so frequently not only mistreated but then further degraded by allegations that they are too anxiety-ridden, too ignorant, too stupid to understand. The Nuremberg judges did not appreciate the code's radical break with the past. Indeed, before setting forth their 10 principles the court observed that even, quote, "The protagonists of human experimentation agree that certain basic principles must be observed in order to satisfy moral, ethical, and legal concepts," end quote, and that, therefore, their code only lists them once again. The tribunal had done more than that. Perhaps it was misled by the prosecution's chief medical witnesses and Alexander Ivy and Leo Alexander. Particularly Ivy invoked again and again the authority of the Hippocratic oath for the proper conduct of research since it is, and I quote here Ivy, "the golden rule of the medical profession necessary for the survival of the scientific and technical philosophy of medicine," end quote. He was quite actually disingenuous in what he had done because he averred that these principles had been accepted by the American Medical Association. On cross-examination, however, the defense made him admit that the guidelines Ivy cited in his June 1947 testimony had been published only 19 days after the prosecution's opening arguments. It is most likely that Ivy, who had studied the prosecution's pretrial records, reported his views on the ethics of medical experimentation to the AMA's Board of Trustees, who then, in turn, quickly issued their guidelines. Seven, 1969. The Nuremberg Code was superseded by the World Medical Association's Declaration of Helsinki, which was revised twice. The requirement of informed consent is much less stringently reworded in Helsinki one than in the Nuremberg Code. It is not even listed as a basic principle. To be sure, the Nuremberg Code requires modification, particularly with regard to research with children and mentally incompetent patients. But here is my question: Should its first principle have retained its majestic force? Eight, 1962. In the wake of the Thalidomide tragedy, extensive congressional hearings were held on the adequacy of the then existing FDA regulations. Eventually they were revised, now requiring investigators to obtain the consent of human subjects in research with investigational drugs unless the investigators believed that obtaining consent was not feasible or in their professional judgment contrary to the best interests of such human beings. The Lord giveth, and the Lord taketh away. The ambiguous language of these new consent provisions was never clarified, thus inviting wide variations in the application of the law. In 1966, following the revelations of the Jewish Chronic Disease Hospital in Brooklyn, Brooklyn's experiments, during which elderly patients were injected with cancer cells to study the rate of rejection of live cancer cells in the wake of these revelations, the FDA regulations on consent were once again tightened. But old problems remained. Let me only mention two: one, in abrogating the investigators' authority to dispense with consent on grounds that, quote, "the best interests," end quote, of patients required them to do so and in not doing so, doctors continued to wear two hats, that of investigator and that of physician for the patient; two, omitting patients in coma or otherwise incapable of giving consent to be enrolled in studies, sanctioned experiments, and seriously ill and terminally ill patients, even those in coma or close to death. Nine, 1966, following a series of preliminary policy statements, the Surgeon General, William Stewart, issued three key guidelines which from then on should govern the conduct of human research of grantee institutions. The guidelines were to assure that: one, the rights involved here of research subjects would be protected; two, investigators would obtain informed consent; and, three, the risks and potential benefits of the investigations would be assessed. The implementation of these guidelines were vested in a review panel of investigators' peers at the research institutions. The number of lay members serving on these panels was not clearly specified. Institutional assurances of compliance with the guidelines were mandated. The third guideline, calling for the establishment of what are now called institutional review boards, was most novel in scope. Moreover, it established the policy that the local research community should administer and review its own research practices in compliance with any regulations promulgated by PHS or NIH. Ten, 1972. As is often the case, the right hand does not know what its left hand is doing. In this instance, while NIH, PHS debated the scope of the new regulations, the PHS did not reevaluate its Tuskegee syphilis study to determine that the study was in compliance with its guidelines. The study continued for six more years, when it became a cost liability, and then was quickly terminated. The facts of the study are well-known to you, and I will not give you any details except to remind you that the study started before the Nazi concentration camps, continued once the Nuremberg Code had been promulgated and did so for 25 more years. In the final report of the Tuskegee syphilis study ad hoc advisory committee, we also made extensive recommendations for the future regulations of research. The cornerstone of our proposal was the establishment of a national human investigation board. Senator Kennedy introduced a bill that incorporated that idea, but it died in committee. And at various congressional hearings that Senator Kennedy held, representatives of HEW argued that the department was in the process of drafting new regulations for the protection of subjects of research and that, therefore, it was not necessary to go as far as the Tuskegee syphilis study ad hoc advisory committee wanted to go. Among recommendations that they were most troubled by, it seems to me, was that we wanted that board to be independent of NIH and PHS. And they wanted to retain authority over the ethical review of research practices. Eleven, 1974. The publicity surrounding the Tuskegee syphilis study led to the federal regulations for the protection of subjects of research. These regulations strengthen the role of local institutional review boards in supervising the conduct of research, requiring them to be in compliance with the new federal mandate. Generally the IRBs were required to determine that the risks to the subjects be minimized and be reasonable in relation to anticipated benefits, that the selection of subjects be equitable, and that appropriate informed consent be obtained and documented. Separate specific regulations also provided additional protection to any research activities that involved fetuses, pregnant women, prisoners, and children. Actually, they came a few years later. IRBs were also charged to report violations of the regulations to the government, but otherwise no formal mechanisms were put in place whereby the activities of IRBs or investigators would be monitored by the federal government. Initially the regulations applied only to research funded by HEW. Twelve, 1975. Senator Kennedy, once his bill on establishing a national human education board proved unacceptable to Congress, introduced another bill that created a national commission for the protection of human subjects of biomedical and behavioral research, which was inter alia charged to identify basic ethical principles that should underlie the conduct of human subjects research. In 1978 the commission published its Belmont report on the ethical principles and guidelines for the protection of human subjects. I shall comment on that report very briefly later on. Nineteen ninety-one. The federal regulations were amended to include all research involving human subjects conducted or supported or otherwise subjected to regulation by any federal department or agency. And then, last, 1994. There are a number of bills being drafted on refining the regulations on human research. Again, I will just say a few words, and I have a little bit more to say about it in my report. There are three other historical facts that should be mentioned here. One is that common law judges have really made few pronouncements over the centuries on the conduct of research. Put most briefly, what common law judges have said is that they believe that human experimentation was necessary, talking mainly, really, about innovative therapies, rather than human experimentation in the ways in which we talk about it now. And they then added that either that kind of investigative activity must not depart too much from common medical practices or to say to doctors when they didn't like it, "Look, you do these things at your peril. Unless you prove the success of your treatment or of your innovative treatments, then you may have to face some unspecified legal consequences." Two, I should say something more about the history of informed consent. That is the reason why I included the second article of mine in the materials distributed to you. Let me just only emphasize once again what I've said there, that, really, it must be remembered that the doctrine of informed consent cannot easily be transformed, and surely not without considerable thought, into an ethical medical doctrine that should govern physicians' and physician investigators' disclosure and consent obligations in their interactions with patients and patient subjects. Recall that the idea of patient economy is not to be found in the lexicon of medicine throughout the millennia of Hippocratic practices and that it only surfaced in medical discourse once informed consent was imposed upon medicine by alien common law judges, you might say by barbarian common law judges. Three, I should say something about the few comments in a handful of cases made by federal judges about the conduct of research. Again, in my prepared version I've included one case: the LSD experiments conducted by the CIA with completely uninformed Army personnel. When one of these cases ultimately ended up before the Supreme Court, Justice Scalia writing for the majority concluded that permitting Stanley even to sue the Army would, quote, "call into question military discipline and decision-making." The two eloquent dissents would have some implications for our work. Justice O'Connor after referring to the Nuremberg Code and its first principle went on to say that, quote, "If this principle is violated, the least society can do is to see that the victims are compensated as best they can be by the perpetrators. I'm prepared to say that our Constitution's promise of due process of law guarantees this much," end quote. And Justice Brennan concluded his dissent with these words, quote, "The subject of experimentation who has not volunteered is treated as an object example. Soldiers ought not be asked to defend a Constitution indifferent to their essential human dignity," end quote. While this completes my sketchy account of the history, let me remind you that Susan commented on the fact that throughout this history, some investigators, like Walter Reed and such giants of medicine as Walter Cannon and Sir William Osler, spoke eloquently to the need of obtaining patient subjects' consent. But whatever the impact of these lonely voices, the fact is clear that neither academic medicine nor the research community has taken the time to explore in any systematic way its obligations to subjects of research. When I arrived on the scene in the early 1960s and began to teach in the area of human experimentation, any literature on the subject barely existed. Henry Beecher would soon in 1966 publish his seminal article on ethics in clinical research, which for years exposed him to considerable criticism and to little praise. Again, I have some comments on the Jewish Chronic Disease Hospital case, which illustrated some of my comments. But I will omit them at this time and hopefully will read it in my comments in the next few weeks. Reading of the Jewish Chronic Disease Hospital case -- by the way, Sullivan, who was a chief investigator in the cancer injection experiments, received the most minimal kinds of sanctions by the Board of Regents of the State of New York. And there was a rainbow on the horizon because the following year the American Association of Cancer Research elected him vice president of the association and a year later its president, for whatever reasons. Reading of the entire case illustrates the license physicians have taken in the past with respect to disclosure and consent in therapeutic settings and how readily such license is extended to research practices. Clearly, at least until the mid 1970s, informed consent was not taken very seriously by the medical profession and the medical research community. Now to point Part 2. Here I must paint with an even broader brush, and I want to bring three issues to your attention with respect to the tensions inherent in human research. One is the obfuscation of therapy and research. Susan correctly observed that experimentation in medicine dates back to antiquity. Though with exceptions until the age of medical science research was by and large conducted at the bedside with physicians trying their best to learn more about the treatment of disease and at the same time to benefit the patients under their care, human experimentation as we know it today is a creature of the scientific revolution which created a new breed of physician investigators during the mid 1850s. And their activities expanded in exponential fashion following World War II. Yet, despite a radical transformation, which enlisted patients to serve the ends of science, physician investigators continued to view patient subjects more as patients than as subjects. And having been socialized as physicians first, they did not take disclosure and consent very seriously. After all, throughout medical history patients had been deemed too ignorant to understand medicine's esoteric knowledge. And patient subjects were considered even more incompetent to understand the intricacies of scientific investigations. Thus, having been acculturated as physicians to exercise considerable authority over the medical decision-making process, they extended this authority to research. In the process, they overlooked that whatever mandate they enjoyed to make decisions on behalf of patients when solely committed to their patients' interests could not necessarily be transferred to research settings where human beings were also used as means for other ends. Consider Tuskegee. Consider Fernald. By what authority could these subjects have been used for science's purposes? Since our charge to investigate human radiation research takes us back to the 1940s, let me also remind you that the doctrine of informed consent was only promulgated in 1957 and did not receive its first more detailed, though inadequate, construction until 1960. In that case, decided by the Kansas Supreme Court, the standard for disclosure was based on, quote, "the reasonable physician standard," end quote; that is, disclosures customarily made by physicians. This, as others and I have argued, is no standard at all since physicians are most apt to follow the Hippocratic command, quote, "to conceal most things from the patient while attending to him, to give necessary orders with cheerfulness and serenity, revealing nothing of the patient's future or present condition," end quote. It was not until 1972 that Judge Robinson, III of the D.C. Court of Appeals announced that in his jurisdictions, now followed by many others, informed consent must be based on a standard set by law. He correctly noted that maintaining a medical disclosure standard would make informed consent meaningless or worse, quote, "We sense the danger that what, in fact, is no custom at all may be taken as an affirmative custom to maintain silence," end quote. This needed to be said, let me remind you, in 1972. Thus, when we evaluate the status of informed consent before the mid 1970s, we must keep in mind that no legal and surely no medical standards existed which in any way could be considered as giving any complete meaning to physicians' obligations to make disclosure for therapy or research. The Nuremberg Code comes closest to doing so. In short, at least until the mid 1970s, it was the ideology of medical professionalism, its benevolent paternalism, that shaped decisively disclosure and consent practices for therapeutic research. Indeed, from the perspective of human rights, disclosure and consent practices became further undermined once the ideology of science joined the ideology of professionalism. The quest of so-called value-free science to add advanced knowledge for the benefit of all mankind readily subverted other moral values; for example, the inviolability of human beings to unconsented invasions of their physical integrity. Two, second tension, the involvement of the state. Until World War II medical research was largely conducted by physicians. The state had little interest in getting actively involved in research. Susan may correct me, but am I right in saying that the malaria experiments were more the brainchild of the physician Walter Reed than the Army high command. Even the Nazi concentration camp experiments began innocently enough when Sigmund Rascher asked Heinrich Himmler, for only, quote, "three political prisoners," end quote, so that he could conduct lethal high-altitude experiments. Rascher had just returned from a medical conference that had discussed the medical problems German pilots encountered after having been shot down at higher than expected altitudes due to the advances in British aviation technology. The request was granted, and the three victims would soon become legions. In this instance, the ideology of professionalism, the ideology of science, and the ideology of the state became joined, utterly corrupting the ethics of medicine and human decency. In our own country, the human radiation experiments, the mustard gas studies, and the mind-altering drug research are telling examples of agencies of the state prodding medical science into directions we now deplore. I can only note in passing that the involvement of the state was vastly different in Nazi Germany than in the United States. In Germany the state ideology that certain lives were not worth living inexorably led to Jews, gypsies, and a smaller number of Russians and Poles as well to be used for research purposes with unparalleled cruelty unheard of in the annals of human research. But the research was also conducted because of the exigencies of war. The plight of German military personnel in the civilian population required quick solutions for many medical problems: typhoid fever, malaria, burns from incendiary bombs, prolonged exposure to the icy North Atlantic Sea, et cetera. In our own country during World War II similar concerns, the use of poison, the expected use of poison gas by the Japanese once we invaded their home islands, and during the Cold War fears of what the Russians might eventually do to us, led to agencies of our government to involve scientists and physicians in the war and Cold War efforts. What happened, however, was not state policy. And, of course, it was never imbedded in a national genocidal policy. This difference is crucial. Yet, parallels exist between medical research in Nazi Germany and the United States. And the lessons to be learned deserve the critical scrutiny of future historians. Three, secrecy. Not different, however, is this, that agencies of our government participated in medical research and that they saw to it that the activities would be carried on in secret, unbeknownst for a long time to Congress and the public. We shall always be indebted to Hazel O'Leary for lifting the veil of secrecy. I cannot put the Secretary's implications better than she did on Pearl Harbor Day of 1993, quote, "We were stranded and clouded in an atmosphere of secrecy," end quote. And then she added, quote, "I call it repression," end quote. Secrecy has many faces. And here I would like to add in passing that the low-visibility decision-making of local institutional review boards is another form of secrecy which only a national human investigation board can remedy. To return to the 1940s and 1970s, as physicians we participated in the secrecy. We were not innocent victims. We struck our own Faustian bargains. In our Advisory Committee's deliberations, we should be careful not to make too much of the Cold War mentality. It was there, but its haunting question remains: Why did medical ethics and primum non nocere prove to be such ineffectual counterweights? Finally now a few reflections on the lessons learned. The problem that has preoccupied me the most in my work on human experimentation is how human beings can be protected through informed consent, not in the sense of its current formulations, but in the sense yet to be formulated and then faithfully applied. To do so requires that informed consent be grounded in the principle of respect for person, as bioethicists call it, or respect for individual autonomy and self-determination, as law calls it. The history of human experimentation demonstrates that, at least until the last 20 years, consent has not been an uncompromising commitment to these principles. A perusal of the literature makes it clear that investigators have placed greater faith in their being, quote, "the guarantors of patient subjects' rights and safety," end quote. The Nuremberg Code attempted to make a radical break with that tradition, but their pronouncement and the pronouncement by the American judgments on voluntary consent expressed the basic value deeply imbedded in our American jurisprudence: the right of citizens to autonomy and self-determination. In my review on the regulations on the conduct of research, I have tried to demonstrate that medical science's commitment to individual autonomy continues to remain ambiguous. The call for balancing the need to advance science for mankind's benefit and to protect the inviolability of subjects of research all too commonly tilts in favor of progress. The evidence for such kind of balancing can be found in the Declaration of Helsinki and in the celebrated Belmont report. In response to Ruth Macklin's wonderful presentation of ethical principles in human research, I already expressed most briefly my reservations about this report. I find the Belmont report problematic because it did not state unequivocally that in research with competent subjects, its first principle, respect for person, can never be infringed upon except perhaps for reasons that must first be most clearly and most stringently justified and then also receive public approval. The Belmont report's other two principles, namely beneficence and justice, need deserved consideration, but their place in research with competent patient subjects deserved explication that I was unable to discern in this document. The author's silence to my mind on that issue is telling. I appreciate that the implications of what I'm setting forth here may be far-reaching. They may impede research by requiring physician investigators to take the time to explain themselves more fully to their patient subjects. They may make some research impossible to conduct because too many patient subjects may refuse to participate. I do not wish to be seen as to dismissive of these concerns, but if they are concerns and concerns to be taken seriously, perhaps they should lead by invoking the principle of justice to compulsory participation in research by all of us. As you know, I do not believe that the current federal regulations on the protection of subjects of research go far enough. Again, I set all of that forth in my St. Louis article which you have, and I've made some brief comments here which I will distribute to you. I also quote from a recent article published. It is really a quite telling article written by two, at least one I know well, a very sensitive person. It's called "The Immorality of Not Knowing." It's in defense of research. And let me only quote -- I have some more in my prepared statement -- one very brief paragraph, quote, "There is an ethical responsibility to acknowledge ignorance. There's also an ethical mandate to conduct investigations responsively and respectfully but also unrelentlessly in order to acknowledge the property of those members of society who are most in need of its benefits and who are victimized by research inactions." And this is my question: How do you reconcile, quote, "the immorality of not knowing," end quote, with the immorality of knowing? Finally and in conclusion, the revelations of the Nazi concentration camp experiments led to the Nuremberg Code. The revelations of the carelessness with which Thalidomide was made available to pregnant women then led to the informed consent requirements of the FDA regulations. The revelations of the Jewish Chronic Disease Hospital cancer experiments contributed to the regulations of research supported by NIH and PHS. The revelations of the Tuskegee syphilis study led to the federal regulations for protection of the subjects of research. We are not confronted with the regulations of the human radiation experiments. They date to a time prior to 1974. We would, however, not be true to our responsibilities if we were to rest content of telling only that story without assuring the public that it would be better protected in the post-1995 period. As I have suggested, we have an obligation to scrutinize contemporary research practices and determine whether we can rest assured that subjects of research are now adequately protected. Whenever egregious practices, such as stir up the public conscience, surface, as the history of human experimentation amply demonstrated, that has been the time for change to occur. That window of opportunity is open to us and to capitalize on. I hope that we shall seize this opportunity when writing a final report that not necessarily embodies my views or not necessarily embodies the views of any individual on the Advisory Committee, but that, more importantly, makes the public aware of the tragic choices that must be made when traveling on one road or the other road in the quest to advance science for society's benefit. Thank you. CHAIRPERSON FADEN: Thank you, Jay. Stay. Please stay. There may be some questions. I can't help but comment that we are fortunate to be able to have access to your eloquence as that report is written. Okay. Are there questions or comments for Jay? Henry? COMMITTEE QUESTION AND ANSWER PERIOD DR. ROYAL: I couldn't help but notice that you said the words "Fernald" and "Tuskegee" in the same breath. Are they equivalent? DR. KATZ: Not really. There are distinctions. And the only point I wanted to make here in which they are equivalent, an over-arching point, what allowed the investigators to begin these studies in the first place, in Tuskegee, what is so interesting about the -- or one of the many interesting things about the Tuskegee study is that the public health physicians really were there because they were interested in helping the African Americans of the South who suffered from syphilis in large numbers. When the money ran out, they, of course, were dispirited. They were at the point of packing up their bags and going home, which I think they should have done. But one night one of the senior Public Health Service physicians got the idea, "My God, this is a wonderful opportunity. These people will never be treated in any case. So why don't we do at first a very limited research project that might advance science?" I think in the Fernald study also the intentions were good. Where should it be done, it needed to be done with a captive audience. But they gave no thought to whether it should be conducted at Fernald, but you also dealt with an uneducated human population, or whether it should be conducted at Exeter or Andover, as I told you yesterday. There we have two captive populations, and maybe that research should have been done there or at all three places. CHAIRPERSON FADEN: Pat? MS. KING: I guess I'm always struck when I hear the history of human experimentation, as I was with the national commission as well, how much weight we give to protecting human subjects, -- I choose the term "protecting" deliberately -- protecting human subjects by focusing on questions of consent. I think I understand why. It certainly is consistent with our political theory. It's consistent with our structure of government. And it fits in very nicely and is a story that should be told. What I hear less of is -- and you're the person to comment on this because you're a historian. What I hear less of in this sense is the history of how the subjects were selected because it seems to me in terms of looking at who was involved in research that I would consider problematic all of the centuries -- we can go back to the use of slave women in gynecological research -- that there has been another story that we have not told, which is why certain groups -- and they're not always the same. The only similarity, it seems to me, that they have is their relative powerlessness. So even if you afforded, even if you -- we went through an informed consent in the ways in which you would find acceptable, I still wonder whether they would have had any sort of meaningful choice. I guess maybe that's a contradiction in terms, but what struck me about the radiation experiments is that this is perhaps the most documented series of cases we're going to get for a while, which really points out that it is certain groups, certain kinds of people who become the subjects in the kinds of experiments that we have concern about. And I actually thought your analogy to the draft versus the volunteer Army was very illustrative because the draft, which always purported to be a draft, in effect, only drafted certain kinds of people. And when we switched from a draft to a volunteer Army, we tended to get the same kinds of people for the same kinds of reasons. We just now have a volunteer Army versus a draft. That's a long way of putting a question, but why do you think there's this reluctance to develop a history -- I'm not even aware of one -- where we focus on a subject from the perspective of trying to protect subjects, rather than just informed consent? Because it's protection that I'm really focused on, not ethics, which I actually think may be a different -- DR. KATZ: Pat, you've just opened up a very important can of worms and, of course, that needs to be given the most careful attention, the whole question of: How do we involve vulnerable populations in research? There is, of course, the tendency, there has been the tendency, if at all possible, to use populations with whom we can identify the least and use them first for all kinds of experimental purposes. And there's more to protection of human research than fidelity to informed consent, autonomy, and self-determination. I want to come back to it in less than one minute but mention something else. One of the few remaining investigators still living of the Tuskegee syphilis study two years ago was interviewed on television. And he was asked the question, "Why did you use the blacks of Macon County? Would you have used other populations?" And he said -- and, by the way, he defended the morality of the experiment without any equivocation. He said, "Look, if white hillbillies" -- it's interesting he then went to the next level of hillbillies -- "of south Virginia had been infected with syphilis to the extent of the blacks in Macon County," he would have selected them for these studies. So yes, you are right these populations are used first. And we can even document this in some of the materials before us. And greater safeguards need to be introduced. When abortions became more sanctioned years ago and I served on Yale's Human Investigation Committee, we got 15, 20, 30 research protocols every few months of doing research with pregnant women about to abort their fetuses. And, finally, I said one day "Look, I will not approve of any more research projects involving these unfortunate persons, who have so much to cope with. Enough is enough. Stop it already." But the point in all of this is two things in focusing on research. First of all, we still have to think through what importance we want to give to the principle of autonomy and self-determination. Do we really want to give great weight to that principle or do we want to say and then specify that for the sake of progress, we have to make inroads on that principle? And that, as you know better than any of us here, is quite a challenge to our democratic values. And, secondly, -- and I'm sure I will say more about that to you as the months go on, and you'll get tired of hearing me saying that -- we do need national human investigations boards. We cannot leave these decisions to the low-visibility efforts of institutional review boards. I think that undermines human dignity. Of course, the counter argument would be, "Look, this is the way we conducted the military draft in the past, by assigning responsibility to," as Guido Calibresi called them, "amoral agencies, who make these decisions without possibility of review." But, as usual, we have lots of things to talk about. CHAIRPERSON FADEN: Eli? DR. GLATSTEIN: First of all, as one who went to South Vietnam as a result of the draft, let me compliment you on your historical overview. I think from a standpoint of trying to conduct research, you emphasized correctly the major -- it's not supposed to be easy. And you emphasized the problem of allowing enough time to get the consent and the fear correctly that too much information will discourage patients from agreeing to it. Nonetheless, this is a day and age if you do not give that information to the patient, you will get your butt sued. I think a major problem is actually the difficulty of most physicians to admit their ignorance and lack of information. It takes them off the proverbial pedestal, which many people feel more comfortable with. I think still another problem is over the last 15 or 20 years or so, insurance companies will not pay for research. So that at one time I don't think that was much of a problem, but it's become a problem now. So if a patient does sign a consent form, the insurance company feels off the hook. And that is a major problem. And you see this surfacing time and time again with the issue of bone marrow transplants and who's paying for it. It actually compromises the research because it's hard to get patients to go in a study now for bone marrow transplant. Anyway, I just wanted to tell you a little bit about my old mentor, who not only insisted on patient consent, but also the referring doctor had to consent to the study because otherwise he thought it would cost him referrals over the long haul. He got the referring doctor involved in the research to the degree that he felt involved with it. And that was important. The final factor that I'd mention is he would not include physicians in studies, but not for some of the reasons that might have been suggested. He was concerned about two things. One, when the physician would find out the results of the -- physicians and physicians' families he wouldn't include because if the result of the study showed that the treatment that a patient got was inferior, he felt that would cost him referrals over the long haul and make for a very unhappy physician. But, more importantly, he felt that he couldn't trust the docs because if he put them on a radiation study, they would take other medications without your knowledge, with good intentions, but complicating the study. DR. KATZ: Yes. Very briefly, Eli, that's many things, of course, that you just brought to our attention. Let me comment just on one thing that you've said and then add briefly another. One is physician ignorance and medical uncertainty. Of all of the work that I've done in this area, I think I'm proudest of the work that I've done on medical uncertainty and its implications for medical practice because that's still a much too unexplored problem, both in medical practice and research. And doctors, for all kinds of reasons, including good reasons, have a devil of a time of becoming aware themselves of the degree of their uncertainty and surely are reluctant to communicate this to patients. But with respect to research, there's another issue here in terms of communicating really honestly to patients, patient subjects. It came up two weeks ago, when I testified before a House committee and the chairman of the committee brought to my attention some research done with recovered schizophrenic patients in New York. And the doctor just lied. He admitted that he didn't tell them very much; in fact, left out crucial information. But he said he didn't do so because the patients would become too anxious if they were told what might happen to them in the conduct of the research. And I said to him, "Well, that's probably true, but, really, what's even more important here is the physician would have become very anxious." If he really had told everything to the patient and told him what he was asking him to do, sweat would have poured down his or her face probably in revealing all of that. That's the first problem. Maybe the patient would be less anxious than the doctor would be under these circumstances. DR. GLATSTEIN: Actually, I think that's true because the more information you give most patients, at least, I think the better rapport you establish with them. And in trying to get patients to go on studies and agree to them, rapport is very important. In fact, I think it's essential. CHAIRPERSON FADEN: Phil? DR. RUSSELL: In most of these discussions, the interface, the interaction between the physician and the research subject or patient is a very personal responsibility. And the ethical debate focuses on that. Then we also shift, then, to a discussion of government responsibilities, but that becomes very diffuse with the government, the CIA, one of the government agencies. And we have bureaucracies that are built seemingly to diffuse responsibility and spread the blame around among multi layers of administrative authority and currently multi layers of committees to review human subject research. Some protocols get reviewed at three different levels. How do we deal from an ethical point, from the point of view of the ethicist, with this diffusion of responsibility? And how do we bring the administrators to deal with the issues from an ethical point of view, rather than a regulatory point of view? DR. KATZ: You raise another very, very important point. You know there has also been recently over the last 15 or 20 years discussed in evolution of medical practice the wonderful book where Daffin Hollings said "In sickness in society with patients being treated by committee, rather than having one patient assigned to them." So the patient really falls between all kinds of stools, and nobody really takes responsibility. I think that at least this is also happening. But what we are looking to is the doctor saying, "Well, we don't have to worry about it, the research. The agencies really have considered the matter. They are taking responsibility." The agency is saying, "Look, we don't really have to worry about the ethical and medical considerations because the doctors will take care of that and responsibility for that." And nobody takes responsibility. So we have to develop a structure where someone is ultimately in charge and assumes responsibility for whatever is being done. DR. RUSSELL: Won't a national committee make the situation worse, rather than better? DR. KATZ: Well, I don't want to give a "Yes" or "No" answer, but I'd love to have an opportunity sometime before we disband to tell in greater detail what I have in mind and then make a judgment of whether it is going to be better or worse. Like everything else, everything is always better and worse. (Laughter.) CHAIRPERSON FADEN: Jay, let's have Nancy ask the last question. And then we'll conclude. DR. OLEINICK: One more question. Whether or not there is a national committee and whether we're going to rely upon institutional review boards at the individual institutions or some oversight committee, it seems to me that the members of the various institutional review boards may or may not be familiar with many of the philosophical dilemmas and practical dilemmas that you've outlined today and that are outlined in a lot of your work. And I wonder if you had some comments on how well-educated you think these bodies ought to be before they pass judgment on these protocols. DR. KATZ: I'm not at liberty to state, but Gary Ellers will soon hear of another experiment being conducted in the United States where extensive testimony already and depositions have been taken. And none of the members of the institutional review board had ever read the federal regulations for the conduct of research, including the chairman. And that's where the famous quote comes from. When he was asked about the Belmont report, he said, "Does it have anything to do with horse racing?"; even though reassurances have been duly filed with the appropriate agency stated clearly that they would conduct their research practices in accordance with the Helsinki Code and the Belmont report. So that's a quote. Enough about it. Thank you. CHAIRPERSON FADEN: Thank you very much, Jay. And I am sure there will be opportunity to continue this discussion. Thank you. All right. We're going to switch gears. It's a little hard to do this. We're going to go from the large foundational considerations to the day to day operations of the work of our staff and our Committee. We're now going to hear reports. These are first reports on two agencies. As you know, over the past couple of meetings, we have been getting staff reports detailing for our consideration how agency data collection efforts are proceeding. The two agencies that we have not yet heard such reports for are the CIA and NASA. And we're going to do that now. Gary Stern is going to take us through the CIA report first. The CIA report, Gary, is Tab J? MR. STERN: That's right. CHAIRPERSON FADEN: Right. So everybody has that. And hopefully you have read it. MR. STERN: Thanks. STAFF REPORT: METHODOLOGICAL REVIEW OF AGENCY DATA COLLECTION EFFORTS-- CENTRAL INTELLIGENCE AGENCY (TAB J) MR. STERN: While I'll be reviewing the CIA memo that we've prepared at Tab J, interestingly the CIA is so far the only agency that the Committee has focused on for which there are no records of actual human radiation experiments that we have uncovered. This is the case despite the CIA's well-known history of unwitting human experimentation, largely through its project MK/Ultra, which included the use of LSD and brainwashing experiments, which Jay Katz alluded to earlier this morning. The fact that no radiation experiments have been recovered is significant because of reports in a 1963 CIA Inspector General report on MK/Ultra that is actually still classified, but that referred to MK/Ultra as a program, quote, "concerned with research and development of chemical, biological, and radiological materials capable of employment in the clandestine operations to control human behavior," unquote. The '63 IG report goes on to state that radiation was one of the, quote, "additional avenues to the control of human behavior," along with, quote, "electroshock, various fields of psychology, sociology, and anthropology, graphology, harassment substances, and paramilitary devices and materials." Now, with respect to this issue, we are somewhat hampered by the fact that in 1973 the CIA deliberately destroyed most of its records on MK/Ultra concerning its research and testing on human behavior. Nonetheless, in 1977 the agency did uncover some documents that hadn't been destroyed because they were in a separate department of the agency and were not indexed under the name of "MK/Ultra." And these records appear to give an outline of all of the sub-projects conducted under MK/Ultra which show that every other avenue was explored except for radiation. And so that's sort of the basis from which we have been investigating the CIA. And the CIA conducted its own search for records with at least an understanding that radiation may have been used. And notwithstanding this understanding, the CIA has not been able to identify a single instance in which it has conducted or sponsored the use of radiation on humans as part of MK/Ultra or any other program. As the CIA representatives reported to the Committee at its April meeting, they have conducted a rather extensive review electronically reviewing approximately 34 million documents, a hand review of over 480,000 documents, plus nearly 50 interviews of agency personnel and retired personnel who were involved in MK/Ultra and some of the other projects, and again have come up with no records or recollection of actual human radiation experiments. The CIA's own human radiation experiment steering group met with the staff on June 16th and reported on their search to us. We discussed a lot of substantive issues related to it. And based on these meetings and on our own independent research, we I guess will confirm that there is no evidence that we have been able to uncover that the CIA itself used ionizing radiation on humans. But this does not mean that the CIA has no information relevant to the Committee. Prior to the meeting we held on June 16th, it became clear that the CIA had not focused its search extensively on other issues of concern to the Committee, principally the issue of intentional releases of radiation, such as the Green Run. And I'll refer you to Attachment 1 as a one-page memo from the head of the CIA steering group, David Greis, describing the search, in which it's clear that the primary focus is human experimentation. And, really, almost no reference is made to the Green Run or intentional releases. So that is an area in which the CIA is continuing to pursue its records and which we will want to work with them because I think there may be relevant information. For example, the CIA chaired the Joint Atomic Energy Intelligence Committee in the '40s and '50s. And that committee was responsible for monitoring and countering the Soviet atomic weapons program and I think did have some role in the Green Run in 1949. And, therefore, it's possible that the CIA had either played a role in that or provided intelligence information. Therefore, the CIA will continue its search. And we plan to continue to work with them on these and other specific issues. The CIA has indicated its willingness to respond to any suggestions from the Committee on how to focus its search. With respect to ethics, following public disclosure in 1975 of the MK/Ultra experimentation, President Ford issued an executive order barring the CIA from engaging in drug testing. And then in 1978 President Carter expanded this order to cover all human experimentation, requiring that they be subject to guidelines established by the Department of HEW at the time. And since then the CIA has followed these guidelines established now by HHS for any human experimentation it may be involved in. I will note that one section of the current CIA guidelines that were provided to the Committee is still classified. And the CIA has indicated to us that it is attempting to declassify this provision at our request. That's included as Attachment 2 to the memo. Interestingly in this area, the MK/Ultra program began in 1953, just at the same time that Defense Secretary Wilson issued his memo on human experimentation, with which I think we're all familiar. The CIA project was coordinated with the Special Operations Division of the Army's Chemical Corps. And the Army, as we also know, conducted its own LSD experiments in the '50s and '60s, partly in coordination and also independent from the CIA. The 1975 Army Inspector General report reviewed this issue very closely and demonstrated how the Army had clearly implemented the 1953 Wilson memo. And, yet, it failed to follow it in its own LSD experiments. The IG report also explicitly made clear that it was limiting its inquiry to the Army itself and was not covering the CIA. So the Army did not kind of expand its inquiry into whether the CIA had any knowledge of or had followed the military guidelines established by the Secretary of Defense. But given the closeness with which the two agencies were working at the time, there is certainly a possibility that the CIA was aware of these ethical standards. And that's another area of inquiry that we want to follow with the CIA. In conclusion, we have identified for the Committee four main areas in which we think the CIA should focus its search at this point. I guess the greatest emphasis we think should be given to CIA intelligence information and reports on Soviet atomic weapons activities and experiments that may then have influenced other agencies in the United States to conduct their human radiation experiments. The first area clearly is intentional releases, such as the Green Run and the CIA's role on the Joint Atomic Energy Commission, but also I think, especially from information that the Committee was reviewing yesterday regarding United States experimentation around atomic testing, the atmospheric testing program, that there may be similar information or activities that were being conducted by the Soviet Union at that time that the CIA could have been collecting. I know of a major test in 1954, the Tomsk test, in which apparently 40,000 Soviet soldiers were sent into a test area about a half an hour after an H-bomb test was done to measure combat effectiveness in a nuclear battlefield. And that's information that certainly would have been of interest, I would think, to the United States policy-makers. And that's the kind of information CIA may have collected. We would also like the CIA to explore in consultation with us searches for records about what the perceived national security threats were to the U.S. that may have motivated again other agencies to conduct their experiments. Jonathan Moreno yesterday talked about the gap, the rad warfare-type gap, that was perceived to then motivate some of these policies in the early '50s. And there's that kind of information that we would like to pursue with the CIA. And then we would also like to pursue with them additional records on ethics and ethical standards, in particular, in light of the possible relationship with the CIA and the Army in the LSD experiments; finally, the completed search for any possible records it may have on human radiation experiments. They indicated to us at the June 16th meeting that they are still going through records of boxes that they've pulled in response to the first round of their search. And so we'll be hearing from them on that. CHAIRPERSON FADEN: Thank you, Gary. That's a great report. We've got questions, I'm sure. Phil and Nancy I see so far and Jay. DR. RUSSELL: Am I correct in assuming that the CIA had no internal capability for conducting research? They had no scientists and investigators on their own staff, that all of the research that was, quote, "done by the CIA" was actually conducted either by the Army acting as a contracting agent for the CIA or by a civilian contractor? MR. STERN: Well, I think a lot of it. Most of it was contracted with even at the time academic institutions, sometimes clandestinely, where the institution didn't know that money it was receiving was coming from the CIA, as well as with other agencies, although I do think that in some of the LSD experiments, for example, agency personnel were involved in actually administering the LSD themselves to some of the subjects. So at that time, at least, there was some direct agency involvement. CHAIRPERSON FADEN: Nancy? DR. OLEINICK: I was struck in this report -- CHAIRPERSON FADEN: Thank you. DR. OLEINICK: I'm sorry. By at least two examples of individuals who have had fairly high positions; in fact, one director of the AEC and then subsequently moved to the CIA -- and I'm sure there are probably other examples. This is not unusual for this kind of power elite to move from one agency to another. And so certainly at certain periods, the management of the CIA and the high administrators would have had intimate knowledge of what was going on at the AEC and how to make the AEC work for them and any other of these agencies. I just wonder if in any of the searches through documents, not just through the CIA's documents, but any of the other agencies, there were cross-references to discussions with the CIA on particular items; in other words, some kind of a lead through other agencies. I don't recall seeing anything in what I read, but, then, I've only read a limited amount. So I'm just curious if there was any other lead through another agency, particularly the AEC. MR. STERN: We've certainly been looking for that in pursuing that. I don't think we've come up with any records yet. Dan, did you want to? MR. GUTTMAN: Yes, a couple of things. Of course, we're looking for it. Two comments. One is we've heard earlier about what Phil Russell was saying, work for others, where agencies, such as DOE, would permit their laboratories to be used by other agencies. And we have been very keenly interested in that. We had asked DOE and have obtained a declassified version of the work for others report, which isn't as a declassified version extremely helpful. And one of the things we're looking to is whether that is still a black -- it is still a black box, at least in the case of DOE, where Secretary Watkins asked for what was going on during his tenure, not ancient history, and was not able to know the full range of the work for others, such as the CIA might ask for. The second, of course, we're looking to see about these connections. One of the interesting questions, which, Gary, we were asking the CIA, when, for example, if you looked at the Dr. Saenger report that we had and it showed these amazingly lengthy cc's to almost everybody in the world and it says "Other Agencies," and you say "Gee, I'm wondering if this could say CIA." And so we've been asking "Normally would the cc list say CIA?" And the CIA's answer, which was pretty candid, was "Well, you know, not necessarily." So you wouldn't know. But we do know, for example, -- and Gregg Herken may mention it in the documents that we just got on a 1950 rad warfare conference. You know, there the CIA was, in fact, giving a briefing. So it's not completely not present, but its absence is not necessarily conclusive. MR. STERN: I mean, I think there's no question the CIA's principal job in the '40s and '50s was to monitor what the Soviets were doing with respect to weapons. So it was collecting lots of information and providing and sharing that information as a general matter. And, obviously, our interest is to establish a much more specific link to specific activities. And we haven't found anything yet, but we are meeting and will continue to suggest to the CIA some of these direct links to look into that. CHAIRPERSON FADEN: Jay? DR. KATZ: Two questions to ask to the CIA, one you probably either may have already asked or plan to ask, namely that: Presidents Ford's and Carter's directives notwithstanding, have they or are they conducting experiments that they cannot tell us about because they have to be done with the utmost secrecy, that when you want to have an answer, that they are conducting experiments for the moment deferring to the necessity to keep these experiments secret? The second question is an extension of what Nancy talked about, namely to muse with them about the fact "Look, you people have really a very distinguished record being concerned about the safety of our country to conduct LSD experiments and other kinds of experiments in order not for us to be victimized by foreign powers. "How come that you did not conduct any radiation experiments in secret? After all, the safety of the country really depended even more on these kinds of experiments than these biological experiments? And that is really an omission that CIA has to answer to in the light of its distinguished record. "And did you at least have some discussions with others? You must have had discussions on that? Can you find the records that you felt satisfied that the security of this country would not be affected if you stayed out of harm's way?" CHAIRPERSON FADEN: Phil, did you want to back -- DR. RUSSELL: I predict that the answer you're going to get is they engaged in the two kinds of experiments that we see documented here: the LSD experiments and other behavior-modifying drugs and the microwave experiments. Both of those relate to human behavior and the ability to modify human behavior, which the agency, of course, is very concerned about. The other areas that they might logically and probably have done or sponsored research is in the area of weapons research for covert operations. But I think we're going to come up with a dry well on the radiation because the logic for the CIA doing it isn't there. CHAIRPERSON FADEN: It's a well-framed way of approaching it. Can I just back up on Jay's first question? I was making a list of things myself. And I have to say, Gary, your report was very, very engaging -- MR. STERN: Thank you. CHAIRPERSON FADEN: -- and gave me much to think about. The question that Jay asked that we ask of the CIA "Are you now going anything that you can't tell us about?" I would assume that would be made plain that we're now not speaking specifically or exclusively to human radiation experiments, but generally are you engaged in research involving human subjects that you cannot tell us the specifics of? MR. STERN: Absolutely. I mean, we can certainly follow through on that type of inquiry. I think it is important to establish the ethical framework for this agency, in particular, and other agencies probably as well to have sort of that broad picture. So we'll certainly -- CHAIRPERSON FADEN: In line with that, the missing, obviously, the classified paragraph or whatever -- MR. STERN: Right. CHAIRPERSON FADEN: -- is of great interest because it suggests there may be some sort of exceptive clause that you're bound by the common world except. And the issue is: Are there any exceptions to your understanding that by executive order, you must conduct all research in accordance with federal regulations governing research in human subjects? Is there any authority that allows you to act in exception? MR. STERN: That's right. Right, exactly. CHAIRPERSON FADEN: So that's the straight question whenever they get around to giving us this paragraph. In the interim, they presumably could kind of do that. MR. STERN: Okay. CHAIRPERSON FADEN: Others? Susan? DR. LEDERER: Is there any CIA record of experiments with radioactivity conducted by other countries on their own citizens? MR. STERN: Well, that's another area that I think was not the initial focus of their investigation, but in our discussions with them when we met, we pursued that to some extent. And I think now following this meeting, we'll go back to them with kind of a much more clear and defined list of types of questions. And that's clearly an area that we want to pursue with them, either in certainly Soviet atomic testing-type experiments I just mentioned and others as well. I mean, we need to follow up on that. CHAIRPERSON FADEN: Yes, Henry? DR. ROYAL: This classified paragraph seems to me that it would be an interesting test case for us to figure out what we're going to do about classified material. You had written letters about declassifying things in three weeks. Is it a possibility that we could ask them to declassify that in that sort of time period? CHAIRPERSON FADEN: Well, we've asked. MR. STERN: We have asked. CHAIRPERSON FADEN: Now, mind you, the CIA is the one letter that we got back that made absolutely no reference to the request for declassification. DR. ROYAL: What I'm suggesting is that we make that a high priority to put pressure on them to declassify it. CHAIRPERSON FADEN: Fine. DR. ROYAL: And the second thing is: Where do we stand with our ability to look at classified material? And is there any doubt that once we get security clearance, that people who get security clearance will be then able to see that paragraph? CHAIRPERSON FADEN: The answer, first of all, I'm happy to take them. I would imagine we would all be happy to take that on. It's been communicated we can reinforce that this is something we would like be classified immediately. I didn't mean to interrupt you. It is striking that the CIA is the one agency that in its letter back to me made no reference to the time frame that was the force of the initial request. Presumably any day now a few of us are going to be cleared. That's the word, but we haven't yet, any of us, officially received clearances. And those of you who are in various throes, I put in my papers before even the first Committee meeting and still have not received my security clearance. It's not like I'm looking forward to it in any great -- you know, this is going to mean presumably that there's going to be a lot more to read. But my understanding -- and see if this is correct -- is that whichever one of us gets a security clearance first, there is nothing barring us from now being allowed to see that paragraph. MR. GUTTMAN: Well, yes. In particular, needless to say -- CHAIRPERSON FADEN: It's moving clear to the top. MR. GUTTMAN: Those of us who have not been cleared aren't familiar with the numerous levels, which we may or may not be entitled to look at. But putting all of that aside, we have been told by the CIA -- and Gary can -- they said -- you know, in general, it was a very friendly conversation -- that "If you want to look at our records in terms of our histories of the various divisions to see what we're up to, it would be very difficult to declassify them. But if you want to come into our reading room with your security clearance," -- Gary can talk more -- "be our guest. Come on in. Look around." CHAIRPERSON FADEN: Spend the rest of your life. MR. STERN: No. That's right. And even in subsequent discussion, they said certainly as soon as we're cleared, they don't anticipate any problems of being able to view materials. We'll make sure because I know the CIA generally has a higher level of clearance than I think the general clearance we're going to get. SCIs, special compartmented information, is different than top secret that we'll get. So we'll have to make sure that they're compatible levels. But they've certainly indicated that they have no problem once we're cleared of looking at most anything. At the same time we have requested declassification of that paragraph. They have responded that -- they're "attempting to do it" was their language only because I guess they can't be 100 percent certain that they're going to be able to do it, or couldn't then, at least. Hopefully we can put more pressure on them to do so. CHAIRPERSON FADEN: If there aren't any pressing questions for Gary, we need to move on only to keep roughly on time. I'm assuming we have a general sense that Gary and the other staff members working on the CIA are authorized to proceed along the lines that he's described in the memo. Thank you, Dan. Can I take that with additional suggestions that have come from the Committee today? Thank you very much, Gary. MR. STERN: Okay. Thank you. CHAIRPERSON FADEN: We're now going to have Mark Goodman give us a report on NASA. And, again, this is our first report on NASA paralleling, Gary's first report on the CIA. Welcome, Mark. STAFF REPORT: METHODOLOGICAL REVIEW OF AGENCY DATA COLLECTION EFFORTS-- NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (TAB K) MR. GOODMAN: The NASA report is -- CHAIRPERSON FADEN: Let me just say: Tab what? MR. GOODMAN: K. CHAIRPERSON FADEN: K. Thank you. MR. GOODMAN: And before I start, I would like to acknowledge Gary Stern and Kathy Taylor, who helped in preparing that report. An overview of my talk is that I will begin with some of the institutional background talking about the technical background, why NASA was interested in radiation research, and then give a status report on ethics documents and specific experiments, and conclude with the recommendations for future staff work. As far as institutional background, NASA was founded in 1958 out of pieces of other organizations, but it had no inheritance in biology and medicine, no significant inheritance. I think that's an important thing to bear in mind. NASA was also intended to be a civilian agency. That has an important bearing on the records research. They say that they believe all of their human research was unclassified. They have not located any that was classified. The second important thing about NASA was that it started off very soon with a tremendous crash program to send people to the moon and back by the end of the decade of the '60s. This created simultaneous challenges of actually doing that, the engineering challenge, and then the organizational challenge, creating an organizational structure to do that efficiently. The basic organization that came out of that more or less persists to this day. That is, NASA is organized around field centers, which are the specific programmatic functional roles. I think this is useful in the record search as well that you know the functional roles of each center so you know roughly what center to look at for records. In particular, the Johnson Space Center, which was earlier called the Manned Space Flight Center or the Manned Spacecraft Center -- I'm not sure which -- was the main site for astronaut medical studies and for human biomedical research, although other centers and headquarters also had some role. The one complication in the record search is the headquarters organizational structure has changed many times since the '70s. So it's not clear where certain records might be located. Also in the institutional background, NASA had relationships with other federal agencies; in particular, with the Atomic Energy Commission. In the early '60s they established a joint research agenda on biomedical research that included a number of, roughly a dozen, items. And we don't have the agenda in front of us. That's one of the things that we are looking to recover, either from NASA or from the DOE, Department of Energy. On that agenda we know Item 9 was total body irradiation studies on humans. These were cancer patients undergoing radiation therapy that had leukemia and lymphoma, studies by the Atomic Energy Commission aboard NASA spacecraft and use for NASA of particle beams at AEC facilities to simulate the effects of radiation in space. In addition, NASA has over the past had projects in nuclear power for space applications, both for power, electric power, and for vehicle propulsion. Some of that may have been done with the AEC, and we don't know whether there are classified records or records involving human research. In addition, NASA had a relationship with the Air Force, which, particularly in the '60s, was interested in extended human space flight. And they had a number of projects, Gemini and the Manned Orbiting Laboratory, where there may also be classified records, although none have turned up to date. As far as the technical background, NASA was particularly interested in the effects of radiation in space on astronauts. It's important to note that space radiation is different from radioactivity from terrestrial sources. Typically you have heavy charged particles. They come from trapped radiation belts around the earth or from the sun or from outside the solar system. The effects of these types of radiation can be different, biological effects. They're more penetrating. And they often have larger effects per unit energy deposit. In addition, the dose rates typically are low. So NASA might have been interested in chronic low exposure rates. Beyond that, there were also artificial radiation sources in space. There were nuclear tests conducted at high altitude which contributed to radiation for a time. And NASA, as I mentioned, was considering nuclear power and nuclear propulsion. I think the keystone document we've uncovered we've received is a study by the National Academy of Sciences from 1967, "Radiobiological Effects of Human Space Flight." One recommendation of that study, one conclusion, was that there was a need for more human data, more data, that is, on human exposures to be obtained through, quote, "every ethical means." I think it's important to put this in context of the other stresses that astronauts undergo: the rigors of medical testing; the effects of weightlessness; and what has turned out to be the greatest risk of all, the risk of accidents. As far as the ethics documents, as I mentioned, I think it's important that NASA did not have an institutional inheritance at its foundation in 1958. And we have not seen any documents that date before 1969, any formal documents, on the ethics of human experimentation. The first comprehensive guidelines appear to come from 1972. They required an informed consent, risk-benefit analysis, and official authorization for each study. This applied to studies performed by NASA, and it was later extended to studies by contractors and grantees. We know that some less comprehensive but still formal policies existed earlier at specific centers and for particular purposes. In particular, a medical isotope subcommittee was formed in 1969. And NASA is continuing to look for documents on earlier informal or formal policies and on the background to each of these formal policy documents. On specific experiments, NASA has undertaken a number of search methods. They've done interviews. They've looked through their records. And, in particular, they did a database search which identified 189 publications on what I would guess are several dozen experiments, studies, on humans involving ionizing radiation. I think that's Attachment 3, although I didn't check. It's 2 or 3. From this, NASA has identified four studies as deliberate radiation exposures that it's pretty sure will be of concern to the Committee. One of these is the total body irradiation studies, the set of studies, that I mentioned earlier. These came to attention, received a lot of public attention, in 1981 because of congressional hearings chaired by then Representative Al Gore. What also came to light in those hearings was that NASA destroyed their files on these studies, at least their main files on these studies, in 1980 in accordance with their standard records retention guidelines, schedules. So our main sources of information are from the congressional hearings and from documents uncovered by the Department of Energy from Oak Ridge, although we have gotten a small amount of information from NASA as well. These studies, there were two studies conducted over the decade from 1964 to '74, a prospective and a retrospective study. The retrospective study reviewed records, patient records, from 45 institutions across the country, involving -- I'm not quite sure what the number is -- over 2,500 human patient subjects. And this, in turn, is a major source of information on the scope of total body irradiation studies. The prospective study involved continued radiation therapy studies for patients who have leukemia and lymphoma and other blood diseases, a name I can't remember. But someone on the panel may be able to refresh our memory. As far as that, NASA funded some equipment at a low exposure rate total body irradiation facility, but NASA maintains they had no role in clinical decision-making. It was there to collect data on certain physical effects while the therapy was going on. The second experiment that NASA identified, second set of studies, was studies on measuring total body calcium content using neutron activation or producing Argon-37, which the subjects then exhale. A third study was a measurement of bone mass, bone loss using X-ray absorbtimetry. And a fourth study involved light flash experiments, where the investigators themselves placed their eyes in the beams of particle accelerators and observed the flashes and proposed an explanation then for light flashes that astronauts saw in space. NASA has also identified studies which they're not sure whether they're of concern to the Committee. They believe that they are primarily involving incidental exposures as part of medical studies. But they're working with the Committee to clarify the scope of the Committee's interest. The Committee might be interested, for example, in the follow-up studies on astronaut health. One thing that came to light in that is that the average medical exposures in an astronaut's career amounted to 20 milli-Sievert, compared to average space radiation exposures to 8 milli-Sievert. So it's an interesting comparison. NASA also undertook bed rest studies where confining subjects to bed for an extended period was thought to simulate the effect of weightlessness. And some of those may have involved vulnerable populations, prisoners in California. As far as recommendations, I'll refer you to Page 11 of my report. I'm not going to go through the whole list. I think our main priority at this point -- like I said, two. One is to continue to look for records on total body irradiation studies either through NASA or through the Department of Energy about NASA; in addition, the other 44 institutions that were doing such studies. And we also want to discuss with NASA strategies for locating documents that we think might be interesting, programmatic and policy-level documents. So we're planning a meeting with the NASA historian and archivists at NASA headquarters. We're continuing. I think the Committee will be continuing their interest in discussing with NASA the taxonomy of areas of concern. Staff is interested in receiving guidance on sort of our longer-term approach. One thing we have mentioned with NASA is the possibility of doing interviews on ethics in case of no formal documents turn up for the earlier years. And also what sort of follow-up should we do on the other experiments that NASA has identified where we don't have extensive experimentation? That's the end of my presentation. CHAIRPERSON FADEN: Thank you. Thank you very much. Are there questions for Mark, comments? The other experiments, I think it will be hard for the Committee to give guidance on that without some more material so we can think a little bit about how to proceed, the last comment that you made. MR. GOODMAN: Okay. Well, we do have sort of one-page summaries of a number of studies, both that NASA has identified are of concern and are borderline. So we can provide those to the Committee. CHAIRPERSON FADEN: It might be useful for the borderline ones -- I'm sure the Scope Committee will be thrilled, Scope Subcommittee -- to have that be the repository. If there's a staff view that some set of experiments may or may not fit, you could send it on to the Scope Subcommittee. We could see where to go. MR. GOODMAN: This is information I think at a slightly higher level of detail than from the Markey report. CHAIRPERSON FADEN: That's fine. Yes, that would be helpful. Dan, did you want? MR. GUTTMAN: Yes. Thinking ahead of it, this is the discussion that I guess we had hoped to have. If the Committee is confident on the format, of formatting experiments, -- this is this Markey pilot project -- then maybe what we can do, staff, in the immediate future with Ron Neumann in charge is begin to format particular groups relative to the numbers of experiments that we're getting from some other agencies and relevant to the interests of NASA. I think it would be relatively easy to sit down, our scientists, with NASA -- and Dr. Close is over there -- and work out how these dozens of experiments should be categorized. It should be a good -- we're past the test case stage, but it should be a pilot, too, working ahead. CHAIRPERSON FADEN: Henry? DR. ROYAL: Two comments. One is the astronauts are an interesting population in terms of getting informed consent. So that would be an interesting area to explore. The second thing is we heard about the radiation dose is 20 milli-Sieverts from medical examination and 8 milli-Sieverts from actually flying in the spacecraft. In the 20 milli-Sieverts are not being counted as research. It's being counted as necessary for their job. It's very unclear to me what the justification is of doing whatever diagnostic tests were done in this otherwise healthy population; that is, what the justification on a medical basis was. So I'd be interested in hearing what the medical justification was for whatever diagnostic tests that they had and why it is that that was medically justified and was not part of their research protocol. CHAIRPERSON FADEN: Mark, have you been having discussions on this point or is it something we need to start? MR. GOODMAN: I haven't had any particular discussions, but I think it is clear that NASA was interested in reducing risk, understanding performance of individual astronauts and identifying potential risk factors that might impede their performance. So that would justify at least some level of increased examination. It's also important to note that NASA has told us that they are looking for ways to reduce radiation exposures in these medical studies. CHAIRPERSON FADEN: To go to the force of Henry's point, how do we characterize this exposure, which is of interest? How much of it really needs to be re-conceptualized, indeed, as investigational, rather than -- MR. GOODMAN: Rather than occupational. CHAIRPERSON FADEN: Precisely. DR. ROYAL: What I think we need is a list of what kinds of studies were done and what the rationale was for doing those studies. And then that will be the starting point. We can decide whether or not it makes sense from an occupational point of view to have done those studies, whether it was justified from an occupational point of view. CHAIRPERSON FADEN: It's a very good clarification. Mark, too, when you proceed to pursue with NASA on the ethics, their ethics policy efforts, it would be good to go very much up into the future, including the experience. I know NASA has hired people to be consultants to them in recent years in ethics and they've had conferences. And it's really been a kind of interesting phenomenon. It would be important for the Committee I think to get a brief education on the more recent energy and effort that NASA as an organization has put into the ethics of its research project. MR. GOODMAN: Well, NASA is engaged in a review of its guidelines, ethics policies for human biomedical studies. CHAIRPERSON FADEN: Jay? DR. KATZ: You know, being so interested in all of history, it would be wonderful to talk to Senator Glenn about all of this and his interest in human experimentation and to ask him to reflect back on what information that he got and now, in that respect, did he think he was adequately informed and apprised of matters? CHAIRPERSON FADEN: Dan and I had a very enlightening and wonderful conversation with Senator Glenn exactly on those questions. I'm sure he would be happy to come to the Committee if that were of interest. It was quite interesting. I wouldn't presume to report on it. I'd rather have the senator do it. MR. GUTTMAN: The relevant germane point -- and this was a remarkable experience -- was that he had at great animation talked about his as an astronaut being experimented upon and being quite aware of what was going on and distinguished that as someone who has been through as much of this history as anybody in the country from what he had heard about as a senator in the human experimentation area. He said that was a wholly different world. And that was I guess to me the most remarkable aspect of it. CHAIRPERSON FADEN: Well, we could certainly ask the senator. I'm sure he would be very happy if we could just make it fit with his schedule to come and meet with the Committee and perhaps have other former astronauts and current astronauts do that. Any other questions for Mark? Can we take it that the general direction that Mark and his colleagues are going in working with NASA is acceptable to the Committee and, with Henry's suggestion, we push on? Thank you very much, Mark. UPDATE ON AGENCY DATA COLLECTION EFFORTS: OTHER AGENCIES CHAIRPERSON FADEN: What I'm going to do now very quickly -- this is in the interest of staying on schedule -- is give you a very summary update of what is going on for other agencies. I've been briefed and talked with staff. So I'm doing this very quickly, and this is so that we can get it out. If there are specific questions about how things are going with particular agencies, we should find time later this afternoon to return to it. But let me just kind of tick them all off for you briefly. And if I misrepresent something, Dan, you will interrupt me. First, with respect to the VA, you will recall as a Committee we asked Denise and her colleagues to pursue material relating to the Atomic Medicine Division. We also wanted to pursue a headquarters policy search to look for headquarters policy documents. And we were interested in activities that apparently were ongoing at various field sites. With respect to the Atomic Medicine Division, we have requested the material. We have not received anything. With respect to the headquarters policy search, our staff has identified a set of accessions that apparently have to do with the headquarters policy documents that are of interest to us. And the VA has started to retrieve at least some of those materials. With respect to the individual field sites, again we haven't received much, but there is an attempt to identify. Our staff is looking at other sources to identify what these field offices might provide us with. So that's basically where we are, at a pretty preliminary stage, with respect to the VA. And hopefully we'll have more to report at our next meeting. Let me just say for all of these agencies, in light of the decision that the Committee made yesterday to endorse a review of currently ongoing research projects, we will be going now to all of the relevant agencies for new data collection efforts to get that denominator of their current portfolios with respect to ionizing radiation. So that's a new data collection effort for all of these agencies, but they obviously haven't received a request from us yet. So they couldn't possibly complied with it. So that would apply to the VA and, of course, to all of the other agencies. With respect to HHS, our energies have been directed at working with the department -- and this is going to require some continuing hard thinking -- to find efficient and effective ways to locate the policy documents and the specific studies that HHS either supported or co-supported or the policy documents and the policy links that fit with our interest in research conducted, in part or in whole, for national security or military purposes, the link-up between HHS and DOD and DOE. We're making that a top priority, and we are trying to work with the department to figure out how efficiently to do that. We're for the moment putting to a side the huge numbers of studies that HHS over the years has supported that seem not to have that connection. And once we get clear on how we want to organize the rest of our world, we've communicated to HHS we will return to them. But we've said "Don't worry about that for right now. Let's concentrate on the links, the co-funding, and the policy connections, both with respect to research conducted for national security or military purposes, and also on the ethics policy story." So in those two areas, we're working with the agency to push ahead. And we're taking what we called last time the great unwashed, the huge numbers of experiments and studies supported by that agency and putting that to the side temporarily until we figure out how as a Committee we want to attack those. With respect to DOE, of course, we're all aware of the Secretary's press conference. It's clear that the department is continuing to go its own active way in identifying experiments that are of interest to this Committee. We are working hard with the headquarter files of the Division of Biology and Medicine of the Joint Committee on Atomic Energy. There is one area of concern. And that is some intelligence files that are of interest to this Committee seem not to be locatable, if correct English. They seem to be destroyed, gone. We're not sure where they are, if that's a correct characterization. MR. GUTTMAN: Yes. Well, go ahead, Ruth, and finish. And I'll -- CHAIRPERSON FADEN: Whatever. So that's basically -- I mean, if you were looking for a problem right now, the problem is this. We're concerned about this particular set of records that seem to be potentially of great interest. MR. GUTTMAN: The short of it is there is a Division of Intelligence, which maintained -- Gregg Herken is the expert. The crown jewels, the family secret, whatever, inner-sanctum. And we had talked earlier about DOE going and looking because there was a good prospect that Green Run-type information and this work for others that we're talking about would be documented, whether the CIA was having its work done. And last week the DOE went in and looked at the Intelligence Office and reported back, couldn't find anything, and was told that this cache of documents was substantially destroyed probably sometime in the late '70s or early '80s. And so we have requested. You've got to be able to tell the public something more than "They're not there." Somebody who was then -- this is not ancient history -- at DOE at that time, late '70s, '80s -- it's recently -- should be able to stand up and say "I knew these files when they were alive, and this is what happened." I mean, that might be acceptable, but it's got to be an affirmative commitment. DOE is here, and I'm confident they'll pursue that. CHAIRPERSON FADEN: So that's where that is. MR. GUTTMAN: Yes. CHAIRPERSON FADEN: That's where that is. With the Department of Defense, we've had some significant movement. We've received a fair amount of materials. We're working on the headquarters documents overall with respect to the military research program, the ethics history, relevant ancient history, agency history, and obviously still issues with respect to rad warfare and intentional releases. We'll hear more about that this afternoon. I thought it might be of interest to the Committee to know how we're doing on the declassification front. And this involves DOE and DOD most directly. We have made numerous requests to both agencies. And in recent weeks, a lot of stuff has been declassified. Dan and I have had discussions that it's sometimes not easy to tell whether something was declassified because it was going to be declassified anyway, particularly out of Energy, or whether it was in response to a specific request that we made. Don Weightman informs me that there are at least two specific instances in which the DOE has responded in a very timely fashion to requests that we have made for declassification. And these include -- MR. GUTTMAN: We hope they've been. I think that's not. CHAIRPERSON FADEN: We don't know if they have been declassified yet, Don? They have not or they have? MR. WEIGHTMAN: Those are specific requests -- MR. GUTTMAN: Requests. MR. WEIGHTMAN: -- that we have made to them for declassification. CHAIRPERSON FADEN: Okay. MR. GUTTMAN: I can explain. CHAIRPERSON FADEN: Why don't we let Dan do it? He's already at the mike. MR. GUTTMAN: Basically, first of all, the short of this is for anybody wants to know exactly what has been declassified per our request, as opposed to been lying around, Jim David is the only living person in our staff who can read these things and figure out whether it was stamped yesterday because that's when they Xeroxed it or stamped yesterday, these documents we got yesterday, because of a declassification. Captain George from the Navy I think, if it's correct, gave us a bunch of documents that he just had declassified himself about a week or two ago. CHAIRPERSON FADEN: Right. MR. GUTTMAN: But he can fill you in. By and large, the bottom line is in our letter to the DOE that the Cold War Subcommittee got about a week and a half ago, much of what we're asking for either was once classified or is still classified. So we're getting documents such as the one we looked at yesterday with Duncan Thomas, which was obviously classified at some point. It's not clear when it was declassified. What Ruth was alluding to is in our letter, we took two categories of documents which are pretty clearly still largely classified and said, -- CHAIRPERSON FADEN: Right. MR. GUTTMAN: -- "Can you make a start biting into those categories?" CHAIRPERSON FADEN: Right. MR. GUTTMAN: I don't know that we got anything in response to that. CHAIRPERSON FADEN: I thought we had. We'll see. I mean, it really is odd to me because I keep thinking, "Well, surely we can tell whether it was declassified per our request or otherwise," but it's apparently not that straightforward. Actually, in a way it doesn't matter. The point is if we get the stuff, we get the stuff. If we don't get the stuff, we have a problem. So it's really the flow that we're trying to monitor. And so far we are not unhappy. We'll see. MR. GUTTMAN: I say today we are not unhappy. CHAIRPERSON FADEN: Today we aren't. Right. MR. GUTTMAN: So far. CHAIRPERSON FADEN: Today we are not unhappy. Tomorrow we may be unhappy, but right now we're not unhappy. We'll see what happens. And, of course, the declassification issue about the clause in the CIA letter is an open question. So that's where we are. And hopefully in three weeks' time we'll have a lot more to report. And we'll try to keep more specific track of how we're doing. Henry? DR. ROYAL: In a most recently released list of experiments from the DOE, would it be possible to find out what their inclusion and exclusion criteria are? How do you make it on that list? MR. GUTTMAN: What they did for that list -- again, we can talk to DOE people at the break. Ellyn Weiss is out there. As I understand it, they went through the materials that they had already given to the Committee and the public, for that matter. To tell you how intense this work is, I've been told -- and Ellyn can correct me -- they took 25 people working about 24 hours a day for a week to go through the boxes that we had in our office. And they had a senior health physicist who reviewed and collated. And as to the particulars, you can talk to the DOE people. Bill LeFergie and Ellie Melamid and Ellyn Weiss in the audience I'm sure would be happy to. CHAIRPERSON FADEN: If that's of interest, we can certainly get that for you in an efficient way and get it back. MR. GUTTMAN: Yes, yes. But they're giving us the collation of the exact reference in our documents to the things that they have identified on the list so we can just -- anything you want about a particular experiment that they have identified, we have the same documents. MS. WEISS: There were criteria. And I'll be happy to tell you about it. CHAIRPERSON FADEN: Right. What we can do is we can get this from -- and Ellyn, unfortunately, is not on the mike now. So Ellyn is volunteering to make those available. We can make them available to the Committee. We'll just fax that out to everybody so everyone can have it. And you can see how something got on or something got off. It's the case, certainly, just hearing the people power that went into it, that a lot of work that we might have considered doing, we now don't have to do about those particular studies, which is very helpful. But how many of those we would want to consider is an open question. The criteria will help us do that. Knowing the DOE's criteria will help us do that. So we'll get that to everybody. Break? Is that okay? Good time. Okay. We'll have a break, and we'll come back at -- it's 11:15. So we're a little behind. Ten minutes. (Whereupon, the foregoing matter went off the record at 11:14 a.m. and went back on the record at 11:37 a.m.) CHAIRPERSON FADEN: I don't know exactly how we're going to get the entire agenda in before lunch, but we'll try. We have an awful lot to go through and an awful lot of people we need to hear from. The way the agenda was set up, it was set up as if there were no time for discussion until the end. I don't think that's going to work terribly well now that I reflect on it. I have a feeling that people are going to want to ask questions after each presentation. So we'll see. I'll just have to be more of a traffic cop and try to keep us pretty closely on schedule. This part of the morning is given over to the staff's educating us about their current thinking with respect to how we might possibly organize the world of information data, experiments, and events that are of interest to us. And we're going to start by hearing from Dan? MR. GUTTMAN: Yes. CHAIRPERSON FADEN: Okay. OVERVIEW: INFORMATION SYSTEM MANAGEMENT AND EXPERIMENTAL GROUPINGS (TABS M, N, O) MR. GUTTMAN: My notes say that we're poised to do serious work but we must be organized. (Laughter.) MR. GUTTMAN: It is so important. I'm reading from my notes. It's perfectly obvious, as a number of you know, that every opportunity to expand what we're studying we leap at. And this is the point where we keep our eye on the ball. What's clear is we have, at least from my perspective, not only a terrific staff, but a terrific Committee. And there are some terribly meaty things. The question is not "Can we do everything?" but "How do we make sure we do some things and do them pretty well?" The Fernald report, which a lot of you obviously found terribly important, -- and it is -- illustrates the question. You can look at something pretty intensely, and there's not much documentation for a lot of the things we're looking at. So even if we had years, instead of months, we wouldn't be able to go through with the lists of thousands of experiments because in a lot of them, there just isn't much that today we can find. So the question is: How do we organize? And the question from the staff perspective addressed to you -- and it's addressed from the outline we discussed, and it will be addressed in the short presentations, and you can address it this afternoon -- is: What's the most efficient way to organize now so that the staff focuses in a way that is meaningful in terms of getting at meaty issues, that's meaningful in terms of our ability to find information that's responsive, and that's meaningful in terms of the likelihood that we can put something like what we're looking at in the final report? Obviously as we go along, we'll learn more and topics will be refined. But how do we break things up? The general framework which I would like to present as a discussion item is, on the one hand, we have before us the pilot project, the Markey experiments, as a template. And on that form, which we'll discuss, we have many data points which you all when you finalize it consider to be important for one reason or another, what the scientific purpose of an experiment was, whether there was another government or military purpose, what institution it took place at, what kind of population. So, on the one hand, we have or will have an agreed-upon set of basic important anchor points or, Duncan's term, dimensions. On the other side of the spectrum, we have these increasing lists of experiments, hundreds or perhaps thousands. And what we're going to talk about in the next few minutes and in the outline is how in the body of a report we can group the experiments in some way so that we can go from our listing of hundreds or thousands of experiments and say, "Well, in the Markey form, we have a category 'External Radiation' or 'Total Body Irradiation.' Let's see how many in our list when we put our scientists to work meet that definition." And it will probably be 40, 50, 60, or some number like that. And can we then meaningfully study that as a group, not study every one of them, but using the kinds of judgment we all have get into the best way to look at that group? It may be, for example, that that kind of grouping poses interesting questions about experiments that are of obvious therapeutic potential but also military potential. That would be a potential theme. We take that group. We've talked about plutonium. Really, I'm not the one who is going to get this right. But it is technically a biodistribution or experiment in how a heavy element in the nuclear weapons complex area traces through the body. And so you could take plutonium and then say, "Well, how many of the lists we're looking at are from the technical scientific standpoint similar?" and group those and do a story. In the story you'll find many crosscutting examples, obviously, that some of those experiments in each group will have been done secretly and some publicly, some on vulnerable populations, some not, some maybe with excessive dosages from the contemporary standpoint, many perhaps not. So that the point is to have our groups anchored in something that's important, and we know it's important because it's in the Markey category, but, yet, the groups in the scientific area inclusive of everything that we've got on this list. Another kind of grouping is -- I guess I'll use the word "other" grouping, but we're also interested in grouping not simply by scientific category experiment by experiment type, but also institutional grouping in the sense of what kinds of government programs and purposes. We might take a government program, such as this joint medical panel on atomic warfare, and look at its portfolio and follow it down. You'll see many agencies involved, and you'll see different kinds of scientific experiments. Again, it would be another kind of crosscut. You might take an institution, an Oak Ridge or a Los Alamos, again crosscut, or another crosscut would be experiments today; my technical reading of that, that in the Markey form, that would be the date category. And you would group by date. That is, 1994-1995 ongoing experiments. The general notion is to begin to organize the staff to work in a way that we can tell stories both in the meaningful sense and the social science qualitative sense, -- we're not just telling mere anecdotes, God forbid -- and also head towards an increasingly refined understanding of the key issues. So what we're going to hear now, first David Saumweber is going to talk about the basics. The backbone of this whole proposition is how the heck we're going to put all of this data together so that we can all share it, "we" meaning the public as well as the Committee, and then get into the particularities of the kinds of -- we did early at the second meeting. We took three experiments, Green Run, Cincinnati, plutonium, and we asked ourselves what kinds of documents are available if we wanted to study them. What we're doing in this grouping exercise today is let's take those as a class. Let's take the Cincinnati and expand it to the class of whole body irradiation. And we studied that class. Let's take Green Run and intentional release. We don't do plutonium injection, but it's clear that we could expand that in the same way. And with that, David Saumweber. INFORMATION SYSTEM MANAGEMENT (TAB M) MR. SAUMWEBER: Well, I'm going to talk about three things, talk about the character of the materials that we have been collecting from a records management point of view and talk about what processes we're subjecting these materials to, how we're organizing them and how we're going to manipulate the information they represent. And, third, I'm going to talk about the review process, how we're going through the materials and selecting the substantial documents to focus on. The collections that we have been receiving from the agencies amount to over 75 cubic feet. This is somewhere in the neighborhood of between 15 and 20 thousand sheets of paper. I won't characterize them in terms of documents. We don't know that at this point. Many of them are arriving in an undifferentiated mass, so to speak. There are certain traditional archival approaches to collection of this type which are unavailable. We do not know anything about the origins of these materials, where they were originally created, who was the original owner of them. We know in many cases that we are receiving information from one agency that is contained in documents produced by another agency. We don't know who had that document in his or her file. We also don't know anything about the original order of these documents, how they originally were associated and whether the first document in the box had any relationship whatsoever to the second document in the box. So there are some traditional sources of information we don't have. However, as you have heard over the last couple of months, the documents, nonetheless, are very rich. In order to manage this information, what we've put in place are a couple of different methods of approach. The first is general collection management. We are describing the collections in some detail. We are in many cases getting a very good listing of the documents and characterization of the collections from the agencies. In other cases we are not. However, we are keeping the collections together. In many cases we're getting duplicate collections. So we are able to maintain the collections in a fairly pristine format as well as providing people access to them. In addition, we are building computerized access to the collections, including subject and person and institution and agency names, access to the collections themselves and also to the documents. These indices are being built in a system called Lotus Notes. And you have it at Tab M. The first part of Tab M is a description of the notes and some of the things we're going to be doing with it. The indices that are being built will be available to the staff of the Committee when we have a network in place and will also be available to Committee members at a distance. And we hope also to make available these indices to the public at both the Committee offices and potentially over the Internet. Though this process now has been completed through the description of the collections, we are just now beginning to describe the documents individually and can now talk about that review process. The review process involves the document by document examination by a group of reviewers who look at each document and evaluate it in terms of criteria that have been contributed by various members of the staff and by members of the Committee. The documents are being pulled in terms of five distinct formats and also in terms of very extensive lists of key subject terms, key institutions, key experiments, key individuals, and so forth. Those documents are briefly analyzed by the reviewers. And lists of those documents are produced. If the Committee is interested, we can provide copies of the full accession list of individual accession descriptions. And beginning today the first of the document lists is being produced as we speak, copies of the document lists. Now, those documents have been identified by the review process as being important to the stories that the Committee is interested in telling. They will be reviewed by the senior research staff, who may request additional review of the documents, additional review of the collections, may themselves review the collections. And at some point we'll determine whether or not the particular collection has been exhausted. From that process will be identified a smaller group of significant or what are known popularly among the staff as hot docs, things that contribute substantially to the stories that we are telling. And those lists will also be made available to the Committee if you are interested. Added to this process will be, as you will hear from Gil Whittemore and Jonathan Engel later, the information concerning the experiments. And that information will be linked to information about the documentation that supports that information and where the documentation was obtained and any number of a variety of other types of information. That's about all I have to say. If people have questions about what we're doing? CHAIRPERSON FADEN: Thank you, David. If there aren't questions, I'm sitting here furiously trying to reorder our agenda because we don't have enough time. So I don't want to stifle discussion, but I sort of want to stifle discussion. (Laughter.) CHAIRPERSON FADEN: Are there? David, of course, is available. DR. KATZ: I'll just say it sounds like wonderful work. I would love to see, really, some of these and see whether something strikes me that I want to call you about and discuss with you. Probably some other Committee members would be interested, too. And so many more eyes will look at them. MR. SAUMWEBER: Sure, sure. Okay. I will supply you with samples, and you can -- DR. KATZ: Then decide. MR. SAUMWEBER: -- decide whether you want to see more. CHAIRPERSON FADEN: That would be great, David. And also we should point out that our Committee meeting in September, which does seem a long way off but will come very quickly, is at the Mayflower Hotel, wherever it is, wherever it is. In any event, wherever it is, we're structuring it so that there will be time to come over to the Committee offices, which many of the Committee members have never seen. And maybe you can schedule some time to come over, and we can do like a show and tell demonstration of the system, which should then be fully operational and accessible. And if you would, -- we'll give you advance notice -- if you want to schedule to stay a little bit extra or come a little bit early, we could really build in an opportunity to get a hands-on. And, please, if anybody wants to come before then. MR. SAUMWEBER: Certainly. You can come and look at the prototype. CHAIRPERSON FADEN: Right. Come look about this and other things. But we need to move on. We may have to cut into the afternoon a bit, but we'll do the best we can. Thank you, David. MR. SAUMWEBER: Thank you. CHAIRPERSON FADEN: All right. We're now going to have Gil Whittemore and Jonathan Engel. And this is the report on the pilot project, where the form that was developed by subcommittees was applied to the material made available to us by Representative Markey. Gil is circulating a new form, a revised form. PILOT PROJECT: ABSTRACTION OF MARKEY REPORT EXPERIMENTS (TAB N) DR. WHITTEMORE: Okay. I'll try and be as brief as possible. I think there is a disease in Washington. After you've been here for only a few weeks, your life revolves around producing new forms and new revisions. First of all, the purpose of this form is to assist in developing the database. That is, it is to make sure that as we begin entering into the computer database each of the experiments, we at least have a place in the database to put information that is of interest so that later on people can extract experiments according to certain criteria, the data points that Dan mentioned earlier, realizing, of course, that, especially in the beginning, as we begin entering experiments into the database, many of these spaces may end up being blank or unknown and then after we select experiments to examine in more detail, we have places to put additional information as it comes to light. So it begins primarily as a finding aid to our documents and from that a guide to further research. And you might think of it as a state-of-the-art filing card system. The danger, of course, is that the way in which you organize your data at the very beginning may place limits on how you conceptualize your analysis at the very end, which is why the design of a form, although sometimes it seems tedious, is a way of avoiding major mistakes that may come to haunt you later on. Where this particular form originated from is from consultation within the staff and also extensive discussions from the subcommittees on scope and Cold War. The parts of the form that have had recent revisions are the parts under the various types of subjects and the parts under the type of research and government applications. At this point I think in looking at the form, the Committee members from the subcommittees I expect may want to comment more fully. The part of the form which has been most thoroughly discussed and worked on is the part under "Type of Research." The part of the form which is probably greatest in need of further refinement and work is the part under "Protocol Consent." And also a trial run was done on the Markey documents primarily to see how well the form worked with a fairly limited number of experiments. And Jonathan Engel can report on his experience with that. DR. ENGEL: I don't have a whole lot to add, just that to really fill out the form in its entirety would take much longer than I had. I worked on 61 experiments that Congressman Markey's committee worked on in the mid '80s. And if I took the raw data, which we had delivered to us from the DOE, those Markey experiments took up roughly three boxes. So it was somewhere about 15,000 pages to fill out 61 experiments. So I couldn't do that in a day and a half. I went down to Markey's office and pulled his fact sheets. And even using the fact sheets that they had created, it still took a day and a half or 2 days or so to get down 61 of these types of forms. And that was mostly skimping on the subjects area. I concentrated mostly in trying to categorize them into types of research area. And I was able to do that fairly successfully. If you really wanted to put the kind of data that some of you would like to see in here, a really extensive protocol and extensive list of publications typifying the subjects, it would take significantly longer. And one of the things the Committee might want to think about is really a question of the economy of time. How much time would you like us to be spending filling these forms out and typifying the experiments? To do it very thoroughly would take appreciably longer. To do it superficially is okay. CHAIRPERSON FADEN: Okay. (Laughter.) MR. GUTTMAN: I should add that the in between is that we have the agencies as possible resources because a number of them expressed an interest in getting their story told as accurately as possible. And to tell us things about their experiments, it would take us a while to figure out. CHAIRPERSON FADEN: Henry? DR. ROYAL: I think the form is extremely important. At some point we're going to have a large number of experiments that we should consider, and we're going to have to decide which ones we're going to consider in depth and which ones we're not. It would be nice to have some rhyme or reason for how we chose to do that. If I heard Jon correctly, he said the skimpy way of doing it was one and a half person-days. I think that there are many more person-days than that that should be dedicated to this task. CHAIRPERSON FADEN: For how many experiments? DR. ENGEL: It was 61. CHAIRPERSON FADEN: And what you had was one sheet, basically, on each experiment? DR. ENGEL: It really wasn't one sheet. I usually had two or three summary fact sheets from Markey plus maybe I had appended a contract or a summary of an experimental report or something. DR. STEVENSON: But that's very different from going through primary documents? DR. ENGEL: Oh, yes, enormously. CHAIRPERSON FADEN: Right, right. I thought I saw other hands, but now I see Pat. Okay. MS. KING: My way of thinking about the data is this is a chicken and egg to me. My way of thinking about the data entry form is it's always nice to have as completed information as possible, but I don't think that's doable for us. And so the question then becomes: What areas are the most important? The only way we can answer that is when we have the discussion, the preliminary discussion, on what we think our report will look like because that's the discussion where we will reveal whether we like what you've done, which says where we think we're headed because we need information to support where we think we're headed. For example, -- and I could be totally wrong -- a listing of publications I would be willing to sacrifice because in my current vision, subject to discussion about where we're headed, that is not the most important item for me. But other people may differ because they may have a different view of what the endpoints are. I just want to say that I think that what we need to do is to cut back on areas. I don't know yet where. I guess I'm disagreeing with Henry. I think we need to just in terms of what it takes to go through documents that are in a box and really not in any kind of category. Now, if I'm wrong about that, if the agencies can be of great assistance in going through the boxes so that they, in effect, serve as almost like our fact sheets that he got from Markey, that's different. But in some ways I would like to revisit this in light of our discussion later on in the afternoon. CHAIRPERSON FADEN: Well, it's certainly something I suspect was going to happen anyway, that we would come back to this document. Gil? DR. WHITTEMORE: Yes. I think also that illustrates the multiple purposes of the form. For example, another purpose of the form is to serve as an entry into the documents, clues for where you might go. For example, we might not want to put publications down for every experiment, but once we selected experiments to look at put it down because oftentimes those publications are the ones that begin giving you contract numbers that then may lead you to protocols. But the question is: In addition to what should be on the form, perhaps to prioritize, in what order should we be filling in the fields? Which fields can we basically leave or areas leave blank until we go through a second round of selection? CHAIRPERSON FADEN: Nancy? DR. OLEINICK: My understanding of this form is a way to categorize the experiments and to lead us or future investigators into a very large realm of documents so that the individual will know what documents to pursue. And it seems to me since we're talking about the example of publications that what we need to know on this form is not a listing of all of the publications, but were there publications? One, were there publications that really were in the peer-reviewed literature or in books and something that were generally available to the public or was the report of the experiment only in agency documents, reports of one sort or another, or were there none? And it seemed to me that that would give one at least one way of categorizing. If there were publications, then where are they, but are there publications? And that information does not have to be on this two-page form, just that there were publications. Now, the fact of the listing of them can be at the next step. MS. KING: Maybe what we need to do is tackle what the purposes of the document are because -- CHAIRPERSON FADEN: Of this document? MS. KING: Of this document because it may be that the purposes are cross-purposes, if you will allow that use of language. For example, this is the only place for me where I would have access because I was interested in this in finding out the number of experiments that involved vulnerable subjects, which I see not so much in terms of future researchers, but in terms of our own report, -- CHAIRPERSON FADEN: Right. MS. KING: -- that we need that kind of information for our own report. We need the information on consents, as I see it, -- CHAIRPERSON FADEN: Right. MS. KING: -- for our report. And that's a different purpose than the purpose that Nancy just described. CHAIRPERSON FADEN: Right. MS. KING: Now, maybe we can accommodate all of the purposes, but it may be that we have to give some priority, attempt to give some relative weight, so the purpose is to be accomplished as well. I don't know. CHAIRPERSON FADEN: Dan? MR. GUTTMAN: I may be wrong. My thinking is that this is all work in progress. The problem, as Jon can tell you and Gil, is that the things that we're most interested in aren't always readily available for normal populations. So the problem, the reason that for me it would be of critical importance to have the publications is maybe if you really were interested in that, you could go to the publication, if you're lucky get something about the population; in other words, if it were that simple to take the key things, risk, vulnerable population, -- CHAIRPERSON FADEN: Military purpose. MR. GUTTMAN: -- and informed consent. But they're residual categories, unfortunately. You need other things to lead you. This would be a form that will be around. And over the course of 6 months or 10 years, people could continue to add to those boxes as they could. That's the -- DR. KATZ: Along these lines -- I hate to complicate forms -- and to make it as simple as possible is that maybe somewhere on the right-hand side or left-hand side of the form, you list sort of the important categories, vulnerable populations, informed consent, risk, et cetera, and just put a star next to any of these items where in your judgment as the reviewer -- and, after all, you're going to develop a lot of expertise if you think that on any of these subjects, these would be good information that's available in what you have already, that you put a star just next to this item, make it very simple. And this is subjective evaluation because then Pat can ask for the documents in her area of interest, I and others can ask for the documents in our areas of interest, but start with those documents where we have in your judgment a reasonably good amount of information available and not look at the great many of them where I think the information will be too scanty and publicly also not obtainable. DR. ENGEL: Let me add ironically particularly with Professor King's remarks, the hardest part to fill in is the subject area. Usually what you wind up with is either a final report made out to DASA or a grant proposal or protocol. So it's actually fairly easy to figure out a contract number or the number of subjects or the kind of ionizing radiation you're working with, but what's extremely difficult is to know if there's informed consent or the exact cross-mix of the population. For instance, frequently you'll have something. It will just be a blurb, "We took 84 volunteer subjects from the greater Spokane area." Well, you could find out who those 84 subjects are, but it would take an awful lot of digging. You could go out to Spokane or you could try to go to federal archives, whatever. You could try to interview the experimenters. And just as an example, I worked with Ron and Dan on the early Cincinnati stuff. And you have those wonderful official reports, but you have to really begin to dig down fairly deep before you can understand exactly who was being picked up. CHAIRPERSON FADEN: I'm trying to think about the most efficient way to deal with this in full Committee. And I'm wondering whether we might not want to put this back again into the afternoon. MR. GUTTMAN: I see this as part of the same discussion you're going to have this afternoon. CHAIRPERSON FADEN: Right, right. So I think we may keep Jonathan and Gil kind of on hold and have you come back. But it seems as if there is this confusion about exactly what this form is supposed to do for us. Part of it is, I think, Committee members not quite understanding how, in fact, the form would be used. I mean, presumably we get in a document or 2 documents or 20 documents about an experiment. They may not all come in at the same time. You know, one may come in. You fill out the form. Then two weeks later another one comes in. The form is kind of a living document for a particular study. But at any point in time odds are that there will be more unknowns. And the way the form is set up, -- Gil and I were talking about it -- there's not a systematic way to indicate there's no information on the subject population. There's no information on consent procedures other than the term "volunteers" being used, which we have no idea what that means. That's all you get. So the form at one stage would simply say "No information on subject characteristics. No information on consent procedures available on what we have so far." And then there's that next level of saying "Okay. Well, once we figure out that for 80 percent or 90 percent of these we don't have that kind of information or we can't tell if there's a military purpose, what is our strategy going to be for digging further? How many of these are we then going to do what Jonathan is describing in saying 'Let's go see if we can't get the publications or some primary source document or interview the investigators or whatever to fill in the missing gaps'? But it would be a mistake to think that we're going to have detailed information about things like subject population or consent procedures or even military relevance for many experiments without a lot of additional work. Would that be basically what you're communicating, Jon? DR. ENGEL: Yes. CHAIRPERSON FADEN: Right. So why don't we keep that in the back of our minds? We'll return to it this afternoon as we figure out how we want this to come together. Thank you both. We're now moving into the category of different groupings, illustrations of ways in which things could be grouped. Is the first one government purpose? MR. GUTTMAN: Yes. Jim David is going to do it. CHAIRPERSON FADEN: I'm sorry, Ron. Stay up there. It doesn't matter. You're next. Things are going to go quickly. Okay. So we'll do this quickly. Jim, are you both speaking? MR. GUTTMAN: I'm speaking. A one-second introduction, as Gil would say, one second in Washington; right? POSSIBLE GROUPING: GOVERNMENT PURPOSE (TAB O-1) MR. GUTTMAN: Basically, there are two thoughts that are prefaces to what Jim is going to report on. One is that if you look at the lists that we have, these unadulterated lists, you would never discern except by rare instance that anything has to do with any government purpose. You would wonder why the government was giving money. And, in fact, we've been told by the Defense Department that some very large percent of the experiments we're looking at were not military purpose experiments. You scratched your head and said, "Why is the military paying for them?" The other thought is from a Defense Department document we just looked at which said -- it was a Defense Department medical review of funding, R&D funding -- that the term "radiobiology" is so flexibly semantic that depending upon the investigator's point of view, any project could be classified as clinical or basic or nuclear weapons effect, the point being that you need something to get you into what's just science and what's science plus. And so what Jim will talk about briefly is the hope that one way of telling our story is looking at programs that are expressly by purpose military purpose or national security purpose and how do you go about finding those programs and are there enough documentary sources to be able to tell that story so you'll see underneath those programs experiments will be in many different types, different types of populations, et cetera. Jim, who has been the key so far to digging out all of these Defense Department documents, in particular the ones you looked at yesterday, -- he led the DOD to this joint medical panel -- can talk briefly about that. MR. DAVID: These four documents in your briefing book from the Joint Panel on the Medical Aspects of Atomic Warfare are a small sample of about three boxes worth of this particular joint panel -- MR. GUTTMAN: Tab O, Item 1. MR. DAVID: -- records, which are in the Secretary of Defense records at the downtown National Archives. The Joint Panel was created in early 1949 and was disestablished in 1953. It was one of many dozens of committees and panels of the Research and Development Board, which was created in 1947, shortly after the Department of Defense was created and was disestablished in 1953. As with all of the other committees and panels of the Research and Development Board, the responsibility of the Joint Panel was to monitor research and development in its particular field or area of responsibility, both within the Department of Defense and at other federal agencies, and then recommend ultimately to the Secretary of Defense what particular programs and projects conducted by or for Department of Defense components should be supported and to what extent. The areas of responsibility of the Joint Panel included: the biological effects of radiation, burns, and blasts; possible therapeutic measures for injuries from radiation or burns; decontamination of food, water, clothing, and other objects; and, lastly, protective measures. With the disestablishment of the entire Research and Development Board in 1953, the Department of Defense created the Defense Directorate of Research and Engineering. This office, in turn, created dozens of committees and panels, just as the Research and Development Board had. It's unclear at this point which particular committee or committees, panel or panels of the Defense Directorate of Research and Engineering continued the responsibilities of the Joint Panel, but that's something that's being looked into at this point. In short, the documents in your briefing book from the Joint Panel list the individual experiments, both within the Department of Defense, to a limited extent from other federal agencies, and where they fit in with the overall program areas or areas of responsibility of joint panel. And this in our opinion is the value of the records of research and development coordinating bodies, both at the Secretary of Defense level and ultimately at the individual service level. CHAIRPERSON FADEN: Thank you, Jim. Are there questions, comments? (No response.) CHAIRPERSON FADEN: We'll return as we talk about it this afternoon. This gives you some flavor of how you'd follow a trail basically through an organized government program. Thank you. Now we're going to move on to -- Ron can come back; come back, Ron -- total body irradiation. DR. NEUMANN: Thank you. I've been given the right agenda. Jim David, as usual, finds the right papers. And it's on yellow for today. POSSIBLE GROUPING: TOTAL BODY IRRADIATION (TAB O-2) DR. NEUMANN: The categorizations that we've been talking about are tools for us to begin to group together experiments, in particular, that have aspects to them that allow us to categorize them in some way that may be useful as a working tool as well as perhaps a type of theme that we might want to emphasize in the final report. And the one I wish to discuss today was indexed, of course, by the so-called Cincinnati experiments done by Dr. Saenger, et al., which led us into the area of this category called "Total Body Irradiation." And by "total body irradiation," we are meaning that type of an exposure coming from a finite point source, be that produced by an X-ray cathode ray tube and incorporated or encased in a radionuclide source or a linear accelerator. That's a different type of an exposure. It's coming from outside the body, and its dosimetry to some extent is easier to calibrate because we know from whence this irradiation originated, unlike fallout, which can come from various different directions. So by "TBI," we mean this type of whole body irradiation produced from a point source of irradiation. We found in our research thus far certainly that the Cincinnati experiments were only a small part of the picture of the government's interest in total body irradiation information. At this point we know at least 45 different institutions did this type of treatment to at least 2,000 different subjects or patients. These institutions ranged geographically from the hospitals in Southern California to Boston and included private, public, military, Veterans' Administrations, and other types of government hospitals. Jim David, as you heard, has found what we believe to be the master tasking documents or planning documents, in which a central planning group from the federal government determined that the government did have an interest in assaying the types of effects that irradiation would have on the function, both physiological and psychological, of human beings who might be exposed to these forms of irradiation. We know that there was both a retrospective and prospective part to the total body irradiation story. The principal investigator for much of the retrospective data collection was Clarence Lushbaugh, who is still alive and well and residing in Oak Ridge, Tennessee, which offers us opportunities to take oral histories, for example, about this experiment that may not exist in other cases. We know the prospective portions of the experiment in much less detail because we simply have not gotten some of the documents that are necessary to understand the planning that went into the need to expand from retrospective data collection, which was generally done by obtaining data from patient trials in which a therapeutic intent was the primary driving concern, and expanding that into prospective experiments, which were designed more carefully to collect data that was of interest to the scientific bodies in the federal government that were concerned with this. We know, for example, that NASA became involved midway along this, both in terms of its need to have the types of information you heard described this morning in terms of safety for its astronaut program, and we know that they provided money for at least portions of the total body irradiation experiments. So there are a number of reasons to categorize the total body irradiation experiments as a grouping on which to focus some degree of our attention. And I think from an ethical standpoint, the most interesting aspect that I've seen so far is this concept of piggyback experiments, which I explained to you in the Cincinnati discussions, where the underlying experiment, which may have had a direct medical or therapeutic bent, has added to it a secondary experiment, whose primary purpose may be more to determine types of information in the military or other government agencies needed for their work. So for these various reasons, the total body irradiation grouping of experiments allows us to pick a category based upon scientific type of irradiation in this instance and use those as a group of experiments that we would look at depending upon your desire to break that or to pick prime examples and to use those to ban the story based upon a few particular examples. And we await your discussions on those points. CHAIRPERSON FADEN: Thank you, Ron. Are there questions? Yes? MR. FEINBERG: I just have a sort of preliminary question. I'm not clear in my own mind what the purpose is of these. Is this a stylistic or a methodological concern that we have as to how to prepare the ultimate report? MR. GUTTMAN: It's both, not the ultimate report. It's immediately when we go to work tomorrow as staff after you all go back to your offices and so forth. What do we do? CHAIRPERSON FADEN: Go back to our regular lives. MR. GUTTMAN: What do we do? And the question we're thinking about is: Well, we're saying "Well, maybe one way to get into these thousands of experiments is if we pair them off into different kinds of groups and if it is a way of doing it that's researchable, makes sense both in terms of getting information that's not biased because we're checking it in different ways, and there's information there." Can we do that? So what Ron is saying is: Well, here is a chunk of the hundreds of experiments we have: whole body irradiation. It seems to be a discernible chunk from the scientific experimental perspective. It seems to be a very interesting chunk from the perspective of the other kinds of questions we're asking, particularly because there's a military purpose that is threaded throughout, there are vulnerable population questions that goes across periods of time, many kinds of institutions. So the purpose is both not simply the final report, but how do we start so by two months from now we can tell you "We've looked at a group of experiments, and this is where we are," et cetera, et cetera? MR. FEINBERG: I guess my specific question is the extent to which the groupings should be guided by what we view as the stylistic approach of the report in terms of telling the whole story followed by looking to the future. In other words, if you said to me "Back it out," at the end of the day, how do you want the report to look in terms of the table of contents and the -- CHAIRPERSON FADEN: Well, that's why we have the table of contents discussion or the outline discussion in the afternoon. We toyed about how to do this. Really, this is to give you a quick flavor of what some of these groupings might -- what shape they would take. They are repeated. If you looked at the detailed draft outline, these groupings reappear. So, indeed, there is a thinking currently that these are meaningful categories for stylistic reliance in the writing of the final report. That may not work. I mean, after this afternoon's discussion, we may conclude that we don't like this way of putting the story together or we may conclude that by the next July meeting or may conclude it in September, after two months of work have gone into this. So it's a problem, Ken, as to whether there's need to even have it first. We might perhaps profitably have gone first to the discussion of the draft outline and left these examples, but the thinking here was that it might help a little bit to hear some of the richness of reasoning behind why, or evidentiary base for thinking that this could hang together. One thing you should see if you look at the groupings -- and the subcommittees that have worked on this can attest to this as well -- it didn't seem possible to come up with a logical category scheme in the sense of mutually exhaustive and exclusive categories to which you would know that every experiment belonged in one and only category and we were going to set it up a certain way. So lacking some revealed logical way to do this, we have come to fall on kind of what makes sense, categories or kind of compelling categories or categories that seem to have interesting twists to them. And that may not be satisfactory in the end. But I'm thinking in the interest of time, maybe we could get one more in. And maybe what we should do, maybe we shouldn't do any more of these. MS. KING: It's actually working to hear it, and I will explain why I don't think it's redundant. I'm learning more from why the category was chosen here at the meeting than I could glean from reading the materials that were sent. And that's because the emphasis here is on the justification for giving something a title. The way it came to us in the -- CHAIRPERSON FADEN: Briefing book. MS. KING: -- briefings books, it came to us like these categories. And so now I'm beginning to understand that what you're really saying is based on everything we've seen to date -- I call them research leagues, research trends. We need to explore these. But so far based on what we've seen today, this is an interesting line of development. And we need to look at the documents in this area. I'm actually finding that helpful in trying to understand what you're going to do later this afternoon. CHAIRPERSON FADEN: Well, then maybe we should go on. But I know that Henry wanted to get in. DR. ROYAL: Yes. I wanted to ask Ron to look to a few specific things. And that is: How were the Cincinnati experiments qualitatively different, if they were qualitatively different, from any of the other institutions that were involved in total body irradiation? What is it that's different about those experiments, if there are differences? So I'd be interested, number one, in whether or not that's something that the staff has started to look into; and if so, whether you have any ideas about that. DR. NEUMANN: Well, I certainly can't give you a complete answer today, but we know, for example, that the Cincinnati experiments come midway into this project. They're not the earliest or beginning experiments. The doses that Dr. Saenger began at are midway doses to the upper-end doses, for example, that were used and earlier experiments that had already been completed and published tended to use lower dose rates. So there are a number of certain differences, but I think it's premature to give you a complete picture of how the Cincinnati experiments fit into the totality of the TBI program at this point. It wouldn't be fair. DR. ROYAL: But that's going to be an important part of the story. DR. NEUMANN: Yes, right. I think -- CHAIRPERSON FADEN: You mean this is a ratified category? DR. ROYAL: Yes. CHAIRPERSON FADEN: I understand. DR. NEUMANN: I think one other aspect beyond the scientific grouping that may help to explain why this is a category onto itself, in the issue of thinking about compensation for physical harm done by irradiation to victims, this may be the best category in which we can reproducibly calculate how much irradiation someone received and whether or not that was within the realm of dangerous exposures. Many of the other categories we don't have the scientific knowledge available to do that. So it becomes not just a scientific categorization, but here we may have the resources to actually go down to the individual subject level and calculate whether harm was, in fact, done. And then you can certainly make a decision as to whether compensation is due. CHAIRPERSON FADEN: Jay? And then I'm going to have to break for lunch. DR. KATZ: I don't know whether we have discussed it, but I think Henry just raised a very, very important point that I hadn't ultimately been aware of, namely: Can we find out -- and it shouldn't be so difficult possibly with respect to the whole body irradiation experiments -- whether Cincinnati really started that trend of whole body irradiation experiments or whether there were lots of whole body irradiation experiments before Cincinnati and not supported by federal agencies and then maybe be able to pull some of these experiments and see whether the way they were conducted was different from the Cincinnati experiments? DR. NEUMANN: I can answer, again in part, today that they were in brief done late in the program. There was much work done on cancer treatment by total body irradiation prior to this. And I may lead you to a more interesting ethical question of this again represents a category of investigation of: How long is one allowed to pursue investigative therapies or treatments that perhaps don't prove themselves and continue to call them experiments? We don't have the equivalent of an FDA looking at techniques. And I think as you see the story unfold, you will see that NASA, the Defense Atomic Support Agency, -- and everyone gives the defense that, in fact, there was ongoing treatment or at least palliation experiments upon which they piggybacked their military purpose or government purpose experiments. Whether or not, in fact, at that point in time it was still necessary to do that fundamental an underlying experiment is an interesting question based upon the literature that exists. CHAIRPERSON FADEN: It's very intriguing. You can see how we can get seduced. If I could be premature, I'd find it hard-pressed to imagine that the Committee would not want to pursue the total body irradiation story as a grouping, I mean, however else we slice it up. But we can see. We can hash it out later. We have a technical problem, which is that Gregg can't be with us this afternoon. I was going to break for lunch. So if you could come up and jump in, we're going to move out of agenda item here. Everyone is going to have to eat fast. MR. GUTTMAN: A quick clarification in response to Pat's point and Ken's. The groupings, the intent of the experimental groupings, is to cover the waterfront of every experiment that could be in our list. If we missed, then we can have other groups. Whether they're a particularly correct group or not is another matter. So, in other words -- MS. KING: I'll raise this after lunch. MR. GUTTMAN: Yes. MS. KING: But that's what's making this confusing. MR. GUTTMAN: Yes. CHAIRPERSON FADEN: Yes, I think that's -- MR. GUTTMAN: That's why I wanted to -- yes. CHAIRPERSON FADEN: The idea would be that every experiment might find a home. It might be more than one home. So it gets messy. It gets very untidy quickly because it would be hard to come up with exclusive categories so that they're so tight that something would only necessarily fit within one group or the other. MR. GUTTMAN: It's not like we're saying we like some and not others. CHAIRPERSON FADEN: Right. Gregg, thank you. We're skipping ahead to rad warfare. POSSIBLE GROUPING: RADIOLOGICAL WARFARE (TAB O-4) DR. HERKEN: What I have that's of interest is a brief historical story about a possible groupings. The staff in looking at possible groupings of human irradiation experiments is considered under the category of government programs military research in the area of radiological warfare, also called rad war or simply RW. The interest in RW stems from the fact that the Army recognized radiological agents, potential instruments of war, even before the advent of the atomic bomb. In the Spring of 1943, shortly after the Manhattan Project's Medical Division was created, research into the offensive and defensive uses of RW agents was made part of that division's charter. Additionally, some of those individuals later involved in the plutonium injection story and in the whole body irradiation of terminal patients under Army contract were among the early advocates of RW. In May of 1943 the possibility of poisoning enemy food and water supplies was proposed by two such advocates, Drs. Joseph Hamilton and Robert Stone. The following year General Groves, the head of the Manhattan Project, alerted the Army to the possibility that radiological agents might be used against allied troops storming the beaches of France. Groves prepared a series of countermeasures under the code name "Operation Peppermint." As seen, early concepts of rad warfare imagined the use of fishing products as radiological poisons or as an area denial weapon. However, following the Baker test at Bikini in 1946, where an atomic bomb was set off under water, the military realized that the most lethal form of RW would probably involve the use of radioactive aerosols. The Baker test was followed by a brief but intense vogue in RW within the military and the government from the mid 1940s through the early 1950s. During this time the Navy's Radiological Defense Laboratory was created to study how to decontaminate ships and sailors exposed to radiation. In the Army the Chemical Corps was assigned responsibility for devising both RW weapons and countermeasures. By Spring of 1948, the AEC, the Atomic Energy Commission, had established within its Division of Biology and Medicine a secret panel of civilian experts to study the rad war threat. The most influential of the various advisory groups to look at RW at this time was the so-called Noyes panel, established jointly under Defense Department and AEC auspices in May of 1948. Until it was dissolved in November of 1950, the Noyes panel met a total of six times. Its recommendations led to the half-dozen tests of aerosol RW munitions carried out at Dugway Proving Grounds between 1949 and 1953, which are detailed in the GAO's report of last November on intentional releases. Several of those involved in human radiation experiments were also members of one or more of the civilian advisory panels created to look at RW. Joseph Hamilton, for example, was chairman of the Army panel responsible for overseeing the safety of the tests at Dougway. Hamilton and his colleagues, moreover, often noted that their work provided data of obvious interest to both the AEC and the Defense Department, even if the research itself was not military in nature. In none of the RW-related intentional releases the staff has yet examined, however, is there evidence of deliberate exposure of human subjects to radiation. Ultimately the Noyes panel would conclude that radiological warfare had the same practical liabilities as gas warfare and was likely to be less effective militarily than the direct use of atomic and hydrogen bombs. Despite a brief revival of interest in RW at the height of the Korean War, the Chemical Corps' program dwindled. And the RW test series itself was cancelled outright in July of 1953. The military's subsequent interest in RW has evidently been focused almost exclusively on detection and defensive measures. Thus far the staff has received from the Energy and Defense Departments several hundred documents pertaining to the once-secret RW program detailing the six aerosol tests at Dugway as well as two ground-level RW experiments conducted at Oak Ridge in 1948. Although these documents provide a wealth of detail about RW-related intentional releases in the RW program generally, they do not yet answer the question of whether other experiments involving human subjects might have been carried out as part of the radiological warfare program. Evidence for RW-related human experiments may yet exist in the following records, which have been requested by the staff and received, in part, by the Defense Department and are now being reviewed by the staff. First and primarily, the minutes of the joint panel on the medical aspects of atomic warfare that Jim has just mentioned that was created under the auspices of the Defense Department's Research and Development Board in early 1949. In addition to an interest in RW, some members of the panel in the late 1940s evidently became advocates of the resumption of large-scale programmatic human experimentation. Secondly, the records of the AEC's Division of Biological and Medicine under its oversight body, the Advisory Committee on Biology and Medicine. The staff has received and substantially reviewed the ACBM records. It is now awaiting DBM records from the Department of Energy. Under the leadership of Shields Warren, the Director of DBM, DBM apparently became a voice within the government against the resumption of extensive human radiation experiments. CHAIRPERSON FADEN: Thank you. Again, a flavor for a different way to set things up. Are there questions for Gregg? (No response.) CHAIRPERSON FADEN: Thank you. I think it's falling victim to exhaustion and the need for lunch. We're going to break for lunch now. We're scheduled to resume at 1:30. That's going to be tight, but if we can, let's see if we can keep to it because we've got a lot of work to do. It's a buffet. So if we eat quickly. (Whereupon, a luncheon recess was taken at 12:36 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (1:37 p.m.) CHAIRPERSON FADEN: We are going to start. We have one of the groupings left. Dan, you're going to do that; right? Okay. So, Dan, why don't you go ahead and do that? And we'll quickly then go on to the outline, which is the only subject until we break at 3:00 into subcommittees. POSSIBLE GROUPING: INTENTIONAL RELEASES (TAB O-3) MR. GUTTMAN: Talking briefly about intentional release, we know that intentional release is a category in the report because it is a category in our charter. And the question is: Is it simply the 13 or 12 identified intentional releases there or are we talking about a larger grouping? And what are they about? A couple of things to be said. One is that, as best as we now know, a lot of those are the rad warfare experiments which Gregg talked about. And we're beginning to get, from the Army in particular, documentation about those. And it isn't clear whether there are in any cases efforts to study premeditated, study of human beings. Of course, the effects, marginal or not marginal, may have been effects on whoever was the environment. But it isn't clear that those were intended to be set off for human study. Now, having said that, once you get into the literature -- in particular, if I commend anybody, it's Dr. Stannard. It's about 600 pages in his book of a category called "Environmental Activity." And if you think about it broadly, intentional release is a fairly global category. I just want to make a couple of observations. One is one extreme in the category, of course, are the bomb detonations, which are the ultimate intentional release. We talked about that yesterday and whether or not that should be a subject for consideration is something we're all aware of. The other is that if you take the two other parts of this, that if you take fallout as another equivalent of bomb detonation, we know that one of the grand experiments, unfortunately or not, of the '50s was everything having to do with fallout. In some sense which we're certainly not going to be able to study, fallout was a cosmic experiment. Within fallout, it is clear that there were lesser included experiments that are within the purview of our charter. So, for example, if you look at the Markey collection, one of the experiments was shooting radioiodine in a meadow. The cows consumed it, and then people drank it. And that, I guess, was a fallout-related experiment. When you read Markey, I think the word "intentional" release is used. Another aspect of that is so that there is an interesting separate set of things that hadn't been categorized in our charter as intentional releases which literally read "Our intent to releases isn't related to a program of interest, fallout." The greater question, whether there were other things in the fallout area that would be intentional releases, we really don't know. We know that Operation Sunshine spawned the stillborn baby activity. I don't know if it's an intentional release, but it's part of the fallout program. The other observation I want to make, which was a revelation for me, when you read Stannard, you begin to realize that people saw their world as one laboratory and that in the excerpts we included from Stannard, one of the investigators in that time refers to the discovery that Oak Ridge or whatever could be an outdoor lab. And you begin to put pieces together. We know that in the '40s, when Hanford was cited, there was a good deal of concern about the effect of radiation on the Columbia River system. So people began injecting things into salmon and so forth. Well, of course, you don't think about that as an intentional release in the sense of one or two salmon and a little bit of whatever it is won't make a difference, but then you begin to see that this is part of a pattern and there's a whole discipline, which was new to me as a lawyer, not surprisingly, many of you know about, radioecology, where there was intense devotion to injecting things into trees and forests. In one of the little excerpts in the briefing book, there was an abstract which indicated severe devastation by gamma rays of a forest in Puerto Rico that was part of the U.S. government-related facility. And you're wondering, "Well, what's that about?" So that these things become orders of magnitude. And then the other part of it, which to me was a striking illustration of the virtue of reading the Stannard interviews, the incident that he talks about at Strong Medical School at the University of Rochester at the time of the Manhattan Project, where in these two transcripts, one of which is Dr. Hodge, who worked with Dr. Stannard, Dr. Hodge is asked "What about this Project Gabriel?" And he tells this wonderful story, wonderful in the sense that we can talk about it maybe 40 years later, about how there was a flight in from MIT with some radiosodium. And Dr. Warren, Stafford Warren, said, "Well, let's all work late tonight." And Dr. Hodge remembered the story because it was the first day that this young coed was on the job. So he remembered the story. He said, "We've got to work late." And they went around spraying. They put on rubber suits, and they put the radiosodium in some solution. They sprayed it all over this field. You're reading this story, and you're wondering "Is this set aside, kind of preserve?" And then you talk about the field is mowed. And then you read the interview. And he says, "Well, and Staff Warren said 'We've got to test this on wood structure.'" So the next paragraph is they went to the parking garage, and they sprayed it on the walls in the parking garage, and then the animal labs. And then Stannard says, "Well, what were the measures on this?" And Dr. Hodge says, "Well, I don't remember. All I remember was radioactive" and goes on to talk about how he remembers the night real well because this was this woman's first day on the job and he knew her father, who was a doctor at Strong, and he had to get her home and dawn was rising. He gets her home and says to the father, "I just want to let you know nothing untoward here. It's the typical day on the Manhattan Project." Now, this was a terrific anecdote. You read the rest of it, which is really incredible. In the Stafford Warren interview, which is in your briefing book, he actually alludes to it and seems to explain it. He refers to, quote, "The contamination of the alfalfa field" on Crittendon Boulevard in Rochester, which is next to the med school, and explains, it appears -- and you all who are the scientists can quickly grasp the implications better than I can -- that they were testing to see what kind of shielding would be necessary in some of the medical school equipment, the basic point being when you're talking intentional release back then, it's not clear what people felt, you know, they could just to experiment. And it wasn't like the 1994 period, where you needed environmental permits to do anything. They just went out and sprayed the alfalfa field and the driveway and -- CHAIRPERSON FADEN: The parking garage. MR. GUTTMAN: Right. So the point being intellectually to me it's very interesting. Whether it means we can find those things; right, whether it means they had danger or risk certain today I don't think may be doable. If people knew about them is another question, but that generically conceptually intentional release is clearly a category that is broader than the 13 that have been identified in the GAO report. CHAIRPERSON FADEN: Henry? COMMITTEE DISCUSSION DR. ROYAL: One item of clarification that I'd like to add is there's a difference between intentional release of an unsealed source and an experiment where a sealed source is put into the environment. There were two experiments that were described in the category of "Intentional Releases" in our briefing book, I think, one having to do with lanthium and the other tantalum, if I remember correctly. But these were sealed sources, meaning that they're put out into the environment and then they can be easily retrieved. When you spray stuff around, you can't clean it up afterwards; whereas, when you put wires down or put a sealed source down, once the experiment is done, you go and you pick up all of your stuff. And you go away, and things are just the way they were before you started your experiment. So the staff and the Committee should keep in mind there's a difference between sealed sources and unsealed sources. MR. GUTTMAN: Two things. Not only is my response to be that I stand corrected. These are the two, I think, Oak Ridge rad warfare. I was absolutely mystified as to what was going on there. So it's not simply that I stand corrected. I welcome it. And the question I would as a citizen non-scientist ask is: When you read about these intentional releases like that, how does one know what precautions, what understanding of environmental effects were assumed or expected by the experimenters, the investigators back then? CHAIRPERSON FADEN: That's part of what we have to do. MR. GUTTMAN: Right. That's part of it. It's the question. In other words, in that case you're telling me there would be a clear understanding of limited distribution, I suppose. DR. ROYAL: Well, that you can put the radioactive material out into the environment for the duration of the experiment. And then you can pick it up, and it's no longer out in the environment; whereas, there are some environmental releases that you have no control over once they've been released into the environment. REVISIT DISCUSSION OF GOALS AND OBJECTIVES CHAIRPERSON FADEN: Okay. We have the outline. Something has to be in the afternoon after a heavy meal. I'm not sure that this was the best topic, but something has to be now. You have had at least some time, we hope, to take a look at it. Let me just underscore that it's a draft. It is intended to get us going and hopefully get us to the point where, at least today, we have enough consensus about enough pieces of it that staff can feel comfortable about proceeding in some areas. The working process objective would be by the end of our 25th, 26th meeting -- I think that's when it is -- we have enough of a consensus about the general shape of this that we can work from it for a while until we want to amend it. The discussion of the groupings is imbedded in Part 2 as the outline is structured right now. Let me just say that Ken couldn't be here this afternoon. And so he left me via Anna some notes about some thoughts with respect to Part 2. And, actually, Ken may come back for some of the discussion. I think he had to go to court. Duncan may be back later today. We're not sure when, but he also left me some comments, mostly on Part 2. But he wanted me to indicate that he's pretty pleased with the way this is going. And by way of an update, I should have mentioned at the outset I want to let you all know that Reed is alive and well. He finally landed in Los Angeles. The concern was he got hung up with airport travels overseas and, with missed connections, apparently, and flight cancellations, didn't get out from wherever he was outside of the country in time. But he is today safely back in Los Angeles. And he sends his apologies. We can understand how that happens. I don't know any way to begin except to begin. And I'm wondering whether we could go part by part and spend a defined period of time on each part because if we spend an exhaustible amount and if we spend an unlimited amount on Part 1, we will never get to Part 2 and Part 3. But if we could get some general reactions? I'm skipping over "Executive Summary" and "Overview" because every report has to have an executive summary and an overview. So we take those as givens, and you can't write them until the end anyway. On Part 1, reactions, criticisms? Nancy? DR. OLEINICK: Well, I would like to see some more information, more lines written on the third number of that, which is "Signs of Radiation: 1942 to Present." And I imagine somebody ought to be doing that. When you described this yesterday, you gave it sort of a one-line summary of there would be something in here about how risks were understood over time. I think we want to go back a little further than that. It's more of a history of what was known and when and within that how risks were and are assessed today and also within that the development of the medical uses of ionizing radiation because what I did not sense in going through this draft as it was written was any of the positive aspects of radiation, -- CHAIRPERSON FADEN: Right. DR. OLEINICK: -- which I think would be very important to put in here, that in spite of all of this negative press -- CHAIRPERSON FADEN: Right. DR. OLEINICK: -- that we're necessarily getting, that there was a development of both the diagnostic and the therapeutic uses of radiation and also the development of the use of isotopes and all that that has done for biomedical science. I'd just like to see some of that put in this section right up front. I mean, I haven't really written this outline, but these are just some of the thoughts that I would like. CHAIRPERSON FADEN: No. This is exactly. This is fine. This is exactly what we need. Mary Ann? DR. STEVENSON: I had some very similar thoughts to Nancy's, the history and science of radiation, 1942. DR. OLEINICK: And I think to start before 1942 because -- DR. STEVENSON: Oh, yes. Okay. DR. OLEINICK: -- it's clearly since 1942. And we want to understand how you got -- CHAIRPERSON FADEN: We could start at 1895. DR. OLEINICK: Right. CHAIRPERSON FADEN: We can do 1895 to 1942 in two or three paragraphs. DR. STEVENSON: It has to be set in sort of that linear context. CHAIRPERSON FADEN: Fine. DR. STEVENSON: Otherwise it won't be clear why you're doing what you are in 1942 and beyond. And, really, everything Nancy said were the exactly the things written that I was going to say. The necessity of stating at each of these periods, whether you want to do it in decades or five-year blocks, whatever, what was understood about the positives and negatives because people had a very much less sophisticated idea of what was going on in terms of radiation effects, positive and negative, at these earlier periods and times, and particularly with regard to isotopes. That was even less well-understood, internally ingested or injected isotopes. CHAIRPERSON FADEN: Let me just add that Mark Goodman had pointed out on Page 2, we're now skipping ahead to Part 2. But this is on Point II at the bottom, where there are themes. One theme is critically missing, which is the theme of the benefit or the value of this work. So that would be reintroduced there. But I'm making notes of all of the suggestions that Nancy and Mary Ann have for fleshing out what is now a place-hold at III. Yes, Phil? DR. RUSSELL: I'm looking at some of the Defense Department documentation, it's quite clear that the benefits went far beyond the radiation research. They had a huge amount of money going into burn and resuscitative fluids. As a matter of fact, it was actually dominant in the program in '51. And so that's a substantial benefit from the total R&D program. CHAIRPERSON FADEN: And has to be folded in. DR. RUSSELL: Yes. CHAIRPERSON FADEN: The interest in radiation effects had impact on medicine, not only in the areas of medical purposes of ionizing radiation, but how to manage burns and -- DR. RUSSELL: It was casualty care concerns. CHAIRPERSON FADEN: Right. DR. RUSSELL: And burns were the biggest piece of it. CHAIRPERSON FADEN: Right. Sure. That's important. Thank you. Jay? DR. KATZ: Maybe later on some -- and I'll leave it for later -- general remarks about the whole outline, but maybe, as you suggest, we'll depart from that to -- CHAIRPERSON FADEN: Excellent. I will make sure we leave time at the end for general comments. DR. KATZ: So I only will -- MR. GUTTMAN: It depends on how bad the general remarks are. CHAIRPERSON FADEN: How devastating it is. DR. KATZ: Only wonderful general remarks. And they are wonderful because they give you more work, and you said you had nothing to do in August. So this will give you work for August. But in general, it is -- and I should draft a memorandum for you sometime. And maybe some of the historians know more about it. I delved into it a little bit. Let me try to be as brief as possible. You know, if you look at the history of the rise of the profession, medicine and law, too, I discussed it at some length and to a limited extent in my "Silent World" book. The medical profession really tried in England ever since the 1100s to gain control, the M.D. medical profession, over the practices of medicine. They didn't really succeed except for short periods of time. To quickly go to the present, it was only at the turn of the century with the help of attorneys who wanted and got the same things medical practice acts were established which gave allopathic physicians control, almost, almost, not quite, monopolistic control, over medical practices. So medical practice acts were established, and physicians were given a mandate of how to interact with patients. But there was another aspect of the mandate not clearly articulated that allopathic medicine would in a sense superintendent of the health needs of the nation in general. And this comes up, I think, in this context, too, because, on the one hand, we are going to talk about how doctors behave vis-a-vis patients in medical practice and in medical research, but then also how the medical profession interacted with agencies, governmental agencies, under the more general mandate for superintendence of the health needs of the nation. And they were being consulted to make judgments about what was good practice of medicine, what was medically permissible. And I think we have to differentiate about these two separate activities and how they then played out in the '40s, '50s, '60s because they're two distinct activities: the individual interactions with patients and making all kinds of recommendations about: Were there any medical indications or contraindications for doing this, that, and the other thing? And then, finally, as I tried to talk about this morning, I think we need to have a section here someplace -- it could fit in -- about how the whole history of the doctor-patient relationship and the broad mandate that physicians had, at least until informed consent, to do almost anything and everything that was considered, quote, end quote, "good professional practice," then influenced the way human research at least evolved for a while until things began to change a little bit in 1974. So this is very brief, but I think it will flesh out a lot of the confusions and the puzzlements that we have about all kinds of things that went on in the '40s, '50s, and '60s. CHAIRPERSON FADEN: Yes. I got that, and I think that's well-taken. Lois? MS. NORRIS: I'm just going to step back to the radiation story again. I think as a part of that radiation story, we should include what was and is known about naturally occurring radiation. We so frequently see exposures compared with flying in a plane between Omaha and Denver or living in Denver for a certain time. CHAIRPERSON FADEN: So that goes. We could certainly lead to that. Who wants to live in Denver? Thank you. I'm continuing to take comments on Part 1. Susan? DR. LEDERER: I have two suggestions. I think, one, in the practices, I would like to leave space, depending on if we are able to obtain these four narratives from the subject participants, depending on the success of our outreach, and if we are able to get any statements from some of the people who participated as subjects. So that would be a separate category, I think, from the subject interviews. My second comment goes to the second part for the sociopolitical context in the culture of national security. I would like to see somewhere explicitly in this a reference to the development of biological warfare and chemical warfare because I think that is an important context in which to evaluate the rad warfare and the environmental releases, et al. CHAIRPERSON FADEN: In other words, you see that as an expansion of IIA? MS. NORRIS: Yes. CHAIRPERSON FADEN: So would I. MS. NORRIS: But I would like to see it explicitly in there. CHAIRPERSON FADEN: Henry and then Pat. DR. ROYAL: In regards to the narratives, we should make an effort to get narratives from people who participated in experiments and who feel that it was a worthwhile thing, as well as people who participated in the experiments who thought it was a bad thing. I don't know how many of the Committee members saw something that was on CNN. "Science and Technology Week" I think is what it's called, -- as a matter of fact, the transcript is in here -- where they interviewed people at Los Alamos, some of the people who had participated in experiments there in Los Alamos. And they have expressed a very different view than the view that we have heard about people who were concerned about participating in these experiments. CHAIRPERSON FADEN: This is one of the problems with narratives. DR. ROYAL: But we should try to get -- CHAIRPERSON FADEN: Right. DR. ROYAL: -- a broad spectrum of narratives. CHAIRPERSON FADEN: If we get -- well, we will work. Pat, you were next. MS. KING: I'm been struggling with this all along. It's a general comment. These are general comments because the way my mind works, I have to do the general before I get to the specifics, how to integrate them. I guess what I'm really troubled about is this structure of Part 1 as a totality. And that is because it doesn't connect in my mind yet to Part 2, which is telling the story through these various groupings, because part of the telling the story is our loose investigation and what we found. There's a story to tell. But we're trying to tell part of that story in Part 1, too. And that to me is confusing. For example, in Part 1, 1B, we're going to talk about practices. We are mixing practices that we developed some views about as a result of our own investigation and what we know about practices that were in the historical record prior to the existence of this Committee. That is what I find confusing. It doesn't link with me to Section 2 unless I missed something on the outline. So, then, that was my starting point. Then my question was: What is the purpose of Part 1? You call it "Foundations." That didn't mean anything to me. Ruth is very tired. I can tell you -- CHAIRPERSON FADEN: No. MS. KING: "Foundations" did not mean anything to me. I said to myself, "What are we trying to do in Part 1?" The way I answered that question, what we should be trying to do in Part 1, the way I answered that question for myself was to think of it in contextual terms, in terms of thinking about the culture in which three things -- I don't want to give them weight because that can produce a controversy itself. But there were what I considered values as expressed through about what you do with human beings as expressed in policies, rules, et cetera. Those values and rules, though, were existing in a context that was for our purposes war and then Cold War, actual war and then Cold War, and also a context that talks about biomedical science. So I won't go through all of the listings. What I'm trying to say is we live in a society. In this society we have clear views about values. We had views about war and the purpose of war and government values, society's values, really, through the Cold War. The way this is set out, ethical principles, historical standards, criteria for judging experiments seem to me to be premature because you can't judge. Part of what we're judging is we're judging what you have here, but we're judging against what's coming in Section 2 as well. I'm not making sense. I was trying to think logically through the structure of the big parts. And your all's view of the structure of the parts did not emerge to me. So maybe what I needed was to hear why you have "Foundations" and then why you have the categories that are what I call telling the story and then why you're going to have the conclusions because it just didn't come through. I sort of think of it as "facts," in quotes, about what we know about culture, what we knew about ethics, what we knew about the science and the culture of science. And then I started to go into what we've learned through this Committee, in addition to what already existed, and then I sort of got to themes. And then I got to judgments. I don't know if -- I had some questions within that, but -- MR. GUTTMAN: Ruth and I I think were having obviously intense discussion of a lot of it. Where we may have a question a bit from perspective is on the thing that you sort of seized on. The great appellate judge is one problem and one footnote on Page 34. And you happened to read the darn footnote. My understanding of that foundation section is, first, we are probably going to be able to tell people of this story that we're getting about all of these government agency ethics rules that there were ethics rules. There may have been no experiments, but there were these ethics rules; right? That's up there, up front. Now, it may have been we were finding ethics rules. You wouldn't have them. But if it's a case we're finding, that's a common foundation. We're also going to be able to tell people that we have done this incredibly arcane job of research and connected every God darn institution that relates to every other institution and every R&D board and every this and every that. That's sort of the second part. They were embedded in the culture, and that culture meant that these institutions were engaged in national security-type programs, you know, atomic bomb combat effectiveness, fallout, nuclear weapons complex. That's a common overview. The biomedical part of it, what Dr. Katz was talking about, there was a culture of the medical business; and the third part, that there was a science of radiation. It had this background. It had these standards. If there was not a single human radiation experiment, you would still have that foundation. Now the public says, "Well, what about these thousands or hundreds of experiments?" And the reason we set it up this way is it seemed easier to lay out those foundations, rather than lay them out in the context of the particular experiments, because every time would be twisting around saying, "Well, as we told you last chapter, the AEC had this rule, and the DOD." That was the logic. Your point about the practices I can see gets into "Well, the practice is kind of a more investigatory." I mean, it's at the -- CHAIRPERSON FADEN: Right. MS. KING: Well, what I think we're differing about, actually, is what does telling the story consist of that we found? Because what you're saying is you're making a part of the telling of the story what existed prior to that. And what I'm saying is the story we tell to a large extent depends on what we found because, after all, what we've done is launch a huge investigation. And I think in terms of setting off to one side what was generally known and understood before this got started and what we have uncovered and how we would tell the story of what we have uncovered because to some extent that was what we got set up to go over the grounds that people knew there was a Nuremberg Code, they knew we had -- CHAIRPERSON FADEN: Yes. MS. KING: -- that kind of thing. The other concern I had is -- I hate to open this debate, but I think of ethics as embedded, that what emerged was to a large extent shaped and determined by the culture. So that when you start off with rules and principles for me, that doesn't do me any good. I want to know the context in which the rules and the principles emerged. This is an age-old debate about whether there are some universal things that we can say about ethics or some of us think that how our rules emerge is very much a product of the institutions as they were in a certain period. She's laughing, but some of the historians will probably argue about this as well. And the way this is written to me strays over into there are these ethical principles, historical standards that have sort of an absolutist quality. Now, that may be because it's an outline and that what you're really saying is what existed. Rather than ethical principles, historical, ethical standards, what you're really saying, "This is what was there," as your head, rather than the outline you have here. CHAIRPERSON FADEN: Yes, yes. MS. KING: So it may be that I'm just being confused because of the reading of the outline. CHAIRPERSON FADEN: No, no. It's confused. It is confused. This is very helpful, but let me hear from Jay and a couple of other people and then react to how we might reorganize. I think I understand what you're saying, Pat, but I want to see if it connects. DR. KATZ: Just picking up on what Pat has been saying, Pat, there is such a thing as foundation garments. And then the garment is on top of the foundation garments. MS. KING: Yes. DR. KATZ: Is that right? MS. KING: Yes. DR. KATZ: And that's the way I read "Foundations," that these are foundation garments. (Laughter.) DR. KATZ: What the garment is going to be like we don't really know yet. You know, I think this is an excellent summary -- and there may be some additions to this; some already have proposed some -- of the kinds of pieces of the puzzle or the pieces of the quilts that we now have to collect. For example, as some of you know, I'm going to teach a course at the law school with about 15 second and third year law students. And I hope that some of them will write some good scholarly papers on Items 1C, the national defense, national security seekers seeing human rights in the world democracy, and hopefully will allow their papers to be shared with the Committee, even Section D and other kinds of things. We will write certain documents, too. Indeed, you know, I think this outline ultimately is useful in beginning to think who on the Committee and who on the staff would ultimately collaborate in writing various sections, but pieces of the -- CHAIRPERSON FADEN: Right. DR. KATZ: This document -- and I don't think that it can only be this way; it's not a criticism -- doesn't say anything about the garment. And I can very well see that Part 1 will become Part 2 and Part 2 will become Part 1 ultimately in putting things together, that we'll tell stories first or whatever. CHAIRPERSON FADEN: Right. DR. KATZ: That is going to be the difficult part early in the early winter months of 1995. So what the passions are and the views are that will inform our final report, that's going to be difficult and controversial as we put the pieces together. The garment isn't there yet, but we may be able to create foundation garments. MS. KING: As I understand what you've just said, -- this is a big leap -- I don't think -- DR. KATZ: I thought I understood you, and I thought you'd understand me. But -- MS. KING: I don't think that we disagree because -- DR. KATZ: No, I don't think that we disagree. MS. KING: -- your use of a metaphor like "undergarments" and stuff is exactly what I was trying to express, which is if you start with what's there, I actually in my own head always called this stuff "setting the stage." CHAIRPERSON FADEN: It is setting the stage. MS. KING: It is setting the stage. CHAIRPERSON FADEN: It is setting the stage. MS. KING: But in the way in which you use "foundation," we are not disagreeing because what we want to highlight in terms of the value of this Committee is there was some feeling that this early was not enough, that we needed a whole committee to help us with the garment. So the major thrust of the Committee's highlight in what we're doing should be what we did. And what we will do is exactly as you described it. In that, the basic structure didn't emerge for me from reading the outline, even though that may have been appended. I'm not saying that. And I'm not quarreling with any little pieces. CHAIRPERSON FADEN: Let me just make two observations at this point. One, we probably ought to be separating whether the pieces that are here are pieces that have to be someplace in the report, which is the short-term critical needs for the Committee staff to keep going, from where they belong in the report, which speaks more powerfully to Pat's criticism and I think to Jay, but especially to the way you're setting up, Pat. And as I hear you talk, I think it's quite right. For example, when I was going through this under I, in an earlier version which was the other way around, C, D, and E were at one point in Part 3. And then they showed up in Part 1. And there's this sort of tension about where that stuff goes. And hearing you talk, I'm now re-persuaded that it belongs in 3. It belongs someplace, but it's part of the thinking that we're going to put behind the positions that we will end up taking on what happened and what needs to happen. So if we could at least just separate for right now, is there anything here that shouldn't be in the report or something missing, as in the kinds of comments we got from Nancy and Mary Ann, or a fleshing-out from where in the report and the Gestalt of the report, I think both of which are terribly important? And in response to the kinds of things you were raising, Pat, I do think it's right that the best thing that we can do is write a report that highlights what we did simply, rather than have it sound like a sort of textbook of "Here are what is known about" this, that, and the other thing. But I'm not sure that you separate. I mean, you can do that in the same section. This was known before we started doing our work about the history of human experimentation. And we did our work, and we discovered the following additional things, however we would set that up. But I think you're right to point us to the value of structuring our writing so that we can properly acknowledge how we made a difference, rather than just having a commissioned scholar working alone to write these sections. That's something that I'm glad you pointed to our attention. So keep that as background. Comments of both sort are welcome: the general Gestalt, "It would be better to get a different theme"; the garment/undergarment sort of metaphors are very important. And also is there anything here you think we don't need to have a section on someplace? MS. KING: I think that we need an additional theme, but I don't know how to express it. It's a theme that goes to openness in government. You have to have something -- CHAIRPERSON FADEN: Right. MS. KING: -- about the relationship between the conclusions about benefit, risk, and all the things, which I agree with, and something. I don't know what we're going to say about the competing needs that government may have. Sometimes those needs are war, national security, et cetera. Sometimes they are health of the population. I don't know how -- CHAIRPERSON FADEN: It's too cryptic, but in Part 3 it's III. MR. GUTTMAN: If you were a careful reader and had gotten to Page 500, you would -- CHAIRPERSON FADEN: No. It's really very cryptic. The word's "disclosure and consent," but it's meant to encompass openness. And if you look at 5, there's again that balancing, and in 2B. DR. LEDERER: See, I place that actually sort of in 2D in putting the pieces together. And I would have added a section "Balancing Acts" because it seems to me that -- I'm on the second page under "Focal Points." CHAIRPERSON FADEN: Let's do this since we're moving forward. Can we go on to comments on the whole report and also comments on -- do we want to do that -- Part 2 -- or not? Henry? Yes, let's go to Part 2. Are you on Part 2, too, Phil? DR. RUSSELL: Yes. CHAIRPERSON FADEN: Okay. Let's go to Part 2 for a little bit. Again, any level of criticism, comment, suggestion, organization is welcome. Henry? DR. ROYAL: I have a simple suggestion. Get rid of plutonium under 2A. CHAIRPERSON FADEN: Just get rid of them? DR. ROYAL: No. DR. OLEINICK: No. Just get rid of the plutonium. DR. ROYAL: Call it biodistribution experiments. MR. GUTTMAN: And plutonium would be an example? DR. ROYAL: Yes. MR. GUTTMAN: Okay. CHAIRPERSON FADEN: Phil? DR. RUSSELL: In the sociopolitical context -- actually, it's Part 1, -- CHAIRPERSON FADEN: That's fine. DR. RUSSELL: -- Subpart 2. I think we need to deal with the management structure that existed within the various agencies because the decision-making in driving these programs and experiments varied widely and was a principal determinant in the outcome of many of them. CHAIRPERSON FADEN: Right. That's quite right. DR. RUSSELL: And so I think we really need to have an annotated description of the management description, the kinds of people that were on the advisory committees, and some way to categorize the different motivational drivers that relate to the different management structures. And I think that concept needs to be carried forward into the -- CHAIRPERSON FADEN: Present. DR. RUSSELL: -- next part so we can categorize experiments based on management categories. CHAIRPERSON FADEN: And by that you mean who authorized it, where they came from? DR. RUSSELL: Who authorized it, where the decision-making was. CHAIRPERSON FADEN: Right. DR. RUSSELL: The example was given of very basic grant-type research funded by the Department of Defense, which was investigator-initiated, then the approval of a specific experiment and so forth and a very low level. So the fundamental responsibility was the investigator. On the other hand, there were other experiments that were driven from the top down, and the fundamental responsibility for the welfare resided someplace very much higher in the government authority. CHAIRPERSON FADEN: That's very helpful, yes. DR. RUSSELL: And we need to first explain what the different management structures were and how the research related to that management structure. And then we need to do the analysis on that basis over in Part 2 because the outcome was very much related to the managerial oversight issues, who was in charge. CHAIRPERSON FADEN: That's very important. DR. RUSSELL: And this goes to Jay's point of the tension between the medical community and the nonmedical community concerned principally with national defense. That tension is very clear in this documentation. CHAIRPERSON FADEN: I see a lot of nodding/shaking heads. So you've touched a point of consensus in the Committee of sorts. That is a theme. MS. KING: And that articulated what I wanted to do. I wanted to tell you that I did not mean what you had on the next page. I did not mean balance. I meant the -- CHAIRPERSON FADEN: Yes. Okay. Thank you. MS. KING: -- theme that runs through this. CHAIRPERSON FADEN: I see Eli and Nancy, Nancy, Eli, Eli and Nancy. Everybody's so chivalrous, or whatever the right term is these days. Courteous. That was the term I wanted. DR. OLEINICK: The relative theme to this is how science is funded. And I don't know whether that has to be a separate item or in here. DR. RUSSELL: If I didn't make that clear -- DR. OLEINICK: You would include that? DR. RUSSELL: Management is the management of money in the government. DR. OLEINICK: Yes. Okay. All right. DR. RUSSELL: The outcome depends on who manages the money and who makes the decisions on it. If you track the money, you'll understand the policy. DR. OLEINICK: He's absolutely right, but I think that that theme ought to come through, at least in the discussion here, because this is how the whole radiation science begins its funding. And how it has emerged from the Cold War would be an interesting -- CHAIRPERSON FADEN: I'm coming away based on these last five minutes with the sense that this section on Page 1, Part 1, II clearly has to be made very particular to our topic. It can still draw on the large themes, but there's a way in which the large themes then provide the background. The more particular context is what we're searching for under these general headings. That can get very specific about the sorts of management issues and the tensions. There's this general grand theme of the tension of science and service to the state. We can talk about that in two sentences and then play it out in the context of particular ionizing radiation considerations that are our charge. But this is very helpful. Dan, did you want to? MR. GUTTMAN: No. I was going to say that I think that at least our thinking was that in Part 1, this foundation part, we state that there is this question about what is military research, what's basic research, and the relationships among the funding bodies. And then in Part 2, by way of example, under what we had called "institutions," maybe you have some case studies of how funding works and how things get called "basic research" or "military research" or the kinds of questions you're asking in the context of Los Alamos or a program in the military if you can find one that you can work out adequate case study material with; in other words, that there would be an overall statement of the general question or concern or principle in this initial part and then worked out in the middle part. CHAIRPERSON FADEN: I think it's got to be more than that, -- MR. GUTTMAN: Okay. CHAIRPERSON FADEN: -- more particular, more specific. MS. KING: Some areas require a lot more sophistication in the beginning. For example, Jay's point about profession and professionalism and the points he was making earlier don't fit naturally so much into the story, at least so far, in generic enough places. MR. GUTTMAN: Right. MS. KING: You may have to play that out a great deal more in the beginning. CHAIRPERSON FADEN: And, again, this is the sort of thing -- thank God for word processing -- that if you write something and then if you decide that it's better in Section 2 than Section 1 -- I'm not going to obsess too much about this right now. The key thing is that we get out what we want to make sure this report includes at this stage so that we can start saying, "Okay. You work on that piece." And later we can do an awful lot of fashioning -- I don't know whether Jay's sense of the garment is really the right metaphor here, but that we fashion how to weave it together as we become more clear ourselves about the whole structure. Pat? MS. KING: In terms of now being Page 2, going back to an earlier discussion about the forms, some things in this discussion emerge to me now as groupings that make a great deal of sense. And in my own mind, some groupings need a little bit more justification. CHAIRPERSON FADEN: Can we hold that for one second? I forgot on the Nancy-Eli. Did both of you speak? DR. OLEINICK: No. CHAIRPERSON FADEN: I'm sorry, Pat. I just wanted to get -- DR. GLATSTEIN: I just wanted to add one theme there for II under Part 2. When you've got A, "Power Differentials," talking about the subjects, you've got B talking about disclosure, consents, and voluntariness, their knowledge of what they're getting into, C for the theme of the level of risk, I think you need D to talk about the attitudinal aspects of the investigators because throughout this whole theme, at least the examples that we're focusing on, there's a continuous running theme of end justifies the means. That's very offensive to a lot of folks, including myself. And I think that that has to be explicitly hit, not -- CHAIRPERSON FADEN: Not danced around, yes. By the way, I meant to say -- I said this to Phil earlier -- I hope that people are not holding back. DR. GLATSTEIN: Did it sound like -- CHAIRPERSON FADEN: No, no, no. That's why I was encouraged by your comments. I would hope that if people have sort of stronger concerns or issues that they think the Committee should be dealing with, that we should not worry about being delicate within reason. DR. KATZ: What you're saying is the ends do justify the means. DR. GLATSTEIN: Oh, you devil. (Laughter.) CHAIRPERSON FADEN: I was encouraging more of the kind of comment we got from Eli. Pat, we're going to go back to you in one second because the groupings thing I think is going to take us a big chunk of time. Before we got on the groupings discussion, I wanted to -- Phil, are you pre-grouping? Yes. DR. RUSSELL: The point I want to make may relate to Eli's point that in that, II-A, B, C, D, I think that the issue of the responsibilities, where and what kinds of responsibilities, -- CHAIRPERSON FADEN: Good point. DR. RUSSELL: -- which is another way of I think stating what Eli said, that we need to be very explicit about -- CHAIRPERSON FADEN: But it's going back to the management. DR. RUSSELL: It's a hierarchical level. What are the responsibilities at the investigator level? And then what are the responsibilities at various levels in this amorphous bureaucracy? CHAIRPERSON FADEN: Now, this theme thing is getting bigger. This is great. Right now we've added to theme so everybody has it. We had inserted as a suggestion from Mark and everybody I thought thought right benefit, the benefit stuff, added to the investigators' or the mind-set view that the investigators took to this, and now the issue of responsibilities, how responsibilities ought to have fallen out or did fall out, things of that sort. This is great. Can we go on to groupings now or not yet? DR. STEVENSON: I wanted to add one more thing that may end up being sort of in the minds of the investigators, but I think continuing on with some of the things that were on the first part. I think we need to acknowledge sort of the theme of national security and living in the atomic age, which was a new concept then. And that may be encompassed in this idea of responsibilities of the investigators that they felt -- CHAIRPERSON FADEN: Not necessarily. DR. STEVENSON: -- an urgency or some sort of an importance that we in retrospect may not appreciate. CHAIRPERSON FADEN: Henry? DR. ROYAL: Another missing piece -- and I'm not exactly sure where it should go -- is how radiation experiments are similar to non-radiation experiments and how they're different from non-radiation experiments and -- CHAIRPERSON FADEN: I don't know where that goes either, but you're right. I mean, in the contemporary stuff, it's fine because we're going to set up our own research specifically around that issue. The old stuff I'm not sure yet, but that's very important. Okay. Can we go to groupings now? Okay, Pat. Start us off there. MS. KING: Well, it makes a great deal of sense to have -- I hate the way you all call it a "government program" because I think it's misleading, but it makes a great deal of sense to have a grouping that focuses on documents that flow from certain structures and places in the hierarchy to be able to tell part of what we can loosely call "the management story." The institutional groupings emerge as something that's cloudier, and I'm not sure. It's not clear yet to me that we need it. Maybe we still need it and there's some reason, but I think that if we need it, it seems to me it's attached somehow to either a management story which is carried down to looking at management of institutions, the actual school, so it's a part of that kind of story, or it's a part of the story that will emerge that the -- well, I don't know because there are different kinds of institutions that are grouped here. You'd want Fernald, for example, because it might tell you something about vulnerability of subjects. If you look at Los Alamos, though, that's telling you something entirely different. And so it's not clear to me that the institutional grouping holds water yet, but it may. It's just that we haven't identified it yet. The current-day experiments groupings may still be long, and it may be necessary for part of this outline that we haven't discussed in as much detail, which is on Page 3, where you have to have some section that assesses -- CHAIRPERSON FADEN: Right, yes. MS. KING: -- the current research that you would need for that. CHAIRPERSON FADEN: Yes. MS. KING: The scientific medical I think obviously we need. As I heard it today, the interest of total body irradiation, however, it may be more with some of these other themes than it was for the science itself. And somehow we've got to break it out so it doesn't look like it's there for a science reason, but some of these other kinds of reasons. But I think it's one you have to keep. CHAIRPERSON FADEN: Total body irradiation. Yes, that's pretty powerful. Let me just that as an aside, what to do with the current stuff is totally confused at this point. MS. KING: Okay. CHAIRPERSON FADEN: I'm not sure but that all of the stuff having to do with the current situation moves into Part 3 with our eye towards the future. I mean, that's again something we can worry about later. We know we're going to report on this stuff. We just don't know where it fits best. It does seem sort of anomalous stuck in here, and it's really part of our database for making whatever recommendations we want to make about changing policies or requirements, things of that sort. So I don't know. Mary Ann? DR. STEVENSON: I guess just following up on sort of Pat's comments, -- CHAIRPERSON FADEN: Sure. DR. STEVENSON: -- the way I looked at this grouping I would change it just for my own logic of having the particular Items 1 through 6 being listed under "Scientific or Medical" or, if you want, "Nongovernment" versus "Government" with the same listings. That makes it much clearer to me and I think much easier for us to look at these experiments in the proper context, of even things that Phil was saying in terms of who are the drivers. CHAIRPERSON FADEN: I'm sorry. I'm lost. What would under the "Government" heading? DR. STEVENSON: I would make Items 1 through 6 subheadings under two larger headings, which would be "Government Purpose or Program" versus "Nongovernment" or if you want to call the nongovernment "Scientific/Medical," but I think you want to split them into maybe groups that were clearly driven by government purpose, defense issues, DOE, or what have you, agency issues, versus things that were out in the scientific community not driven by national security interests. CHAIRPERSON FADEN: Dan? MR. GUTTMAN: A comment. Yes. Obviously it's a central and a difficult question. I can't say it's staff's thinking, but a way of thinking about it is we really don't know at the onset what is government. We know some things that were government purpose, but it's really a real hard thing to find out in a lot of cases. And the notion of having these six scientific categories was not that you be telling solely scientific stories, but that you would know that you're addressing all of the experiments in some respects. And by telling them, you could then bring out your other themes, depending upon the judgment of those writing the stories in the Committee. So, for example, in the total body irradiation, you're talking about a uniform group of scientific activities, ultimately uniform, but a theme could be, as Ron was saying, this piggybacking notion, which has got a lot to do with the government purpose issue, or if you are talking about the biodistribution, -- I think you probably made this point to me better than anybody else -- you're talking about, at least at the onset, experiments with elements that people don't normally deal with in the normal life unless you're around nuclear weapons. So it's clearly -- DR. STEVENSON: Right. But I think just for clarity, it would be easier to have the subheadings under two different groups. They are going to mesh in certain places. MR. GUTTMAN: Right, but we don't know. We just don't know. I mean, we just can't -- DR. STEVENSON: Well, you will, though. If you find out it's got DOE funding or AEC, then by definition the government has been involved, as opposed to something happening at an institution where it's not clear that the government had funding behind it. MR. GUTTMAN: Well, no. See, that's the problem. DOD tells us. The Navy out there tells us that out of these 800 or so experiments, 20 or 30 are military purpose experiments. The other 700 are in your scientific grouping. I mean, that's why it's not clear. MS. KING: I don't think this discussion is moving the boxes around. I think it's -- CHAIRPERSON FADEN: This is not. No, this is not. MS. KING: Mary Ann is onto something. MR. GUTTMAN: Yes. MS. KING: I think that we have to ask ourselves "What is the purpose of grouping by science and medical?" It seems to me there are several purposes. And so it may mean that you don't have this kind of grouping. One purpose is you're going to need the information from this and from Page 1 to tell us something about benefits, where valuable things are, in fact -- you've got to have that someplace. Two, the experiments themselves are the context in which the other themes are generated. So, basically, what I think is the more useful cut is if we like our themes, we classify for other purposes the groupings you have as "Science" underneath the themes. And, for example, a theme that talked about disclosure, consent, and voluntariness may take account of all of the scientific experiments. I'm going to backtrack. I mean, I think that's a lawyer's question. Why is it here? What purpose is it going to serve? MR. GUTTMAN: I'll give you an answer. MS. KING: Okay. CHAIRPERSON FADEN: A lawyer's answer. MR. GUTTMAN: Not a lawyer's answer. Well, it's not an ethicist's answer. It's hard to research by the themes because the themes are kind of residual. You're always looking to find things that relate to your themes, but it's only when you're finished, you know, where your theme -- we know that we've got X experiments. We know that X percent or whole body irradiation, X percent. And we know that because the public wants to know about experiments, we want to in some way address them. As we get into those experiments which we know exist which we have studies for, some of them may fall -- this is my perspective -- as more likely to be able to express one or two themes, as opposed to others. That's why I just take the Ron Neumann's point about the total body irradiation gets you into this government purpose theme as it develops. The problem is to do it the other way as staff is sitting there, I'm not sure how you tell that we've been doing it. We're saying "Look through these boxes for things that illustrate these themes." And it's a harder thing to investigate. Maybe ultimately you'll integrate and write the report by themes, but to proceed initially I'm not sure how you go about researching the themes in the way that we're -- CHAIRPERSON FADEN: It's really a midpoint problem -- MR. GUTTMAN: Yes. CHAIRPERSON FADEN: -- where we are right now. And one strategy we could adopt -- I'm trying to take account of Mary Ann's comments and Dan's comments -- is to say "Look, if we" -- before I had said we couldn't find categories that were mutually exclusive and exhaustive -- "Do the medical categories qualify? Could you take every study that we look at and put them in one and only one of these six boxes?" If you could do that for interim purposes and then, going back to the data form discussion, make sure that the data form relates to all of the themes so that there is something said for every theme about every experiment, like "There's no information about military purpose one way or the other" or "There is something," "There's no information about consent" or "There is something," "There's some indication that vulnerable populations were used" or "You can't tell" or "There was a clear indication that they were not vulnerable." So for purposes of work right now, take those six medical categories if we get clear enough on what they are and believe that everything could be slotted into one of them, then have a data form that covers the themes. And that as we proceed in our work, we may conclude -- and I think this is Dan's point, fitting with Mary Ann's. Maybe we'll conclude three months from now that we aren't going to write the stories along these six groupings or maybe we'll just pull out two of the groupings. We may write one story about exploitation of the powerlessness and pull out all of the ones that -- I mean, we don't know yet because we don't know how it could go, but for purposes of staff work, might this not be a bad way to proceed for right now? MS. KING: It would be a great way to proceed for right now, and I would not have a working outline, though, which is not a lot of report that listed the science categories. CHAIRPERSON FADEN: So we could pull all of that out and say we don't know how we're going to do this middle part yet? MS. KING: That's right because you -- CHAIRPERSON FADEN: That's fine. MS. KING: I think that Dan is right. You do need to put them together in terms of science, medical groupings simply because that's the way most of your data is blowing in, for one thing. And you've got to have a way of getting to the themes. But the report itself is going to concentrate on whatever the themes are. And so we ought to think in terms of this kind of classification as being one of organizing data only. DR. STEVENSON: That's how I see it. CHAIRPERSON FADEN: That's your sense, too, Mary? DR. STEVENSON: Right. I mean, actually, going back to the data entry form, in essence, we've sort of done that because there's the type of research category. And above that is the government applications. So I guess, in essence, that's happened on the form. I mean, I think, like Dan's saying, you may or may not know whether or not there was a government program or purpose. If you can identify it, great, but we still have to put them in these subcategories. Just for organizational purposes, I think it's useful anyway. And maybe that's the way. But I wouldn't have government programs as a separate grouping. I guess that's my problem. I mean, it is separate, but it doesn't make sense. CHAIRPERSON FADEN: It doesn't make sense now. Yes. Phil? DR. RUSSELL: This discussion of government purpose and government program I think requires some comment here. There were two themes that drove a lot of funding in the Department of Defense: casualty care and human performance. Human performance in biomedical terms is physiology. And so there was a philosophy of research investment that was very intensely executed by the Navy especially, that if you just poured money into investigator-initiated, grant-supported research in the general fields of human physiology and anything that related to the care of the acutely injured individual, that eventually you would amass a body of knowledge that was of great benefit to the U.S. military. And by law the Defense Department spends money for a military purpose. CHAIRPERSON FADEN: That's right. DR. RUSSELL: Now, the rationalization of exactly what that purpose is and how directly the research is related to military purpose is a matter of some discussion and debate. But all Department of Defense research had an ultimate military purpose. And it may just be a better understanding of human physiology so that we could understand performance limitations, so we could understand combat casualty care a lot better. CHAIRPERSON FADEN: That's very helpful. I mean, I think we ought to remember that, that this is -- DR. RUSSELL: It's kind of hard to make a translation from some arcane study of sodium metabolism to combat casualty care, but the thought was there someplace. CHAIRPERSON FADEN: Eli? DR. GLATSTEIN: I'm a little confused on the scientific, medical categories as to the distinction between five and six, intentional releases in exposure and experiments of opportunity. I mean, the intentional release was actually the creation of an opportunity. And I think that what you may means by experiments of opportunity reflects more accidental or inadvertent opportunity than planned. DR. STEVENSON: That's exactly how I'm reading it. I mean, there were true accidents that people quickly decided they could do some dosimetry and figure out, you know, and that did happen at these various facilities. So those I agree with Eli, and I read that as being just that. They were related to accidents where people actually gleaned some data from it. DR. GLATSTEIN: I made the distinction because without that distinction, then it's not clear what the difference is. MR. GUTTMAN: The distinction, at least in one person's mind, was that the intentional releases per our charter were instances where there was an intentional release. It isn't clear there was a human experimental purpose, but there was an intentional release. The experiments of opportunity and the uranium miners, I don't know if it is one, but an example would be where Party A may have done something intentionally, the AEC says "We're going to intend to put the Navajos in the mines." So it's intentional. And Party A says, "Oh, I'm going to take advantage of it." Now, it could be an accident. So the experiments in opportunity could have intentionality, but is it a vision of intentionality in the premeditative sense? CHAIRPERSON FADEN: It's not going to be easy in some cases is what it comes down to. And we're going to need to refine our account of these two categories conceptually if we really want to sustain them. I thought a little bit about this, too. I mean, assuming we, for example, decide to discuss the Marshall Islands, we'll have some difficulty figuring out for atomic effects sort of where they would fit in between those two. All of them cause some consternation. So there would be the need for more thinking, and we might end up putting them together in some respects, rather than try to work too hard at keeping them apart. What I'm hearing so far is a sense that we keep either five or six of these medical groupings for purposes of staff work, make sure that the data form captures, I've got now, up to eight themes, at least a summary thing about "Is there some information on this theme? Yes? No?" and whatever it is and leave open for the moment how we're going to write up this focus, this huge section of the report, whether we're going to use some combination of medical grouping stories and themes or solely themes or whatever we don't know yet. But that's, in part, a function of what we learn as we go further. Is that all right? MR. GUTTMAN: If I can ask a practical question and pick on Dr. Neumann because he's capable of defending it? But take total body irradiation. In the next period, can -- Ron and Mark and Gary happen to be working on it. In addition to sort of collecting the data points, can they begin to explore the kinds of questions that you were all asking them? Well, was this in the middle of total body irradiation experiments or at the beginning? In other words, it's not simply just going to collect data, but actually do the thinking that would result in a story addressing these themes. Is it -- MS. KING: I'm very comfortable with that because I think that's what you have to do. MR. GUTTMAN: Yes. Okay. MS. KING: And part of my discomfort with some of the materials in the package today was that it wasn't clear what the thinking of a person who wrote the memo was. And so it left us in great confusion trying to piece it together. So at the next point if people -- if this is what you intend to do -- who report on various aspects of this don't just tell us what the documents are there, for what they see as the emerging themes, instead of conclusions, I mean, that is the next stage that we need to go. That's what needs to be clear for us because we have to understand what the person looking at the document understands, to a great degree if we're not going to have confusion. CHAIRPERSON FADEN: That's quite right. MS. KING: Yes. CHAIRPERSON FADEN: I should draw your attention. Are we clear, then, what the direction is to staff? We work with these five or six groupings, five and six being an area for further conceptual clarification as to how we mean the word "intention" and whose intention against whose seizing of an opportunity. We'll work more on that. The themes are the themes that have been articulated. They go up to H at this point. We go back and revisit the form. I don't think we should try to do that collectively, but we can go back, staff and some of us, and try to look at the form and make it in some respects more comprehensive, in some respects simpler with an understanding that it's the first cut. You know, is there information on this or not? I want to draw your attention, in part, because this obviously evidenced a lot of work on Duncan's part. The boxed area in the middle of the page comes from the document that Duncan drafted. And it was his sense of what needed to be discussed about any group, however we set it up, that we would want to focus on. He had one suggestion, which is one correction: f, g, and h really belong out under what should be Number 3 under his kind of grouping. But in some ways this relates to the themes. I think we can make the two go together. But this was his thinking of what needed to be covered in any discussion of what went on in any of the medical groupings. So I just wanted to draw this to your attention since he did put the effort into it. And if you look at it, some of it comes close to the themes we're discussing as relevant. We'll work on putting that together. MS. KING: I think the groupings will be the themes, whatever they are. I take back what I said. That's sort of the direction I think that you inevitably have to go through if you're going to pull from all of the different kinds of research experiments. This grouping, the most clearly defined grouping that we got today was what you called "government program," which is not government program. It still is being -- CHAIRPERSON FADEN: Of management. MR. GUTTMAN: Query, though. Can I ask? In terms of what the staff can do on this B part, can the staff go back? Because you can't have management in the abstract. You have to have a particular program to look at. And Don's nodding his head. Can staff go back in the interim between this and the next session and see if they can dope out and propose to you specific examples of government programs and specific institutional examples that they would propose to look at? CHAIRPERSON FADEN: I think the problem is the language of "government programs." That's not what we're talking about here. The concern is to understand, and it's not even clear that it belongs in this part of the report. MR. GUTTMAN: Right. CHAIRPERSON FADEN: The concern is to understand, and it's not even clear that it belongs in this part of the report. The concern is to understand who made decisions and who authorized these experiments and who paid for them, whether they're programs of experiments or particulars. So for each of these categories, -- MS. KING: Right. CHAIRPERSON FADEN: -- who is deciding that this should be done? Who is reviewing them? MR. GUTTMAN: Okay. But -- CHAIRPERSON FADEN: Okay? Who is paying the money for it? MR. GUTTMAN: Let me explain why it is that I think what I'm suggesting is useful, because we have these disparate experiments. And if we had perfect knowledge, we'd know exactly where everyone was coming from. But what we've got is you've got 40 biodistribution experiments or 60 or 100. You know one of them is connected maybe to the Defense Department in 1962 and one to the AEC in 1954. And you don't know what else they're connected to. By virtue of this government program approach, if you have something like this panel, you can see that there was a coherent burns program, of which there were the following experiments, some of which were biodistribution, some of which were total body irradiation. In other words, you can see a cut that you would not be able to pick up because of the data you have, the limits of the data on the individual experiments. That's the point on that cut. CHAIRPERSON FADEN: Perhaps the way to look at it is, as before, we're working at it from both ends. MR. GUTTMAN: Correct. CHAIRPERSON FADEN: Okay? MR. GUTTMAN: Right. CHAIRPERSON FADEN: And if you're saying "Does the Committee want the staff also to work from the" such and such "overview committee out" -- MR. GUTTMAN: Right, right. CHAIRPERSON FADEN: -- "as well as from a particular study in?" -- MR. GUTTMAN: Right, right, right. CHAIRPERSON FADEN: -- that's fine. Okay. Just the language of "government programs" throws people. We want to get to the same place. MR. GUTTMAN: Right. CHAIRPERSON FADEN: We want to get to the same place. MR. GUTTMAN: Right, right. CHAIRPERSON FADEN: We want to understand where the authority came from, who made these decisions, -- MR. GUTTMAN: Right. CHAIRPERSON FADEN: -- what combination of military types versus science types versus medical types were involved around what kinds of ultimate outcomes. And however we need to get there, we do it. So if in some cases it's tracking the minutes of some oversight committee and that takes us into four of these areas, that's fine. Is that okay? All right. DR. STEVENSON: It's important to not put that down as just a category per se. CHAIRPERSON FADEN: Right. It's not a category. DR. STEVENSON: It's an overriding organizational -- CHAIRPERSON FADEN: It's a theme. That's right. To use the language of this, it's a "theme." So, for example, if we had another way to get to what we -- we have to come out vulnerable. It's a problem when you have shorthand. If there were another way to find out about vulnerable populations other than study by study, if we could find some document or some group somewhere that said "Hey, let's use dying people. That's a great group to do this work on" and there were a committee that actually deliberated on using dying people, we'd love that stuff. We'd like to find it. We could work at it from that way as well. So any way we can get at these themes. The disclosure, consent, and voluntariness themes we're also getting out from policy documents, this debate about -- MR. GUTTMAN: I don't think there's any disagreement because we're all saying what makes sense, ultimately hopefully will make sense collectively. But the point is sort of an information -- it may be -- DR. STEVENSON: You know, again, I think maybe just move that -- MR. GUTTMAN: Yes. DR. STEVENSON: -- to the first section. MR. GUTTMAN: Well, I'll tell you -- DR. STEVENSON: Then that will make it easier, I think. MR. GUTTMAN: This is why I want to make the point because there is a point. In the first section, you're not going to have the detailed rich description that people are going to want to get in all of these issues of vulnerability and consent. In other words, you may hypothetically -- let's say the Department of Energy says "We want you to come in in the next phase of the investigation and go take Oak Ridge or take Los Alamos and follow it from 1944 to 1995." Now, if you had the DOE to get a kind of richness of information about that institution in a longitudinal sense, you just couldn't get -- you're not going to put it in the introduction. It's not going to be a couple of pages. You couldn't get elsewhere -- I don't know. There may be a way of telling the story that you can only do by adding a particular institutional case study or case studies. If you have your perfect information, you wouldn't have to do it because you could just plug everything into one experiment. But you just don't see the -- MS. KING: The point is true that the President's Task Force on Health Care, where we were instructed to no longer use the term "ethic," but use "alliance." It took it a while for it to sink through. Part of this discussion is only about calling this something different. MR. GUTTMAN: Oh, okay. MS. KING: But in calling it something different, we also had developed a different understanding. And that's the tracking point. The government program, what has already been done in tracking those committees and the documents for the committees we want retained. MR. GUTTMAN: Right. MS. KING: What we don't want anybody to call it anymore is the "government program" grouping. CHAIRPERSON FADEN: Right. Out. MS. KING: Yes. What we want you to call it is, at least for the time being, "management theme," -- CHAIRPERSON FADEN: Right. MS. KING: -- is what I want you to call it. I don't know about the rest of the people. CHAIRPERSON FADEN: And if you want to have a case study about the management of Los Alamos, we may have it. MS. KING: Right. MR. GUTTMAN: Okay. Fine. Don, is that adequate for your -- DR. STEVENSON: It's really the same thing for institutional because I don't think that -- CHAIRPERSON FADEN: Right. I think that what's happening now is we're seeing how that all comes together. Institutional might be a special case of the management theme, a particular institution's involvement in this, who made the decisions, if you wanted to take the Fernald school, as they did in that report, who decided that the Fernald school was a site for this work, and how much did the people in the Fernald school versus whatever, you know, that kind of stuff. Phil? DR. RUSSELL: I think that to follow that point along a little bit, we may find it very important to link the program and the institutional analysis because I sense from looking at some of these documents that what happened was that the program management put big chunks of money into laboratories and institutions. CHAIRPERSON FADEN: That's right. Fernald school versus whatever, you know, that kind of stuff. Phil? DR. RUSSELL: I think that to follow that point along a little bit, we may find it very important to link the program and the institutional analysis because I sense from looking at some of these documents that what happened was that the program management put big chunks of money into laboratories and institutions. CHAIRPERSON FADEN: That's right. DR. RUSSELL: And that Put all the decision-making at the critical level; i.e., the protocol's approval -- CHAIRPERSON FADEN: This is great. DR. RUSSELL: -- at that institutional level. I think we're going to find when we look at this spectrum of laboratories from Oak Ridge to the School of Aviation Medicine, the burn unit at Fort Sam and so forth, that we're going to see a spectrum of appropriate management and decision-making vis-a-vis human volunteer experiments. And I think there's going to be a lot of very interesting revelations when we get to that level. CHAIRPERSON FADEN: This is great, by the way. I mean, I have to say how appreciative I am of how good this discussion is going because I'm really feeling as if there's enough input now from the Committee that we can rework this and staff can feel confident that the work that they're doing follows your direction, our direction, so that if we don't like it three weeks from now, it's our fault, not their fault kind of thing. Don't panic, not that the work that you've done is not important, but it is very critical how it's packaged. And we may repackage it yet again 60 times -- not 60 times, but 4 or 5 times this repackaging may occur as we come to have deeper understandings of what we want to say as a Committee. But when Pat made the point about Mary Ann's comment being more than box-moving, this is more than box-moving. This is not simply saying "Okay. We're going to have this discussion in Part 3, rather than Part 2." This is rethinking how we want to set it up. And the themes now loom really large and certainly set us up well for what we want to say about the future. And if Ken were here, he would say that one of the themes he wants is government culpability and liability. He left us with the notes. And we might add that in there. He very much wants a theme. He would now, I think, accept that language, although he didn't have benefit of this discussion, that speaks to as we go through all of these just what level of government involvement in some sense, some account of culpability. DR. RUSSELL: That speaks to the compensation. CHAIRPERSON FADEN: Exactly. That's what he's trying to set us up for. He's trying to make sure that the theme thing sets us up for whatever we want to say about compensation. CLOSING REMARKS CHAIRPERSON FADEN: Now I have a suggestion. It's 3:00 o'clock, and our closing person is here. Phil Caplan is here from the White House, which is great. I'm almost thinking let's not worry about Section 3 yet. Is that okay? Let's not worry about Section 3. It's too late. We're too tired. Phil is here. We can do that in July. And we have a lot to do to reorganize 1 and 2 and get going. So, remember, some people are staying for subcommittee meetings after this, but Phil is closing the full Committee. We're al