ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS * * * * * PUBLIC MEETING * * * * * * JANUARY 19, 1995 * * * * * The meeting was held in the Empire Room, Omni Shoreham Hotel, 2500 Calvert Street, NW, Washington, D.C., at 9:00 a.m., Ruth Faden, Chair, presiding. COMMITTEE MEMBERS PRESENT: RUTH R. FADEN, PH.D., M.P.H, CHAIR MARY ANN STEVENSON, M.D., PH.D. HENRY ROYAL, M.D. PATRICIA KING, J.D. DUNCAN THOMAS, PH.D. ELI GLATSTEIN, M.D. KENNETH FEINBERG, J.D. LOIS NORRIS RUTH MACKLIN, PH.D. REED TUCKSON, M.D. JAY KATZ, M.D. NANCY OLEINICK, PH.D. SUSAN LEDERER, PH.D. PHILIP RUSSELL, M.D. ALSO PRESENT: ANNA MASTROIANNI, STAFF DAN GUTTMAN, STAFF PHILIP CAPLAN, SPECIAL ASSISTANT TO THE PRESIDENT FOR CABINET AFFAIRS C-O-N-T-E-N-T-S OFFICIAL CALL TO ORDER - PHILIP CAPLAN 3 OPENING REMARKS - RUTH FADEN 3 APPROVAL OF MINUTES 9 UPDATE ON SUBJECT INTERVIEW STUDY - JEREMY SUGARMAN AND NANCY KASS 10 UPDATE ON RESEARCH PROPOSAL REVIEW PROJECT - SARA CHANDROS AND GAIL GELLER 59 COMMITTEE DISCUSSION: GOVERNMENT STANDARDS AND GOVERNMENT CULPABILITY 83 JONATHAN MORENO 85 RESEARCH PRACTICES: REPORT ON ETHICS ORAL HISTORY PROJECT - SUSAN LEDERER, JON HARKNESS, AND GAIL JAVITT 206 COMMITTEE DISCUSSION: INDIVIDUAL AND PROFESSIONAL CULPABILITY - ALLEN BUCHANAN 245 P-R-O-C-E-E-D-I-N-G-S 9:09 a.m. CHAIRPERSON FADEN: Good morning. We have Phil Caplan here from the White House who's going to officially open our meeting. Phil? MR. CAPLAN: Good morning -- three more after this one; right? (Laughter.) Good morning. My name is Phil Caplan, Special Assistant to the President for Cabinet Affairs, and I hereby declare this meeting of the Advisory Committee on Human Radiation Experiments open. CHAIRPERSON FADEN: Thank you very much. Phil, he waits once a month for this responsibility. Thank you very much. I was saying when I came in there are certain memories I'm going to have of this experience, and one is going to be Phil and Anna in the back talking. It's anecdotes. It's wonderful. I'll miss that. Okay, this is the tenth meeting, and I guess at the tenth meeting you start to get a little nostalgic. We can see the end in sight. That is both a source of comfort and a source of intense panic, but we need to proceed. I want to welcome everyone and, as I am want to do, take two minutes to kind of give the overview of what we hope to accomplish in this, our tenth meeting. As always, we have at least several different irons in the fire, all of which need to be addressed. We're going to start the meeting with an update on the two contemporary empirical projects that the Committee has sponsored. This was in response to a request we had last meeting we not repeat -- provide a report for every single activity that staff and Committee members are currently engaged in, but for large activities that are just getting into the swing of progress that we need to hear about what's happening. So we're going to begin with two quick reports on the status of both the Subject Interview Study and the Research Proposal Review Project. Most of the time in this meeting is to set aside, however, for Committee deliberations in general and, in particular, for Committee deliberations with respect to questions about retrospective moral judgment and culpability or blameworthiness. The hope is that by the end of this meeting the Committee has reached a tentative framework concerning those issues for making judgments both about the government, about professions, and about individuals such that not to have it completely set forever, but enough of an agreement about a general structure, so that in February we can have a parallel emphasis on the question of now moving from culpability to remedies. So the idea is by the end of this meeting we've got enough of a culpability analysis in place, the Committee is comfortable enough with the way in which it wants to understand who can be held culpable for what, by what criteria, so that we can then very carefully address the companion question of remedies. So that by the end of the February meeting we've got a basic structure in place around which everything else will hang. Now, obviously, we may in the months remaining either want to make major or minor changes in the structure that we tentatively adopt today then in the February meeting, but that's the agenda. That's what we're going to try to accomplish today and then tomorrow. As part of the focus on questions of culpability and how we might understand ethics criteria or ethics standards for making judgments, particularly with respect to the conduct of individuals, we wanted very much today to hear from the Oral History Project to get some preliminary sense of where the oral history project data are going. So we will have a report in the afternoon from the Oral History Project on that subject. We're also going to look again at the revised version of the document that Allen Buchanan has -- is preparing for us because it now has taken on a different shape in some respects, particularly with regard to questions concerning professions and individuals. On Friday, we will turn our attention to what is always a priority for this Committee, which is the public comment period. We will have our public comment period in the morning, and we will follow that public comment period with a switch, a short switch to the contemporary again, where we'll hear our first report on the status of the current situation with respect to agency oversight concerning research involving human subjects, with the hope of again setting ourselves up for looking at questions of specific recommendations. Forward-looking remedies is the language that some members of the Committee have adopted, recommendations that this Committee could make about the future, as well as about retrospective types of remedies in terms of attempts to redress people who have been wronged. We are then in the afternoon tomorrow going to try to do two things. First, we're going to try to take the framework that we may have tentatively -- that has tentatively emerged about questions of retrospective moral judgment and culpability and look at the context of the total body radiation experiments as a kind of test case. Let's see how well the framework that we seem to be adopting would serve us in the context of a specific set of examples. So we're going to try to do that tomorrow afternoon. We're also tomorrow afternoon going to get a report from staff about the status of progress toward the final report and a sense of grand plan. Dan has this grand plan with the rest of the staff about how we're going to get this all done in time, what the priorities will be over the next couple of months, and that will be laid out for Committee discussion and deliberation. So we can begin to see whether this program makes sense, including, for example, when experiments of opportunity, of intentional releases will appear on the agenda, how we're going to attack those. My understanding is that's a February agenda item. Yes, yes, but we need to get the whole program out before the Committee, so that the Committee can see the plan as it stands right now for what is going to be attacked and what's going to be brought to closure, when on the time frame that we're working with. So that's basically how the meeting is going to be structured. Let me begin the actual formal process of the meeting with our regular call for comments or criticisms, suggestions for amendments to the December 15th and 16th meeting minutes. Are there any calls for changes, anybody we forgot to note as absent or present, or otherwise any part of the discussion that we got incorrect? Can I -- I'd like to call for approval of the minutes, please. Would someone make a motion? DR. GLATSTEIN: So moved. CHAIRPERSON FADEN: Thank you, Eli. Is there a second? Thank you, several seconds. All in favor? Thank you. The minutes of the December 15 to 16 meeting have been approved by the Committee. With that, let's just move to our first agenda item, and the first update that we're going to get is on the Subject Interview Study. Jeremy? Nancy, why don't you go ahead. Nancy and Jeremy back from the wars. DR. SUGARMAN: We provided you a packet, a manilla folder that's on your -- right in front of you that is a packet of stuff related to the Subject Interview Study. In there you'll be able to find a memo which covers some of the factual information I'll briefly cover, copies of the most recent versions of the instruments to be used in the Subject Interview Study, and the finalized work plan for the subcontractor Research Triangle Institute with how they hope to carry out the work outlined in our task order to them. Of the 15 institutions originally selected for the Subject Interview Study, IRB materials have been submitted at every institution. One institution, Rex Hospital in Raleigh, has given us their approval to go ahead. Most of the IRBs are meeting this week and next, and so we should have more approvals shortly. There was some talk, and there continues to be some talk, about the possibility of going to a fifth geographic site, recalling that the sampling frame for the Subject Interview Study is currently to go to four geographic sites: Baltimore- Washington, Ann Arbor, Seattle-Tacoma, and Raleigh-Durham. And we realized that we were missing some areas, especially the Southwest; we were lacking some Latino representation in our sampling scheme, and if budgetary and practical considerations permit, we will go into a fifth site. We've identified some sites in Texas to make up that site. These were, again, based on agency funding lists, and we have had some meetings at two of the four possible institutions we would go to if budgetary considerations permit us to go. I had a meeting in San Antonio at Wilford Hall Air Force Medical Center that went extraordinary well. The folks there were interested in pursuing IRB, starting the IRB process in anticipation of the possibility of our coming there. So that if things did happen, we wouldn't need to rush. Likewise, last Friday I had some meetings with some people at the University of Texas at Southwestern, and, thanks to Eli's help, met with the appropriate people, and they also have agreed to move forward with the IRB process. We're now completing those materials and getting them to the University of Texas, and they believe that they can do this under an expedited review. Tomorrow I will be going to the Dallas VA to meet with some folks there. The final component of that process would be to identify a community hospital to complete the sampling frame, and we are eliciting input as to the appropriate place for that to happen. With respect to the instruments, I want to say thank you to the folks that were able to comment on the earlier drafts; the folks who said that they have no experience working in the area, Nancy, whose comments were among the most helpful. She reminded us of some things that you miss when you play in the science world and not maybe in the real world. They were extraordinarily helpful to outline some of the things that we had missed. It occurred to us, as we were reviewing people's comments, that there are some things that take place during a survey or an interview-type study that may not occur in the instruments you see. Nancy's point, for instance, says, well, you're going to VA medical centers and you'll be talking to some of these folks, and it's conceivable that they may have been a veteran that participated or was somewhere near one of these things going on, and they may be sensitized in different ways. Well, this isn't rocket science, but it's a very important thing to consider. We toyed with the idea, and then thought hard about the idea, about including particular survey items about such participation and realized that doing so might influence everyone's response in ways that might not be helpful. But we have included in the directions, in the draft directions to the interviewers, to try to tag that information and get that written down in sort of an open-ended fashion so we can look at features like that, adding items such as: is there anything else that we should know about with respect to things like this? The instruments you see now have been sent out to a group of expert consultants to help us also see the forest, and they provided us with very good comments and very helpful suggestions for how to conduct this study. We're in the process of revising the instruments yet again that you have in front of you, based on their input, some focus group data being conducted at Georgetown and the University of North Carolina. The focus groups were conducted last week, some this week, and they'll be completed next week. We hope to finalize these instruments by Monday at the latest. We are actually hoping to do it by tomorrow, so we can go for final pilot testing. We realize that we have -- we would like your input one more time. We are going to need your comments back very quickly again, and the reason for that is that the training of our 35 interviewers out in the field is going to take place next Friday. So we have to finalize the instrument before we can train the interviewers. If at all possible, we'll provide you with the penultimate version before you leave tomorrow and ask for your feedback by Tuesday at noon. If don't make that, they'll be faxed to you by early Monday morning. Finally, you have a work plan. You've received an earlier draft copy of a work plan. This is helpful in answering a lot of the questions you may have about the actual conduct of the study. I would keep it as a reference because some people may ask you how is this being done. Most of the answers are there. And the final item is there is an analytic plan for this study that is being worked on. We are willing to share and would welcome the input of anyone who wants to comment on the analytic plan, but we need to know who wants to comment on the analytic plan. CHAIRPERSON FADEN: I see Duncan. (Laughter.) DR. SUGARMAN: Okay. Is there anybody else that would be willing to help us with the analytic plan? CHAIRPERSON FADEN: Sandy will help. DR. SUGARMAN: Thanks. So that's all I had to share this morning, and Nancy and I are here to answer any questions you may have with respect to where we are with the study, where it's going. CHAIRPERSON FADEN: Before I open it completely, can I just get clear on something you just said in terms of instruments? Should we disregard these versions of the instruments and wait for what, your penultimate draft, and if they want to be really compulsive and look at them tonight, they shouldn't? DR. SUGARMAN: Well, I think you can look at those -- I would look at those drafts -- those are the drafts that are circulating to IRBs -- because you may have strong opinions. You may vote to keep some of those items. I mean, there was a lot of work that went into these items. I wouldn't dot "i's" and cross "t's" on those instruments if things are slightly out of order. We will be changing ordering of items based on experts' opinions. We might be changing some of the wording, and you may prefer this version better. So I would -- CHAIRPERSON FADEN: The version that you were saying we might have by tomorrow, shouldn't we just wait for that one, though? DR. SUGARMAN: You can; it's up to everyone. CHAIRPERSON FADEN: All right. With that, questions for Jeremy and Nancy? Henry? DR. ROYAL: In terms of the instrument, the answers that are listed on the sheet are agree/disagree and I thought it might be difficult for someone to give a binary answer as opposed to some qualitative answer. I assume that's all been discussed and it's clear that a binary answer is better? DR. SUGARMAN: There is always a debate about how many items or response items to have. Realizing that the brief interview will be conducted with folks waiting for their appointments in radiation oncology and medical oncology and cardiology, we're going to work hard to get a private space, but these are folks that we thought that if we increase the number of options, we then decrease the numbers of things we can ask about in a 10-minute interview, and it's also in sort of a very busy environment. There are some items which don't -- DR. ROYAL: I don't know that I agree. I agree that someone's going to have to think long and hard about whether they agree or disagree if, in fact, they don't have an opinion about it. DR. SUGARMAN: There are -- DR. ROYAL: It might take them longer to answer the question. DR. SUGARMAN: Go ahead. MS. KASS: I guess I would like to thank you for that comment because I think that is actually one of the things that is, I think, still under consideration. We have heard that same comment from multiple people in the last week, including some of our other expert advisors, and it was recently suggested that that may be something that is appropriate to look at in the pilot, conceivably even administering it in two different ways and see which goes better. Because I think you're right, we could envision -- I think our goal here is expediency, and people argue differently about which way will be faster. DR. SUGARMAN: Well, Henry, we have heard arguments on both sides, and I just wanted -- I guess we've shared both sides of that, and we would like to open up -- some of the items just don't make sense to make that agree/disagree. We want to flag those items and make sure we at least have "I don't know's" or "unsure" characteristics. The danger of that is we have bunches of people in the "unsure" category and then -- CHAIRPERSON FADEN: When you do that, you test it. If you do it that way, you might want to consider using a card with a like-it range, so that you don't have to read it every time. That saves you the time of having to say "strongly," indeed -- some of the -- you don't have to say it every time, and see if that doesn't save the time and still get the range. Nancy? DR. OLEINICK: No, I was going to say -- I think I brought up before that nowhere on here is the opportunity to say, "I just don't know," "I don't want to answer that question." DR. SUGARMAN: Okay. DR. OLEINICK: You've commented on it. So I think you need that option. DR. SUGARMAN: I think people are free to skip any items, and these are the kinds of things where people can skip an item if they want to -- maybe we need to make that more explicit -- that prefer not to answer or also some of these areas -- we'll see on pilot testing what happens and be able to modify our instructions according to that. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: Yes, I guess I want to second the comment that "don't know" has to be an answer to questions that appear to be factual in nature. Some of these questions are opinions of the subject. Others are questions the answers to which I wouldn't know. They're empirical questions. Most people do such and such. Most patients are treated -- I mean, for somebody -- I mean, it's really asking their generalizations that rely on some knowledge of facts, and I think it might give more inaccurate answers to ask for agree or disagree if people are forced into those questions without -- when they're not opinion questions. I mean, opinion questions are something else, but these are really factual empirical questions. DR. SUGARMAN: There has been some considerable discussion about those items. Those are meant to be attitudinal items, not factual items. Their current iteration, some of them appear like factual questions; I think you're right. Our hope, I think, is to modify most of the items to be attitudinal. It's not a test. We don't want to be testing people. We really want their attitudes to these specific elements, and this was our attempt to get around some prior comments, but it clearly needs more work and that's what we hope to do. CHAIRPERSON FADEN: Duncan? DR. THOMAS: Could you just tell us a little bit about your plan for sampling for the in-depth survey? DR. SUGARMAN: Sure. The in-depth survey sampling is akin to a quota sampling method. It's a purpose of sample using the qualitative folks' language for it. What we hope to do is, of all the folks at every institution who say or believe that they're participants in research, and who are willing to be conducted or eligible to be sampled for the in-depth interviews, we then hope to strike a balance with respect to several characteristics that are felt to be important with respect to differences. So we would like, if possible, to get representation from each institution, if possible. We would like to get representation from each type of clinic, cardiology, medical oncology, radiation oncology. We'd like a balance with respect to ethnicity, gender, and age. That's about as detailed as we can. We're going to try to strike that balance during the process. The way this will be operationalized is, since there are four geographic sites and fifteen institutions happening all at the same time, is a central team at Research Triangle Institute is going to be receiving on a daily basis a census of folks with those characteristics outlined who are willing to be contacted. They're going to schedule all the in-depth interviews to take place probably the week following the brief interviews, and so that they can consolidate their time. So they'll be able to balance things across the country. Finally, we wanted to leave a little bit of openness in there. If the brief interviewers identify something that's of interest that for some reason this person would be good to talk to, that there's something about their story which seems compelling, the person volunteered some information, that they can make that indication and mention that to the site supervisor, a Ph.D.-level person who's going to be at each institution -- to sort see if that -- if there is something that we've missed in that scheme. DR. THOMAS: At this stage, do you have any estimate of how many from the first sample will consider themselves research participants, how many will you have to work with? DR. SUGARMAN: No. I mean, this -- I think we can be confident that we're going to get the 125 because, if we go just to the 15 institutions, our sample size is 2,500 in terms of brief interviews. If we take the lower estimates -- this is a debate we had about six months ago about what proportion of folks in waiting rooms are, in fact, research participants, and those estimates have ranged between 5 percent and some people have said, you know, if you go on a certain day, 30-40 percent. Our best guess is it's probably 10 percent overall. Some institutions like the NIH, just about everybody is a research participant. Now whether -- and so I think we're going to be able to accrue an adequate sample of the 125. In community hospitals we don't know. You look like you had some -- a lingering -- DR. THOMAS: Well, 10 percent of what is it, 2,500, the total sample size is 250, which means we would be taking about half of them. You just don't know whether you're going to be able to fit into all the boxes of your purpose of sample? DR. SUGARMAN: Right. Those are -- that's our aim. Underlying that number is the actual -- or that's our best guess from going around to lots of places and asking. This is a very hard number for people to come up with. This is one of the things we're going to be able to answer with the study, what proportion of the folks sitting in waiting rooms are actually research subjects. My guess is that more people are going to believe that they're research subjects than there actually are. So I think that actual number is going to be greater. My hypothesis is that people who go to research institutions are going to believe their research subjects in some sense even when they're not. So I think that that "N" of 250 is going to be much greater. And the other thing is we also have this possibility of going into a fifth site, which will then increase our sample considerably. DR. KATZ: How do you know -- how do you know whether the subjects are accepted or not? DR. SUGARMAN: That's been the toughest question that we've had, Jay, and I think it's been -- it's going to be an institution-dependent process. Some institutions have a computerized record of everyone who is a research subject. That's the best -- from our perspective, that's the best for us because it's easy. In other institutions, we're going to have to go survey each institution to find out how to find this out. Some places have a separate research office which maintains hard copy logs. Some places have just lists of investigators who maintain their own consent forms. Some institutions put things in the medical record in a separate medical -- in a separate section. So what we have done is, as we tailor the protocol and the consent information at each institution, is try to identify what that process will be determining accurately whether someone's a research subject and getting the participant's permission to go to those appropriate sources. In some institutions we are going to have to go to every investigator and say, "Is this person one of your research participants?" DR. KATZ: My second question is: okay, you've identified, as best you can, that they are research subjects. Are you going to evaluate whether their participation in the research is of minimal minuscule no list versus data lists, and also in the same continuum whether the issues involve about the selection of therapeutic intervention and an experimental intervention creates all kinds of complex problems of communication. DR. SUGARMAN: Yes. DR. KATZ: There's both this problem and the communications problem. DR. SUGARMAN: We are going to -- DR. KATZ: Have you made some judgments about that or not? DR. SUGARMAN: We are going to make some categories. I don't know -- we'll maybe leave it to you to make the judgment. We are trichotomizing our data collection into three groups: first, the therapeutic trials; second, the diagnostic trials; and, third, the epidemiologic quality-of-survey sort of studies. That's about as far as we thought we could go with the abstraction process. In the in-depth interviews we will get more detailed information of people's perceptions of the process, their motivations for participation, how their decisionmaking went, but we won't be looking at every research proposal that ever -- or every research project in detail to assess concordance. Again, we're not trying to get at the facts of their participation; more, their attitudes and perceptions and these overall issues of volunteeriness, motivations, things like that. DR. KATZ: Finally, I know it's going to be difficult. Will it be possible for us to -- of the 125 people you ultimately select -- to get a thumbnail sketch of what the research project is all about? Is that easy to do? DR. SUGARMAN: It's not easy, but we may be doing it anyway. DR. KATZ: You're doing it anyway. So ultimately you'll get there? DR. SUGARMAN: We need to speak with folks about what level of detail we can get at, and the training of the interviewers is different than the people that can review those materials. If there is a general consensus that that information would be helpful, so you could look at participants' reports, we could certainly pursue that to gather additional data with respect to the project. DR. KATZ: Just from my perspective, I do not know how the rest of the Committee feels about it, but from my perspective, even a one-paragraph summary statement about it -- DR. SUGARMAN: So an abstract of -- DR. KATZ: -- I think would be helpful to me -- DR. SUGARMAN: Okay. DR. KATZ: -- to get an idea of whether just a blood sample is taken or whether it is a study that compares radiation therapy with chemotherapy -- DR. SUGARMAN: I see. DR. KATZ: -- and things -- DR. SUGARMAN: Okay. DR. KATZ: -- information of that kind. DR. SUGARMAN: Sure. That would be helpful. CHAIRPERSON FADEN: That's a -- I've got Nancy, Duncan, and Mary Ann. Yes, Nancy? DR. OLEINICK: Since one of the purposes of this exercise is to determine whether patients know they are or are not on a research protocol, it seems to me that you will have some instances of patients who won't know they're on a research protocol. I don't know what the probability is of determining that, but I was concerned with your statement that you were going to do in-depth interviews only with those who knew they were on a research protocol. Would you interview these in-depth? I mean, these are people who, presumably, if they are identified, are on a re search protocol and don't know it. It seems to me that the -- DR. SUGARMAN: Yes, we're not going to be able to get at that, that group. We are going to -- but you raise the ethical issue of people who are on and who don't know they are because our scheme is of the people who are research participants. The fact of asking people who don't know that they're research participants, we will get the information you see in the brief interview. DR. OLEINICK: Yes. DR. SUGARMAN: We will also be notifying their investigator that this person does not know that they're on your research project. DR. OLEINICK: There would be no attempt of including them in the in-depth interviews? DR. SUGARMAN: Well, actually, we would get less information -- if they don't even know that they're in the project, the kind of information we would get from them, I don't know what additional -- you know, "what were your motivations for signing up," the whole scheme, "What were your" -- you know, if we go through that -- it's an interesting group. I think the other part is going to be very interesting, the people who believe they're research subjects when, in fact, they're not, and so what they understand this whole process to be of their receipt of care. CHAIRPERSON FADEN: Just to clarify, we will try to assess the extent to which people fail to appreciate -- DR. SUGARMAN: Correct. CHAIRPERSON FADEN: -- that they are research subjects when they are. That is a major research question. DR. SUGARMAN: Yes. CHAIRPERSON FADEN: To link that up with -- for all the 2,500, we're going to check to see if there's evidence, if there's a research subject, whether they say they are or not. We're not going to interview them, but we will go to their medical records, go to whatever that possible system is for flagging someone who is a research subject to see if there's -- DR. SUGARMAN: Right. CHAIRPERSON FADEN: To clarify, even if the subject says, "I'm not a research project," you're still going to make an effort, or RTI is going to make an effort, to establish -- DR. SUGARMAN: Correct. CHAIRPERSON FADEN: -- indeed, whether they are? DR. SUGARMAN: Yes. For everyone who's interviewed, that assessment will take place. The problem is it is different folks who will be doing the abstraction of the records from the people doing the interviews. It just takes different skills. Is this clear, Nancy, or are you still -- DR. OLEINICK: Not terribly. DR. SUGARMAN: Okay. For all 2,500 people in the brief interview, we will be seeking their permission to validate whether or not they're research participants. We will have at the end for you numbers which say this many people believed they were research participants, this many people believed they were not research participants, this many people were on research, and these people weren't. DR. OLEINICK: But we want these two lists matched together. DR. SUGARMAN: Yes, we'll have that. DR. OLEINICK: Okay. DR. SUGARMAN: We will have that information. What we won't have is in-depth interviews with those people because the in-depth interview is really focusing on motivations to be a research participant. CHAIRPERSON FADEN: It occurs to me that I'm violating the rule; I should put myself on the list because the important thing between what Nancy has just raised and what Jay raised, it would be very important to know if the people who don't appreciate that they are research subjects are, in fact, on low- risk, low-intervention-type research projects. It would be much more troubling to discover, for example, that people don't appreciate that they're involved in research projects that pose a significant level of risk. It's not that the first would be happy news. DR. SUGARMAN: Right. CHAIRPERSON FADEN: Neither would be good, but it would be important to understand just how much -- at what level, how egregious this problem is. I don't want to suggest that it doesn't matter if it's a low-risk study -- DR. SUGARMAN: Correct. CHAIRPERSON FADEN: -- but it certainly matters more if it's a consequential, complicated high-stake study and they don't appreciate that they are a subject in it. DR. SUGARMAN: I think -- yes. CHAIRPERSON FADEN: So there might be a way to -- DR. SUGARMAN: I think there is a way to link those. We wouldn't want to link it, obviously, for all 2,500 people -- CHAIRPERSON FADEN: No. DR. SUGARMAN: -- because gaining the information about everyone -- multiple people on multiple projects, you'd be writing abstracts about research proposals until next year. But I think what we can do is, for those where there is a discordance -- CHAIRPERSON FADEN: Yes. DR. SUGARMAN: -- between their beliefs about research participation and their actual participation of either kind, that whenever there's a discordance we gain abstract information about the project or projects that they're on and abstract those materials and have them available to be analyzed. CHAIRPERSON FADEN: Duncan, is yours right on this point? DR. THOMAS: Yes, I wanted to pursue this topic a bit more, too. CHAIRPERSON FADEN: Okay. DR. THOMAS: I have two concerns. The first is it isn't evident to me quite how you're going to establish whether or not somebody is on a research proposal and doesn't know it. There may not be an annotation in the patient's chart. DR. SUGARMAN: Okay. DR. THOMAS: And I can't see you getting an exhaustive list of all the research that's going on in the institution and then going through their patient lists and doing it that way. So I'd like some elaboration on that point. And the other point is I think you dismiss too easily that sector of people that is on a research protocol and doesn't know it. They're really at the core of what this whole Committee is all about. This is informed consent. Those are the people we really should interview in depth. It may not be the same in- depth interview that you would give to one of the other people, but you really want to find out what they were told. It may take a lot of probing to find out that, oh, yeah, well, maybe somebody did tell me something about this and I kind of forgot, or maybe they do it and they don't want to admit it, or who knows. DR. SUGARMAN: Okay. DR. THOMAS: I really those should be candidates for a real in-depth interview as well. DR. SUGARMAN: Okay. Let me start with your first point about assessing -- coming up with a valid way of assessing research participation. Again, this is an institution-specific task. One of the things that RTI is doing this week is visiting every institution and doing an institutional survey, speaking to investigators, clinicians, research offices at each institution, to try to find out how they suggest verifying this as accurately as possible. You're right, medical records are not the best way of getting at this, but each place, through triangulating in on this information -- we are not simply taking one-stab at looking at one roster. This has been actually the area that the institutions, and when we were going around seeking input around the country, that people said, gosh, this is an impossible thing. There's a good reason why people don't know what proportion of folks in a waiting room are on a research proposal, but the guess is somewhere from zero to 50 or 60 percent. We will be able to do that in an institutionally- specific way. And if you have any suggestions of ways to get at that in a better way other than surveying the institution, then we would love to hear it sort of now, because once we hit the field in two weeks, we'll need to have that. But I am confident that we are going to use multiple methods and it won't be -- it's not going to be one method that's going to work at all places. The second thing, the second point about the proportion of research participants who are on a proposal and don't know it, yes, that is a critical group of people. There is no information available about that. We don't know what that number is. One of the things that we are going to be able to describe is that number. This is a benchmark investigation. It's a descriptive study where we're going to provide things that no one has ever been able to provide before. People may not know it for several reasons. Just like all of us, they may have forgotten. Just like -- it may be that there was some sort of an exemption provided by an IRB. It's almost a separate study. Now I think that the comments you gave us today, the constellation of comments, will give us an ability, based on, first, we will have the brief interview data on those people. So if the number is high, we will have some good numbers, and we may need to even increase the number of items that we can include there. The second is we can pursue all this discordant folks, the kinds of projects they're on, so that we can then use those as part of our analysis. The question is, do we have time, with the deadlines coming down on it, to design a method of talking with all of these folks in addition to the folks we've already spoken to? I think we can provide some pretty powerful descriptive information based on what we're accumulating anyway. We run an awful risk of a lot of conflicts and I think also a lot of institutional resistance if we -- in advance -- if we were to pursue that as the sort of central question when, in fact, we're going to get a whole lot of valuable data anyway. So if there's a way that we could sort of rapidly incorporate going back in some way at a future time or incorporating some other items in the brief instrument, I think we can do it. Realize we really do have to hit the field in February or we're not going to have any data to work with. I think we are going to provide some useful information with respect to the questions you have, and that's all I have in terms of response. Do you -- MS. KASS: Well, the only thing that I would add to that -- I mean, I think it's a very good point. I guess my only other practical concern that Jeremy didn't mention is that all of the materials already have gone to the 15 IRBs, and if I were an IRB member, I would be a little bit concerned about this particular question in terms of the area of who is going to disclose to this respondent that we have this information. I think that's a rather tricky issue and is in certain ways a completely different study. We would need to redo all of these materials. I mean, it's a good point and it's hard to know what to do with it at this point. DR. THOMAS: Yes, I appreciate these difficulties, and I really hope that we will find that there aren't any subjects that are in research protocols and don't know it, but we may just cross that bridge when we get to it. If it happens, though, I'd like -- I think you should let us know at the next meeting, if you're already in the field by that time -- DR. SUGARMAN: Okay. DR. THOMAS: -- that this is happening, and we should reinvestigate that question. DR. SUGARMAN: What would be very helpful is, as you all look at the instruments, if you can incorporate some items that we have excluded or not considered putting into the brief instrument, which would then permit a more thorough evaluation of those sorts of questions -- I think as you look through the instrument, you will -- you know, we've just given this to you. It has changed incredibly since the last version you've seen. If there are items that you want us to include, so that we can cover such domains, so that we don't have to go back through that process, we're happy if it's going to improve your ability to use this information because that's the whole goal. We want you to be able to use this information to inform deliberations about policy, the recommendations for the future. So please tell us what else you need. We need it early, like six months ago, but, no, we're happy to use it. CHAIRPERSON FADEN: Okay, Ruth, Henry, and Jay. This was the five-minute discussion that we're having, just so we know. (Laughter.) DR. MACKLIN: This is a little more on the same point. CHAIRPERSON FADEN: Uh-hum. DR. MACKLIN: I'm sorry to go over the ground again, but whenever I see a questionnaire or instrument that has a lot of questions on it, I want to know why are we asking these things and what are we going to do with the information; how's it going to help us. Now in Section A, which we have here, Section A, I understand, goes to -- I mean, all the people get Section A, Section B, et cetera. Section A asks a lot of questions that you've explained to me a few moments ago look like factual questions, empirical questions, about what most people do, but they're really meant to get at the attitudes of -- DR. SUGARMAN: Correct. DR. MACKLIN: -- the subjects. Now why do we want to know this stuff? It seems to me -- I mean, so people thing this. They think that -- why does it matter? One thing that might matter is if people who are research subjects and know it have very different attitudes in this Section A -- DR. SUGARMAN: Correct. DR. MACKLIN: -- from those who are research subjects and don't know it, because that, it seems to me, goes to the question of being a participant in research, the motivation, et cetera. So this second group -- that is, if there are any people who don't know that they're research subjects -- it seems to me would be interesting to see whether their attitudes toward research or their beliefs about it are any different from the other subjects. And I would, as I look through this, want to be asking the question: why do we want to know these things and what are we going to do with the information? Since I don't myself look at what other people collect, I want to know: why is this important and why are we finding it out, and how is it going to help in the analysis? DR. SUGARMAN: Okay. DR. MACKLIN: Now about the question of how you know whether someone's in research or not, is it not the case that, not by federal regulations but by practice, a patient's or subject's signed consent form is supposed to be with the patient's chart in the clinical setting; is that right or not? I mean, our IRB has, if not a requirement, an expectation that there will be a copy of the signed consent form with the patient's chart; there will be a copy of the signed consent form in the records, in the researcher's records. DR. GLATSTEIN: It's the legal documents. DR. MACKLIN: It's a legal document. Well, that's a separate question of whether it belongs in the chart. But is your -- DR. GLATSTEIN: The chart is a legal document. DR. MACKLIN: Right, right. Okay, now, I mean, this seems to me to be relevant (a) to how you know and (b) whether a person is or is not a subject. That is, if someone is a research subject, claims not to know it, and there's a signed consent form in the chart, that's one piece of curious information. If a person is a research subject, gleaned through some other collateral information and there is no signed consent form in the chart, that provides information about something else. So it would seem to me one of the things one would want to look for or look at is the practice of keeping signed consent forms in a chart. So, for example, suppose a patient asks the resident taking care of her, "Am I -- is this research," and the resident may not know. How could the resident find out? The resident would have to go look in the chart if the investigator weren't there on the scene all the time. Now I don't know if this is important to anyone else, but it seems to me where a consent form is kept and whether that counts as a documentation that a person is a research subject seems to be part of this investigation. CHAIRPERSON FADEN: I think there are several pieces to that. DR. SUGARMAN: Yes. CHAIRPERSON FADEN: One is, what I'm hearing very clearly from the Committee is that the Committee wants as much information as they can possibly get on any participant in this study who seems to be an anomaly, who does not -- who appears not to know that they're in these. That particular anomaly is of concern. DR. SUGARMAN: Right. CHAIRPERSON FADEN: Going further, if a person says, "I'm not a research subject," and you find out that they are by some list, you ought to ask or see if we can find whether a signed consent form exists. DR. SUGARMAN: That is part of the plan. CHAIRPERSON FADEN: So that would be for several reasons, not the least of which is it will add more confusion and more potential alternative explanations about how is it that this person doesn't know that they're at least a subject when they sign the consent form. We can all speculate on how it could happen, but, nevertheless -- DR. SUGARMAN: One of the items they will be looking for is a signed informed consent form for research, much less the other 20, whatever, documents people sign when they come into hospitals, and I think it's difficult for residents -- it would be an empirical question -- to distinguish which form that's for, whether it's for research or for treatment or for admission or for whatever else they sign. Now the other thing is I would hate to say -- we don't find a signed consent form for research in this patient's chart could also be reflecting that there's a bad medical records department, and I would hate to overgeneralize that information because I know my clinic notes don't get into the chart and I know I wrote them. CHAIRPERSON FADEN: What I'm wondering about is, to underscore the significance of Ruth's point, again, with the acknowledgment that we hope that nobody falls in this category, but it's say it's 500 people we've got a big problem, a huge problem, obviously, not just us, but the nation. But if it's 50 people or it's 10 people, we could, presumably, go to some considerable level of effort, so that if there's no signed consent form in the chart for Mary Smith, but it looks like she's in Mary Jones' research project, could we go to Mary Jones and say, "Do you have a record of a signed consent form on Mary Smith?" -- and this is something we can't decide now because we don't know what the volume's going to be like, but I think the preference of the Committee and the message to you is, are you clear -- given resources, constrained as they are, let's make every effort we can to try to track down as much information as we can. DR. SUGARMAN: And I think despite the degree of conversation we've had about this, that it has been our intent to aggressively pursue the accuracy and to show where that information comes from, and we plan to give you that information. With respect to the first part of your question, Ruth, about why do we want to know that stuff, that comes out of a series of focus group equivalents around the country, talking with both -- mostly talking with investigators, and, also, one of the most interesting days that Gary Stern and I were at the University of Michigan, and the University of Michigan has assembled a group to look into their experience with radiation experiments. The community member said to me, "I was so happy when I looked back over what the University of Michigan did that all they were involved was in research, not any experimentation." (Laughter.) And that is an incredibly powerful construct that I think has never been really carefully looked at. If you talk to people about what is research and what is an experiment, I think that in the popular view that they don't share the same paradigm of understanding that researchers do that these are somehow related; that experimentation -- and this is a hypothesis -- is somehow different. If you look at press releases, experiments, any time something's bad, it's an experiment; every time it's good, it's medical research. This is critical to understanding whether people believe that they're participants in either one. People may believe that, if they believe research is good or better or untested -- better or good -- of course, you would be silly not to sign up for that. If you were asked the same questions about a medical experiment and you believed experimentation was evil or bad or untested, and then you didn't sign up, it could be that one policy recommendation might be that we need more education as to the equivalence between research and experimentation. I think it's what we're hearing from folks, that it's very powerful in who agrees and may agree and what their perceptions are, based on whether they showed that understanding. That's why I think we need to know that stuff. DR. MACKLIN: Just one quick footnote, and that is, maybe you need an additional question about the meaning of the word "study" -- DR. SUGARMAN: Yes. DR. MACKLIN: -- because I know you have in here research and experimenting, just eloquently expressed what some of the misunderstandings are. I often wonder whether people know what a study is because a doctor might say to a patient, "We have to do some studies," meaning, for therapeutic value, we're going to do some studies for you and for your benefit. Whereas, very often, the word "research" appears nowhere on a form, and it says: this is a study" -- DR. SUGARMAN: Correct. DR. MACKLIN: -- to do such and such. So that might be an additional term you want to -- DR. SUGARMAN: The purpose of -- those terms are being floated this week in focus groups, along with several other candidates. We, because of a need to economize on time, we didn't really want to burden respondents for more than 10 minutes in the clinic. Study, trial, protocol, clinical trial -- several terms are being floated. If any of them are incredibly salient to the focus group participants, we can then swap those items or move them in and then add them and move others. We really are at our limits of 10 minutes, but we are exploring them in focus groups. CHAIRPERSON FADEN: Henry and Jay. Henry and then Jay. DR. ROYAL: My question had to do with this experiment/research problem. What are the people who are going to be interviewed going to be told if they say to the interviewer, "What's the difference between an experiment and a research study?" DR. SUGARMAN: I'm sorry, what will the interviewer say? DR. ROYAL: Whether the interviewer is instructed in terms of what they should respond to if the interviewee asks the interviewer, "What's the difference between a research study and an experiment?" MS. KASS: There's going to be a general instruction that says, according to your own best understanding, and I think particularly that argues for having a "don't know" option and allowing people to feel very comfortable saying they don't know, but really making every attempt possible to not put any words into their minds. Whatever those terms mean to them, that's how we'd like them to answer it. DR. ROYAL: It's just going to make it hard to interpret their answer if you don't know what question they were answering because we don't know what the word meant to them. DR. SUGARMAN: We will then -- this is where we get at a better understanding of the in-depth interviews. We can explore that and we can see what the range of those responses are, and we'll explore asking people to define or describe for us what they mean. That's more of an open-ended set of information, the kinds of questions you're asking, and that's why we have the two components. We'll also have some -- we should have some information, similarly, from the focus groups about what these things mean to folks. Your input has been extraordinarily helpful. CHAIRPERSON FADEN: We have Jay still on the list. DR. KATZ: No, no, no. I can raise it with Jeremy later. CHAIRPERSON FADEN: Are you comfortable with that? And you thought you were almost done; right? (Laughter.) DR. SUGARMAN: It's been very helpful to us, and, please, if you do have any comments about design, we are going to be training interviewers next Friday, we need to know what you have to say about this study before that. We can't really change once we get out into the field. We really want to conduct this in a rigorous fashion. If you do have inputs and other suggestions come to mind, please pour over those instruments, tell us what's wrong with them, tell us what else you need. That's going to be our opportunity to change things and get more information. If you want to participate in any other aspects of this project, please let us know soon, so we can include you. It's moving at a very fast pace, but we're happy to have as much help -- CHAIRPERSON FADEN: Could I ask of the Committee guidance on the first sequence of questions and really what's the more important question. Given, as you rightly point out, that we want -- we only have a few minutes with each respondent, is the Committee more interested in knowing whether patients understand the terms to be different -- that goes to say, experiment versus research versus clinical protocol, whatever terms turn out to be the most significant ones to use -- is the Committee more interested in knowing whether patients understand these terms to have different meanings than in understanding patients' attitudes toward medical research in general or human experimentation in general, assuming that it's not possible potentially to do both? Jay? DR. KATZ: I would be very much interested in knowing the attitudes toward human experimentation. In this study what I would be interested in, if they know that they -- that either the entire study or the significant part of the study, experiment, whatever you want to call it, that they are involved in, are not in their own individual interests, but they are participating in a project that seeks to gain information for the sake of science or for other patients, something like that. DR. SUGARMAN: So what their motivations were for participation, Jay? Is that an accurate -- DR. KATZ: To begin with, just the fact -- the study by Brad Gray done in the late seventies and early 1980s, with the approval of the IRB, with the approval of the researcher, he went to persons in the hospital with just a complete research study. Thirty-six, 39 percent of the persons found out for the first time when he talked with them that they had participated in a research study. That was news to them. You know about that study, don't you? DR. SUGARMAN: Jay, are you talking about Brad Gray's? Yes. DR. KATZ: Yes, yes. And it's those kinds of things that I think would be important to me. DR. OLEINICK: Well, Jay, I believe that at least an attempt has been made -- DR. KATZ: Yes. DR. OLEINICK: -- a very large one, an attempt has certainly been made to get at those kinds of questions. For each kind of research, there's "I wanted a chance to get better treatment," "I wanted to do something to help others," "This is the only way I could get specific medical treated I wanted," et cetera. CHAIRPERSON FADEN: I think this is related potentially. This is the issue of whether they appreciate that either a part or a portion of the purpose for doing this research is to obtain generalized modalities, not because it's good for them. Do they understand that that's what research means, basically? Whatever they call it, do they understand that at least a purpose, and often the purpose, is not to make you better, but to find out something that has general scientific knowledge. Is there another sense? I'm just trying to, given the shortness of time that we have with the respondents, are we -- is it very important for this Committee to get a sense of whether people don't understand an experiment to mean something different from research or are we just -- or do we just generally want to be more interested in finding out what their attitudes are toward research as good or bad? DR. SUGARMAN: I think part of the reason that we have that early on is so that if someone believes they're in research, we capture them, or if someone believes they're in an experiment, we capture them. So that we're trying to use a bunch of terms to be able to get the broadest number of people who believe they're in something related to what the Committee is all about. CHAIRPERSON FADEN: So then we could use a bunch of terms? DR. SUGARMAN: Yes. CHAIRPERSON FADEN: I know you have real strong feelings. So the time table is you need our comments on the draft that you're going to give us -- DR. SUGARMAN: By Tuesday at noon, and we will -- CHAIRPERSON FADEN: And that goes to you via the Committee -- I mean, at the Committee, not at -- DR. SUGARMAN: Sure; correct. We'll provide the fax number in big font. (Laughter.) CHAIRPERSON FADEN: Thank you both very much. DR. SUGARMAN: Thanks. CHAIRPERSON FADEN: When I hear the numbers and I hear the time frame, I also feel just this overwhelming sense of the enormity of this activity. Okay, now an update on our other major contemporary project, Sara and Gail, on the Research Proposal Review Project. MS. CHANDROS: Good morning. I passed out this morning a status report to everybody at your seats regarding this project, and right now I'd just like to highlight the most important aspects of what staff has been doing over the past few months to get this project moving ahead. First, we were able to finalize the sample of human radiation studies as well as nonradiation studies for the parallel sample. That's discussed in Section 1 of the memo. We have a total of 225 studies that we plan to review. That's 145 involving ionizing radiation, and the control group has 80 nonradiation studies. The table on page 2, Table 1-A, shows the final distribution of these studies. This is basically the same as you saw it last time with one addition. We found out that there is -- we can include six DOD extramural studies to the sample. So you'll notice there's a breakdown of 60 extramural and 85 intramural studies. This looks a little off-balance, but it's due primarily to the fact that there are relatively few DOD extramural studies and no VA extramural studies. So that represents the true distribution within the agencies. Just as a reminder, we tried to pick anywhere between three and ten studies per cell. So that's where the distribution lies. Regarding the sampling of the nonradiation parallel sample, we took those same 145 studies that you see in Table 1-A, but we stratified it slightly differently. We looked at whether they were cardiology, cancer, or neither, and that distribution is represented in Table 1-B. In parentheses -- the numbers in parentheses represent the breakdown of the radiation sample, and from that we took approximately half the number of studies in each cell to get at the nonradiation samples. So we came to a total of 80 studies that way. The next step in this process was sending a request to the various agencies and the extramural institutions who conduct the research, universities, hospitals, and other institutions. Specifically, we asked for in total the grant proposals submitted to the federal agency for funding, the full application submitted to the IRB, including the consent form that was submitted, and then we asked for the consent form that was finally approved by the IRB, so that we can get at any differences or improvements, hopefully, in the consent form. We also asked for the official approval letter from the IRB, documentation to any changes that have taken place to the protocol over time, especially for the -- well, only for the radiation studies, we asked for, if applicable, the Radioactive Drug Research Committee or the RDRC application, and the approval letter, and also any other human use committees at institutions that might be relevant to our review. Now as these materials come into the staff offices, they are now being reviewed for their completeness and to see if they fall into the correct categories. I want to mention Shobita Parthasarathy on staff has started helping us with this activity. She's a new member of the staff. It's been a pretty complicated task. So we're trying to make it as easy as possible for the reviewers once they receive the materials. Some of them actually happen to be miscategorized or we were given a surplus of information. So that delayed the review process slightly, and we'll give a complete account of what the actual breakdown is after we go through this review at a later meeting. In particular, I want to comment on the extramural response that we've gotten from the universities and hospitals and other extramural research institutions. We're very gratified to report that over 90 percent of the institutions have complied with our request and we do expect a full 100 percent within the next few weeks. To date, 37 out of 40 institutions have given us the materials we requested, and they are listed on pages 4 and 5 of your report. We're just waiting on three additional institutions with whom I'm been in touch with, and we expect that after they have reviewed them, they will send them to us. So we had originally expected 50 percent response rate, and that had gone into the planning, the review, and where we were going to spend our time. So we really have our work cut out for us now because we've gotten everything we asked for. So now we have to -- CHAIRPERSON FADEN: May I just interrupt? MS. CHANDROS: Sure. CHAIRPERSON FADEN: I can't help but underscore just how extraordinary this is. When we began this process, everybody was warning us that we were going to have great difficulty in seeking compliance, that institutions would be very -- they may be very uncomfortable about doing it, but their next sentence was: we'd be very uncomfortable about doing it; we're not going to do; the lawyers at the universities are going to make this impossible, and so on, and whatever. The most optimistic predictions we got were, well, maybe 50 percent of the universities you contact will provide you with the materials you requested. The fact is really that it looks very likely that every single university that we have approached will provide us with the information that we requested. Three outstanding -- Duke, Stanford, and the University of Washington, I gather you're feeling good, Sara, that they're going to come through. MS. CHANDROS: Through conversations even that I had with them yesterday, they have either -- they're on their way in them now or they're just going through the final stages. CHAIRPERSON FADEN: So by February we should be able to say there isn't a single institution that's denied us access to relevant information. I think that's really extraordinary, and it means, of course, that we now have tremendous responsibility, which we've got to do this; we've got to do it right. People are actually cooperated with us, and that just increases the level of our accountability, I think, in taking on this very important task in a responsible fashion. I really just have to express how overwhelmingly delighted and relieved we should be by this response and now the opportunity that this response has given us to make some very serious comment about the state of the situation. MR. GUTTMAN: Does it mean that Dr. Katz will still be able to read every piece of paper? (Laughter.) CHAIRPERSON FADEN: Dan was teasing, though. MR. GUTTMAN: Your commitment to read every piece of paper, was it based on a 50 percent response or 100 percent response? (Laughter.) DR. KATZ: Only 50 percent. (Laughter.) MS. CHANDROS: I just want to also add that the cooperation we've received from the federal agencies has been equally helpful. CHAIRPERSON FADEN: That's right. MS. CHANDROS: So on all sides we've received complete cooperation. CHAIRPERSON FADEN: I only failed to mention that only because we expected -- we had high expectations for cooperation from the federal agencies, given the nature of our relationship to date. They've certainly made this possible by providing us with sampling grants and given us all the relevant grant proposals. The universities, though, aren't obligated by Executive Order specifically to provide us with anything. So the fact that they did is just tremendously important, and I'm going to take it -- and I think we should all take that the universities have cooperated with us -- in the spirit that this is in the best interest of the medical research community, that to get the answers to these questions is best done in a cooperative fashion. So that if there are any difficulties, we will work on this in collaboration with the university community and not in an antagonistic kind of relationship with them. Of course, our wonderful staff who is so terrific in dealing with the universities and making them feel good is -- MS. GELLER: I want to underscore that. I just think it's been an enormous amount of work for Sara and Shobita, and particularly with the 100 percent response rate and with the excess, the volume of proposals that we're getting in excess of what we requested. We're really doing our best to pare them down, so that reviewers really get only that aspect that they've been asked to review. On that point, should one or two fall through the cracks and should you get a pile -- should any of the reviewers get a pile of proposals that extend back to 1977, we request that you just remember that our time frame is from 1990 to 1993, if at all possible. So those are the proposals you should pull out to review. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: A couple of practical questions from a reviewer: my general question is: will there be -- and if so, how will there be -- revisions in the coding form as we find the need for additional items or something that doesn't fit quite right, since I've tried on my forms to indicate or ask the question, "Does this belong here" in discussing it with my co- reviewers. So that's my general question. A specific question that came up in every protocol that I reviewed with different answers that came from my co-reviewer on these projects is: how do we know whether we have the full protocol? What counts as the full protocol, No. 1? And how do we know when we've got it? Henry had one answer when we reviewed something together, and he said, "Well, this can't be the full protocol because...." And Barbara Berney had another answer and said, "This can't be the full protocol because...." So how do we know that and what is the criterion that we should be using to determine whether we have the full protocol -- or the full proposal, I should say? MS. CHANDROS: Well, to address your first point regarding the coding form, I think collecting the comments I've received a number of people who have started to conduct the reviews and from my own experience in using it, and I discussed it with Gail, and so far the changes seem to be mostly in just wording of questions that already exist. So I've put that into effect and, hopefully, for the second or third round of reviews we'll have new coding forms that should work fairly similarly to the other ones, to the old ones, but they'll just be clearer. This is still an ongoing, iterative process. So continue to give me your comments and we'll do our best to incorporate them, to make some sense of them. Regarding the second question, to some extent, we're depending simply on the words of the agencies and the universities who are supplying us the materials. If they identify a certain object as the protocol, I'm -- we are reviewing it and we're even trying to identify it in the package that we now send out, so that it's somewhat more straightforward to the reviewer, but we haven't decided what to do if they have -- we're actually -- we've in some cases written back to the agencies or to the universities and said it doesn't like -- there's some pages missing or very obvious things that are wrong with the protocol, and we're asking them for a complete set. That's as far as we've gotten with that point so far. DR. MACKLIN: Could I just -- I mean, maybe that's not a question that the reviewers have to grapple with since if the staff knows the answer, if you are looking at them, as Sara described to me now, before they're sent out to the reviewers, it's a simple factual question; namely, does what you consider the full protocol -- have you received it? Because, obviously, the reasons that any one of us may have for thinking we don't have the full protocol -- I mean, somebody said, well, there's no full proposal. Someone says there's no CVs. Someone else said -- I mean, it was Henry's point that this isn't a scientific proposal; this is not something that one would submit to the NIH and have it as a full scientific. So I think there may be different criteria floating about as to what counts as the full proposal, but this is sort of a simple factual question that maybe the staff can -- MS. GELLER: Can I just comment on that? One of the observations that I made in the review that I did with Henry is that -- and this is a factual matter, I think, that we can investigate; I don't know that we have done it. It's whether intramural proposals differ from extramural proposals. Of the four -- I've only reviewed four so far. They've all been intramural, and they look significantly different from the proposals I'm used to seeing. It's possible that there is a different, much more expedited review process internally, and it's one of the things that I want to find out, whether what NIMH, for example, considers a complete protocol will look different from the extramural protocols we're used to seeing. CHAIRPERSON FADEN: I think that that's a very important point. For the extramurally-funded ones, what we want is the grant proposal. If we don't have the grant proposal, we don't have it. So it's kind of easy. Now if pieces are missing, we can as a committee decide do we need the CVs. I'm not sure. I mean, what we really want are the 20 pages that you have to put in in order to get funded, plus the human subjects then that comes after the 20 pages. That's what we want for the extramural one. Gail's point needs to be underscored. I at least don't know enough -- and Gail doesn't know enough -- about what you have to do if you're working at NIH or you're working at a lab at DOE in order to get a research project authorized. So that's what we have to get the right language and the right mental image of what that needs to look like for intramural research. For extramural research, we're all on board. It's the grant proposal, the scientific portion of the grant proposal. We don't need to see the budget. Is that okay with everybody? We don't need to see the CVs. But we need to see the scientific part of the grant proposal, and we want the analogous thing for intramural research, but we don't know what that thing looks like. I've had that same experience. I've looked at some intramural ones now, too, and I keep looking for what I'm used to seeing on a study section, and I don't know if it just doesn't exist or -- MS. GELLER: Just one other point about revisions to the form, I feel like it is -- it will be a useful form to the end and revisions will be ongoing, and it doesn't make it any -- specifically, what will be necessary, though, in a couple of areas is for you to keep good notes because in a few cases we may actually do some retrospective recoding. So, for example, I can just think off the top of my head, the first question that asks about RDRC application, in a few of the proposals that I reviewed, the RDRC approval was included, but not what looked like the application. So if I write that note in the margin, we can actually change the form to say approval instead of application, and we can do that retrospectively. CHAIRPERSON FADEN: Sara, you never got all the -- Lois, I'm sorry. DR. NORRIS: Has anyone else found the multiple meaning of "N/A" blanks difficult? I just find it very clumsy where "N/A" in all these questions can mean both not applicable or not covered. I think it's just clumsy to have to go through and note at the bottom what you really meant when you marked "N/A." MS. GELLER: Yes, that's another areas where good annotations will help us retrospectively. We intended for there not to be any question skipped. In other kinds of forms you often have a skip pattern. So "N/A" is what was intended to be the sort of catch-all, if it truly does not apply. If it does apply and was not covered, the intent is to circle "inadequate." So "N/A" was not intended to apply to questions that should have been addressed and were not. It was intended to apply to questions that were not intended to be addressed. So, for example, if it's not a randomized study, then the question about randomization doesn't apply. DR. NORRIS: Okay. I guess I didn't read the instructions that accompany the reviews that way. DR. KATZ: Yes, it's important that we indicate this for the future because Jon and I were uncertain about that, too. DR. MACKLIN: But I think even when you read it, I second Lois' comment. I mean, some -- in some cases it's very clear what "N/A" means. It doesn't involve children or it's not randomized. That's the clearest example of "N/A." But in my co-reviewing, when that situation did not apply, my co-reviewer and I debated, should we put "N/A" or should we put "inadequate" where "inadequate" is a judgment about something that should have been there but wasn't, and yet there may be a category not mentioned when it's not clear that it had to have been mentioned. So, I mean, I think Lois is right; there are things in that category. MS. GELLER: Again, if you -- I appreciate that, and if you keep good notes, we'll be able to reconstruct categories that can be entered and analyzed. CHAIRPERSON FADEN: I think it's important to emphasize that while it's clearly a high priority to get this form as meaningful and useful as possible, that we're not -- the plan is not for our findings to be reported as to the answers, the collated answers to these forms. The notion is this data collection instrument is more of a guide for our judgments collectively about the status of these protocols. So that while -- I mean, I'm only trying to sort of emphasize that it isn't as critical as it might be in survey research, where all you're going to have available are your answers, that we be totally perfectly precise and totally completely happy about the integrity of each item standing alone. So that while it is -- we don't want to waste our time and we don't want to introduce confusion by questions that are not well constructed or response answers that are not clearly interpretable, at least we don't have to assess that that's how we're going to record it: 16 percent said "inadequate" and 20 percent said "not applicable" or something. We will be reporting this in a way that, hopefully, will allow for the validity of our judgments to override the inadequacy of our instrument. This is the fancy way of saying it. We'll try to get it as right as we can, but if we screw up on some of the items, it doesn't mean we're going to screw up on how we describe what we're doing or what we've included, I hope. MS. GELLER: I just have a quick substantive question, which is, in a study that is not a therapeutic study, how does the Committee understand alternatives to participation? That's the one question that has caused me some difficulty, unless we're including in that not participating. Alternatives to participation usually, I think, refer to if there's more than one kind of therapy. DR. GLATSTEIN: There are different ways to get the same diagnostic information. So alternative procedures in a diagnostic study would be other diagnostic tests that are available to get the same similar information. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: Well, I think this points to a difference between -- I mean, in other cases there may not be. I understand, and my IRB understands, in many instances on the consent form you don't have to participate in this study. That is, the alternative to participation is not participating. But it has raised the question -- so in cases where Henry's example applies, then that's the answer, but there may be situations in which it doesn't apply, in which case the alternative is not to participate. But it did raise for me the question whether the protocol has to say that. In fact, I debated that with one of my co-reviewers. Since the proposal is intended not for the subjects, but for the IRB of the study section or the funder, or whoever, to say the alternative -- I mean, that's one of the questions: should there -- what are the alternatives to participation? Well, this may matter very much if we're talking about a new drug or device, where the alternative is the -- but if the alternative is simply not participating, what would ever incline or require an investigator to put that in the protocol? So it seems to me that we would be mistakenly misjudging if we said "inadequate" because it wasn't there, when, in fact, it really doesn't have to be there. CHAIRPERSON FADEN: Sara, we never finished your going through the memo. Is there more you wanted to say? MS. CHANDROS: There's just one last point about the actual reviews. Twenty studies have been completely reviewed to date. I've gotten coding forms back for that many, and that's out of the 225 studies that we have facing us. So now that we've ironed out some of these problems with the materials, we have to go at a much quicker pace, hopefully, 20 to 25 joint reviews per week. So this going to only be getting more intense in the next few weeks, just as a heads-up, I suppose. (Laughter.) CHAIRPERSON FADEN: This is the classic good news/bad news. We've got the money for the grant and now I need to do the work. We have the data; now we have to analyze it is basically the analog here. So the good news is we have the full complement, and the bad news is we all have to work very, very hard, and every member of the Committee has signed on to do some, I believe, or virtually every member of the Committee -- MS. CHANDROS: With a few exceptions. CHAIRPERSON FADEN: -- and a good chunk of the staff. CHAIRPERSON FADEN: While we have lots of people we're throwing at this project, we still -- doing 20-some a week is -- it's going to be a lot and a lot of processing. Are there more questions for Gail or Sara? Lois? MS. NORRIS: I may have missed something, and I apologize if I did. Do you have a target date for completing the project at this point? MS. CHANDROS: None has been -- I suppose we should, but we haven't specifically. MS. GELLER: Originally, when we were still expecting a 50 percent response rate, we had originally planned to review about 20 proposals a week, I think, for a 10-week period. So we were hoping to be finished -- starting in mid-December, we were hoping to be finished by the end of February. DR. NORRIS: And you were late getting started, too. So -- MS. GELLER: And we have more. So I'm sure -- CHAIRPERSON FADEN: Actually, we have to do more than 20 a week is what it comes to, if we want to get done in the same time. So we hope maybe we'll be done by the middle of March, but not later than that because we have to make use of this. So we should plan for the February meeting, for there to be an interim report of just not only how many have been done, but what is it looking like. So in the next four weeks, if we can knock out 100 of them, that would be really -- look at Sara -- if we can knock out 100 of them in the next month, and all of us working very hard, we should have something to say at the February meeting and wrap it up at the March meeting. How does that sound, Lois? If you have nothing else to do with your life in the next -- DR. NORRIS: That's true. (Laughter.) CHAIRPERSON FADEN: Ken, did you have a question? Is there anybody else who has a comment or a question on the Research proposal Review Project? (No response.) Thank you both very much. We're behind schedule, but I'm not worried about it because we've obviously accomplished a lot on these two projects and we have a lot of time set aside for the discussion. I propose that we take our break now, only a few minutes earlier than we had planned to otherwise take it, and then begin with our ethics criteria discussion. (Off the record.) CHAIRPERSON FADEN: We were just figuring out the lunch plans. Would the Committee members please come to the table? All right. We always lose a few people at the telephones. The phones here are a long way away. I know it causes problems. I know we always lose people to the telephones. If there are any Committee members in the room, would they please come to the table, so that we can start? And for those of us who are in need of a serious caffeine, the coffee is out and is coming. I don't know if this is a source of distress to anyone, but it's on the way. We're going to now switch gears rather dramatically and pick up with the discussion that we had in our December meeting on questions of how to look at the past in terms of ethics and the question, in particular, of how to make judgments with respect to culpability. If you'll recall, we had focused in our last meeting on the question of the culpability or blameworthiness of the government, how we could come up with or how we would come to understand whether and under what conditions the United States Government, through its departments and its officials, could be understood to be culpable for what. And we had been working pretty much systematically, painfully through the Department of Defense at our last meeting. What we'd like to do now is return to the question of government culpability and ethics standards before lunch, and then after lunch, following -- and, essentially, spurred by or initiated by the presentation on the preliminary findings from the Oral History Project -- turn from the question of the culpability of the government to the culpability of professions and individual investigators, how we can understand that, how we can make judgments about that. Jonathan and Allen and Val have joined us at the table. Jonathan, do you want us just to turn to the Tab F? DR. MORENO: Tab F, please. CHAIRPERSON FADEN: Tab F is the Tab F1 through whatever -- DR. MORENO: Three. CHAIRPERSON FADEN: -- F4, F3, that's been consolidated in one memo. So that Tabs F1, 2, and 3 present staff's analysis of how we might continue to think through the question of government culpability for human radiation research in the historical period from '44 to '74. Jonathan, do you want us to start with F1? DR. MORENO: Please. CHAIRPERSON FADEN: Why don't you just launch the discussion? DR. MORENO: Here we are again. Rather than rehearse the details of the documents from which we're drawing in F1, what I propose to do is tell you the provenance of the documents, go to our conclusions drawn from the documents, invite you to raise questions about why we get to those conclusions. We may end up going back to the documents themselves, the verbatim quotations from the documents, anyway, but, mindful of the time and the fact that sometimes it isn't necessary to read all of the words that we quoted out loud, that you can do that for yourselves, let me just tell you what the documents are that we're drawing on and, first of all, what the staff's generalized conclusion is. The general conclusion is that the AEC had some policies in the late forties. For various reasons, those policies should be regarded as the standard that would have applied on any reasonable account, would have applied for the federal government on ionizing radiation research involving human beings at least through the Wilson memo, and that the elements, the philosophical elements, of the AEC standards developed in the late forties, as a matter of fact, carried through beyond 1953. So that's the basis of our -- the general view is that there was an evolution of these philosophical elements that we can see as beginning in the late forties in the AEC. The documents that we've drawn on are, admittedly, few in number but they're very rich, and they're not always obviously consistent, although they can probably be rendered consistent with some thought. The first two documents, we've already referred to them repeatedly when we were reporting on the ethics data collection process last fall. The first two documents are two 1947 letters. The first letter, April 30, '47, from AEC General Manager Carroll Wilson, not to be confused with Charlie Wilson of the DOD, to Stafford Warren; the second letter, we don't -- is a November 5, 1947 letter. We don't have -- and this is also from Carroll Wilson, this time to Robert Stone. We don't have that letter. What we have is a 1951 letter from Shields Warren in response to an inquiry about AEC policy on these matters, and in that '51 letter Warren quotes this November 5, '47 letter. I think it's not unimportant, as they say in Washington, however, that in response to an inquiry in 1951, Shields Warren refers to this letter as the authoritative source of guidance on these policies. Then in 1956, again in answer to an inquiry from Tom Chapman at Los Alamos, in the D Division, Charles Dunham of the AEC Division of Biology and Medicine, Shields Warren's successor, writes a letter in which he explains the approach to volunteers. The second area that we haven't talked about very much before that has provided us with a source of policy statements is the Subcommittee on Human Applications, which played an important role in the isotope distribution process in the AEC beginning around 1946, 1947, and the Subcommittee on Human Applications is the source of two statements. The first statement, from March 29, 1948, we don't really know very much about its context. What we've got is a fragment of a story in that case. It appears to be a resolution from the Subcommittee on Human Applications that establishes a fairly broad and straightforward consent requirement. Unfortunately, we don't know whether the resolution was even passed by the Subcommittee, nor if it was passed, whether it was actually given to anybody, and if it was given to anybody, we don't know if it was actually accepted by anybody. It's a fragment, but it's an interesting fragment because in an oral history interview with Shields Warren in 1974 he recalled the plutonium injection controversy and said that the AEC decided to deal with it by issuing rules to the Subcommittee on Human Applications. And these, these rules, may, indeed -- may, indeed -- have been the rules that he was referring to; we don't know. The second document -- the source is the Subcommittee on Human Applications -- is -- was, apparently -- was, clearly, adopted by the Subcommittee and implemented in March 13, 1949. This -- these rules had to do -- and this is on page 6 of your F1 -- these rules had to do specifically with the administration of larger doses for investigative purposes in cases where patients are suffering from diseases that make this possible. And these requirements, which I read to you last time, and you wanted to see, of course, on paper with analysis, these rules were actually published in the 1949 Catalog and Price List for Isotopes that was published in 1949. Sears, take note. (Laughter.) So they were given substantial publicity in 1949. Now, again, rather than read out loud what you can read for yourselves, namely, the quotations from these documents that we're drawing on, let me rehearse the analysis. And we've decided to do this in terms of the ethical standards that the Advisory Committee had already agreed in previous meetings ought to be applied to these kinds of discussions. First, the favorable balance of harms and benefits -- and this starts on page 7 in your F1. This is a very important category of analysis because it, I think, is quite clear when you read these materials from the late forties, not only the AEC materials but also the transcripts of the DOD policy committees, that this, the category of potential harm and the significance of the harm was very important to the experts who were thinking through these, what we today call, consent issues, information issues. Today we don't put the same emphasis on expert a priori judgment about how much people need to be told and how much consent we should ask for, but in those days they did. And so you do find both in the AEC and the DOD a lot of consideration about what we know about how much harm this could do and how significant it is, and so forth. So this is a very important category of analysis, if you think back to the categories that were relevant at the time and perhaps had less significance -- have less significance now. Both the 1947 letters from General Manager Wilson required that radioisotope administration be accompanied by therapeutic intent. The one phrase in the first letter in '47 was the expectation that it may have therapeutic benefit, therapeutic effect, rather; the second letter, that reasonable hope exists that the radioisotope will improve the condition of the patient. However, the Subcommittee on Human Applications listed therapeutic significance as only one of three valid purposes for radioisotope administration. The others were diagnostic value and contribution to knowledge on radiation protection. Now how can we resolve the differences between these policies? Well, if the 1947 letters did not exclude these other purposes, and I think for different reasons such an exclusion would have been odd, then the policies are consistent. Now why would such an exclusion be odd? Well, presumably, the AEC in '47 wouldn't have wanted to exclude tracer research for diagnostic purposes and, presumably, they were concerned about radiation protection. That's why they got started on this course in the first place. So it's entirely -- it makes sense to conclude, I think, that these were not inconsistent policies. Furthermore, the Subcommittee on Human Applications discouraged the use of radioisotopes in normal children, again on safety and harm/benefit grounds, with exceptions possible if the issues, the scientific issues, could not be studied in any other way and if the doses are "low enough to be considered harmless." The Subcommittee also strongly discouraged the use of radioisotopes in pregnant women when no therapeutic benefit is to be derived. Now, again, all of these conditions are consistent with the requirement that in the experimental use of radioisotopes there must be either therapeutic intent or the administered doses must be so low as to present no plausible risk of harm to the subject. So you could say that they were dealing with a kind of disjunctive standard. In a variation on the latter point, the Subcommittee on Human Applications was prepared to approve the administration of higher doses for what they called investigative purposes, depending on the disease from which the patient was suffering, but that required, among other things, a local committee at the institution for approval. You might say that that was a kind of predecessor to a local IRB. Jay was relieved at the last meeting when I reported that the local committee had to be comprised of three competent physicians. The selection of subjects category is one that does not get explicitly described or treated in the AEC documents from which we're deriving our conception of the policy. Perhaps, based on what we know about what was going on in the DOD at the time, the subject selection issue was driven not by the kinds of equity considerations that have dominated research ethics since Belmont, but rather by concerns about who could be compensated for injury. So that kind of a concern about subject selection was treated in a different category. That was an indemnification problem. It was an insurance problem rather than an equity issue. With respect to the information that was to be provided to the patients or subjects, both of the 1947 letters stipulated that patients should be informed of the proposed treatment and ipso facto, if patients are to be informed of the proposed treatment, then surely what we would call healthy volunteers should be informed of the treatment or of the intervention. The Subcommittee on Human Applications required "full knowledge of the act by the tracer subject whether a normal volunteer or a patient." And the 1956 letter required that subjects be fully informed, and that letter was specifically referring to normal volunteers. With respect to consent, the first 1947 letter stated that the patient must have expressed his willingness to receive the treatment, and there was a debate about who should record, you'll recall, who should record the willingness, whether the patient should record in writing his or her willingness to receive the treatment or that should be done by three physicians, two or three physicians. And they decided finally to leave it up to the physicians to record it. The second letter in '47 used the expression "complete and informed consent," where there would be patient-written consent and next-of-kin consent as well, a very strong standard, obviously. The Subcommittee on Human Applications specified subject consent to the procedure for both tracer doses and higher doses, and the 1956 Chapman letter referred to volunteers. Now with respect to prior review, which is the last of the sort of contemporary categories that we're trying to apply to the world in those days to understand it in our terms without distorting it, as I mentioned, the Subcommittee on Human Applications required that investigations be approved by the local medical director and by the Director of the AEC's Division of Biology and Medicine, again, if there are larger doses for investigational purposes. In 1949, that was the requirement. So if we could try to summarize the stream of AEC policies in this period with respect to the populations of potential recipients of exposure to radioisotopes, clearly, these policies considered healthy volunteers and patients for whom benefit was not anticipated, and the standards with regard to information and consent were strikingly contemporary from our point of view. Exposures were not to be harmful relative to the condition of the subject or the patient; consent information required, including when the dosage was that of a tracer level in healthy patients. Now there is, perhaps with an understanding of what the world was like in those days, there's -- it's possible to be somewhat surprised by the specific inclusion of these standards with respect to patients who are being exposed for reasons of alleged or believed therapeutic benefit. That is to say, what has been believed by historians of medical ethics of this period is that, for the most part, when there was therapeutic intent, the consent standards and the information standards were lower. Yet, at least the 1947 letters don't suggest that. And so that raises a question about the possibility that there was either an error in the historical understanding of what was actually practiced or that what people said they did or what some people said that people were supposed to do was not what people actually did. And so there is a continuing question there. The subject selection and prior review, as I've said, in summary, were less-well-developed themes, but in a twist that might have been unique to radioisotope usage at that time, prior review mechanisms were required in certain cases by the Subcommittee on Human Applications. Now the staff proposes that, for four reasons, that these AEC policies should be applied to other government agencies at the time. That is to say that other government agencies should have been expected to conform to these policies at that time, and there are four reasons that we take that position. First, that the AEC was the primary sponsor and promoter of radiation-related biomedical research at that time. Secondly, that the AEC was the site where one would have looked at that time for reflection on these questions with respect to radiation research. They were the place that had the people who were in a position to understand the potential harms and the significance of the potential harms. They were the people who were in a position to think about these issues. They were the ones to whom one would reasonably have referred if one were in another agency of government for thoughtful reflection about these questions with respect to human subjects. Indeed, third, the people who were at the core of the AEC in these policy issues who were doing this work, who were thinking about these things, were, in fact, the people who were being called upon by other government agencies at the time to advise them on radiation-related human subjects research, and that's quite clear that this was a small world in which basically the same people were advising, for example, the DOD and the VA; they were wearing different hats, but they were the same people under those hats. And we summarize in F1 some of these connections that individuals had as consultants to other agencies. Fourth, the standards that were stated by the AEC, at least the philosophical elements of those standards, were, in fact, those that were subsequently developed by other agencies. The DOD is one example that we've already chronicled and are continuing to chronicle. The NIH clinical center in 1953 required signatures on consent forms, at least for healthy volunteers. So the elements that are being discussed in the late forties in the AEC are elements that are being carried through the fifties and early sixties in other agencies. So we conclude in a brief, but my favorite peroration so far in everything the staff has written this year, that even if the government, in fact, spoke out of both sides of its mouth, policies from one corner, practices in the other, it at least did so with one voice. (Laughter.) You can practice that in front of a mirror, if you like. (Laughter.) MR. GUTTMAN: I don't think Ruth saw that sentence. DR. MORENO: Right. She would have redlined, if she had. (Laughter.) CHAIRPERSON FADEN: All right. So we have, essentially, then, I suspect, a proposal from staff that we first take the documents that staff has surveyed as evidence that, indeed, there was an AEC policy governing the conduct of research involving human subjects that included at least standards for consent and standards for some assessment of risk and benefit. And then the second part of the proposal is that these standards not only be understood as having applied to AEC-supported or conducted research, but that it should be understood that other government agencies, as well as the AEC, should be culpable for failing to follow these same standards in the conduct of any radiation research that these other agencies may have conducted or supported. Again, the focus is government culpability here. We're not now talking about whether these are the standards by which we ought to be judging the conduct or culpability of individual investigators. We haven't even quite yet gotten to government officials. The notion is the proposal is here is this was the policy of the AEC, and the AEC is culpable insofar as it failed to assure that research that it supported or conducted was performed in accordance with this policy. And then the second part is that this articulation of policy should be applied everywhere else; is that right? Dan, do you want to clarify -- MR. GUTTMAN: Yes, I just want to make one point. One of the things we left the last meeting hung up on was the question of what was a policy because, obviously, as Jonathan is saying, we've got these fragments, and so forth and so on. Clearly, if they were implemented in a plain, obvious way, we wouldn't be here. We spent a lot of time reflecting on it. What Jonathan is presenting is our present thinking, is that the proper question isn't, well, you know, if you write a letter and you don't put it in The Federal Register, it goes to person A instead of person B, is it a policy or is it not a policy? But the context was, as Jonathan said in his quick way, but I want to really emphasize because it explains where our thinking has gone, AEC was not simply the center of radiation research. As we know, it was out there promoting in the best way, as well as in the American entrepreneurial way, the use of isotopes for all kinds of research. The result was literally, as we have seen, thousands of experiments, many of -- most of them with tracer doses, but it was not simply someone, StaffOrd Warren, being asked what's the policy and stating it; it was in the contents where the United States Government was actively promoting what did become an extraordinarily and would class successful enterprise. So that we were talking to a law professor, a constitutional law professor, and his question was: well, what you're describing is not, you know -- he said, I don't know what the Administrative Procedure Act said in 1947, was it a policy or not, but if it wasn't a policy, since they were out there promoting -- and this was what they said the standard should have been, and it's a failure of policy rather than a question of was it a policy or wasn't it a policy. So that's the context in which I think this group could use the word "policy." CHAIRPERSON FADEN: That's a point. I've seen Duncan, Henry. Let me just take a few names and then -- Ruth, Susan. And our standard rule: if you feel like you need to, right hand; otherwise, we'll follow them. Duncan? DR. THOMAS: Before we get into the big question, I just wanted to clarify this point on page 7 about the nontherapeutic uses. I'm having great difficulty seeing how these two statements are not in conflict with each other. As I read these 1947 letters, they use words like "only," "should be administered to the patient only where there is an expectation of therapeutic benefit," or "unless," "unless the following conditions are met," that are reasonable -- and so on. It would certainly seem to me to exclude the other two uses unless this is just a part of a larger whole which is dealing specifically with therapeutic uses. So could you elaborate a little bit further on that point? DR. MORENO: Well, it is puzzling. I've had loss of sleep trying to figure out the question, too, and worry that my interpretation is way off. It doesn't -- I'll tell you where I started from in trying to think this through. It doesn't make sense to exclude diagnostic use. Therefore, I can't believe that the word "only" means only. DR. THOMAS: Yes, except that diagnostic use would -- DR. MORENO: Could be therapeutic. DR. THOMAS: It may accrue to the bad presentation -- DR. MORENO: Yes, except that the -- except that the Subcommittee on Human Applications explicitly distinguished between therapeutic and diagnostic in their list. DR. THOMAS: They didn't include therapeutic x-rays because they didn't think -- DR. MORENO: Think it was going to help. Yes, I know. Look, this is -- here's where I ended up, and I think -- and Valerie's sort of helped me think this through as well. This is an historical interpretation that I probably have no business offering in public. My thinking is that the General Manager's Office was not technically well informed about the medical side and they struggled to do their best with the understandings that they had and the meetings that they did have with the physicians, and they wrote this letter hoping that it reflected what the reality was. But then when the Subcommittee on Human Applications, which was composed of people who really knew this stuff, got together, they were much more accurate, and they explicitly addressed some areas that the General Manager was not in a position to know very much about. That's -- again, since it's hard to imagine that they would have excluded diagnosis, and it's still hard to imagine that they would have excluded concerns about health-related injuries, because that's why they got started in this process in the first place with the lab workers, I just have to think that there's more to AEC -- or less perhaps to the General Manager's letter than meets the eye. CHAIRPERSON FADEN: Dan, did you want to comment on just this point? MR. GUTTMAN: Just to make the other side of the tension, based on what the staff knows, Duncan, here, it's equally possible -- not equally possible; who knows what the level of probability is. When the -- the March '47 letters were right in the middle of the discovery of the plutonium business and this real agony about, my God, nontherapeutic experiment is a special conscious agonizing category. So you could also perhaps see that they were saying, "We're not going to have anybody fooling around with anything that's nontherapeutic." As Jonathan is pointing out, well, this was not a technical medical analysis, but it was reaction to the immediate situation. A year later, the Subcommittee on Application, which is including most of the people who are doing the experiments, are back pushing the other direction. So that's another way in which it may well have been an inconsistency, which is explained in the context -- DR. MORENO: Right. CHAIRPERSON FADEN: Just to parse it out, the inconsistency turns on the permissibility of what we would call nontherapeutic research. All of these different documents make a mention of consent. So there isn't an inconsistency on the consent issue. DR. MORENO: Right. CHAIRPERSON FADEN: There's an inconsistency on the question of the permissibility of isotope research -- DR. MORENO: That's right. CHAIRPERSON FADEN: -- in a nontherapeutic context. So that's -- DR. MORENO: That's important. CHAIRPERSON FADEN: That's important to get clear on there, where the inconsistencies in the evolution of these documents lies. Duncan, did you -- I've got Henry next. DR. ROYAL: I couldn't help but notice the stark contrast between the oral histories which we got this week and the discussions in the AEC about the ethics in medical research. It seemed to me that the AEC was very much ahead of the rest of medicine in terms of its expressed concerns for the ethical conduct of research. Is that also your impression? DR. MORENO: Well, I think Dan said something very important a minute ago. They were in a special position, having been highly sensitized by an internal debate about those plutonium injections. So it is probably true that these issues were on the table for them with a special force that was not the case perhaps for other groups in medicine. DR. ROYAL: What's the evidence that the ethical conduct of medical research was being discussed in other groups besides radiation research? DR. MORENO: I'm going to defer to the historians on this one, if they'd like to comment. Yes? MR. GUTTMAN: This is a widening -- this is where we are. This is -- internally, within the last week or two we've been having a very intense -- Ruth, certainly you may step in -- widening circle debate. We've gone in terms -- we started off sort of assuming that the Nuremberg Code was sort of out there and, as Henry is saying, that if you asked people today what they did in 1947, Dr. Katz was not taught the Nuremberg Code at Harvard Medical School. So now we do this intense scrutiny of six and a half documents and we say in 1947 people were saying these things. Ruth says, well, I can see them talking about consent, but the therapeutic contents, that's a tough one because there's one tradition of consent that comes from General Russell's -- you know, the infectious disease and healthy volunteers, and that's sort of plain and clear, and you can piece that together. But this other thing, where does that come in? So now what Henry is suggesting -- and this is where staff is trying to struggle as we go, and Jon Harkness is actually trying to reconstruct the actual Nuremberg Code AMA House of Delegates debate, in part directly as an answer to Henry's question, as to what was the consciousness in the medical profession of -- DR. ROYAL: Don't the oral histories address that? MR. GUTTMAN: Well, it does and it doesn't -- not in the focus that we're now trying to -- in part, because, in fact, Sue Lederer has provided us with a document; we had not understood until two weeks ago that the secret Defense Department Nuremberg Code had been disseminated to contractors, and then Sue Lederer found in the Yale archives in 1954 the Army Surgeon General sent it to contractors -- and Phil Russell, of course, could talk about that -- but it also seems that it may have been applicable beyond the common biological and chemical. And the question is: to what? So that we're in this -- as we begin to peel the onion back, the question is: where is the stopping point because, as Henry is saying, at one end of the spectrum we know that it wasn't universal. You know it wasn't universal or there wouldn't be this Committee. CHAIRPERSON FADEN: I think we may be jumping ahead. DR. ROYAL: I think an important thing that the public wants to know is whether or not experiments involving radiation were conducted in some way differently than experiments not involving radiation, whether or not -- when Secretary O'Leary was here at our first meeting, I asked her whether or not there was any evidence that informed consent was obtained less well with radiation experiments, whether or not they were more risky than other kinds of medical experiments, and at that time she said that they had no evidence for that one way or the other. It would seem to me that that's an important question to ask. When I hear this discussion about the AEC, what I hear -- and maybe I have selective hearing, but what I'm hearing is that there were discussions of ethical issues and that their standards appeared to be higher than standards not involving radiation research. If that's true, I think that that should be acknowledged. DR. MORENO: Can I say that, Henry, we may falling into a confusion between the ethics of the profession in general and what policy there was the federal agencies. The former discussion we're going to get to a little bit later today, but with respect to federal agencies, I think the staff conclusion is, indeed, that the AEC was the site where this discussion was happening, and in a more detailed way than we at least know about anywhere else. CHAIRPERSON FADEN: Let me just elaborate -- DR. ROYAL: Is that to their credit or is that something which is discredit to staff? CHAIRPERSON FADEN: I think -- can we just widen it a little bit? DR. ROYAL: Sure. CHAIRPERSON FADEN: First of all, the question you raised about conduct is not in any way answered by the existence or absence of these policy debates. So whether, in fact, human radiation research then or now was conducted according to -- actually conducted according to different standards from other research is more answerable by the kinds of work that comes out of the Oral History Project than by the discussion we're having now about policies. What I think has emerged so far from our work is that it is both in the AEC and in the DOD -- and in the War Department -- that you are seeing discussions about how to conduct research involving human subjects and standards taken with respect to consent. And we ought to acknowledge that. Why they had these policy discussions and why they took these positions on consent, we have to unpack and it bears on whether they should be praised for this or not. But the point is we have found, I think, pretty clearly both in the War Department and the DOD and in the AEC explicit discussion saying you've got to get consent before you can do something. Now to link into what Dan was saying, what is clear in the DOD training is that the focus, at least during the War Department years and immediately afterwards, is on research involving healthy subjects. That's the focus of the claim. It's the prisoner research and it's other research where the argument is saying you have to get consent before you can do this infectious disease research, or whatever the issue is. The AEC is confusing because, while it sometimes speaks to the -- especially the later stuff -- the '56 letter speaks to research involving healthy subjects, the immediate letters, the Wilson stuff, talks about therapeutic research, and, as Duncan points out, even suggests that maybe this all should be restricted to therapeutic research -- is confusing. And that does seem quite different from anything else going on at the time, depending on how you understand Nuremberg and how you understand what the AMA did. So we're having a puzzle here trying to unpack what exactly the AMA -- I mean, excuse me, the AEC was doing, but it certainly is -- and why it was doing it, but it's certainly correct that the AEC and the War Department and then the DOD stand out, from some people's point of view surprisingly, as clearly having stated the position saying that research requires the consent of the participant. It's there. DR. ROYAL: I agree that it's there. CHAIRPERSON FADEN: Yes, it's there. We all agree that it's there. Whether the research, in fact, was conducted differently is a separate matter, and that the AEC seemed to have been making these statements earlier than other agencies were making them also seems to be the case. DR. ROYAL: Well, there's been a lot of discussion about failed policy. I think those were some of the words that were being used. That has to do with implementing this policy. I think that's another topic -- CHAIRPERSON FADEN: Right. DR. ROYAL: -- is whether the policy has failed and whether 100 percent requirement or 100 percent compliance is needed for it to be a successful policy or 70 percent or 50 percent, what the number is before it's a failed policy. CHAIRPERSON FADEN: Or if we ever find it out. Ruth and then Susan. DR. MACKLIN: Yes, I'm not sure whether what I'm going to ask Jonathan has been answered or not been answered by this discussion, but it follows directly. Jonathan, you used the expression that there seems to have been an error in historical understanding. DR. MORENO: There might have been. DR. MACKLIN: There might have been, all right. I'm not talking about the certainty -- which I take it historical understanding is nobody talked about informed consent; nobody had any policies; nobody thought about it; nobody used those words, et cetera, that that was the historical understanding, and now we have all this other evidence and information. My question is whether the historical understanding, such as it is or was, stems from these kinds of documents and the AEC and these policies or something entirely different; namely, the kind of information that came out of the Oral History Project, where you're talking to ordinary docs who did some research, not government-sponsored, having nothing to do with radioisotopes or the AEC. So, in a sense, both can be true; namely, that there were these policies and awareness and knowledge of it, and at the same time talking to docs around the country who did research, especially therapeutic research, where they were helping their patients -- there may not be an inconsistency. DR. MORENO: Yes, right. DR. MACKLIN: I mean, so that's sort of the question, and I guess another point -- I mean, I think we have to get to this eventually when we talk about the conduct. Sometimes people know or have been told what they're supposed to do and then they say, "Yeah, but nobody else is doing that" or "Everybody does it this way." In fact, a very common justification for behavior that departs from what we might think of as strictest ethical standard is nobody does these things. I mean, that was the Bert Lance defense or something, you know. (Laughter.) You know, "Everybody was doing all this stuff, and I didn't do anything illegal, and how could it be unethical if everybody was doing it?" So I guess a question here that we may have to grapple with when we come to the question of conduct is I could imagine -- and this is only a question of imagination -- people seeing these things, the Nuremberg Code, or seeing a letter or a memo or a directive or hearing them and saying, "What is it? We don't -- we never do this stuff. I mean, we're doctors. We're helping our patients. I mean, what is this about therapeutic?" So, I mean, it's partly a question -- my question really had to do with the error in historical understanding, but, I mean, we can think of what might be an explanation for conduct departing from what was at the time evolving standards. CHAIRPERSON FADEN: Susan? DR. LEDERER: Jonathan, do you want to respond to what -- DR. MORENO: Although there might have been a question mark at the end of some of those sentences (laughter), I take it that I can, nevertheless, say, yes, that's right. (Laughter.) And, you know, it's interesting that in 1956 you have this exchange between Dunham and Chapman that issues that '56 letter. Presumably, if those discussions in '47, '54 had percolated through the bureaucracy, you wouldn't have had to have that letter in the first place. So, I mean, I think you're right that the world is a complicated place and people can say, well, there's a policy out there, but then they start saying, well, but we're not really doing it this way anyway, and then nine years later nobody remembers that there was a policy out there because everybody's doing it a certain way, and then they say, well, gee, there ought to be a policy. So I think that's probably the way the world does work sometimes. CHAIRPERSON FADEN: Ruth? DR. LEDERER: I guess I have two questions for you, Jonathan. The first is I'd like you to elaborate on your claim that there may be another error in the historical record and that there is lesser standard of consent regarding use of patients in research, therapeutic or nontherapeutic. Could you elaborate on the type of evidence that you're using to counter that, what has been a claim in the literature -- DR. MORENO: No. There is a very widespread -- I can't elaborate on the evidence. I can only elaborate on the claim. There's a very widespread assumption -- and I think you see it in a lot of people who write about the history of medical ethics -- that the sanctity of the doctor-patient relationship traditionally, at least up through the later sixties, has been such that if the doctor said that this is going to help my patient, then institutions were leery about interfering. Now I think we actually have gathered some evidence to support that proposition. For example, when the -- when in 1947 the General Manager's Office tried to get written consent and the doctor said, "No, thank you very much. We'll say the patient record ourselves to confirm that the patient agreed to do this," that's one kind of evidence that we, ourselves, have found. DR. KATZ: Well, take, just as an example, the 1957 Salgo case, the beginning of informed consent. In that we find the doctors did not contest -- and that was early -- when they didn't inform. The Kansas Medical Society submitted a legal brief saying that patients shouldn't be informed about this, that, and the other thing, and there is a lot of other evidence to support the claim that this information -- DR. MORENO: Since what I know about that claim I've mostly gotten from your book, I'm glad you're here. (Laughter.) DR. KATZ: You didn't want to mention that before? DR. MORENO: No, but I'll give you the footnote. But to what extent that's up for grabs is something that will be debated for a long time following the work of the Advisory Committee. DR. LEDERER: Okay. I guess I had a second question which has to do with -- I don't know whether the staff has a special expertise now in Shields Warren. Is there a "Shields Warrenologist" on the staff to whom I can refer my question? (Laughter.) DR. MORENO: Everybody. Everybody. DR. LEDERER: I guess I found particularly striking in this April 9, 1974 oral history, I guess, with Shields Warren -- and I'm referring to page 11, the top of the page. He's asked, "Was there any discussion as to whether or not the patients had consented to be subjects for these injections?" He says, "Yes, because we were reasonably sensitive to these things at that time and I had always made it a point to explain to patients injections." Then he goes on to qualify that. And I guess my question is, is he answering that -- my question refers to the "we." "We" as a member of the medical profession -- DR. MORENO: Yes. DR. LEDERER: We have a source of professional responsibility or is it "we" at the AEC because we're extraordinarily sensitized to the political problems that are going to arise out of isotope distribution and enlisting the U.S. -- I mean the citizenry into the atomic program? DR. MORENO: Maybe the context of the transcript will help us with that. I don't know. We'll have to go back to look at that again. That's a pretty good question. DR. ROYAL: Along the lines of that same quote, some of the Committee documents talk about the plutonium injections as unconsenting patients or subjects, and yet Shields Warren here makes it sound like there was some kind of consent. What is your take on all of that? DR. MORENO: Well, unless Shields Warren was more intimately involved with the plutonium injections and the process than my understanding is he was, I don't know that he could have been referring, in all sincerity, to that series. DR. ROYAL: Wasn't he involved in the plutonium -- DR. MORENO: Yes. CHAIRPERSON FADEN: But, also, Henry, if you look at the quote on page 6, the impression is that he knew this before -- the F1 memo -- that he knew before that things were done as they should be -- DR. MORENO: Not going well. CHAIRPERSON FADEN: -- and now the institute needs rules to make sure that it doesn't happen again. DR. MORENO: There was a pretty big reaction in the AEC administration to the plutonium injections while they were going on, and I think he was referring to attitudes that were generated partly as a result of that experience. MR. GUTTMAN: To just show the level of detail, but I don't want to confuse matters, but Susan asked. Take two characters. Take Shields Warren. One of the many puzzles, he, of course, has said all these things that sound terrific. After the NEPA Committee that debates the TBI and the military decides there's not going to be any human experimentation, and then they go ahead and do it at M.D. Anderson, expressly on the understanding it's not human experimentation -- what we found, in 1952, Shields Warren is down at M.D. Anderson as a consultant to the Air Force looking it over. So you're saying, well, what is he -- what's he saying here? Is he saying, "Well, I hope you're enforcing all the rules," or what's he say there? The other side of it, Dr. Stone, who was in the middle of the plutonium injections, if you really want to argue a piece of evidence, in response to Sue, that, in fact, we are rewriting -- that history was in error. In the debate between I think Gregg and Stone about not plutonium, but whole body radiation, Stone says, well, of course, I got the consent of patients. So, in part, what you're seeing is, when confronted directly with a question -- part of this is -- it really maybe explains why the AEC said what it said. People weren't going around asking normal doctors, "What's your consent policy?" But when that question gets posed in a bureaucratic setting with all the implications, the answer may be the one that a normal person might give: "Oh, yes, I've got the consent." And Stone, by way of example, in one document that we have, when he was asked about TBIs, said, "Oh, yeah, of course, I got consents." So you could use that as evidence, well, even Robert Stone, it was obvious to him in 1947 that you had to have consent. We're not arguing that, but it's just the way the evidence -- you know -- DR. LEDERER: Yes, but, again, we come back to this question of what people -- whether their sense of the meaning of "consent" was the same as our meaning of "consent," and if they meant "consent" in the way of assent: did I get my patient to agree with what I wanted to do? Yes, of course. It's different than "I presented to him what I was going to -- what I intended to do, what I wanted his permission to do, and he consented to that request. MR. GUTTMAN: But I guess I was -- take Stone; we have a document, a plutonium document, in 1946 where they tell California that -- they say there's not any need for consent because they don't -- they've found it's not legally useful, and that strongly suggests they just didn't tell anybody because it wasn't legally necessary, but here we've got Stone saying, you know -- CHAIRPERSON FADEN: We also have to be mindful of the day here. I would like to pull us back to government policies, and there's a real temptation to go from government policies to conduct, but what's on the table now for discussion, let me remind everyone, is whether we want to accept the staff recommendation that we take these documents as evidence that the AEC had a standard with respect to consent and with respect to harm/benefit at the time. DR. KATZ: But, Ruth, there's the problem here that Susan raises, that at least I have a problem with. Yes, there are government policies on consent, but what does "consent" mean? The government has never specified -- CHAIRPERSON FADEN: Well, you have -- we can get to that, Jay. Let us first say that we accept this as policy. Then let's look at the documents and see whether they say what you said -- the issue here is -- DR. KATZ: Policies then -- merely that there were documents; right? CHAIRPERSON FADEN: No, that there were policies for which the government can be held culpable for failing to implement, and it's not merely that they had a piece of paper. I'm not interested -- we know they had a piece of paper. The issue is whether we want to say that these pieces of paper shall be taken as evidence by this Committee that the government had a standard against which its culpability with respect to the conduct of the experiments it supported or conducted can be judged. DR. KATZ: And implementation means also lack of clarification? CHAIRPERSON FADEN: Sure. DR. KATZ: Yes, okay. CHAIRPERSON FADEN: Sure. The issue right now is, is there a standard against which we can judge the government, as articulated at the time? That's what's on the table. For the AEC, first; the second part of the proposal is, do we want to now say that it should have applied or do we want to hold the rest of the government by this AEC policy? The first one, if we can get it on the table, are we ready for a -- did we vote last time? We did vote. Yes, we voted. DR. KATZ: Not by raising our hands, though. CHAIRPERSON FADEN: Well, a general sense, okay. DR. KATZ: Yes. CHAIRPERSON FADEN: Are we ready for a call on the general sense of that? Jay? DR. KATZ: Might I ask one question? CHAIRPERSON FADEN: Sure. DR. KATZ: What's the definition of "culpable?" CHAIRPERSON FADEN: Blameworthy. DR. KATZ: Clearly, it doesn't mean criminal guilt, which is the other meaning of culpable? CHAIRPERSON FADEN: Blameworthy. DR. KATZ: Just sort of some -- CHAIRPERSON FADEN: Another word for blameworthy. DR. KATZ: Understood to be defined idea of blameworthiness? CHAIRPERSON FADEN: Right. Did they do something wrong for which they should be blamed? DR. LEDERER: I just need a clarification about what is the AEC policy toward experimentation on patients. What is required to conduct experimentation on patients, on sick people? DR. MORENO: That the levels to be administered be safe in terms of what is known about radioisotopes at the time. DR. LEDERER: Okay. DR. MORENO: That is to say, that they -- DR. LEDERER: So the favorable -- DR. MORENO: That, so far as we know, they won't do more harm -- DR. LEDERER: Right. DR. MORENO: -- than good. There's got to be a risk assessment. Is that better, Ruth? CHAIRPERSON FADEN: Yes, that's better. DR. MORENO: Thank you. CHAIRPERSON FADEN: That's safe. DR. MORENO: That they be informed about the act and that they consent to the act. Now consent could be, again, understood in a variety of ways, but that's the kind of language that they used. DR. LEDERER: Well, I don't want to make Ruth tear out her hair, but my question -- my next question would be: what do we mean by that they were informed of it? I mean, what does that mean in this context? MR. GUTTMAN: Actually, there is a qualification which is possibly useful in both '47 letter. To me, this is important, that there be document -- something be "susceptible to proof." It's got to be in writing, so that we here 40 years later would have something that we could look at, and that was, I think, in both the '47 letters; right, Jon? DR. MORENO: Yes. MR. GUTTMAN: Exactly what -- DR. MORENO: They wanted something in writing. MR. GUTTMAN: Yes, something. DR. MORENO: Either from the physician or from the patient. CHAIRPERSON FADEN: If you look on page 5 and 6 of F1, 3.3 refers to radioactive materials in patients, and then on the next page, 3(b) would be as close as you get to what they mean by "informed": "The subject is of sound mind," "has full knowledge of the act." That's the language. Duncan and then Nancy. I'm sorry, whatever -- DR. THOMAS: Go ahead. DR. OLEINICK: Okay. My question has to do with the dates. If we are going to be voting on the AEC and the applicability of all of these standards, are we concerned with, were they applicable in 1947, and we have some letters or sort of hearsay evidence, and then later on, when there's actually some policy -- I would like to have some clarification as to whether we are being asked to vote on the whole package or on these subcomponents. CHAIRPERSON FADEN: Jonathan, what is the staff proposal? I'll tell you what I took it to be, but why don't you articulate it. DR. MORENO: I was hoping you'd tell me what you took it to be. (Laughter.) Look, it doesn't seem to me, since we're not in a court of law -- we're trying to figure out what the ethical standards were at the time. I don't know why we should think that the day before the first AEC letter was written the ethical standard was different. It seems to me it's an expression of views that were in the air in the post-War period, and, certainly, through the further articulation of these attitudes in the Department of Defense in 1953. So I would say that certainly in the post-War period and through the early fifties this was the best you could -- probably the best you could do in the federal government if you were looking for policy in this area. CHAIRPERSON FADEN: Duncan? DR. THOMAS: Before I feel comfortable voting on this, I still need some clarification on the meaning of the word "policy." To me, that word connotes some sort of publicly- articulated consensus, broad consensus of an agency about their rules of operation. And I find it hard to infer that that is the case from either a letter, even if it's from the head of the agency to a single individual or from a set of minutes of a meeting making certain recommendations with no evidence that those recommendations were actually formally accepted by the agency. I'm happy to take that as the intent that was in the minds of the heads of the agency, as evidence for that, but I'm not sure that quite denotes what I would call "policy." DR. MORENO: I'm happy to appeal to the lawyers when it serves the argument I'm trying to make. (Laughter.) As Dan mentioned, we did consult a constitutional lawyer on the question: what counts as -- or a lawyer on what counts as policy in an agency, and the answer we got was that, even if it's only in the head of the person with authority, so long as that person is in authority, that's the policy. Now the extent to which it fails to be implemented is the extent to which the individual whose job it was to see that it gets publicized is perhaps technically responsible for that failure. Let me also point out, though, that at least in 1949 some of these standards were published by the AEC in its isotope catalog. So there was an effort to publish and publicize, and the fact that letters were written as early as 1947 to important AEC labs indicates that there was an intent to publish and publicize. (A fire drill announcement is made on the PA system.) CHAIRPERSON FADEN: Anna reminds us this happened the last time we were here. So either it's brought on by our presence or they do this every Thursday, or whatever. (Laughter.) If it doesn't get any louder than this (referring to the fire alarm), it will be okay. Duncan, does that satisfy you? DR. THOMAS: I'm satisfied. CHAIRPERSON FADEN: Okay. Ruth? DR. MACKLIN: Just one other point about the meaning of "consent" in this document: I wouldn't know how else to read the words "full knowledge of the act," except to mean that the kinds of elements that we talk about in consent were told to the subject. What is "full knowledge of the act," that we're going to do something to you without describing the details? I mean, it seems to me those words, "full knowledge of act," convey an intent to convey a lot of information. Whether that was done or not is a separate question, but it says "full knowledge." It doesn't say you've got to ask the person if we can do something to him. So those words, "full knowledge of the act," I think meant the same in 1948 as they do now, even if informed consent didn't mean the same in 1948 as it does now. CHAIRPERSON FADEN: Mary Ann? DR. STEVENSON: I just wanted some clarification from the group down there. In looking at the price list and catalog, there are a few things that trouble me. This special pathological condition where they're talking about higher than tracer doses for therapeutic purpose, the first condition is full responsibility for the conduct of the work is assumed by the special committee in the institution. Is your interpretation that the agency is signing off? Then they go on to require consent, which is not explained any further than that. DR. MORENO: I don't know how else to interpret it other than that. DR. STEVENSON: So when we get to the question of government culpability, were they a priori are signing off once doses got beyond tracer levels? DR. MORENO: I guess they were trying to. I don't know if they -- technically they are able to waive liability like that or moral responsibility, but it looks like that's what they were trying to do. DR. STEVENSON: Okay. And then another question I had was whether or not on the same document, page 1, there's a discussion about what cancer research is, and there is a very explicit discussion about the use of cobalt-60 both in breaking forms as well as into therapy units. It's stated that it would not be considered -- or it would be considered research only if the techniques to be employed departed from those already established or if a considerable program is to be undertaken looking at the biological effects of radiation. So, again, what's included and what isn't included in this umbrella -- and I think it's not germane toward the discussion right now, but it will become very germane to our discussion on TBI -- DR. MORENO: Right. DR. STEVENSON: -- tomorrow. CHAIRPERSON FADEN: Would you remind everybody where is that therapeutic? DR. STEVENSON: That's AEC, September 1949, preceding the F tabs. CHAIRPERSON FADEN: Just before the F tabs then. Thank you. All right, the question on the table is specific to the AEC right now. We're not going to the next part. Is there more discussion on the question of whether we can take these documents as evidence of AEC policy for the AEC? Then we can go on to the extension to the rest of the federal government. DR. KATZ: A very brief comment: I do not know whether that is what Duncan has in mind. I would suggest that at this point, if we need to take a vote, that we only take a vote that says, yes, there was culpable kind of conduct, but we cannot -- at least I cannot -- vote on this matter as a final opinion of mine because it depends how ultimately it's been worded. There's so many layers within layers that -- so as a general expression for the moment, fine, but I think we can't do any more than that until we see in more time about -- CHAIRPERSON FADEN: Let me respond, Jay, first, by a clarification and then by responding to your concern. The question on the table is not whether there was culpable conduct today. The question on the table is whether there's a standard that the AEC had. Then we can see whether the AEC and its officials were culpable for failing to implement it or execute it. Right now the only question on the table is whether the AEC had a standard that covered research ethics that required at least the question of consent, however we interpret as it's written here, and some assessment of risk versus benefit. Always, in response to your second concern, Jay, I tried to make it clear this morning that what we're trying to reach is a tentative set of conclusions. We may find a document tomorrow that may cause us to want to change or we may come to a different interpretation, but we need I think at this point, since it's late enough in the game to be making some general sense of what we think is going on here, and, obviously, the wording on anything in the final report is open for anyone who wants to modify, dissent from, change, or whatever. So that goes without saying. But, just to clarify again, what's at issue here is whether this Committee at this point feels comfortable in reaching an agreement that there was something that could be taken to be AEC policy on consent and harm and benefit with respect to human radiation research, beginning roughly in this 1947 period, to respond to Nancy's concern about it. We're talking about it starting roughly around then, but we wouldn't want to say, just because the first letter we found was in '47, that three months before or a year before there was nothing. What to do with that is difficult. Are we ready for -- it's just a general sense. Do we want to show a thumb or raise an eyebrow, whatever? (Laughter.) Are we ready to call it as a general sense? Is there agreement? Is there anyone who wants -- all right, so I'm going to take it, seeing no one arguing otherwise, that the general sense of the Committee is that -- I'm going to hesitate to formulate it again. The second part of the staff's proposal is that this articulated AEC standard for human radiation research, roughly beginning in '47, maybe earlier, post-War, be understood to be the standard to which the rest of the federal government should have been held, even if it's various branches didn't articulate -- have a piece of paper on this -- for the four reasons that Jonathan outlined that begin on page 9 of the memo. They're the staff arguments why we should look to the AEC to have been the agency to have set the standard for the rest of the federal government, and then the rest of the federal government should be held culpable against the same standards of the AEC. All right, now it's open. Ruth? DR. MACKLIN: This is a quibble, but, as I look at the reasons articulated on page 9 -- there are four altogether, 9 and 10 -- it seems to me that the third reason is particularly salient, and I'd like both to hear a little -- I mean, I would be inclined to put it first -- I'm sorry, the third reason is: the members of the AEC core biomedical research group played central roles in the development of radiation research programs in other agencies, and there was previous documentation -- that has previously been chronicled. I would, first of all, like to hear a little more about it. Maybe Phil has something to add, as he has in the past, about the interactions among these various players and the influence that someone -- that people from the AEC might have had on the others. I mean, one is -- the first reason is certainly important, that the AEC was a vigorous and primary sponsor and promoter, but we're really asking a question not only about who took the lead, but how much was known, and not only reasonably, but was, in fact, known by other agencies and whether or not we have documentation that it was. So I would put that third reason as pretty important and (a) would like perhaps to hear a little more about it and whether or not we have a lot of documentation. I mean, you said it's been previously chronicled, and unlike Dan Guttman, I don't have it all in my head (laughter), but also whether or not there are other collateral pieces of information that can help us to make this claim, such as the ones that Phil Russell has given us before about people in this position of authority and the way in which they sat on all these committees and influenced each other as the great movers and shakers in that era. CHAIRPERSON FADEN: Dan? MR. GUTTMAN: Yes, first of all, it's easier to have facts than wisdom in your head. But, just to give a couple of -- first of all, what we, of course, are all aware of is that this whole community at base -- not all of it -- some of it came out of the cyclotrons. What we're looking at in the radiation research, part of it came out of the private cyclotrons, you know, at Berkeley and Rochester, MIT, pre-War. But then, of course, when you get the Manhattan Project, as Phil told me when I first met him, everybody who's anybody is in the War in the Manhattan Project. So that the people that go out, the Hymer Friedells who go to Kansas and western Missouri, the Stafford Warrens go to UCLA, et cetera, et cetera, they all are in, either civilian hats or military hats, part of the -- they're all there together in '44 to '47. They're working in Chicago. They're working at Berkeley, and so forth. So let's just take two or three characters. You've got Stafford Warren, who comes and he is -- as Jonathan pointed out, in the first 1947 letter, Stafford Warren is the one that apparently gets the AEC to back off from written patient consent and get the doctors. Stafford Warren goes to UCLA Medical School, and he is a key player -- he is one of the people General Groves, the Manhattan Project, has heading the Central Advisory Committee that sets up the VA radioisotope program. Well, according to VA, they did 3,000-plus human radiation experiments. So we haven't counted up PHS, but if you're talking about bulk, that's magnitudes above DOD or AEC. But the VA is a direct product of Stafford Warren and the committee that also included Hymer Friedell, and if you look at the minutes that Denise found, the 1949 Central Advisory Committee of the VA, we don't have all of them, but what they did was they conducted a review and Hymer Friedell said, "I went around to the Bronx VA," or so forth. And so the point is not, of course, that they -- at those meetings Stafford Warren said the AEC policy is such and such, but that Hymer and Stafford Warren were overseeing it. Take the DOD side of it. We all now are increasingly familiar with the NEPA debates. After the plutonium discussion could be ground one of this experimental data, then all the sand cast of characters move over, sometimes to the same room. So you just go out and take a coffee break and discuss the nuclear airplane. In all the transcripts you have this -- you know, Dr. Stone, Warren, Friedell, and it is a Defense/AEC debate with beginning of participation by the Public Health Service. You then have Dr. Andrews, Howard Andrews, that Jon Harkness talked to, who was the PHS person, who's sitting in on these debates. You begin to get the beginning of a PHS/NIH practitioner group, and that, then, gets merged as the bomb testing develops, and the biomedical component of bomb testing, which didn't involve -- that's where the human experimentation took place, by and large. It was the same cast of characters. The final point I want to make -- and this can be the most ironic and interesting one; I don't know what to make of it -- is the National Cancer Institute's Advisory Panel in 1951 had as its members the Chairman of the Armed Forces Medical Policy Council, Dr. Meiling, who starts the train going to the Nuremberg Code, but it's Executive Director was none other than Andrew Ivy, who's one of the people who we think may have been responsible for writing the Nuremberg Code. So two points: one is that it's obvious that they didn't sit around and say, "This is the AEC's consent policy per a 1947 letter." But were there, you know, accord -- you know -- CHAIRPERSON FADEN: I've got Ken and Phil. MR. FEINBERG: I just want to say that I concur in the recommendation of the staff for the four reasons stated. I would only add that I think, for reasons that we're going to discuss later in Tab H and the three-page staff memo of December 12 on ethical standards and government culpability, that the concept of the one government principle probably renders this less important than we would otherwise think. I think it's all well and good, and I'm in favor of it. I concur in building the case for the pervasiveness of what the agency did and its impact on other agencies. But at the end of the day, it seems to me that the one government concept would probably hold -- I would probably find the government as an entity liable or culpable or blameworthy regardless of these four reasons. But I do think it's helpful, and I concur in what is said. CHAIRPERSON FADEN: Phil? DR. RUSSELL: I think the -- it's quite clear that there was an oligarchy of people that gave advice to all the agencies. One of the questions I would raise is whether their advice was equally accepted and acted upon. I think that it's more likely that the AEC accepted it more quickly. The Defense Department is much larger and has more competing interests and other overwhelming concerns at times. So that although I generally agree with this, the question of acceptance of the advice and how rapidly they implemented it I think does require some independent documentation, which I think we have. I think there is documentation. CHAIRPERSON FADEN: Is there more discussion on this proposal about extension of this? Pat? MS. KING: This is just a comment because I just worry about what's in people's mind at this point. There are many ways to reach a destination, and so our job is to build a case, so that we get the most people there at the end. Some people can get there by seeing this as a one-government approach. Some people can't do that. That's too big a leap for them. So it is very important that we build a step-by-step case because the idea is that wherever we start from, most of us, if not all of us, will end up at the same place. We don't all have to agree, I don't think, with every assumption that goes to build the case in order to make an individual judgment at the end of this that's an agreement. Am I being clear? CHAIRPERSON FADEN: Uh-hum. MS. KING: Okay. MR. GUTTMAN: Can I -- CHAIRPERSON FADEN: Yes, and then I'm going to -- MR. GUTTMAN: Yes, the reason -- yes, because when we originally thought about it -- this is important and it may go to something about Ken's -- we thought, well, what is the legal principle? If agency A does something, is that -- and, of course, when you think about it, agencies can have different policies. So you can't say because agency A has a policy that if you're a beneficiary of agency B, you get the benefit of Agency A. So what we're trying to do here in that four bases is give some reasons by way of -- you know, we weren't thinking like lawyers. We were just thinking about what's before us. These are the non-courtroom policy reasons. CHAIRPERSON FADEN: And I think, Pat, your point is important. I don't know how to extend the metaphor, but the notion is, if we're going to a place, we can all jump on at different points as long as we all get there at the end. We're trying to get as many arguments toward in the same direction as we can, toward the same conclusions, so that we can all agree with the conclusion. I'm not sure whether this is a fifth argument for the proposal from staff or a variation of the one-government, or how exactly to frame it, but we could also have set it up something like the following: The AEC had this standard. If the other government agencies didn't have this standard, they should have had it. It was available at the time. People were debating it, saw the significant of human radiation research, arguably, all human research, and if they didn't have these sorts of standards, they should have it and could have it. That is to say, it was not out of reach of the government to be considering these sorts of issues because at least one branch of government, indeed, was, and the expertise in that branch of government was expertise we know available to the other branches of government. These people were moving around, and it's not as if they weren't accessible to people in policy positions at the other relevant agencies. So I don't know if this is an elaboration of the four or of the one-government or another piece of the link of the armor, but we could also import an argument like that for the position, that the AEC standards should be standards operative -- should be taken to be the standards that the government should have had and against which the government should be judged for all human radiation research, regardless of where the money came from to do that particular study. Reed? DR. TUCKSON: I find myself sort of being moved in a particular direction, but before we vote, let me just ask the converse. From our conversation, studies, and going back and recreating the past, have we met anyone -- or maybe we've heard it and I just don't remember it -- have we met anyone who just said, "Look, folks, it was such chaos back then. It was just so much confusion. We were all upside down. Some of us believed that this was important; other people didn't. It was a healthy debate. It was just mass confusion. Now, of course, it seems" -- I mean, have we met anyone that's just simply said, who was in a position of authority, power, influence, who just simply said, "You've just got to understand back then."? I mean, have we had that? DR. MORENO: No. I think there are lots of people on the staff that could respond to that, I hope in roughly the same fashion that I'm about to. I think we've found that people said, of course, things were different back then in lots of ways, but, of course, we were concerned about ethics, what we today call "ethics"; we were concerned about these issues. Of course, being a national crisis and maybe we were sliding into World War III, but, nevertheless, we were worried about these things for various reasons. MR. GUTTMAN: You've got to understand we're picking -- and I think this should be clear -- we're picking the best opinions. We're not taking the lowest common denominator. And the other quote I want to make, because Jonathan brought up when he was in the classified vault at the Defense Department looking at the classified records that we hope to get out in the next couple -- CHAIRPERSON FADEN: From which he emerged. (Laughter.) MR. GUTTMAN: -- from which he emerged, but he couldn't tell us what happened. But one of his comments was he was -- and he can tell you -- amazed. He looked through the classified remains of the Armed Forces Medical Policy Council, which was the one that recommended to Secretary Wilson the Nuremberg. He said, when you look at their records, they were doing a hell of a lot of other stuff. That was not the major focus. That was -- Jonathan can tell you. What was your reaction? DR. MORENO: It was actually the AFMPC and the Armed Forces Policy Council, which is a direct advisory group to the Secretary of Defense. My reaction was that this was an incredibly complicated period, '50 to '52, '49 to '52. There were so many things on the table, and, yet, they still had an item of concern for these matters. DR. TUCKSON: So I guess what this starts to say to me, ultimately -- I think that's where this issue hangs -- is that once you raise the issue and once it is raised in a variety of places by a variety of people who are interacting -- someone used the word, this "oligarchy" -- that once you start to say and question these fundamental issues, you cannot then say very easily that, therefore, once we've all raised it and talked about it and decided to ignore it, that that's a legitimate reaction. I mean, someone will say, once you ask it, you're caught. DR. MORENO: That's well said. CHAIRPERSON FADEN: Okay. Ken? Ken, did you -- DR. FEINBERG: No, no. CHAIRPERSON FADEN: I don't want to push this because, I mean, these are -- as Pat's pointed out, these are blocks we're building and it's important that we get the structure in place. We can obviously can decide to replace the block if later we conclude we were in error; there was an earthquake. But short of that, we're trying to construct whatever -- I don't know what the language is. We all know what we're trying to do; maybe we don't. (Laughter.) Anyway, so the issue is, are we ready to call the question on whether we want to take -- the federal government can be held to the same standards as the AEC we have said can be held? For the question now, we're judging culpability of the U.S. Government; we'll go to people and professions after lunch. Ruth? DR. MACKLIN: You just worded it slightly differently from the way the proposition is worded, and I just want to be clear whether we should take your wording now -- CHAIRPERSON FADEN: I'm not sure I was precise enough. DR. MACKLIN: Okay. I mean, the wording on page 9 of the F1 I think is very good wording, and I would like to see us use that because it doesn't have a lot of "should haves" in it and it doesn't mention, as stated, culpability, unless we want to change it. It says, "We propose that the AEC standards, at least for radiation research, as supplemented," dah, dah, dah, "be interpreted as applicable to radiation research conducted and supported." And, I mean, I think that's very clear, and if we want to change those words, we should know what we're now voting on because I think -- CHAIRPERSON FADEN: We can -- we can -- DR. MACKLIN: -- these propositions that are -- I mean, the reasons, the justifications support that proposition, and as we broaden it or change the words, we may -- these same propositions may not support this -- I mean, these justifications may not support it. So I'd like to see the question, if it's all right -- CHAIRPERSON FADEN: Well, we have the question called as this, but I think it's very important to go to the next inference about culpability: that having concluded this, if we conclude this, that we then agree that we will hold the government culpable, much as we have previously held the AEC culpable. DR. MACKLIN: Okay, that's good enough, but for the reasons Pat articulated a moment ago, I think each step becomes CHAIRPERSON FADEN: Fine, let's do it. DR. MACKLIN: -- stronger if we have the justifications lined up. CHAIRPERSON FADEN: Fine. So the question is called: do we agree with the italicized statement under IV on page 9? Yes? All right. Any opposed? All right, then we take it that that's now the Committee's current view. The next statement or corollary to that is, and as a consequence of holding this, we will hold the government culpable for failing to implement those standards across the board, not just the AEC. Anybody opposed to that? Let's have a discussion. I thought we were having -- I guess we were having the discussion flow simultaneously. DR. ROYAL: I'm having a little bit of trouble with the across-the-board concept because the thing that we just accepted had to do with radiation research. CHAIRPERSON FADEN: Right, and then that -- DR. ROYAL: "Across the board" means other government agencies? Is "across the board" ever going to mean nonradiation research or are we going to conclude that radiation research should be held to different standards than nonradiation research? CHAIRPERSON FADEN: I guess the Committee do it any -- our mandate is radiation research, but I don't think we're restricted from commenting beyond it. Ruth? DR. MACKLIN: Can we hear again, because it's somewhere in here, the evidence that these policies did not apply only to the ABC? CHAIRPERSON FADEN: We can do that. After lunch, we can do that. DR. MORENO: AEC. DR. MACKLIN: I know. ABC. DR. MORENO: Oh, Atomic Biological -- well, we're going to get into that. That's another longer story. DR. MACKLIN: Well, I mean, doesn't that go to Henry's point right now? We're going to get into it, but, I mean, Henry wants to know whether we're talking only about radiation research. In a narrow sense we are, but then we have this other information that suggests that it was not to be limited only to Atomic Biological -- DR. MORENO: That -- I think we can show that. CHAIRPERSON FADEN: We can show that, but not for the AEC. DR. MACKLIN: Right. CHAIRPERSON FADEN: See, the awkwardness is we're rooted in the AEC; the AEC is a radiation agency. What we can show is when you move from the AEC to the DOD, the DOD intent was not too restricted. Obviously, it goes to biological and chemical, not just to atomic, and then, beyond that, we have evidence that it goes beyond atomic, biological, and chemical to other forms of research involving human subjects. But rooted in the AEC, it's a little awkward because the AEC's origin is clearly by its mandate concerned with, and exclusively concerned with radiation-related research. So I think we move -- to go those steps, we can build those steps out of the DOD part of it, where we can show it's all consonant. Do you think? Reed? DR. TUCKSON: I think I understood that (laughter), but let me -- it would just seem, and maybe I'm simplifying what the concern is, that if the concern is that we find at the end of the day that there was blame in the area of radiation, that we don't -- that we couch it in such a way that we're not saying that other people in other areas of research in American life were not to blame. CHAIRPERSON FADEN: Right. DR. TUCKSON: In other words, it's moot to those issues. CHAIRPERSON FADEN: That's exactly right. DR. TUCKSON: The only thing that we are concerned about in other areas of research that are outside of radiation is to the extent that it helps to inform us about the prevailing standards and knowledge of the day. Other than understanding the prevailing standards and knowledge of the day, our report is moot on whether or not other areas did, in fact, do good or bad or not. So that it should not be implied by our investigation of this area anything one way or the other about anybody else. MS. KING: Well, I hate to tell people this is like making sausage, but you've heard those proverbs: it's not so pretty in the making, and you're getting an example of that. But I think that what Reed just said is the only way you can sort of proceed, and that is, because unless we come across in our search for a specified kind of data -- CHAIRPERSON FADEN: Some other kind of data. MS. KING: -- with some other kind of data, that is what, in effect, you are left with -- CHAIRPERSON FADEN: Right. MS. KING: -- which is a neutral stance with respect to what might be out there yea or nay with respect to other areas of research. Now it seems to me that you say that upfront when you're talking about your charter and your mandate and what its implications are, but I don't understand what else you can do. You just can't make any inferences one way or the other, except to the extent that we come across documents that we want to raise separately that relate to other areas of research. CHAIRPERSON FADEN: As it happens, we have. MS. KING: Right. CHAIRPERSON FADEN: But that is another discussion. I am concerned about returning to rounding this out on the question of culpability and doing it before lunch. MS. KING: I have no problem with what you just expressed, Ruth, because I have to tell you I'm not wedded to the words. I think everything matters in terms of how these chapters end up being written, and that's where the words become critical, but it is my sense that, based on what I have read here and what I have heard discussed, that I can vote yes for your proposition. CHAIRPERSON FADEN: This is the proposition that we think -- MS. KING: This is the sense that we have enough here, based on what we have gleaned from the AEC, to make what I consider logical inferences -- that's all we're doing; this is circumstantial evidence and what we've drawn from it -- that would extend beyond the AEC. That's my sense of the discussion and the memo, and I'm comfortable with that. CHAIRPERSON FADEN: Are we ready to call it? Yes? All in favor? Yes. Okay, well, we've done a lot. So we can have lunch. Otherwise, we were going to hold lunch up. (Laughter.) We will return when? We're starting -- let me just check before everybody goes. We will return at 1:30. We've an hour for lunch. Lunch for Committee members is being served in Monique -- the same place -- it's on the main lobby level of the hotel and they are reserving some tables for the Committee in a regular restaurant. It's the same place we had lunch last time. (Whereupon, at 12:29 p.m., the proceedings recessed for lunch to reconvene at 1:53 p.m. the same day.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1:53 p.m. CHAIRPERSON FADEN: All right, group, we need to start. I know this is hard. We can't avoid it anymore. We have to go back to work Okay? We are marching through the agenda. We're behind schedule, but not really in the sense that we have lots of time. Reed is literally marching through the agenda. We have time tomorrow. So I'm not worried about things moving over. What we want to do now is continue to plow through the F sequence, in particular, the F2 memo -- we tend to use shorthand for everything -- the memo about the Department of Defense. We're going to do that more so that all the Committee members can be onboard with the scholarship and current thinking of the staff and some members of the Committee that had been working with the staff in trying to reconstruct what was going on in the Department of Defense at the time, given that we've already made the judgment that we've made with respect to the applicability of the AEC standards toward all of the federal government. This is more in the spirit of clarifying, so that everyone is working with the same set of understandings about what seems to have been going on at the Defense Department. We'll try to do that -- I don't know what -- in about a half hour's worth of time? Then we'll move on and have a report from the Oral History Project, and then follow that with a discussion on individual and professional culpability, which, if need be, will continue into tomorrow. But this is all in a pace. So, Jonathan, we're turning to Tab F2. And can you just walk us through it very quickly, and then we'll have a short discussion? This is now not in the context where we're going to be calling for votes or that kind of thing. It's more toward the goal of our all understanding as best as we can what was going on at that time. DR. MORENO: Right. F2 actually resembles some of the memos that the staff wrote last fall on ethics data collection and followup. There are various kinds of issues addressed here, several of them in response to questions raised by the Advisory Committee last time. For example, one question that was raised last time was, if there were human experiments unambiguously identifiable as such in the DOD at the time, what would a list of such experiments, to which the Wilson memo would have applied, look like, without getting into the specific question of whether these were, in fact, identified as human experiments or not? And we've simply provided a list under No. 1 of what, if they were human experiments, justifiably so-called, would have been under the rubric of the Wilson memo. Another question that was asked, which we address in No. 2, on page 2, was whether the policies outlined in the Wilson memo were intended to apply to experiments done for multiple purposes; that is to say, both for, say, atomic war radiation effects research, on the one hand, and also for cancer research on the other. And, very briefly, we looked to see -- we consulted with each other to see if there were any -- there's any evidence that it was intended that multiple purpose research not be included in the scope, in the reach of the policies, and we have found no reason not to conclude that they were intended to be included. No. 3, which I'll not get into in detail right now, has to do with contractors. The Advisory Committee agreed that, at least in the case of the Army, the reach of the Wilson policy reached to contractors, and this is simply giving some more evidence that we turned up recently that that was the case. I'll return to some of that evidence in a minute in another context. No. 4, which begins on page 4, refers to the application of Wilson policies, Wilson-like policies, which turned out to be Nuremberg Code-like policies, to non-atomic, biological, and chemical warfare experiments throughout the Department of Defense. We've, through the good offices, as they used to say, of Professor Lederer, have turned up a 1954 Army Surgeon General guidance. Naturally, Sue Lederer found it, I gather, in the papers of Dr. Enders, a Nobel laureate in physiology or medicine. This policy, if it was, in fact, implemented, would have applied to human experiments in areas other than atomic, biological, and chemical warfare. It was articulated by the Surgeon General of the Army in 1954. Now it's essentially the Wilson memo without the prefatory remarks about ABC research for defense purposes. In that 1954 guidance, there is no statement that it's limited to atomic, biological, and chemical research. Secondly, in 1960, a survey of the number of active contracts involving human subjects in the Army cites approximately 3,000 students, 250 patients, and 300 prisoners as active participants in research. It's highly unlikely that all of those participants in research were in atomic research. So our conclusion is that this goes beyond the strictures of ABC research in the Wilson memo. And, thirdly, the Advisory Committee is in possession of 1956 letter to the Armed Forces Epidemiological Board from a Tulane University public health researcher, who basically says, "Thank you for sending me the Army Surgeon General policy, and now I know about it, and I'm sure that we will be able to comply with it. And please send me my money now." So that, for various reasons, we think that the reach of something like the Wilson memo policy went beyond atomic, biological, and chemical warfare-related research. At least we need to do some more work to find out where and in how many other files of contractors and others that that 1954 Army Surgeon General document finally made its way. The fifth part of this memo has to do with Navy policy from 1951. That was motivated, apparently, by what were called medical-legal problems arising from the use of radioactive isotopes in naval medical installations. This appears to go -- it appears to go to therapeutic work with radioisotopes. We haven't found any similar policy in the other uniformed -- sorry? CHAIRPERSON FADEN: Late-breaking news on that one. DR. MORENO: All right. MR. GUTTMAN: Captain George, who is sitting out there, is tracking it down for the Navy and thinks that this is just a patient consent, not a -- if I've got it right -- not an experimental -- DR. MORENO: All right. The only reason that there is some doubt about that is that on page 6, as you see, the statement refers to the majority of the treatment, and I'm not sure whether the majority of the treatment is another way of saying that this is innovative treatment or it's a way of saying a layperson might never have heard of this treatment. So that's a question, I guess, that we have to continue to investigate. In any case, the important fact is that this was a consent policy, and if it was a consent policy for a therapeutic use, then ipso facto, presumably, there would have to be consent policy for nontherapeutic use, which again goes to the discussion we had this morning about what was in the air, what philosophical principles or elements were around, and so forth. On page 6, No. 6, back to 70-25, the Army regulation that was published in 1962, which, as you'll recall, was the reg that essentially published the Wilson memorandum, that had, as you might also recall, three exemptions from coverage. The first had to do with occupational hazards would be exempt from coverage in this policy. The second was human factors research, and the third, and perhaps most interesting, seemed to exclude what we would call therapeutic research from the reach of these policies. Now we found a draft Army, so-called draft Army document that was apparently intended to be the implementation of AR70-25. We don't know whether this draft actually became more than a draft. So at this point we don't really know what kind of status to attribute to this document, but it's evident that there was an attempt to interpret AR70-25 and, in particular, one of the interpretations of 3C that is particularly interesting was No. 7: the use of radioisotope tracers in accordance with AEC regulations is not considered unusual or hazardous as such. Now there are a number of things that are interesting about that. For one thing, we see the reach of the AEC is still pretty significant, even in 1963, in helping to set standards in this area. Secondly, we see again and again that what were considered to be reasonably safe, low doses would not be considered to be matters about which people had to be very well informed necessarily or about which there necessarily had to be a specific consent process. No. 7 goes on: "However, all investigations involving radioisotope tracers must be in conformity with existing AEC and Army regulations." Now we've had a lot of screaming fights about this in the staff about what this means, and Dan and I might rehearse our screaming fights about this for you in the next few minutes. I don't quite know how we're going to resolve it, the question here. We'll have to think about it and talk about it some more. We'd welcome your input. My interpretation is that, if you called it an investigation, then AEC rules and Army rules apply and that the Army rules that apply include 70-25. Now this might all be moot if it turns out that this was just a draft that didn't go anywhere, or we might take it that it's helpful information about what people were thinking, but it wasn't official. Again, we're somewhat hamstrung by not knowing how far this goes. But perhaps the most important point -- and I'll conclude with this -- the most important issue that 3C raised with respect to 70-25 last time was why therapeutic research would not be within the reach of these Army regs. And Phil Russell actually provided us with an account that disabuses us of the notion that it wouldn't be, at least in principle, within the reach of 70-25. And he calls our attention to the language in 3C. The language of 3C is: "ethical medical and clinical investigations involving the basic disease process or new treatment procedures conducted by the Army Medical Service for the benefit of patients." I had read past "Army Medical Service" and gone right to "benefit of patients." All the therapeutic benefit, all the philosophical stuff that might be represented by 70-25 doesn't apply if it's therapeutic benefit. Phil Russell points out that this was -- that 70-25 was an R&D -- was written by R&D people who were concerned about cooperating with Army Medical Service people. This doesn't mean that the philosophical principles of 70-25 would not have applied to people in the Army Medical Service. It means that they're trying to work out an arrangement whereby turf issues don't overwhelm the ability to make 70-25 into acceptable regulation by consensus. He's permitted us to reprint his facts to us in this tab. It helps to explain how 3C worked in the bureaucratic arrangement of the day. CHAIRPERSON FADEN: So it's in your blue -- it's in our blue folders? DR. MORENO: Yes, I guess it's in the blue folders, on the back of -- CHAIRPERSON FADEN: But it's not in your briefing books? DR. MORENO: It's in the back of -- it's the last page of the F2, Appendix A. CHAIRPERSON FADEN: It's in the blue folder. So if you look in your blue folder, you find that you have to replace F2. Some of us had it in a blue folder. Yes, revisions to Tab F2. It's in the blue folder. All right, so that's the summary, Jonathan? DR. MORENO: I hope so. CHAIRPERSON FADEN: Behind that summary stands maybe two weeks of constant -- DR. MORENO: Unbelievable. CHAIRPERSON FADEN: -- debate? Well, I think we should acknowledge that Sue's finding that document was exceedingly helpful and Phil's being available at a moment's notice to explain the Department of Defense to those of us who don't understand it was extremely helpful, not only as expressed in this memo, but just generally in terms of trying to figure out who these people are and what could plausibly this mean. It's just been wonderful that we can come to people and ask them to Xerox their heads and actually make progress quickly. (Laughter.) Susan? DR. LEDERER: I guess in you -- in Section 5, I'm curious to know, what were the medical-legal problems arising from these radioactive isotopes for the Navy? I mean, is that another case of anticipating problems or were there actual problems? MR. GUTTMAN: I can tell you what the memos say, and we'll get the complete set. I think we can give it to you. Captain George is looking out there for the rest of it. It looked like it was mostly anticipatory. Actually, the initial question that came up was, who is it? They were looking at their Human Use Committee structure. Remember this morning one of the things that is very interesting is the AEC standard not only is consent, but it's also what Jonathan has described as the precursor for peer review, the Human Use Committees. And the Navy had such a structure. So what was first raised was, hey, who is it that's sitting on these committees? Let's send around to Oakland and San Diego and find out whether they're doctors. And then as they got into that, it looks like the lawyers said, you know, you might as well have this down on paper that people are agreeing to this. So it was an aspect of a review of the Human Use Committees, it looks like, not a particular incident. CHAIRPERSON FADEN: I'm sorry, I was just seeing those memos. I hadn't seen it yet. Sorry. Phil? DR. RUSSELL: I think that the evidence that the Army leadership, a certain general, intended to promulgate the intent of the Wilson memorandum to all research sponsored by the Army is quite clear. I think Dr. Enders, who was doing the measles research before the AFEB and in that time period, and John Fox was doing research on typhus, which were outside of the NBC arena, and so I think especially the communications from John Fox to Dr. Dingle is very clear that they intended to cover anything that was being funded by Army research under these rules. There are two parts about this 70-25 that I think are important for the Committee to understand. The exclusion of inherent occupational hazards, with the occupation of being a soldier, and the exclusion of training and other military duties as coming under this is very important because it's quite clear that the operations and personnel folks in no way wanted the medics involved in what they were going to have to do to win the next war. So that speaks to some of the issues that went on during the atomic tests. The ethical medical and clinical investigations exemption was quite clearly -- had nothing to do with the intent of ethical behavior. It had to do with whether the research community was going to get into the business and oversee the patient care system, and the patient care system was very powerful, very strong, and they said, no, we'll take care of our own patients and the research community can take care of their business. And the 70 series of regulations are the series of regulations by which DOD and Army research and development is carried out. It starts with how you manage the funds and goes on through. So this is not a medical regulation. This is a research regulation, 70-25. Even though it's promulgated and supervised by the Army Surgeon General, it's fundamentally a research regulation. This exemption C was put in there, I'm sure, by the patient care guys that said we'll take care of our own protocol review and oversight. CHAIRPERSON FADEN: So, if I understand what you're saying, Phil, then, I think the interpretation really isn't that different from how we constructed it, and we really -- it sounds as if to use language that would translate outside of the Army, that clinical research or research involving patients for their benefit, that's, by and large, done by the medical services, not by the R&D command, and this extension over the years of the Nuremberg Code is not intended to apply -- or at least we have no evidence that it's intended to apply -- to the way in which research conducted by physicians in the medical services is to be done. I'm throwing that out as a question. I mean -- DR. RUSSELL: I don't think you can say that. All you can say there was an administrative separation, and this didn't speak to how the docs in the hospitals behaved. CHAIRPERSON FADEN: We haven't been able to find anything yet that is a guide for how the conduct of research in the context of the Army Medical Service should be -- DR. RUSSELL: Right, and I think you'll find that that's an exact parallel with academic medicine at the time. CHAIRPERSON FADEN: Exactly. DR. RUSSELL: You don't find any evidence -- CHAIRPERSON FADEN: That's right. DR. RUSSELL: -- for institutional review boards -- CHAIRPERSON FADEN: That's right. DR. RUSSELL: -- in civilian medical centers in 1962, and you didn't find them in Army hospitals in 1962. CHAIRPERSON FADEN: Yes, I'm making the same point. DR. RUSSELL: And as the civilian community didn't see a need for oversight and codification, neither did the military -- CHAIRPERSON FADEN: The military -- DR. RUSSELL: -- in the patient care context. CHAIRPERSON FADEN: That's right. DR. RUSSELL: They did see it in the sponsored research. CHAIRPERSON FADEN: And the sponsored research would have been -- DR. RUSSELL: It falls under 70-25 -- CHAIRPERSON FADEN: Right. DR. RUSSELL: -- Program 6 funds. CHAIRPERSON FADEN: The sponsored research that falls under 70-25 would have been largely, but not exclusively, research with healthy subjects? DR. RUSSELL: No. CHAIRPERSON FADEN: Or we don't know? DR. RUSSELL: It could have been either. CHAIRPERSON FADEN: It could have been either. DR. RUSSELL: It could have been either. The regulation was going to apply fundamentally to Program 6, which is research and development funded operations, not to operations funded under operational programs. One of the things you have to look at in all of these is the authority, the oversight, and the money chains are always the same. Here the R&D system was dealing with how to carry out the responsibility of expending research and development funds in an ethical, structured manner, and they just excluded things that weren't part of that business from this regulation. CHAIRPERSON FADEN: And whatever was going to be in that other stuff, we don't -- DR. RUSSELL: Whatever is going on on the other side of the fence, that's another series of regulations and somebody else's problem. I think it also speaks to the generic issue of who within society was held fundamentally responsible for the ethical behavior of patients -- or physicians in the patient care context, and it wasn't seen to be in need of oversight; the physicians were professionally responsible and that was -- it's quite clear that that's the way the Army patient care people felt about it at the time. CHAIRPERSON FADEN: I don't want to monopolize -- I feel like we've got a Committee member who's also like an expert witness. But if I could ask you one more question and then other people may want to as well. How would we think about, then -- let's say, the R&D command supports -- provides a contract to a civilian physician to conduct research and that research is conducted by that civilian physician on subjects who are also that person's patients. This regulation would have applied, though, because the chain of money comes from the R&D command. DR. RUSSELL: Right, it would have applied. CHAIRPERSON FADEN: And do we have any way of knowing -- I guess we could go back to the Army and ask -- the extent to which research funded by the R&D command at that time involved what was at the place in which it was done research with patients by physicians who were both the investigator and the patients' physician? DR. RUSSELL: You probably will find that if you look for the burn research that was going on at the time, that was the -- burn research and possibly some other kinds of surgical research would have fallen into that category. CHAIRPERSON FADEN: And that would have been R&D funded? DR. RUSSELL: It would have been R&D funded and would have been research on patients. I'd look in the correspondence of the people that were doing burn research under Army auspices in the civilian medical centers. I think you'll find it. DR. LEDERER: In fact, don't we have somebody who's going down to look at MCV's archives and -- DR. RUSSELL: Yes, that's true. DR. LEDERER: -- Evans was a burn researcher, I mean capable Army R&D -- DR. RUSSELL: That's the place to look. MR. GUTTMAN: Right. The question is whether they went past '62. CHAIRPERSON FADEN: But it should have been from '54 forward, from '54 onward, for the period from '54 onward, they're saying. DR. RUSSELL: It would be interesting because that was not being done through the AFEB oversight; it was being done by direct -- but it would have fallen under AR70-25. It would not have fallen under the AFEB. CHAIRPERSON FADEN: So that's a good place to look? DR. RUSSELL: That's the place to look. MR. GUTTMAN: Is this what we call "big government," all this complexity? (Laughter.) CHAIRPERSON FADEN: I don't know if -- I apologize. Some of us on the Committee -- DR. RUSSELL: I could refuse to comment about understanding the Department of Defense. No one person understands it. (Laughter.) CHAIRPERSON FADEN: Yes, Duncan? DR. THOMAS: A couple of points, but it's on a different matter from what we've been discussing -- CHAIRPERSON FADEN: Sure. DR. THOMAS: -- if other people want to continue this. The first point is I'm intrigued by the use of the word "ethical" in 3C. Is this to be interpreted as a statement that medical research for the benefit of patients is by its nature ethical or is it to be interpreted as saying that, provided the research is done in an ethical manner, then it's not under consideration and it's only if it's done in an unethical manner that it comes under this, which there's a certain similarity in both? That's my question. DR. RUSSELL: I don't think it's answerable, but I can guess. I think the guy who wrote it was a doc on the patient care side of the house who made the presumption that if it was medical research, the clinical investigation was ethical. (Laughter.) That's just a guess. There's no way to know. DR. THOMAS: The other has to do with 3B. I'm really disturbed by 3B. Some of us have been reviewing HumRRO documents and that's what immediately comes to mind here. There seems to be an implied statement that it's okay, to take an example, it's okay to lie to a bunch of recruits in the course of an experiment if you're deliberately trying to try to find out what the psychological implication is of being fed misleading information, and so on. I just found this profoundly upsetting, and that's why I really like this idea, this sort of one-government idea that would enable us to set this aside and say we don't buy into this, and the principle -- the broader principles outlined by AEC, for example, really ought to apply despite this exclusion. DR. RUSSELL: This doesn't speak to any ethical judgment at all. This speaks to purely that the -- let me explain a little bit about how an Army regulation comes into existence. It comes into existence only when there's a consensus of the senior Army staff, period. Perhaps the two most important people on the Army staff, other than the Chief and his deputy, are the Deputy Chief of Staff for Operations and the Deputy Chief of Staff for Personnel. There's no way in the world that those two guys are going to let the medics get in the way of their doing what they see necessary to train people to win the next, and that's what this speaks to. This regulation wouldn't have gotten through the Army staff until the training and other military duties were excluded from it. It had nothing to do with any ethical or no principles involved except who's in control here. (Laughter.) And this didn't -- this didn't fundamentally change for another 20 years. The potential dangers within these exclusions weren't recognized at the time. DR. MACKLIN: But isn't -- could I -- Phil, or anybody who knows, is human factors research a term that applies only to psychological studies, behavior -- CHAIRPERSON FADEN: And sociological. DR. MACKLIN: Yes, social -- I mean social and behavioral. CHAIRPERSON FADEN: Right. DR. MACKLIN: That is, not, in other words, when we're talking about human factors, we're not talking about physiologic responses, but we're -- DR. RUSSELL: I think it also had to do with issues like research on people, the interface between people and equipment. DR. MACKLIN: Right. Right, but -- DR. RUSSELL: It had to do -- DR. MACKLIN: But it's performance, behavior. In other words, it's not biomedical. It's on performance, behavior. When I say "psychological," I'm including performance, behavior, and a variety of measures that are not biomedical -- DR. RUSSELL: There's an organization in the Army called the Human Engineering Laboratory that did all that kind of research. DR. MACKLIN: Right. DR. RUSSELL: And they were not part of the biomedical research community. DR. MACKLIN: Right. DR. RUSSELL: They did it separately, and most of the time they were testing equipment, not the people that were driving it. The focus was always on the nonhuman aspects of the research, even though it was, obviously, an interface. DR. MACKLIN: Right. Yes, the reason I asked the question specifically -- I mean, I've heard the term used, but I didn't know its precise meaning in the context of the Army -- is that, to the extent that this is not biomedical and that it's psychosocial or psychological, Duncan's surprise -- I think your surprise would be even greater to know that even today psychological research under some carefully-worded description need not disclose. In other words, if certain factors about the experimental -- or what is it called here, the disclosure of experimental conditions -- would bias or alter the results, the codes of ethics of, for example, the American Psychological Association even today, even though elsewhere in the same code they said, oh, complete informed consent, allows for nondisclosure and even deception, and there's a few additional clauses such -- conditions such as you could never find out this information any other way, and it's important to find it out, et cetera, et cetera. So this is not terribly different from what is generally, and certainly back then, was widely accepted as a condition of psychological or sociological research, social science research. DR. TUCKSON: I'm not surprised by that and I can understand the essential need for such loopholes for scientific validity, but I'm having difficulty seeing how you square it with the common rule. How do IRBs think about these things? DR. MACKLIN: It would probably take us off-base to answer it. CHAIRPERSON FADEN: Yes, it will take us off-base. (Laughter.) DR. MACKLIN: But let me give two very short answers. How do IRBs think about it and deal with it? Differently in different cases and situations. A researcher at my own institution who submitted the studies involving outright deception and was rejected, the protocols were rejected, went on a mission gathering information about what other leading famous high-ranking IRBs would do and came back to the committee saying: this would be accepted at institution X down the road and Y across the town, et cetera, et cetera. So the answer is differently in different places. The other question is: how can it be squared with the common rule or any other provisions for informed consent? It cannot. They are blatantly inconsistent, and people live with this inconsistency, apparently, with some comfort. (Laughter.) DR. KATZ: Can I add something to the answer that Ruth gave? This goes to an important issue; namely, what kind of authority should IRBs really have to make the decisions that they are making in these kinds of instances and are they really competent to make these judgments in the way in which they are organized, the time they have, the personnel they have, et cetera? And we will see it in cocaine research and hospitalizing addicted persons and supplying them with cocaine for research studies. It wasn't approved by an IRB, but should they have been given the authority to make decisions for the conduct of this kind of research? That's still an unanswered question. DR. THOMAS: But in this case it's an issue of the legality of providing the cocaine or is it -- DR. KATZ: It's legality. It -- DR. THOMAS: It's not a consent informed issue? DR. KATZ: Well, it's an informed consent issue; you know, can an addicted person give informed consent to -- DR. THOMAS: Oh, I see. DR. KATZ: -- and all kinds of questions like that. CHAIRPERSON FADEN: At the risk of changing the subject, it seems like almost every meeting, or at least every other meeting, just as we have a question, Jon has a document that answers the question. We obviously have a lot more research to do with respect to 70-25 and the context that surrounds it. I just got handed -- this is stepping back a minute -- the exchange between Duncan and Phil about what does it mean, the word "ethical," before it, "ethical medical and clinical investigations?" And the response was we'll never know. Well, May 1964 memo to the Surgeon General from G. W. Power, Acting Chief of Research and Development, responding -- and I'll explain the context or I'll let Jon do it better than I can in a minute. But on subparagraph (c), "The word `ethical' was recommended during the staffing of the Army regulation to emphasize that" -- catch this -- "all U.S. Army medical practices are considered to be in strict accordance with the highest standards of ethics. However, to avoid any misinterpretation, the word `ethical' will be deleted at such time as the Army regulation requires substantive revisions." (Laughter.) So that's very interesting. We have it right on point. Apparently, what Jon's uncovered is that the Surgeon General convened an ad hoc advisory committee on the use of volunteers as subjects of research in December of 1963. This ad hoc advisory committee met, raised some questions, and the response from the head of the R&D command, the acting head of the R&D command, is in response to this advisory committee's challenging or raising of concerns about some elements of 70-25. Now this is going to be a lot of work. We've got to put all this together, but we're pointing out to you that Henry Beecher was on this advisory committee. So we have -- as well as other names of people who are familiar with the military world will recognize -- we have Henry Beecher here. The committee is chaired by Stanhope Baine Jones. I don't know who he is, but perhaps Susan or Jon -- big name? DR. LEDERER: Yes. DR. MORENO: Big name. CHAIRPERSON FADEN: Big name. All right, so this is a high-level advisory committee, and they will now try to track down all of this and see if we can figure out more what's going on. I have a personal -- I think the Committee, and I believe it's not just my own -- interest in trying to figure out the world at the time with respect to whether there -- how one did understand then whatever differences might have existed between what we might call therapeutic research and nontherapeutic research and how much of what seems to be going on both in '62 and before then can be explained by reference to some kind of a distinction of that sort. I will read one other thing in here, and I shouldn't probably do this because we don't have the context. But also in this memo to the Surgeon General from the acting head of the R&D command there is a statement that says, "It is the policy of this office to seek the approval of the Secretary of the Army for all research wherein human volunteer subjects are exposed to ionizing radiation from any type or source. It should, however, be emphasized that the use of radioactive isotopes in medical diagnosis and therapy for patients is not within the purview of AR70-25, nor are experimental clinical procedures undertaken on a patient for his benefit." So here you have a real separation, clearly stated. What we don't know is exactly what the standing of this all is yet. I don't know why they single out ionized. It must have been in response to some question about radiation research, but it's very clear in this memo that carrying forward the Nuremberg principles in this context to radiation research, in particular, if it's what we would call, used to be called, therapeutic research, 70-25 doesn't apply. What applies in its stead, presumably, are whatever the ethics of the profession are. Or there's something else we don't know about. DR. RUSSELL: There may be embedded in the medical regulations regulations that relate to that, but you have to go to the medical regulations at that time -- CHAIRPERSON FADEN: Which is what we have yet to do. DR. RUSSELL: -- to look. CHAIRPERSON FADEN: Which is what we've got to do now. Jon Harkness has to do that. No, I mean, we have to now put this -- but this is all -- obviously, we, even as late as the tenth meeting, we still have so much that's coming in and so much work yet to be done to try to piece out exactly what was going on at the time, but lots of threads suggesting a certain way of interpreting the world seem to be pulling together. Maybe because this new material's coming in and we haven't gotten it fully digested and we shouldn't go on too much further with this, with this discussion, or we can pick it up tomorrow in the context of the TBI experiments, which bear very directly on this, but if there's discussion, I don't want to stifle it. If not, we could go on to the Oral History Project. Nancy? DR. OLEINICK: Well, I would just like to follow up on one small point. Phil made the point that, in followup to Duncan's question, that particularly the HumRRO types of experiments were singled out for exemption at this time, but that maybe 10 years later or so the Army finally came to realize that perhaps this exemption shouldn't apply. Do we have some kind of a history -- maybe we've seen this, but I can't remember it -- a history of when these kinds of exemptions were no longer exemptions? DR. RUSSELL: '75. DR. OLEINICK: It was '75? DR. RUSSELL: Right? CHAIRPERSON FADEN: We think this holds from '62 to '75. DR. OLEINICK: Is that true? Is that for the Army -- CHAIRPERSON FADEN: Well, we don't know. We think so. We're going to fill them in. You want to know forward? DR. OLEINICK: Yes, forward. I want just a little bit of a history, if possible. DR. RUSSELL: My guess is that there wasn't any substantial change until '75, but I don't know. DR. OLEINICK: Well, it may not be the most important point -- CHAIRPERSON FADEN: No -- DR. OLEINICK: -- but it does bear on what's going on today. CHAIRPERSON FADEN: Yes. No, it's very important. And, in fact, we -- MR. GUTTMAN: I'll tell you, it's remarkable that Ruth has focused us on this, what we call the Defense Department, without trying to get too many people in too much trouble, that we had to find the Surgeon General's policy in the Yale University archives, not in the Department of Defense. (Laughter.) And that we can't find a quick answer in the Department of Defense as to what their policy was. In the lifespan of recent college graduates, it's hard to -- it's big government, you know. CHAIRPERSON FADEN: We're working on it. MR. GUTTMAN: Yes. CHAIRPERSON FADEN: But we need to fill in the '62 to '75 period -- DR. OLEINICK: Yes. CHAIRPERSON FADEN: -- especially because it's important to understand at what point HEW's policies start becoming the lead policies. If you look at the government as one government, at what point do the regulations regarding subjects, the HEW history start to become the prominent history? We now know that in the immediate post-War year periods it was not HEW's rulemaking that was the dominant rulemaking. Now when did it shift over? DR. OLEINICK: Yes, and I think there is -- it's not clear in my mind, and maybe it never will be, but it's not clear in my mind exactly what policies apply at what time to what. And I'm particularly concerned about this one from the Army regulations because even today where we have in federal regulations of human research, we've got special conditions for children and for prisoners. There are none for soldiers. So the question is: what applies to soldiers and what doesn't? Is this a concern today or is this beyond our purview? CHAIRPERSON FADEN: We'll try. We should be able to answer those questions, you would think. MR. GUTTMAN: Oh, that -- do you mean today? We can answer it today? Well, with Phil you've had -- you want to know about the standard of rules today? DR. OLEINICK: Yes. CHAIRPERSON FADEN: Well, we're going to have a discussion tomorrow about the standard of rules today. So maybe we should wait. DR. OLEINICK: All right. CHAIRPERSON FADEN: But what's going on today is one thing. Filling in what happened from '62 to '91 -- DR. OLEINICK: Still continuing. CHAIRPERSON FADEN: Yes, is what gets dicer, but we can leap from '62 to '91. Tomorrow we will be talking about '91 and forward. MS. KING: You may find it easy to find out what went on before '62. CHAIRPERSON FADEN: Than between '62 and '91? MS. KING: Right. CHAIRPERSON FADEN: This is despite the fact -- MS. KING: For a different reason. CHAIRPERSON FADEN: But, interestingly enough, despite the fact that you have your National Commission and the President's Commission intervening in the interim -- I mean, that's what's sort of interesting in terms of how -- you would think those periods would be well-articulated, given that there were bodies similar to this body operating and looking to these things. To some extent, we have a report from the National Commission that -- MS. KING: The National Commission didn't really spend a lot of time looking at other agencies, though. CHAIRPERSON FADEN: But there was one report from the National Commission -- MS. KING: Right. CHAIRPERSON FADEN: -- on the status of human subject protections at the other agencies, all of the agencies governing research at the time. That's like a 1978 report. So we have that, Nancy, to look at and work backwards from -- DR. OLEINICK: Okay. CHAIRPERSON FADEN: -- how the staff of a commission similar to this, different but similar to this, thought the world was structured for all the federal agencies in around '78, and then we can work backwards from that one to the '62 and try to see if we can't piece that world together. Are we ready to go on? I have a feeling we will revisit this when we talk about the TBI stuff tomorrow, and certainly we will revisit it on February when we try to take the new documents that Jon Harkness has, plus all the other leads we're trying to track down, and try to see if we can't fix on just exactly what the thinking was. But we need to get the history as close to straight as we can get it. Can we move on to the Oral History Project, if that's acceptable to everyone? If we could ask -- we need to sort of shift these people at the table. I'm going to ask you to come back when we return to the discussion of culpability of individuals and professionals, and so on. When you get a chance, if we could get copies of these documents you just handed to me? While we're shifting the focus here, I just want to apologize for the poor quality of some of the Xeroxing of some of the documents that you've been asked to put in your reading books. I just looked at my copies and in some cases they aren't legible. I have seen other versions of them and there are legible versions available. So we'll try -- using mine as a model, we'll try to send you replacement pages of legible copies. It's just a multiple copying problem, and some of the original documents -- the copies of the documents that we received just cannot be read. So if you get unhappy about that, please know that we'll try to fix that. Okay, Sue, Gail, Jon, who's going to -- DR. LEDERER: Jon will join us in just a moment. CHAIRPERSON FADEN: Jon is occupied. DR. LEDERER: All right, he'll be joining us in a moment. As you know, we've been in the process of recording the experiences and recollections of a number of clinical investigators and research administrators active in the years after the Second World War, particularly in the first three decades after the Second World War, and in an extraordinarily compressed time frame we have assembled this group of individuals that we had reason to believe were well situated both to report and to recollect their experiences as to the standards and practices that governed human experimentation in this period. I just want to say that the oral histories do not stand alone. They're not our only source of information about reconstructing standards and practices from this period. They are one strand of evidence that must be interwoven with the documentary evidence that we are still in the process of assembling, both from the published record, the medical literature, newspapers, as well as the unpublished archival resources that are still becoming evident. I just want to say that, in my opinion, the oral history represents a contribution not only to our immediate endeavor to place the radiation experiments in context, but I think it represents a real contribution to future historians who will be trying to understand the history of clinical research in this period. This is a period of time for which there has been little history written as yet, and we have left or are in the process of leaving, I think, important resources for future historians. I'm going to turn to Gail now to present a brief synopsis of our preliminary findings. MS. JAVITT: Based on our first reading through of the transcripts -- we received most of the transcripts; there are a few outstanding ones -- we've seen evidence to support at least three working hypotheses which have been set out in more detail in your briefing books, along with some excerpts from the various transcripts to support our hypotheses. I just want to review these three hypotheses very briefly to get our discussion started. First of all, for the most part, it seems that American medical researchers did not view the principles of the Nuremberg Code in the years immediately following the promulgation of the Nuremberg Code as heralding a change in the practice of medical research, although they were aware of the atrocities committed by Nazis doctors and they were aware of the Nuremberg trials as well. Their failure to identify with these principles seems to have stemmed in part from their revulsion at the conduct of the Nazis doctors. They saw no similarities between themselves and these doctors. Therefore, they didn't see an application of the code to their own research. However, the fact that they failed to see the application of the code per se does not mean that they never asked for consent and they never gave information to their research subjects about what they were -- the experiments they were conducting. Several physicians recounted informing their subjects in some fashion, although it's not clear whether it would count as informed consent as we understand it today. In some cases it's clear that it would not. Those who stated that they did practice so-called informed consent cited various reasons for doing so, either personal conviction that this was just the way you treated subjects or this is what they had been taught from their families or from their professional mentors. Our second hypothesis is that the increase of funding for medical research in the post-War era gave rise to a new hybrid, and this hybrid was the medical investigator. Success in this new career track required both research and publication, and for some investigators the imperatives of research and patient care seemed to have been in conflict, and this conflict led in some cases to nontherapeutic experimentation with patients, again, sometimes without their consent. Finally, our third hypothesis concerns the dichotomy between research on sick patients and healthy subjects. It seems that there's some evidence to support that researchers felt a greater obligation to inform and get consent from healthy subjects than they did with sick patients, in part, because sick patients seem to have been more accessible and were perhaps less able to distinguish between what was research and what was part of their treatment. Also, it seems that there was a greater use on the part of researchers of justifying conducting research without the consent of their patients, since at the same time they were treating them, and the treatments that they knew to be beneficial. DR. LEDERER: I guess we're open for discussion. DR. KATZ: Well, let me just say that I had a chance to read what nine of the interviews -- and they're just the richest kind of documents that I've seen. They give you a special kind of -- they give you a window in how distinguished people thought about research, about informing people about the Nuremberg Code, and et cetera, et cetera. And this last document is very well done, but, of course, it can't convey the richness of the materials in all the documents. I guess the only issue at the moment, because at least, Gail, soon I will, sometime in the next week or two, review my notes, that I think the only thing that I would emphasize a bit more, it surely comes out in the passionate discussion of one senior investigator who again and again said, because I guess he saw this interview in this whole endeavor also being critical of research, he said, "Why are you casting all this aspersion on research? Look what's going on in clinical practice. Look what doctors did. They are doing many more dangerous kinds of things to patients than we are doing without safeguards, and they don't talk to the patients very much," and there is sort of this contrast. There is sort of this, what I call, the homogenizing research and therapy, not taking very much into account, that maybe research must have its own ethical kind of rules. They go back to their own experiences as physicians and what their physician colleagues are doing and saying, well, maybe we're behaving in the same kind of fashion, but at least we're doing it more safely and we're giving greater attention to what we think these subjects clearly need. CHAIRPERSON FADEN: Lois? DR. NORRIS: I do have a question and it's sort of on Jay's point. How -- do you have a feel at all from these interviews how the patient consent would differ with respect to standard procedures and research participation? I mean, were doctors accustomed to seeking permission for standard treatment of patients at that time, discussing it with the patients? MS. JAVITT: I don't think so. I got the sense -- and maybe Jon and Sue have a different sense -- that some physicians felt an obligation to be courteous to patients, not to do something painful, for example, without letting them know it would be painful, but there isn't the idea that the doctor explains the proposed procedure or treatment and gives ideas of what the benefits are, what alternatives are, the way that we conceive of informed consent today. DR. HARKNESS: I think an early and somewhat important exception to that generalization, which I agree with as a generalization, is in the realm of surgery. The consent form for surgical procedures date -- I don't have a clear idea of when those started, but it's pretty early. DR. LEDERER: At least to the teens and twenties. There's a register, I know, at NYU of consents to surgery, where people just marked their names in, I guess that they knew they were undergoing surgery. DR. HARKNESS: And in some cases the earliest -- I think some of this even came up in some of our interviews -- that the earliest consent forms employed in research projects were in some cases very hastily and superficially altered consent forms that were employed for surgical procedures. DR. LEDERER: You mean adapted to the research now. DR. HARKNESS: Right, yes. Yes. DR. NORRIS: Would the early surgical consent forms be liability motivated, I mean like protect you -- DR. GLATSTEIN: You bet! (Laughter.) DR. LEDERER: Yes. CHAIRPERSON FADEN: Reed, do you want to comment? DR. TUCKSON: It kind of -- you get to it at the last comment about separating out some of the various different disciplines and what were the comparisons among disciplines. The issue has already been raised earlier today about whether or not by singling out radiation investigation, that that unfairly castigates, by the very nature of the Committee's charge, that particular group. Are you getting a sense -- and I don't think we statistically have enough in categories to be able to do that, so maybe the question is moot, but any sense of any particular disciplines that were more or less sensitive to these sorts of issues? DR. LEDERER: I guess it's my sense that in disciplines where there was a tradition of using healthy volunteers -- for example, infectious disease research -- there was sensitivity to getting even written consent from participants. There was a long tradition for doing that when you're using healthy individuals and infecting them, for example, with a disease or giving them a vaccine. That's the one sort of disciplinary distinction or separation that readily stands out. DR. HARKNESS: I was formulating the same answer as you were talking about it, as Sue just gave. To push it a little further, the question arises, is that really a disciplinary difference or is that a difference related to the sort of subjects employed, that happen to be employed, by a particular discipline? DR. TUCKSON: And then, again, the notion that you present is that despite the discussions that are going on, what you don't see translated now, at least to the level of the investigator, is an infrastructure, a system that seeks to implement or guide actual practice consistent with the discussions that are happening in certain rooms in the policy arenas. DR. HARKNESS: I think that's generally true for this early period. A notable exception, again, to that generalization is the NIH clinical center which opened in the early 1950s. And even the people at the clinical center recognized that they were sort of outfront on this in systematizing the conduct of clinical research both on healthy and sick subjects, and the clinical center in the early fifties pioneered what was called by the people at the time group consideration of clinical research proposals. It isn't hard to see that as the forerunner of today's IRBs. And the clinical center at this time was also recognized by some outside the intramural world of the NIH as a leader in this regard, and, yet, there is not a -- from what we've learned or I've learned in the interviews, it was a less- than-obvious connection between what people were doing outside of the NIH and what they saw the NIH doing. And, likewise, the NIH at this time was doling out lots of money, and there wasn't a concern to directly and systematically impose the measures that were being developed at NIH for NIH researchers on researchers outside of NIH. DR. TUCKSON: I think it would be important as you write this up again, is this is notion of the distinctions regarding, not by discipline, but by kind of patient, and so forth. The last question is just -- which, again, as you preliminarily think about this, the notion that the response to the Nuremberg Code not applying to us, I mean, on the one hand, that comes across as extraordinarily arrogant, to be mild. (Laughter.) Do they appreciate, as you talk to them now, the extraordinariness of their statements or do they -- do you get a sense that -- I mean, do they get it? (Laughter.) MS. JAVITT: I think I would have to say those that didn't get -- the people we interviewed who didn't get it then don't get it now, but it varied. I can't give you an unequivocal yes or no. I remember one response was, well, they were murderers and we weren't, and there's really no reason for us to have thought that that applied, whereas others, when they reflected back on it, maybe said, well, yeah, maybe we should have paid more attention, but we just didn't. DR. HARKNESS: The responses to this vary, I mean wildly. One researcher that we interviewed -- and I can't remember what made it into the final report -- one researcher we interviewed maintained the position, "Look, we didn't really need Nuremberg. We were already doing all that stuff anyhow. We didn't need to pay attention to it because it was just a summation of what we were already doing." I mean, other researchers were saying, when they spoke with us that, "We weren't paying any attention to it. It just didn't have any resonance for us." And a researcher that I just interviewed a week or so ago -- and I don't think his interview has been transcribed yet -- he made the claim that he was highly aware of Nuremberg, that he discussed it extensively with his colleagues. As he put it, the reportage was extensive. It was in the news. It was part of the history of the time. So, I mean, the picture of what Nuremberg meant at the time isn't simple. CHAIRPERSON FADEN: Jon, can I just check my own recollection? The investigator who said that this wasn't news, we were doing it already, was one of the investigators whose work involved healthy subjects -- DR. HARKNESS: Yes. CHAIRPERSON FADEN: -- was that not right? MS. JAVITT: That's correct. CHAIRPERSON FADEN: I mean, that's where you start to see how the difference emerges, and if this bears out, this will perhaps be an important way of getting coherence out of what seems inconsistency from lots of different perspectives. DR. LEDERER: Just to return for a minute, though, to Reed's point about arrogance, I think from the point of view of at least some of the interviewees, they assumed that what they were doing was ethical. So that it's not arrogant to say, well, that we don't need a special code because we are already doing ethical medical/clinical investigation, as it was then conceived. CHAIRPERSON FADEN: Let's see, Ruth and Jay. DR. MACKLIN: Yes, I'm having a little trouble understanding what lies behind hypothesis one, as mentioned, and this is on page 2 in the G tab. Gail, when you presented the hypothesis, the three hypotheses, I understood they had relation -- you did them in a different order. MS. JAVITT: I did. DR. MACKLIN: It doesn't matter. That's right. I could follow them. (Laughter.) But I don't exactly get this one because it's worded in a somewhat ambiguous way, and I'm not sure what the expectations would be. It says, "Changes in funding and organization of medical research in the post-War period did not foster sensitivity to the ethical dimensions of human subject research." Now that could mean that they simply failed to do so or it could imply they fostered more insensitivity to the ethical dimensions of human subjects research than otherwise might have pertained. And as I read -- so you're all laughing. What are you laughing about? DR. HARKNESS: We're wondering if we should huddle up and then answer. DR. MACKLIN: Okay. Well, you can -- I'm not interested in challenging any of you. I'm trying to fit what's here with the comments, and it seems to me that the commentary and the examples, some of which we've just been talking about and others that are here, are in support of a different hypothesis. I mean, they're in support of the hypothesis that there was an increased separation between doctor as therapist and doctor as researcher, and that may or may not have had to do with the funding and organization of medical research. I mean, that seems like a kind of accidental characteristic. So maybe if you could just explain a little more because what I see coming through here is the separation between physician as doctor and hippocratic welfare of patient and the research mentality perhaps which didn't seem to foster -- because one of your questions here is how such an attitude can be adopted by the same physicians who had taken the Hippocratic Oath, and it sounds like it was sort of a new, almost a separation of roles and a tension between them that hadn't existed before. So, anyway, that's my comment. MS. JAVITT: Well, if it's ambiguous, it's in part because we struggled a lot with that hypothesis, and we're not sure how much to make of what we saw as a correlation between -- or not only what we saw; what some of the people we interviewed identified as a cause and effect of some sort between the rise of funding for research and the fact that so many more people were doing research and the way in which it affected patient care. So we didn't feel that we had enough, I think -- or I didn't feel there was enough to say, well, the fact that there was more money and more research meant that doctors started being less ethical or some -- or that kind of blanket statement. I don't think that's correct, but we were trying to convey the sense that there was a correlation between this new phenomenon of the medical investigator and this separation and, as Dr. Katz was saying, confusion of roles. DR. LEDERER: Well, I think, in fact, some people have made the claim that, in fact, in the post-World War II era with the availability of research funds and the success of medical research in World War II, there is a new sense on the part of investigators that anything goes, like we're going to find the cure to cancer; we're going to break -- you know, we're going to have to hurt some people to do it, but we're going to bring that about. I think we struggled with the wording on this because we were trying to be much more sensitive to what people were actually telling us, and so many of the interview subjects did comment on how the universe seemed to be different in the forties and fifties with the availability of research funding and new research opportunities. Now I'm not willing to posit some sort of causality between that availability and a marked insensitivity to human subjects, but just to be responsive to what they are reporting to us about what's unique to them and what they recollect is so powerful and pervasive through many of the interviews. CHAIRPERSON FADEN: Reed? DR. TUCKSON: This really is obviously such important work. I mean, to me -- and it may be the lawyers will show me at some point I'm wrong, but, I mean, this is going to color a lot of what we -- I think of how we decide some of these issues. I think it does. I've learned later that I'm wrong about objective technical stuff. (Laughter.) It would seem to me that it would be useful, then, to understand specifically at that time the notion of the Hippocratic Oath. All of these people, except for two, that you interviewed have M.D. behind their name. I can appreciate this new -- and I think it's very important that you make us think about this new -- creation called the physician clinical investigator with a whole other set of dynamics. But because it was a new thing, that meant there was an old thing that they were, and this notion of, above all, do no harm, I begin to understand, at least in terms of my training, I understand what I thought that meant in terms of the culture of medical education in 1978, but I don't know what it meant back then. I don't know whether it was more or less an issue or more or less relevant, but at some point I would like, not now, but at some point I think this Committee would need to help us to understand what that meant, the Hippocratic Oath, whether it was more or less important back then than it is today. DR. HARKNESS: The dictum "above all, do no harm" is a problematic one, it seems to me. I mean, I guess I'd like to ask you, in 1978, did "above all, do no harm" allow nontherapeutic research in your mind? DR. TUCKSON: No, but then, again, at that point there were structures. I guess what I'm saying is -- and I'm not advocating the point; I'm just saying that I wonder that in a situation where there are no structures, at a time when for the first time you've got pharmacotherapeutics available, really available now -- I mean, you're really starting to -- for the first time in medical history, you can actually do something, really do something for people at an extraordinary scale, which means that people have to be at that time really, really discovering what your responsibility is about the "do no harm" business. And if there aren't any other rules, does this rule then take a certain preeminence because there aren't any other rules? I'm not saying that is true, and I'm just saying I just wonder whether or not -- and you may just say that we don't need to go and explore that because it's not relevant. I'm just throwing it out as a question. CHAIRPERSON FADEN: No, it's relevant, and we will do our best to fill the context in as much as we can, Reed, I think. DR. HARKNESS: One thing I can say about the Hippocratic Oath that's -- sorry -- CHAIRPERSON FADEN: No, that's okay. Finish. DR. HARKNESS: -- is that Andrew Ivy on the stand at Nuremberg made the somewhat fantastic claim, frankly, that the Nuremberg Code could be found embodied in the Hippocratic Oath. CHAIRPERSON FADEN: It may not be so fantastic. DR. HARKNESS: Pardon? CHAIRPERSON FADEN: It may not be so fantastic. We'll see. DR. KATZ: He didn't quite say it, but he came close to it. DR. HARKNESS: You only read the abridged transcripts, Jay. (Laughter.) CHAIRPERSON FADEN: He actually said that? DR. FEINBERG: No, he didn't. (Laughter.) CHAIRPERSON FADEN: Good for you, Ken. (Laughter.) I saw Henry. DR. ROYAL: I'm confused about the dichotomy that's being made between the therapeutic and nontherapeutic research because at the last meeting we were talking about measuring thyroid uptakes in people with disease, and it's hard to imagine how you would know how to interpret those results without also getting a similar value in normal people. As a matter of fact, if you're promoting a test as being useful in disease, you have to study not only diseased patients, but nondiseased patients to show that, in fact, it's a useful test. In terms of therapy, drugs, I'm not an expert in how pharmacologic agents are approved, but it's certainly my understanding that the serum half-lives of drugs is determined in normal volunteers. So it's -- to neatly separate out therapeutic research from nontherapeutic research isn't easy for me to do. Maybe it's easier for other people. CHAIRPERSON FADEN: Let me just respond real quickly because this is -- we have been struggling with the staff to come up with stipulated definitions, so that we can sort of work with them for our purposes. Therapeutic research is one of those terms that people went through a period of loving and hating, and it's just been whatever. I think we should try for February to get out a couple of these things with definitions that we can use, but I would take it, the way in which we have been using it today, by and large, to mean therapeutic research is not merely research that's directed at medical ends, but research that holds out a prospect or potential of benefit to the person who's the subject. So the same study can be therapeutic research sometimes with the ill person who's the subject and not for the controls. DR. ROYAL: Exactly. CHAIRPERSON FADEN: Right, exactly. So you would say that when you're thinking about the subjects that are normals for that person, they are evolved in nontherapeutic research. Conceivably, the patient subject might be involved in what is therapeutic research. DR. ROYAL: I thought I had just heard that the Hippocratic Oath prevented us from doing research in -- nontherapeutic research. CHAIRPERSON FADEN: Without consent would be the argument. I mean, that's the hidden suppression, that -- DR. ROYAL: I didn't hear any phrase -- CHAIRPERSON FADEN: We didn't say it, but, I mean, I think that the notion is not that you might never do it, but you certainly couldn't do it without -- it's totally different; I would agree. But I don't -- I'm not -- I think that we need to get the language out in a way that, whether the rest of the world uses it that way, if we're going to use it as shorthand, we ought to know that we're all using it the same way. Dan and I have spent endless hours realizing we were talking about two different things. MR. GUTTMAN: Law and ethics. CHAIRPERSON FADEN: Right, that, too. (Laughter.) DR. ROYAL: If I could touch on that one more time, you said nontherapeutic research without consent, and I guess I don't -- one of the things that troubles me is I don't think you should do therapeutic research without a consent either. CHAIRPERSON FADEN: Oh, we'll agree, but I'm talking about going way back. We'll pick this up later. I'm sorry, I didn't mean to say it so glibly. CHAIRPERSON FADEN: Reed? Ruth? You figure it out. DR. TUCKSON: Ruth, you go first. DR. MACKLIN: Well, it's right on this point. Is that okay? First of all, I think it would be useful not to use any terms that admit of such systematic ambiguity as therapeutic research for the reasons Henry just gave, for the reasons Bob Levine has long been railing against, because when therapeutic modifies the term "research," you're going to get into this ambiguity because one and the same piece of research may be therapeutic to some patients, not therapeutic to others, or be directed at therapy for future patients. So it's not helpful. We might want, in order to avoid any such ambiguities, to talk about it's not a felicitous phrase, but research that promises or holds out the prospect of direct benefit to the subjects. CHAIRPERSON FADEN: Direct medical benefits. DR. MACKLIN: Direct medical, yes, a direct medical benefit by -- yes, that they would -- and not the altruism and all that other stuff. DR. HARKNESS: Well, the problem that Sue and I, two historians, are having with that is that even if we don't like the distinction -- and I tend to agree with the current thinking about this -- a problem arises in that the historical actors in whom we are interested do see this as an important and real distinction, and it seems to me that we, in order to understand and make sense of them, that these people in the past need to keep this distinction at least as they defined it before us. DR. MACKLIN: That's fair enough, and I think that's right. I mean, it's important to get at what they meant by it and defined it, but using the term without seeing what they meant by it -- I mean, if they were all uniform on what they meant for it, then it requires a gloss and an explanation. What did they mean? And we may decide in our deliberations in discussion we don't want to use that language anymore, but I agree entirely for your purposes, or for our purposes, in trying to figure out what they meant, it may have been a useful term. The other thing that disturbs me about all this with the Hippocratic Oath, which has always been given more due than it ever has deserved, I think, is the notion that consent had anything whatsoever to do with the Hippocratic Oath. I mean, Jay can speak to this more -- in more detail and more eloquently than I, since I've learned everything I know about it from his descriptions, but the idea of doing research that doesn't benefit individual subjects may have something to do with the Hippocratic Oath for doctors; that is, don't do any harm or don't do any harm without compensating benefits, but the idea of consent had nothing in ancient Greek medicine or in Hippocrates -- and, as Jay has pointed out in his writings, Hippocrates counseled people to keep things from the patient and don't tell them what's going to happen and don't tell him about his bad condition, et cetera. So I think when we talk about the Hippocratic Oath, we have to talk more about the questions of harm or harm and benefit and forget about the notion that consent could have anything to do with it. DR. KATZ: Including the additional fact that many people who studied the Hippocratic Oath have made it quite clear that it was a therapeutic code and it was not a code that could easily be tied to the ethics of medical research. And if I can add something just briefly now -- CHAIRPERSON FADEN: If Reed can be patient, yes. DR. KATZ: So I guess -- CHAIRPERSON FADEN: No, Reed is happy; he's letting you talk. Reed is letting you do it. He's quite happy. (Laughter.) DR. KATZ: No, no, I'll stop. Reed, you speak. I'll speak later. DR. TUCKSON: No, you're on a roll. Go. (Laughter.) DR. KATZ: No, I'll have my chance. DR. TUCKSON: No, I wanted your -- DR. KATZ: No, I just wanted -- okay, I'll just say one thing in relation to what you said on the arrogance issue of physicians. I think, in all fairness, a distinction has to be made between what they are saying about the Nuremberg Code and what they are saying about the Nazis concentration camp experiments because they are up to a point quite right in saying that certain aspects of the Nazis concentration camp experiments have nothing to teach us because never in the history of medical research has research on human beings been conducted in such an atrocious fashion as the Nazis did during the War. But, unfortunately, one of the consequences of that was that they turned their back on a great many other things that the concentration camp experiments had to teach us and said there's nothing there for us to examine, and many people who talk about the Nuremberg Code in a totally disparaging kind of fashion when they haven't read the Nuremberg Code with any kind of care, because if they had read it, they should have at least said that, look, we can't really use the Nuremberg Code in clinical research on human beings unless we introduce all kinds of modifications or really interpret the various provisions. Of course, as Beecher and others have pointed out, the Nuremberg Code in its original form is only -- if strictly applied, would probably make a great deal of human clinical research impossible to conduct. DR. TUCKSON: I know you're trying to move the agenda. Let me just say briefly on that -- I mean, there's a lot in there. Certainly, there's nothing as frightening as people, though, who feel that they are superior or better than and, therefore, don't need to be questioned. I mean, I'll just -- I mean, that's frightening as heck. But, on the other hand, I appreciate that point. As far as Ruth's point is concerned, I think she's right on. I'm not -- and I probably shouldn't have been so specific in my sense of the Hippocratic Oath literally interpreted. I think Ruth is right on. I was just searching to try to see -- and I really should probably put Hippocratic Oath in quotes, "Hippocratic Oathish." Whatever there was as a culture -- and even the absence of is an important -- I just wanted to understand what was there because there must have been something there, and if there really wasn't anything there, then that's important because it kind of says that these folks were pretty much hanging out there without a lot of guidance. That begins to help us to humanize and understand who these people are and what they had available to guide their actions. That's an important thing for us to understand. So let me "genericize" that a little bit. Finally, I would just ask that if -- I imagine in the report I would -- I think that we've -- I'm not sure if we've presented this or not, but there's a certain symmetry that my mind is calling for that says if -- after we do the oral histories and we begin to see that there was precious little guidance and even less systems in place regarding this kind of work, and given that we are stuck though with exploring this radiation part of the bigger puzzle, it would be good to have an analysis of the presence or absence of systems in other areas of research. So, in other words, that, again, that -- because what we're going to wind up with perhaps, conceivably, is you've got folks who can clearly fall back on the notion that says nobody told us; there weren't any systems; nobody communicated from the feds on down to us what we were supposed to do. It was ambiguous and unclear, even though it should have been, you say -- perhaps they should have known; we didn't. Now whose fault is that? And one of the things I'm just wondering is, did those systems exist other than at NCI -- NIH/NCI? -- it's all the same thing, yes. But you said that maybe there were some systems at NCI, but were there systems and infrastructure placed anywhere else, so that, again, that it was either normal or expected or the normal course of action for there not to have been systems, but, in fact, if there were systems that were taking care of this issue anywhere, it would be important at least to understand that, I think. It just helps me to understand, again, those times, anyway. CHAIRPERSON FADEN: Eli? DR. GLATSTEIN: Well, I'd just like to add I found this section to be stunning. I've tried to figure out why the attitudes here are so different than the way I was trained, what I've seen. DR. HARKNESS: When can we schedule an interview? (Laughter.) DR. GLATSTEIN: Well, I'll tell you, I think you have it. On page 3, toward the bottom of the page, you say the guy responded that the Hippocratic Oath was not developed for physician investigators, or a term which is more common today, "physician/scientist." An investigator, you say, was -- or he said was a new departure in medical history in '45/'46, and I gather that that was considered an elite group, at least considered by the people themselves as being elite. I guess I may have been very fortunate that my mentor had gone to NCI and brought the NIH approach to a university. DR. HARKNESS: When was that? DR. GLATSTEIN: He came to Stanford I think in '49. And in terms of trying to get the patients on-study, whether it was a service patient or a private patient, they're approached the same way. Each patient was presented with protocols when we had protocols; never made a distinction that way. And on weekly chart rounds, we'd view each patient. We were obsessively taught to look -- to be sure -- there were two things on that chart that had to be documented. One was a path. report to confirm the diagnosis of cancer and the other was the informed consent, whether it was for regular treatment or investigational treatment, either one. DR. KATZ: What year was that? DR. GLATSTEIN: When I was a trainee; this would have the late sixties. The same guy was still in charge. DR. HARKNESS: Did you have the sense that those policies were longstanding? DR. GLATSTEIN: You bet. You bet. And the idea about having the consent form on a patient, if we discovered that, which was maybe once or twice a year, treatment was stopped until the consent was obtained. DR. TUCKSON: Is he still alive? DR. GLATSTEIN: No, he's been dead for 10 years. But I presume he brought it from Bethesda. I never honestly thought about it until this Committee, but all I can say is I found this to be pretty incredible reading -- CHAIRPERSON FADEN: No, Eli -- DR. GLATSTEIN: -- and to describe that as rich, rich in the sense of mining. CHAIRPERSON FADEN: Eli, we might -- we can do this at the break or whatever. There may be people who are like 10 years ahead of you who trained there whom we might speak with them to sort of track down -- DR. GLATSTEIN: Sure. CHAIRPERSON FADEN: -- about their experience. DR. GLATSTEIN: Sure. CHAIRPERSON FADEN: That might be worth doing, would be to talk to someone who precedes you. Mary Ann, you trained there "X" years later, and, presumably, you had the policy -- actually, notice I didn't mention how many years later. DR. GLATSTEIN: Thank you. Thank you. (Laughter.) CHAIRPERSON FADEN: But "X" years later, Mary Ann trained there, and you found the procedures to be much the same? DR. STEVENSON: Actually, I went to medical school there but trained -- went to medical school at the same university Eli is talking about, but actually did my radiation training on the other coast, but had the exact same experience, which is leading me to believe that there was at least an academic radiation oncology at some point, a very firm policy that sort of disseminated to at least two academic centers on two very different coasts under different leadership. So that -- DR. GLATSTEIN: Yes, but there is a link between those two departments. DR. STEVENSON: Oh, no, I absolutely agree, but there -- DR. GLATSTEIN: Your boss is out of the same house. DR. STEVENSON: Yes. DR. LEDERER: I was just going to say that the one person that we interviewed from Stanford is the person who reported so differently about the Nuremberg Code. In fact, his quote, which is on page 10, goes on to -- that the Nuremberg principles were surely familiar to everyone that I came across, and that's someone from the Department of Radiology at Stanford. So it could be that there are different institutional practices. DR. GLATSTEIN: I think with respect to Nuremberg, in all honesty, I don't think you can eliminate the ethnic issues, either, because that department was a very Jewish department. DR. HARKNESS: And this physician was Jewish or is Jewish. DR. GLATSTEIN: Yes, I know. I know. I know him well. CHAIRPERSON FADEN: An interesting point. That's an observation worth noting. It would make a lot of sense. It would make a lot of sense that the sensitivity would be different based on people's identification with the Holocaust. Okay, well, we probably don't need to -- but this is an interesting lead. Maybe we could find somebody who precedes Eli by about 10 years to eclipse in on the period -- DR. GLATSTEIN: I'm sure they exist. (Laughter.) CHAIRPERSON FADEN: I didn't mean it quite the way it sounds. You are so young. I think we all agree, can agree, though, about the significance of the Oral History Project and what a delight it is to see one of the independent research projects of the Committee actually coming to completion and already bearing fruit, even in this preliminary stage of analysis. If it's all right with everyone, I'd like to take a break now, come back in 10 minutes. (Off the record.) CHAIRPERSON FADEN: We have a call to resume our deliberations. Would the Committee members please come to the table? And would the other people go away? Thank you. All right, I want to thank everyone for returning from your break more or less on time. We're going to now -- I'm not sure if this is really pick up because in some respects it's a new topic. We're going to expand our consideration of questions of culpability from the focus that we've had up until now, which has been on the government, to potentially professions and individuals. We'll begin that discussion now. We have a revised version of the manuscripts that Allen has been working on for us, and that's Tab -- somebody help me with the tab -- Tab E that we can pull out. Allen, can you start us off? DR. BUCHANAN: Yes. As I understand it, my task today is to talk about two documents, the new version of the long paper that Ruth just referred to on ethical relativism and retrospective moral judgment and the short piece on ethical criteria for the Committee to apply to the data that's being gathered on the experiments. With regard to the first document, the long one, let me thank the Committee for the extremely helpful suggestions and criticisms I got on an earlier version of the manuscript at last month's meeting. I think this version you have now is improved as a result of those comments. I found them extremely helpful. I think there are some better treatments of some sensitive issues and that your comments introduced needed complexity. I apologize for the length, but it just turns out that this material is very complicated, and I want to thank the staff for editing the longer version and for providing an index and subheadings which are extremely helpful. I think it makes it a little more readable. Now what I'd like to do, if this seems appropriate, is to just look to the conclusions of the long document. I tried to give a summary of the main conclusions at the end on pages 27, 28, and 29, and see if there are any comments or criticisms of those conclusions, if there are things that need to be added, if there are things that aren't clear, things that deserve comment one way or another. And then after that, I'd like to proceed to what I take to be the main new point or the most significant new point in this version. That has to do with judgments about the medical profession. So if we could now look at pages 27, 28, and 29 of that, of the long paper, and see what you have to say about it, I think that would be helpful. CHAIRPERSON FADEN: Henry? DR. ROYAL: I thought that the writing was quite passionate. (Laughter.) DR. BUCHANAN: Oh-oh. Oh-oh. DR. ROYAL: I wanted to read an example of the writing was passionate and then ask you a few questions about it. And I'm on page 26, and I was going to start with the third sentence of the first paragraph. I was just going to read two or three sentences. "To fail to acknowledge that rights were violated is to fail to show proper respect for those whose rights were violated, to act as if they had no valid grievances, as if no moral injury had been done to them. It would be a sad postscript to a very disturbing chapter in American history if the body assigned the task of setting the moral record straight on radiation experiments failed to show proper respect for those very persons whose dignity was assaulted by their own government," et cetera. One of the things that I want you to clarify was the phrase "very disturbing chapter in American history." In particular, I didn't know what the chapter referred to, whether the chapter was radiation experiments, whether the chapter was the Cold War, whether the chapter was medical experimentation. So if one could know the chapter, and then the "very disturbing" adjective, I was also interested in compared to what? The preceding chapter was less disturbing? The following chapters were less disturbing? So I wanted some clarification of what those words meant. DR. BUCHANAN: Yes. I was referring to the radiation experiments, not to the Cold War as such, though, obviously, the Cold War is the context for this. And it may be that -- it may be that it's premature to make this kind of judgment about that period. I mean, it struck me that -- DR. ROYAL: Well, now that I know that the chapter refers to the radiation experiments -- DR. BUCHANAN: Yes. DR. ROYAL: -- I'd like you to explain what you meant by saying that they were very disturbing, if you could articulate what it is about them that's very disturbing. DR. BUCHANAN: Yes, I guess, you know, it's a mistake to say that all of the experiments were disturbing, certainly, but I think there has been enough evidence uncovered so far to indicate that there is reason to be disturbed about whether policies that were articulated were taken seriously. There is disturbing evidence of the use of especially vulnerable populations and, as I also argue here, some evidence that there may have been a failure on the part of the medical profession to exercise its collective will to protect patients. I mean, disturbing in one way is, I think, sort of an artful term. I mean, it's just to say there's cause for concern; there's reason to worry. It's not to say -- it's not to issue a blanket condemnation, certainly, but -- I mean, that's how I intended it, anyway. DR. ROYAL: I think "very disturbing" will mean different things to different people, and we need to be aware of that. The other issue is that you argue strongly that the Committee find culpability, and one of the issues I think that we have to struggle with is there are two possible harms that we could do. One harm would be not to recognize culpability when culpability exists, and the other harm would be to assign culpability when culpability should not be assigned. You seem to be much more concerned about the former -- that is, not assigning culpability when culpability should be assigned, as opposed to making an error on the other side, where you assign culpability when there shouldn't have been culpability assigned. Is that true that that's the -- that you believe that we should be more concerned about what I would call a false negative -- that is, not assigning culpability when you should have assigned culpability -- than a false positive -- that is, assigning culpability when you shouldn't have assigned culpability? DR. BUCHANAN: No, I don't -- I don't feel that way at all. I guess I viewed my task as trying to make clear under what circumstances it's coherent and justifiable to make judgments of culpability, while emphasizing that, of course, whether in any particular case a judgment of culpability is justified depends upon, first of all, having sufficient evidence that a standard was violated, et cetera. I mean, I tried to emphasize that and also not to try to make a judgment about, in most cases at least, about when there was sufficient evidence. Where there's any controversy about whether the evidence was sufficient, I tried to remain completely agnostic as to whether standards were violated and whether there was culpability. I mean, I think that it is, of course, important to be concerned about both kinds of errors. DR. ROYAL: In the judicial system, it's customary to err on the side of not convicting someone if they're not guilty, knowing that you're going to let some criminals go free. Should we apply that same standard with ethics? DR. BUCHANAN: I don't know if there's a general answer to that for all cases of ethical judgments, but I guess I believe -- I think I believe that even if one accepted that presumption in the case of all of the ethical judgments that I've considered, I don't think there's anything that I've said that's inconsistent with that because I really haven't talked about what the standards of evidence should be. Instead, what I've asked is whether there are any conceptual or moral barriers to making judgments, given that one has the same kind of evidence that we have about things that are going on now. Now it may turn out that in a lot of cases that we don't have that evidence, and I did distinguish between judgments of culpability about organizations or agencies, making judgments about leaders or people in authority in those organizations on the basis of whether they failed in some fairly clear duty that they were assigned by virtue of their role versus making judgments about individual physicians, say, who conducted experiments. I think that there's good reason to be especially careful about drawing conclusions of individual culpability in the case of individual experimenters because we simply don't know much about that. What we've seen today and at the last meeting is I think a good deal of evidence about -- a good deal of evidence that can be marshalled to make a judgment of culpability about an agency or about several agencies, and also perhaps about people like Charles Wilson, who were at the top, who issued standards but then, it so appears, didn't do much to see that they were followed. But that's quite different from saying that there's evidence for individual culpability in the case of particular experimenters, and I think that concerns about whether we have adequate data to make a judgment of culpability are especially strong for those kinds of judgments of individual culpability. But, no, I agree with -- I mean, I think if you had to make a generalization, your presumption would be correct; that is, that one should be more concerned about making an erroneous judgment of culpability than about failing to make a judgment of culpability. DR. ROYAL: I feel like the movie "Home Alone" here. (Laughter.) MR. FEINBERG: Let me pick up on that, on Henry's point, and ask a variation of it. How much of the dignity of the wronged victim do we undercut in your mind, how much of the dignity of the wronged victim do we dilute, if we conclude that although there is, as you say on page 26, no conceptual bar to imposing culpability on individuals, the passage of time, the conflicting or lost evidence, the inability of individuals like Wilson to defend themselves -- how much -- the question I have is: assuming that we conclude that for those reasons we will not impose individual labels of culpability, how much have we diluted, in your opinion, the moral legitimacy of announcing wrongs done to individuals, which on page 26 of your paper seems to be a very serious concern of yours, the balance and the tension? DR. BUCHANAN: Yes. I mean, I think that if we're cataloging the moral risks of one or another kind of a position that the Committee might take, Henry has pointed out one important one, right. One moral risk is to make an unfounded judgment of individual culpability. But you've just pointed out another risk which I think is extremely serious, and that is not to recognize that individuals' rights have been violated when they have been violated. DR. FEINBERG: Now that's a given. I don't think -- I think your paper is absolutely -- in my opinion, it's a foregone conclusion that this Committee, in my opinion, should announce that wrongs were committed to individuals in the Cold War period. That is a conclusion I reached personally a long time ago. The question I have is, in your opinion, as a moral/ethical matter, if this Committee so concludes and concludes that wrongs were done and that these victims were victims, and it was an outrage, does it follow, in your -- I'm asking you to weigh how much we dilute that message if we only conclude that there was -- "only" in quotes -- that there was institutional agency government culpability, but we do not attempt to label Charles Wilson morally blameworthy in the absence of time -- in light of the time and in light of the fact that Charles Wilson is not here to defend himself. I'm just asking that question because I think -- you know, you say there's no conceptual bar to, but I think there's a clinical and an evidentiary problem, and I'm very concerned about your view, as sort of an ethicist or as a reporter on ethics, whether we have, in fact, done what you warn we should not do on page 26 and dilute the message to the victim by our unwillingness to paint Wilson or somebody like Charles Wilson as a morally blameworthy person. DR. BUCHANAN: Well, you've gone right to the heart of it, as far as I'm concerned. DR. FEINBERG: I want you to tell me what's the heart of your position. DR. BUCHANAN: Okay. DR. FEINBERG: That's what I'd like. (Laughter.) DR. BUCHANAN: All right. DR. FEINBERG: People tell me all the time I laid out the issue. Now what's the solution? DR. BUCHANAN: Here's what I think. CHAIRPERSON FADEN: Well done. DR. BUCHANAN: If the Committee only makes judgments that individual rights were violated and judgments about institutional failures, but makes no judgments about failures of duty in the case of people in positions of authority in those institutions, I think that's going to be rather odd because what it amounts to then is it's a kind of prying apart of the notion of a right and a correlative duty. If you say somebody's right was violated, the immediate and very strong assumption is that there was someone who had a duty -- DR. FEINBERG: Yes. DR. BUCHANAN: -- that was not fulfilled. Now let me -- DR. FEINBERG: The United States had that duty, and the Defense Department had that duty. DR. BUCHANAN: All right. DR. FEINBERG: But did Charles Wilson have that duty? DR. BUCHANAN: Okay, here's an intermediate position between just saying that the Defense Department and the United States Government had a duty and saying that Charles Wilson had a duty which he failed to fulfill: depending on how you view the evidence about how you can trace the chain of command, you might end up saying something like, not only did -- not only was there an institutional failure, but that there was a failure of duty in the highest positions of authority; that is, those who should have done something to try to see that there was compliance with the policy. And I say "something" rather than 100 percent compliance. I agree with a remark that Henry made this morning, that one shouldn't assume that a policy is a failure if there's not complete compliance with it. Instead, what I'm suggesting is that even if you didn't point the finger at Wilson himself, you might, with good reason, be able to say that there was a failure in the high command, as it were, in that agency, that either Wilson or someone else at the top of the chain of command should have made some sincere good faith efforts to see that the policy which Wilson had articulated was implemented, and if you have evidence that that wasn't done, then that's at least a prima facie case for saying there was a failure of duty on the part of individuals in their role responsibilities, even if you can only give a list of, say, two or three people who were at the top and even if you can't make it clear exactly what the apportionment of responsibility was among those two or three individuals. I'm just saying that's an option that's intermediate between saying Charles Wilson was a bad guy and just making the sort of blanket, bland statement that the government was culpable or that the agency was culpable. DR. FEINBERG: Why -- just if I may -- DR. BUCHANAN: Yes. DR. FEINBERG: If I may just one more minute, just one further question because it's very helpful to me. Why is it a bland statement -- DR. BUCHANAN: Okay, it's not -- DR. FEINBERG: -- to say that the United States Government is culpable? I mean, why is that a bland -- I'm very concerned about the perception that that's a bland statement. Why is that a bland statement? DR. BUCHANAN: Well, I guess there are two reasons why -- I'm not sure "bland" was the right choice of words, but why I think it may be less than satisfactory if one stops by saying that the U.S. Government was culpable. It seems to me to suggest that the government is somehow this sort of super-entity that exists independently of individuals in their role responsibilities in the government. And I think especially for the forward-looking purposes of the Committee, it's extremely important not to convey that message; in other words, to give a clear message that people who are doing things now which may not be appropriate or who may be tempted to do them in the future should realize that accountability will be focused, where there's evidence for it, upon individuals in their role responsibilities, and that accountability will not just be limited to these general statements about agencies or about the government in general. I think that will make the forward-looking suggestions of the Committee more effective and that it will speak to people more clearly, and that the incentives will be stronger for deterring abuses in the future. CHAIRPERSON FADEN: Duncan, Phil, Henry, and Jay. DR. KATZ: By the way, are we only talking now about government culpability or are we talking about the whole document culpability -- CHAIRPERSON FADEN: Well, the conversation seems to be going toward the individual culpability, which was what the focus was this afternoon, and it seems to be right now on individuals who are government officials. We haven't gotten yet to -- DR. KATZ: We'll get to that later? CHAIRPERSON FADEN: -- investigators, but right now we're focused -- I'm sorry, I missed a part of the discussion. I didn't want to cough all over everybody. So I am back. With the aid of one of Anna's cough drops, have returned to the living. But, as I understand, the conversation now is on -- has taken the turn, based on coming in in the middle, on this issue of, can we -- should we and can we make judgments about government officials in relation to the policies that we've already said the government is culpable in some general sense? Thank you. DR. BUCHANAN: Yes, and, Ruth, if I might just add: and I was just suggesting that there are really two kinds of judgments about government officials that might be made. One is to single out a particular individual and say, definitely, this person is someone who failed in some duty that he or she had as a result of the role. The other is to say that we have reason to believe that some person or group of persons who were ultimately responsible for the policy in the agency failed in their duty to take reasonable steps to see that a policy which they formulated and promulgated was, in fact, implemented. And that might mean mentioning Charles Wilson or it might not. But, again, I think there's something to be gained even if one made that kind of somewhat impersonal statement about people at the top of the hierarchy that capture something important that's not captured just in saying the government was amiss in its activity or the agency was, because it puts people on notice in those positions that they will be held accountable for doing or not doing certain things. CHAIRPERSON FADEN: I've got Duncan, Phil, and Henry. DR. THOMAS: Maybe I misunderstood something. I thought the discussion was actually a little bit broader even than whether we find government agents culpable. I thought we were talking in general about individuals which might include -- CHAIRPERSON FADEN: We will. We can start now. Yes, absolutely, at any point -- DR. THOMAS: The discussion now is not limited to -- CHAIRPERSON FADEN: Uh-hum. I mean, we can take it. DR. THOMAS: Well, I find myself very much swayed by the passion in Allen's document, maybe in part because it says things so much more eloquently than I had been grappling toward at the last meeting and hadn't been able to say anything about very convincingly. I'd like to suggest -- but, at the same time, I am very sensitive to the issues which Henry raised about the concern about making false positive statements, and I'm very much concerned with the issue that we had a long discussion about last time and Ken raised again, about the evidence that we need in order to find culpability. I guess I'm leaning toward the view that perhaps the proper way to view our role here is as a sort of a grand jury. We're not a court of law. We're not actually charged with responsibility for finding people guilty either of criminal violations or necessarily even of moral violations, and we're certainly not charged with doling out any form of punishment. And, yet, if we were to drop the ball on this and fail to in a sense make the charges, I don't see how anyone would ever follow in our footsteps, then, to actually -- in cases where there is adequate events or a basis to pursue these questions. I think if we are persuaded that we do have the evidence -- and that's a big "if" -- that we have a responsibility, for the reasons that Allen lays out in this paragraph, to proceed to make those accusations. Somehow we have to be very careful in doing this. We don't want to be a runaway grand jury, either. We need to think very carefully about what are the protections that we can reasonably offer individuals that we might say bad things about and what evidence we would want to have before we were persuaded that we wanted to make such an accusation. But I think that's -- perhaps we'll be getting into trouble because we think we're actually passing judgment, and I think all we're doing here is really making accusations. DR. KATZ: Making? DR. THOMAS: Accusations. CHAIRPERSON FADEN: Phil? DR. RUSSELL: I think pronouncements of the Committee are going to be viewed as judgments. DR. THOMAS: But not a final judgment. I think the -- DR. RUSSELL: There's not going to be an appeal. (Laughter.) There's no way it's going to be very final, I think, in real terms. One of the things that makes me concerned about assessing specific culpability within a bureaucracy is one of the issues is predictability, the predictability of a bad outcome. And you can be virtually certain that most of these people, if they predicted a bad outcome, would have done something about it. Then the way they would have gone about that was to assign specific responsibilities to see to it that bad outcome doesn't occur. Of course, in the Army that happened in 1975 when the specific responsibility for monitoring all human volunteer research was given to the Surgeon General of the Army, and that put the onus for anything bad that happened after that on him. So that after 1975 I could say that, if something bad happened as a result of negligence within the system, that you could quite clearly assign this culpability to the Surgeon General or his surrogate in that. But at the time this was occurring, the ability to predict a bad outcome was not quite so clear. This research was being driven not by medical folks, but it was being driven for a variety of national security reasons. By and large, the medical people were peripheral. The Surgeons General were -- had primary responsibility for clearing the battlefield and taking care of patients. They were not research people. They -- as the oral history tells us, the concept of physician research and clinical research is just beginning to emerge, and let me tell you, it was not there institutionalized in Army medicine at the time; far from it, there was no tradition of clinical research that was very well established, except for the very small area of infectious disease. So what I'm getting to is that here we have this big bureaucracy, and eventually we had a bad outcome in several areas relating to biomedical research, but trying to find a trail of responsibility through that bureaucracy after all this time has passed I think is going to be very, very difficult. You can see from the way things evolved since then that one of the fixes that was put in place was to assign by law and then by regulation specific responsibility for certain oversight, but that wasn't in place at the time. In the absence of specific assigned responsibility, are you going to look in the research chain where there's virtually no medics until you get down to the very end of it or are you going to look in some of the advisory chains, and who knows how seriously and how much concern there was about the advice of the medics in this? So I think that I'm going to not have any difficulty at all assigning responsibility for the bad outcome to the Department of Defense or the Atomic Energy Commission, but to go take the next step for individual culpability for the leadership, I find it becomes very difficult. And I think we're going to look to a fairly extensive documentation to take that step. DR. BUCHANAN: Could I ask a question about that, Phil? I thought you were about to conclude and say that, once you get beyond the very upper reaches of the leadership, say in the Department of Defense, and you get this complex chain, then we just don't have evidence. It would be extremely difficult to make judgments about individual researchers or medics or, you know, anywhere down the line. But you also seem to have concern about making a judgment about the very top end of the chain, and are you concerned both about -- are you reluctant both to make judgments, say, to the effect that Charles Wilson failed in his duty and that, something more general, that the highest leadership at the Department of Defense failed in its duty to take reasonable -- would you be -- would that -- does your discomfort come after that or at that point, is what I'm asking. DR. RUSSELL: I don't have any way of knowing whether the Sec. Def. at the time made strong demands on his staff to see to it that this was carried out and assigned some responsibility and the next person failed or it was the next person that failed. DR. BUCHANAN: Right. DR. RUSSELL: I can't tell. DR. BUCHANAN: Right. DR. RUSSELL: So given that, I'm very reluctant to say Charlie Wilson was responsible because the failure could have been in several areas in between. He had the responsibility. There's a tradition in some parts of the service just to hang the commander and forget about who really was driving the ship when it ran aground, but in this case I think we have to look very carefully at whether the failure was a systems failure or a personal failure. DR. BUCHANAN: Would you sort of set -- for those reasons, setting aside a judgment about culpability of, say, Charles Wilson or of the highest leadership, in the forward- looking part of the Committee's task, would you be willing to say something -- I'm just testing your views about this to try to get an idea. Would you be comfortable saying something like that when policies are developed at the highest levels, that it's the responsibility -- it's not just the responsibility of the leaders in the hierarchy to make reasonable efforts to see that they're complied with, but that there's also a responsibility for creating a paper trail to make it possible to determine accountability? In other words, there are responsibilities of accountability and there are responsibilities for accountability; that is, for having an organizational arrangement in which accountability can be assigned, and at least for the purpose of recommendations for the future, it seems to me to be important for the Committee to say something to the effect that -- and this is true, of course, in the contemporary conception of informed consent. It's not just important to get informed consent, but it's important to document in such a way that it's possible for others to tell whether the requirements have been met. DR. RUSSELL: All of these regulations and all of these issues are built with the "retrospectoscope" firmly in place. (Laughter.) It's extremely expensive in terms of dollars and manpower to create regulations, put in, implement regulations, follow them down, create an audit trail, a reporting chain, and so forth. It's usually not done until there's a predictable need for it, and my question would be, was there a predictable need at that point in time to put this kind of a thing in place -- DR. BUCHANAN: A perceivable risk that -- DR. RUSSELL: Yes, was the risk of harm to subjects and the risk of biomedical -- of violation of human rights, and so forth, perceived as a real high risk, and, therefore, would it necessitate putting in place -- it turns out that by 1975 that was done in spades, but I would -- DR. BUCHANAN: But don't you think there must have been some perception of significant risk to have generated this debate that went on at the highest levels? DR. RUSSELL: That's a good question. DR. BUCHANAN: Otherwise, it's hard to explain the -- as Jon was saying, considering all of the things that were going on in these departments at the time, for them to have taken the time and the energy to have a debate about this at the highest levels would seem to indicate that there was some perceived risk that they needed to do something to address this. Now if the risk was great enough as they perceived it to warrant having a debate and formulating a policy, then why wasn't it sufficient to warrant taking some steps to see that it was complied with? Now we don't know whether they took steps, but at least that's the question we ought to ask, I guess. CHAIRPERSON FADEN: Dan, do you want to get in for a minute? MR. GUTTMAN: Just to make a comment and observation on Phil's -- to me, this is like an analog, the whole question of the retrospective ethical judgment. The question is, looking backward, what were the bureaucratic standards in the day? From my technical perspective, what was remarkable about the 1947 AEC memos is they did precisely what you are talking about, that the common thread denominator of the two letters was, whatever was done by way of consent, whether it was patient or doctor, it had to be in writing "susceptible to proof" 40 years later. So to look at Allen's question, well, that's what they did back then 40 years ago. The AEC said in 1947 this had to be in writing. Now we're looking backward and we're saying, well, there was no clear chain of command and we didn't know -- then the question is, well, it's this same kind of question because they weren't -- they knew the policy, but they didn't organize themselves in a way to permit the accountability to be adequately defined. Does that mean they're off the hook? And that's sort of another variant of the -- well, does the Defense Department get penalized because they've got the ethics and the HHS not because -- you know, in other words, who gets -- Allen, if you could enlighten us. They were forward enough thinking to say in '47 we know that this can't be just an oral thing; it's a bureaucracy we're talking about and it's a history that's going to have complex -- people looking back and they prepared for it; they said put it in writing. Now we're saying, well, it wasn't organized enough for us to see who's responsible. DR. BUCHANAN: Well, I guess you could make -- you can give someone a mixed report card. You can say that a particular agency was, in fact, to be commended for taking the lead in bringing these issues to the surface, discussing them, attempting to formulate a policy, but that they didn't carry through on it, if that's what the evidence was. So it's not as if -- I mean, what I've tried to do in this paper over and over again -- and I may not have succeeded -- is to avoid blanket approval or blanket condemnation; that is, to sort things out and say that a particular individual or an agency or a profession may have been commendable in certain respects, but in certain respects may have fallen short in some way of their own standards or of what they should have been expected to do, given that they have articulate standards. So I think it would be appropriate to say, yes, the Department of Defense and the Atomic Energy Commission, and at a certain point the Navy, stepped forward and made some moves that were quite progressive in a way, but they failed to carry through in certain respects. DR. MORENO: Can I just get -- as a point of information -- CHAIRPERSON FADEN: Jonathan and Phil wanted to say something right on point; right? DR. MORENO: Yes. To the issue of the extent to which the bureaucracy felt itself to be at risk, it's important to appreciate, as we said before, that I think the evidence shows that the bureaucracy felt itself to be at risk with respect to public relations issues and with respect to insurance issues. In the public relations issues, the most obvious case is the hepatitis deaths that occurred on -- what? -- four or five occasions over a 10-year period in military medical research. This was -- you see repeated references to this in the transcripts from the policy committees in the DOD. You also see repeated reference to insurance issues. What you don't see is anybody saying, wait a minute -- except maybe for one or two people in scattered fashion, you don't see people waving their hands about human rights per se in sort of contemporary language. That kind of bureaucracy -- that kind of risk is not there, but there is a perception, however, whatever implications it has for this discussion, that the bureaucracy is at risk in at least a couple of identifiable ways. CHAIRPERSON FADEN: Phil? DR. RUSSELL: The way we're going about finding if we can identify some of major players, we can identify some of the proponents for positive action in this; what we can't identify is who has thrown the roadblocks in the way of progress; who was stopping the development of an oversight system and who was advising the senior leadership not to listen too much to this business about informed consent. "Let's get the job done and the war won." And those are the people that will never be able to be identified who perhaps carry much of the blame. CHAIRPERSON FADEN: I've got Henry, Jay, and Ken, and I'm looking for other people, but Henry? DR. ROYAL: Allen, you mentioned about finding -- one of the good things about finding individual culpability is its deterrent effect, especially for the future. One of my concerns is that it might have a deterrent effect, but not the kind of deterrent effect that we might want, and that is people who are willing to introduce new policies because, if you can't see them from beginning to end -- and by "beginning to end," I mean introducing the policy and then seeing that it's implemented -- it seems to me that you're not about to introduce policies that you're not sure that you can implement, no matter how much you might believe in that policy. In regard to Wilson -- I don't mean to speak as an expert about Wilson in any way, but say it hypothetically -- I'm not sure whether or not he's the villain or the saint. I mean, is he the person who got people thinking about these issues? Maybe it's not feasible to think that someone in one fell swoop could not only introduce a policy, but also introduce a feasible implementation to that policy. Maybe it is a trial-and-error process. Maybe different people had to think about this problem in different ways and that it takes two or three iterations before it begins to work. So, as I said, the fact that I can make an argument either for Wilson being a villain or Wilson being a saint disturbs me when we start talking about culpability because, if he's a saint, I'd hate to say that he was culpable. DR. BUCHANAN: Well, what -- how would you feel about a judgment not that Wilson was culpable, but that, given that there was this high-level discussion and given that, as the Committee seemed to agree on this morning, that a policy standard was articulated, that there's evidence that the policy was not complied with in some significant cases, and there's no evidence of implementation, not of fully effective implementation, but that there's not -- if this is correct on the basis of the archival work, that there's no clear indication of even taking the next step, not of adequate steps to implement, but of a further step beyond the circulation of the memorandum. And that's not to say that Charles -- that's not to fix the blame on Charles Wilson himself individually, but to say that there was a failure in the leadership of the institution to carry through on what's necessary for putting into effect a policy which they had formulated. But -- DR. ROYAL: I think then we would have to know what the obstacles were to implementing the program, implementing the policy. I mean, we did see the AEC catalog which seemed like a reasonable attempt to implement the policy. And, again, I, in my own mind, are thinking these guys are out doing things that no one else is doing, and, yet, they don't get any credit for doing that. DR. HARKNESS: If I could interject with a concrete historical case that speaks to this, I think, at almost exactly the same time, there is a discussion and reasonably successful implementation of policies like this at the clinical center, at the NIH clinical centers, lots of research going on, therapeutic, nontherapeutic, fairly heated internal discussion, and fairly extensive and reasonably successful implementation of group consideration policies, informed consent, signing consent forms -- DR. ROYAL: What years are you talking about? DR. HARKNESS: '52, '53. DR. ROYAL: To me, the big difference is the NIH is one place, one institution, and we're talking about the AEC dealing with institutions all across the country. DR. RUSSELL: That's like saying that Walter Reed was doing a good job, which it may very well have, but what's going on in a small institution, where everybody knows everybody else and works together, is totally different than a huge bureaucracy like the Department of Defense. DR. GLATSTEIN: In Bethesda you can find out where your obstacle is -- usually. (Laughter.) There's no way you're going to find out where the obstacle is in the Department of Defense. They thrive on anonymity. (Laughter.) DR. KATZ: Do we know how successfully these regulations have been applied? Do we have any -- DR. HARKNESS: At the clinical center? DR. KATZ: At the clinical center, or are you just looking at the internal documents -- DR. HARKNESS: Well, some internal documents and also the interview with Irving Ladimer, who was chiefly responsible for developing the policies and had a large level of responsibility to insure their implementation. DR. KATZ: And his chief didn't know anything about really much of what Ladimer was doing, which was the second interview. What was his name? DR. HARKNESS: Charles Kidd. DR. KATZ: Charles Kidd was unaware, you know, of Ladimer's work under him. DR. HARKNESS: Right. DR. KATZ: He liked him, but he said in his interview that he didn't even know much about what Ladimer was doing. DR. HARKNESS: Right. I -- I hesitate to say this on the record, but I (laughter) -- I don't -- CHAIRPERSON FADEN: Don't say it. DR. HARKNESS: Okay. CHAIRPERSON FADEN: Don't say it. DR. HARKNESS: All right. CHAIRPERSON FADEN: Well, we'll pursue this later. Let me just point out that it happens, in the order of things, Jay, you have the floor and Ken has it after you. So if you want to make your observation, you've got it. DR. KATZ: Yes, I've tried to be as -- yes, I've had to be as brief as possible; I'm sure I'll talk more about it in the future. As I was reading this document, as I finished the document and made all my marks on the side, the first thing that occurred to me was, gee, in the light of all the work that you have done, why didn't you feel completely satisfied with what Allen Buchanan set forth in passionate language, et cetera, because in some many ways it resonates with all that I've done over the decades, but I have problems. First of all, I think this is dealing not just with one proposal. You made very many different suggestions here and there where one could really focus on this, that, and the other thing. And you really need a rich document but from which we can still select and say we want to emphasize this or we want to emphasize that, and that must be stated at the outset. One more preliminary remark and then one other remark -- an interview must be needed -- I think we must appreciate that, first of all, the whole notion of human rights is used in a very interesting fashion. Human rights, indeed, for you go back to the beginning of time. It's almost that they were always there, even in the Middle Ages. You know, when some scholars talk about human rights being a development of the 18th century or somewhere around there, after divine rights and rights of kings, we developed the idea of natural rights and then, finally, human rights, and human rights is a relatively recent development. And I only mention that in passing. It's to me unimportant because we have to realize that really until the mid- 20th century the medical profession really still lived in a feudal system. They knew nothing about the idea of that human beings have rights, the issue that there is such a thing as autonomy and that patients have a right to autonomy was unknown to the medical profession. That's sort of a new idea beginning to percolate with the promulgation of the doctrine of informed consent. So medicine finds itself in an entirely different position with respect to the issue of human rights, and this was, then, translated also from therapy to research. But without really connecting all this, I want to ask you really just one question. If we follow you, where do we go, government culpability, individual government officials' culpability, the medical profession's culpability, individual physician's culpability? Not so much that they did terrible things -- I have no questions about it, that they must say this -- but how are we going to write about it? I think with respect to the way the medical profession has conducted research almost from the beginning of the age of medical science in many ways has been abominable. The research in the 19th century on pregnant women, children, prostitutes, syphilitics, you name it -- in the 20th century, take many studies, but really take the syphilis study. It was really the syphilis study that got the process really going with respect to regulation, new regulations, outwardly going with respect to the regulations of human research in 1974. We were -- it's not really -- the issue of the culpability for radiation experiments has to be put in the context of the culpability of the medical profession for research almost in general and again and again and again. How do we think we ought to put the radiation experiments in the context of human research as it had been conducted until the late 20th century? DR. BUCHANAN: Well, I hope the Committee doesn't have to respond to the whole history of research involving -- DR. KATZ: We know we won't, but -- DR. BUCHANAN: -- human subjects. I guess I have in mind something fairly simple, and that is, if one believes that it's part of the hippocratic tradition that physicians are not to harm their patients without the prospect of a balance of benefit, and, generally, that physicians are to be advocates for the interests of their patients and protectors of them, then isn't there something very wrong and disturbing about physicians using the authority which they have in their roles as the physicians of this or that patient to subject patients to nontherapeutic and risky experiments? And isn't this in some way something that we should be very disturbed about because it seems to be something that goes contrary to a constituent duty of the medical profession, as a medical profession? Now if that occurred, it seems to me that's worth saying something about. Whether it's occurred many times in other contexts of experimentation outside radiation or whether it's still occurring is another matter. Let me just -- DR. KATZ: You would be able to leave that alone? You think we can write about it and not put it in a more general kind of context? DR. BUCHANAN: I think there can be remarks about it being a mistake to assume that, if these things occurred, they only occurred in radiation, but that it's not the task of the Committee to look into this, and that, as complex as the evidentiary issues are with respect to radiation experiments, they're even more complex when we get into a wide range of other kinds of activities, and that it would not be appropriate for the Committee to make any judgments about that. Sorry, Ruth. Go ahead. CHAIRPERSON FADEN: We have a long list here. So we're trying to get it right on point. Jay, did you -- DR. KATZ: Okay, thank you. CHAIRPERSON FADEN: I've got Ken, Pat, and Ruth. Ken? DR. FEINBERG: One possible solution to this issue is to recognize that telling the whole story acts as a deterrent. I mean, people can draw their own conclusions about Charles Wilson without us labeling Charles Wilson morally blameworthy or not morally blameworthy, insofar as our Committee report brings sunlight to the story and lays out, almost as a disinfectant, what happened. DR. KATZ: I know, Justice Brandeis. (Laughter.) DR. FEINBERG: Justice Brandeis. Sunlight is the best disinfectant. Insofar as the story is told and people can draw their own conclusions, I suspect there's a certain deterrent impact there. The second point is, to pick up on your question, Allen, I have much less trouble trying to detail or delineate responsibility prospectively where the ex post facto problem is avoided and the evidentiary problems are absent than I do, as Phil points out and Henry points out, talking about history. I mean, when you develop prospective guidelines that put everybody on notice and sanctions as to how this should be done in the future, I'm perfectly willing to try and build into our report some degree of Phil's predictability in advance by sort of requiring what we expect in the future, and that may be the way to deal with the past and deal with the future, one suggestion. DR. BUCHANAN: Can I respond to that briefly? CHAIRPERSON FADEN: Yes. DR. BUCHANAN: I think there are two -- well, if you're concerned about deterrence and about effective deterrence, there are two main strategies. One is to make judgments of culpability about past agents or groups of agents and their role capacities, but there are these problems, these severe problems of evidence about that, and the kinds of problems of sort of where things went awry in the chain of command; who was an obstacle; who wasn't. Did Charles Wilson do his best, but he was thwarted by powers beyond his control? There's that problem. The other strategy is, as you said, not just to lay out regulations for the future and assign sanctions for us or designate bodies who will develop sanctions, but to make it clear that beyond those specific recommendations there are some general duties to be articulated; namely, that people who are in the highest positions of authority in organizations have a responsibility to provide a structure for accountability; that is, to make it possible for assigned risk of accountability to be made, not to leave things in such a mysterious soup that it's hard to know where things go awry, hard to know who's responsible for it. Those kinds of duties for structuring an organization to make it accountable are extremely important. Now there's a compromise between these two quite different strategies, and that is to emphasize mainly the prospective approach, but to say that, though the evidence is not conclusive, there is some reason to believe that some of the people in positions of authority in these organizations did not take seriously enough the task of providing accountable structures, of making sure that there was a chain of command in which there was accountability, and that they did well by articulating a policy, but may have fallen short by going to the next step. Those are all possibilities which the Committee should consider, I think. CHAIRPERSON FADEN: Can I introduce one more, and then I want Dan to comment on this. That is, however this ends up, insofar as we end up -- and I'm not sure how this is going to end up -- refraining from making judgments about whether individual officials, primarily talking about government officials, failed in their duty, we could remember that one option, to follow the line of the argument that you put out, Allen, is we could say they failed in their duty, but we don't know how culpable they were for that because we don't know exactly what was going on. Somebody failed in their duty. I think what we need to do to get around this faceless, nameless, "it's just the government," is to point out that we recognize as a committee that there were really human beings that stood behind these policies, real government officials. Evidentiary problems, the passage of time, make it impossible for us to really fix in some cases exactly who was responsible for what, but that there were people responsible who failed to do their duty and who ultimately can be held accountable, if we could ever go back in time, is clear, and that we can -- that's the message for the future. We can't figure it out now in some cases because life is just too complicated 50 years later and the paper trail isn't preserved and we don't have 60 years to dig this up. DR. BUCHANAN: I think that makes really good sense and it avoids this thing of acting as if institutions aren't constituted by people. That's what we want -- CHAIRPERSON FADEN: We have to say that. DR. BUCHANAN: We've got to say that very clearly. CHAIRPERSON FADEN: There were real people; we just don't know exactly who the people were -- DR. BUCHANAN: Yes. CHAIRPERSON FADEN: -- and how the responsibility was parceled up. Somebody screwed up. DR. BUCHANAN: Right. And we've got to make it clear -- CHAIRPERSON FADEN: That's really the message here. DR. BUCHANAN: In the forward-looking recommendations, we've got to make it clear that it will not be an adequate defense in the future to say, "Oh, well, the chain of command wasn't clear." CHAIRPERSON FADEN: Right. DR. BUCHANAN: "Oh, well, we don't really know where the obstacles were." If all of that's done, then I think there's much less of a case for making judgments of individual culpability about past agents, and the evidentiary problem may be completely -- may sway the balance here and lead us to say that we shouldn't make those judgments. CHAIRPERSON FADEN: Dan once again, and then Pat and Ruth have been waiting very patiently. MR. GUTTMAN: I'm going to make an important request question and an important observation. It sounds like part of this discussion is what we call internally "the no good deed goes unpunished" problem. We've seen it again and again. (Laughter.) You know, if you hold the DOD responsible, what about the -- you know. Can the ethicists -- can we -- can I direct the ethicists on the staff to give a brief capitulation, recapitulation, of the -- you know, how do you deal with that problem? That's one kind of -- does that mean you just walk away from it? That's just one question. It's a question. You know, how do you deal when that raises its head; right? What's the risk, the moral risk, on both sides of that one? The other thing is just an observation. In the report that we outlined, that we drafted last time and is in the book this time, the conclusionary section, Section 3, before the final conclusions, lays out four ways of looking at the information, evidence, stuff that we have prospectively, and I guess retrospectively. I think what you're talking about now is in that. There are four ways and Allen is focusing on institutional structures as a prospective one. In the future you've got to have institutional structures to assure that we can look backward. The other three ways that we -- so we put this all in one package. The secrecy/openness -- it's Ken's sunlight is the best disinfectant. Well, one thing you could say is, forget structures; you're never going to be organized in bureaucracies and everything's open. Well, the problem with that is it isn't. So that's secrecy/openness, institutional. The third way that's obvious is ethical training. Well, we can't trust the institutions because it's still going to be a screwy bureaucracy. So let's make clear that if you're a doctor, you've got the following ethical obligations and you're going to go to jail if you don't. Well, the problem with that is they're limited, they're complex, blah, blah, blah. Then you get to the fourth thing, which is the story- telling. The best that you can do is the public understanding of how complex this is. So all I'm saying is an observation, is that it looks like we're beginning to focus on the future as well as the past. There are kind of four parallel iterative, interactive ways that you can tell the public we've seen all these things in the past, but it isn't like you just pass a law. Maybe you can add other ways. What we put in the final report as a set of placeholders is the balance between secrecy and openness, institutional structures, put it on the individual, and the best we can do is the public should learn these stories, so that they can keep the government and the professions honest. I just wanted to capsule it. CHAIRPERSON FADEN: Pat and then Ruth. MS. KING: I've got to say I don't even know if I should talk now. This has been one of the most confusing conversations. (Laughter.) Oh, it has been. There's been a lot of mixing of apples and oranges, I think. So that I'm not sure I even know what the issues are anymore. I think I started with the view that we were having a discussion on whether it would be possible to find individual accountability, but that sort of roamed broadly. And I think that certain things got all mixed up. I think it's very different to talk about bureaucracy versus profession, to talk about structure, and I think, by the way, we should talk about them and we should talk about them separately. There is -- to the history, to professions -- and I have a profession -- there is a long sociology, a long history, a long emphasis on individual accountability in relationship to particular others. There is also -- and this is the way we think about it -- an enormous amount of leeway we have historically been given -- been willing to give to professionals for certain reasons, and we expect them to respond with certain kinds of judgments. I'm not yet willing to say that that is our view of bureaucracies. In fact, I would daresay that a bureaucracy sort of runs counter to some of the things that I associate with professions. In bureaucracies one is encouraged not to use one's individual judgment. One is, in fact, socialized to be a team player. I mean, I could go through the whole lot of differences. So I think that, one, when you talk about -- when we talk about individual accountabilities, we have to separate out when we're talking about roles, when we are talking about trying to draw accountability issues out of the roles that you play, and the way society sees your roles, and I'm much more comfortable, quite frankly, on the professional side than I am so far with what we have said about the bureaucracy side. That is not because I'm unwilling to find individuals accountable in a bureaucracy. It is simply because I haven't yet heard an articulation about the individual's role in a bureaucracy that has yet convinced me that that's the direction in which we should go. It may be that being in a bureaucracy is only one thing I should take account of. It may be that, in thinking about individual culpability, I have to think about roles in a bureaucracy; I have to think about what harms eventuated, what happened to people, what type of harm, the extent of harm. Maybe I have to think about the distance between the bureaucracy and the actual person harmed because we are talking about long chains. Maybe there is a range of factors that even I can't sort of think about yet, that I don't know how to think about, that would be helpful in trying to -- for me to determine whether you get some individual accountability out of this. And I say this deliberately -- this is so far without a name attached to anything, just in terms of how we articulate that it is -- it's not enough to say that governments are not faceless; governments are composed of people, and it is people in governments that make a decision. Yes, you could say that, but unless we say something more -- and I don't know quite how to say it -- we haven't said very much. What we want to do for the future is to have a way of thinking about individuals in bureaucracies that warrants placing -- making them individually accountable. I happen to think that that's very important, and I understood what Jay's remark was. I mean, what came out of Nuremberg for me in the Nazis period, and even true in what some of the Japanese did in World War II, is how easy it was for us in Vietnam, was to hide behind a bureaucracy for actions that we took in ways that minimized individual responsibility all along the line. That needs to be reversed. I don't think that any of us have heard anybody yet with a problem about that, but pointing at a name is not what our problem is. Our problem is how we develop something parallel to something I think I could probably articulate with professionals. So maybe it might be useful if we had spent during this meeting to talk about why it is -- am I right that some of us also have the same resonance with us as the difference between professionals and bureaucracies, why it is that with professionals we would approach the question of individual accountability a far easier way? I think that's absolutely right. Figure out why that is so. What are the features of the doctors who actually conducted the research that might lead us, if we had enough evidence, to condemn them really quickly and find them culpable, and why is it that we sort of go, "Oooh" when we talk about Charles Wilson? I don't think it's because Charles Wilson was the Secretary of Defense. I think it's because we don't know how yet to think about what it means to be Secretary of Defense and what we think those responsibilities and obligations and duties are, so that we're willing prospectively, as well as retrospectively, to say you were blameworthy in some way. That, to me, is what's been missing from the discussion, those elements, those factors. What guidance do I give? Because if I can give guidance, then I can look back and tell you whether there are some people for whom I have enough evidence to say we don't want this to happen again, and this is what so and so did. DR. KATZ: Could I ask Pat a question? CHAIRPERSON FADEN: Ask Pat a question, and then Ruth probably -- DR. KATZ: Just a question and that's it. Maybe she can elucidate something for me. I'm not sure about both it's easy to say something about professional accountability because we do know from the sociology of the profession that professionals only really hold themselves in a certain sense accountable to their own professional norms. And these professional norms, as we see in informed consent, for example -- that's just one example -- may not comport with societal norms. How do we deal with that issue? MS. KING: When I said before let us start with the professional side and figure out what it is, one of the issues for a person like myself who's outside of the medical profession, but well within the legal profession is that the issue of the professions having to conform to society's expectations because society has given us permission to be professionals and given us certain freedoms and certain privileges, I think is a hard question, but I know how I come out on that question. That is, that as a professional, I don't think I look to my peers for my accountability. Now this may make us -- this is the issue when you talk about professional sociology. I think professionals are accountable to the people who permitted them to operate in a certain fashion, and that means they're accountable to all of us, and I am, too. DR. KATZ: That's quite an interesting notion. MS. KING: Well, it's been around, by the way. It's not -- I know that when the sociologists who write about the profession of science and profession of medicine take a different -- will make different arguments, but I don't think that what I've just suggested is far off in terms of thinking about professionals, but it's easier -- I'll go back to my earlier point -- it is easier to talk about individual accountability, whether we like it or don't like it, in the context of the profession, because we have a longer history to work with and we know what we're talking about, than it is to talk about it, yes, with respect to bureaucracies. That's the great, unexplored area, and all the literature on whistleblowing is testimony to how difficult it is for us yet to deal with the bureaucracy, but I want to get to it because I'm interested in this, because I want to get back to this. It may be that it is the whistleblowing literature -- the President's Commission did, in fact, do a volume of whistleblowing and ethics. God knows I have forgotten what it says or what was in it, but it may be that that's where we can get some start on thinking about a bureaucracy and holding people accountable that actually may be very useful prospectively. CHAIRPERSON FADEN: Very interesting point. DR. BUCHANAN: Pat, actually, I wrote something on this that I deleted from the paper because the paper was already monstrously long. CHAIRPERSON FADEN: Don't worry about that. Never worry about that. DR. BUCHANAN: All right. Well -- MS. KING: Maybe we'll have to put it back in. CHAIRPERSON FADEN: Let me just point out as a -- whatever matter; I don't even know what the right descriptor is -- that we have lots of flexibility with the agenda tomorrow. So I would like it if Ruth could make her comment and we'd have a discussion of it, if anybody would want to respond, and then we'll need to end because it's going to close the day, but we will continue this discussion tomorrow. We'll continue with it where we, more or less, left off. I took it that most of the discussion today, although Duncan was right to point out that the agenda was broader, most of the discussion seemed to focus on the question of accountability or culpability in the context of the bureaucracy. We have not talked much about the profession as a profession or of individual professionals and how we want to think about that. We can continue with this discussion tomorrow, but, Ruth, you have been waiting most patiently. So we'll have the discussion of whatever point you want to bring up. It will be the last thing we do today. DR. MACKLIN: Well, I certainly can't begin to answer Pat's questions about bureaucracy. So I will be silent. What I wanted to do, if it is at all useful, is come back to Allen's paper and to this whole discussion and pose a question for the Committee just to think about with the retrospective moral judgments. Allen made very persuasive arguments about the cogency of retrospective judgments, ethical judgments in general and with respect to individuals. I didn't hear anybody question the cogency or question the argument that it is meaningful and appropriate to make retrospective judgments of individuals in bureaucracies, in professions, or anywhere. Allen also made the strong point, which some people seemed at times to forget, that lack of evidence about -- I mean, I took Allen's paper and his conclusions to be conditional or hypothetical in nature. If we have the relevant evidence -- and that evidence may not exist, he said again and again -- then we can make these judgments. So he made two strong points: the appropriateness of the cogency and the appropriateness given the evidence. Now what I want to ask the Committee, in all of this discussion, which maybe was a little clearer to me than it was to Pat, although I don't know the answer to the bureaucracy question, is: does anyone have any objective to the principles that Allen articulated and to the argument? I heard the following things: well, there's lack of evidence all over the place. Who knows who did what? Other arguments: it's a possibility of wrongful assignment of culpability. That was Henry's point. Well, I want to know whether that says anything more than it's important not to make wrongful assignments of culpability, but does it say anything more than we may not have enough evidence or we may be using the wrong evidence? We heard someone say -- I forget who -- we have to look not only at who did what, but who failed to do what; that is, Wilson may have stated this, sent his memo around, but who failed to implement it? That's also lack of evidence. We don't know who failed to do what. Then we heard and had a long discussion about the complexity and uncertainty of bureaucratic structures making it unclear who should be held responsible. Now, in part, that's the problem Pat just laid out for us and that goes beyond the evidence because it requires us to know, whatever the evidence, where does the buck stop. All right. But we did hear one rejection. I think it was Phil who rejected one possible solution, which is the blame-the-commander solution; right? (Laughter.) And I didn't hear anyone say, in response to what I heard Phil reject, well, some people do it that way; blame the commander, whoever else did what, and I didn't hear anybody say, well, wait a minute, maybe we ought to be blaming the commander. So there is one solution even when you don't have the evidence, and that is blame the commander, but no one seemed to be opting for that. So, in sum, what I want to ask is: are there any objections other than the objection that we don't have, might not have, or will never have adequate evidence to assign culpability to individuals? And that I think will take us some way down the path of saying under what circumstances and what is this Committee's conclusion about assigning responsibility. DR. KATZ: What's the question? You haven't asked any question yet. DR. MACKLIN: I'll ask it again. (Laughter.) No, the question is: is there, among all the things we heard in this discussion, is there any reason for not assigning blame or culpability, any reason other than we don't have the evidence? DR. KATZ: The wisdom of it, I would say. DR. MACKLIN: Ah, but that's a different -- now then you have to articulate what would be needed by way of wisdom; that is -- DR. KATZ: I was wrong. (Laughter.) DR. MACKLIN: Well, we could do it tomorrow. I'm just posing the question. I'm just posting the question because I didn't hear in the discussion any consideration that did not reduce to the issue we lack the evidence. MS. KING: Ruth, I think -- CHAIRPERSON FADEN: Phil wants -- Pat and Phil -- MS. KING: -- I am not yet ready to commit in principle, and, in part, I'm not yet ready to commit in principle because I'm still working through retrospective judgment. But even with my distaste for doing a lot of things in principle, I want to see an incident in which I'm willing to do it and then I can figure out why, and then I'll know my principle, and I haven't seen an incident for individual retrospective, which is what we're talking about -- CHAIRPERSON FADEN: As opposed to government? MS. KING: -- as opposed to government, where, actually, we began to have evidence, and that was what was making the voting I think a lot easier than asking the question in principle, because the evidence in part went around your in principle question. The evidence suggested it was not retrospective. CHAIRPERSON FADEN: The judgment? MS. KING: The judgment is not retrospective. So that has clouded the issue. So the fact that I was able to find government blameworthiness does not have to rest on making what I term, still understand to be, retrospective judgment, which is by the standards of today. I don't think that's what we did. I think we did it by the standards at the time. At least that's what I think I did. Now with respect to individual accountability, I think I know all the reasons why it is important to do it if it can be done. I am still doubtful -- what I'm saying is that I think maybe in the professional arena -- and that's why I want to talk about it, and I'm struggling hard with the bureaucracy because until I can even understand what the standards are that we would judge a bureaucracy by today, I'm surely having a hard time in principle doing it retrospectively. So, for me, your question triggers not an in principle problem, but a methodology. I don't work that way. I work the other way, and I haven't worked it through the other way. Maybe I'll get there. CHAIRPERSON FADEN: Phil? DR. RUSSELL: I think the -- in answer to Ruth's question, the one thing that I would be concerned about is the -- not just the lack of evidence, but the wisdom to understand the context and the mitigating circumstances. That, I think, is very much a concern. The Korean War was going on during part of this exercise, and the issues of national security were uppermost in many people's minds, and the -- so it's fairly hard to be very judgmental about very high-level officials for something that, although now looms of great importance, at the time was very much of a sidebar to their principal concern. So I think the combination of Jay's "do we have the wisdom" and understanding the mitigating aspects of the circumstances at the time are going to be difficult problems. CHAIRPERSON FADEN: Ken? DR. FEINBERG: With the caveat that wisdom goes to the quality of the evidence (laughter), I would say that it is purely evidentiary in my opinion. In my personal view, if the evidence is there, I'd be willing to allocate responsibility. I don't think the evidence is there, and I also can be convinced that I think probably professionally the evidence isn't there either. I'm talking like a lawyer. The passage of time and the inability to gather that evidence, and the inability of those individuals who have long since deceased or disappeared, or they're not around, to defend themselves bothers me. So I really do think that it is a practical problem of allocating individual blame to bureaucrats or professionals that leads me to presume in my mind that it's purely an evidentiary problem in allocating individual culpability. CHAIRPERSON FADEN: Jay? DR. KATZ: Well, just in the aspect of the wisdom issue -- and we may want to discuss it more through tomorrow -- there is a whole body of evil literature emerging. It deals more with issues of punishment. Should the East German war criminals be punished? The Argentinean situation, should they be punished? Should we really look to the past rather than to the future and to bring about a healing and understanding -- healing process and also say you -- we will make it very, very difficult and we'll try as hard as we can that this can -- that this will not happen again and not spend a lot of time putting it in our context of debating: do we have the evidence? Do we not have the evidence? Is this -- how culpable is this? How culpable is that? What we say, as you said earlier, among other things, we've learned from the past. We learn from the present. We look to the future. From now on, we will hold you to standards that you've never been held before, and if you seriously deviate from them, whether you are a physician investigator or not, sanctions may be imposed; you'd better know that. CHAIRPERSON FADEN: Allen, did you want to -- DR. BUCHANAN: Yes, I just wanted to suggest that, especially since this last version of the paper is so long, that if people haven't had a chance to look at it or to review, they might particularly want to review the difference between the treatments of basis for judgments of culpability for bureaucrats and for the profession, okay, because I do think those -- I agree with Pat those are different. What I'll try my best to do tonight, if I can get it printed off and copied for you by the morning, is to give you a summary of the section that I did on bureaucracy that I didn't include in this, and it will be -- I promise it will be short. It will be a page or two at most. (Laughter.) And, I guess, my suggestion is that in some ways I generally agree with Mr. Feinberg, but I think that in some ways it's going to be easier to make judgments about professional culpability of the collective of the profession than it is for any judgments about bureaucrats. DR. FEINBERG: Well, what does that mean, "collectively?" DR. BUCHANAN: No, the medical profession, I think the medical profession puts itself forward as having certain constituent obligations and one of them is to engage in self- regulatory behavior, to formulate and to do something to insure the compliance with its own standards. It may be easier to make a judgment like that than it is to make a judgment about whether Charlie Wilson did something or not. I just raise that question. I just raise that question. DR. FEINBERG: I agree with you 100 percent. CHAIRPERSON FADEN: Part of the confusion is the confusion on the collective rather than the individual. That's part, I mean quite apart from whatever future developments there are to be by the nature of the profession -- DR. BUCHANAN: Right. Exactly. CHAIRPERSON FADEN: The fact is you're talking about a directive in that instance. DR. BUCHANAN: Yes. CHAIRPERSON FADEN: All of the Department of Defense. It might have been Charles Wilson or Dr. Johnny Smith. DR. BUCHANAN: Yes. CHAIRPERSON FADEN: And that makes it -- DR. BUCHANAN: Just one other briefing, in this whole long paper I don't anywhere talk about even a prima facie case for judgments of culpability about individual researchers. I just think the evidentiary mess there is far too great. At most, I suggested that a case might be made for the leadership of an agency or for the profession as a collectivity, but I am aware of the problems of evidence. The further you get down the chain of command, I think the more difficult it is, but I'll address something about that in this thing that I'm going to be doing tonight after the Mark Russell performance and circulate tomorrow morning. (Laughter.) CHAIRPERSON FADEN: With that, we're going to adjourn. I'd remind everyone that we'll start at eight o'clock tomorrow morning, not at nine o'clock. The agenda is now different. (Whereupon, at 5:15 p.m., the proceedings adjourned to reconvene the following day, Tuesday, January 17, 1995, at 8:00 a.m.)