ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + PUBLIC MEETING + + + + THURSDAY, MAY 19, 1994 + + + + The advisory committee met in the Washington Room at the Ramada Plaza Hotel, 10 Thomas Circle, N.W., Washington, D.C. at 9:00 a.m., RUTH FADEN, Chair, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H., Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. SUSAN E. LEDERER, Ph.D. RUTH MACKLIN, Ph.D. LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. HENRY D. ROYAL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. REED V. TUCKSON, M.D. STAFF: FAITH BULGER, J.D. KRISTIN CROTTY JAMES DAVID, J.D. JERRY GARCIA DAN GUTTMAN, L.L.B. GREGG HERKEN, Ph.D. DEBORAH HOLLAND, M.A. JEFFREY KAHN, Ph.D., M.P.H. LANNY KELLER JEANNE KEPPER STEPHEN KLAIDMAN ANNA MASTROIANNI, J.D. RON NEUMANN, M.D. DAVID SAUMWEBER, M.A. JEREMY SUGARMAN, M.D., M.P.H., M.A. GARY STERN, J.D. DONALD WEIGHTMAN, J.D. GILBERT WHITTEMORE, Ph.D. I-N-D-E-X AGENDA ITEM PAGE NUMBER Opening Remarks 4 Ruth Faden Conflict of Interest Presentation 5 Kathleen Whalen, Assistant Counsel to the President Committee Question and Answer Period 18 Moderator: Ruth Faden Methodological Review of Agency Data 32 Collection Efforts: Department of Energy (Tab G) Staff Presentation: Dan Guttman, Faith Bulger, Jim David, Gregg Herken, Ron Neumann Committee Discussion 61 Moderator: Dan Guttman Methodological Review of Agency Data 121 Collection Efforts: Department of Health and Human Services (Tab H) Staff Presentation: Dan Guttman, Faith Bulger, Jim David, Gil Whittemore Committee Discussion 135 Moderator: Dan Guttman Committee Discussion--Committee/Staff 171 Working Relationships: Subcommittee on Public Outreach (Tab J) and Formation of Other Subcommittees Moderator: Ruth Faden Closing Remarks Ruth Faden P-R-O-C-E-E-D-I-N-G-S (9:03 a.m.) OPENING REMARKS CHAIRPERSON FADEN: I want to welcome everyone to the second day of our second meeting. And we hope that everyone is still able to focus because we have a lot. Nancy smiles. Can we still focus? Is there enough grey matter left that's operational after all the information that we've had to take in? We have a very important sort of busy day to do today, busy set of tasks to do today. So we need everybody to concentrate hard. We're going to begin with a presentation by Kathleen Whalen, who's sitting to my right, who is Assistant Counsel to the President. We've all received, we hope, by now our personalized conflict of interest statements. I guess it's Kathleen's office that's reviewed all of our personal forms and reported to us personally about areas of potential conflict of interest about which we're to be mindful. Kathleen's kind enough to give us some time this morning collectively, not to speak about our personal reports, obviously, but to orient us generally to the conflict of interest considerations that provide an important safeguard and backdrop to a federal advisory committee such as ours. So I'll just give the floor over to Kathleen. And there will be time for questions? You would -- MS. WHALEN: Sure. CHAIRPERSON FADEN: Okay. Great. MS. WHALEN: Thanks. CONFLICT OF INTEREST PRESENTATION MS. WHALEN: I'd like to introduce Drew Peel, who is with me also. Drew, you might want to just -- there we go. All of you should be fairly familiar with Drew. I think he's the one that handled each of your files as we were doing the appointment process. And I want to make sure that now that we're putting faces with names, that you're able to do that as well. What I want to set out for you today are the conflict of interest statutes and regulations that apply to each of you as special government employees. As a member of this committee, you are a special government employee. A special government employee is an individual who provides service to the government for less than 130 days in a 365-day period. That subjects you to certain regulations, certain statutes. And you've been given a little bit of information about that, but what I'd like to do is provide you with a broad overview. As Ruth mentioned, we have sent you memos outlining your particular interests and the potential conflicts that arise from those interests. If you have a question concerning any of those specific affiliations or specific stock holdings or whatever it might be, I would encourage you to call me or to contact Drew. And we can talk about those situations and how you might resolve a situation or if something new comes up, if something comes to light that you weren't aware of previously, please give me a call and we can talk about that or you may want to talk to Dan initially. Dan isn't aware of this yet, but we're going to have a memo for Dan that outlines sort of how to monitor the process to make sure that as issues are presented to the committee, he is aware of who needs to be disqualifying themselves from what. So you may want to use Dan as your contact person if you have a specific concern. There are two basic sources of ethics rules. There are criminal conflict of interest statutes that do extend to special government employees. And then there are standards of conduct regulations. Have the standards of conduct been provided? So you should have received a copy, and I see you have yours, a copy of the standards of conduct regulations that govern your conduct as a special government employee. And you also should have received with our memorandum a more general memo that talked about special government employees, individuals who serve in part-time positions. So those are the basic resources. The basic conflict of interest statute that applies is that which prohibits you from participating in a manner that will have a direct and predictable effect on your financial interests. Your financial interests include those of a spouse, a minor child, a general partner if you happen to be a partner in a partnership, an organization that you may be a director or officer of. So those are the financial interests that are attributable to. So if your spouse is employed and they have some sort of ownership interest in the entity with which they're employed, that would be a financial interest for you. If your dependent child has a stock holding, that would be a financial interest that's attributed to you. If one of those entities has a matter before you, if you have a stock holding in something that is presented to the committee for action or it was a company involved in some of the experiments, then that's where you need to immediately disqualify yourself. And then we will look at other options that may exist. It may be that you can get a waiver if the interest is insubstantial or if we make a determination that the need for your participation outweighs any potential conflict. So don't automatically assume that a conflicting financial interest rules you out from substantial participation. There may be a way around that. You should talk to me if you have a question about that. And we can work that out. But the immediate remedy is disqualifying yourself until we can pursue other remedies. In addition to actual conflicts, financial conflicts that are presented by stock holding or by outside employment or what have you, there is an appearance standard. And that's in the standards of conduct regulations. And that goes either to individuals with whom you have what the standards call a covered relationship, and that would be a member of your household or it would be a close relative or a former employer within the last year of leaving that employer. So that if you find yourself in a situation where one of those individuals or entities with which you have a covered relationship is a party to a matter, it's a specific party matter, then you need to disqualify yourself until we authorize your participation. And you would need to contact me to get that authorization. This does not go to past affiliations that are more than a year in the past. I think that in talking with Ruth previously, there is some concern about previous affiliations and collaboration and what have you. The statutes and the standards of conduct do not directly address those situations. By the nature of the committee, I think there are going to be situations where there may be an appearance created because of a past affiliation. That's a situation where I think we need to look at it and specifically look at the actual facts and make a determination as to what type of affiliation it was, how long ago it was, whether there's any continuing relationship. There are a number of factors that I think would go into an assessment as to whether a current conflict or appearance of a conflict exists. I think partly the committee doesn't have a clear picture of everything that will come before it. So I think we're going to evolve. And we will address these issues as they come up. So as you have questions about past affiliations or past participation in different experiments or participation in different research projects, you may want to get in touch with Dan or get in touch with me. Going back to the conflict statutes, there are a couple of statutes that prohibit representing somebody before a federal agency or court while somebody is an employee. With regard to special government employees, that goes to matters that are before your agency. For purposes of the reading, it would be matters that are before the committee. You would not be able to represent somebody or represent their interests before the committee. I think it's probably unlikely that you would be put in that situation. But just so that you know that, there is a statute that prohibits you from doing that. There are some post-employment restrictions that apply. So that when you have concluded your work on the committee, the likelihood of them actually coming into play is slim, but what you would be prohibited from doing is representing somebody with regard to the particular matters that you have dealt with on the committee. So it's a very narrow restriction. It goes to your personal and substantial participation in a particular matter, but it's a permanent bar. So you would not be able to participate in that same particular matter. Because what the committee will be doing has a finite term, it will cease, I doubt that there is going to be any participation in the same particular matter once you have terminated as a committee member. But if you have any questions and maybe toward the end of the committee, we'll meet again. And we can talk more specifically about the post-employment, sort of a strange term, the post-service restrictions. And we can go into that in a little more depth at that point. I don't want you to worry about that now just as you're getting started. There are a few other rules that are in the standards of conduct regulations. There are rules against accepting certain gifts. For you all, it would largely be gifts that are given because of your official positions. If somebody extended a gift to you because you were on the committee, you would be prohibited from accepting that gift unless it was $20 or less in value unless it was given by a personal friend and it's clear that the reason was because of the personal friendship. You can accept invitations to what we call widely attended gatherings. If you're here for a meeting and there's a reception that is sponsored by some outside organization in the evening, you can accept an invitation to attend that provided the invitation comes from the actual sponsor of the event and not, say, some company that's bought a table or something like that. That's one of the most frequent situations that we see sort of in the Executive Branch, invitations to events. If it comes from whoever is sponsoring the event, the Office of Government Ethics, who put out these regulations, has decided that that's acceptable. That doesn't have quite the appearance that an invitation from, say, -- I don't know -- Phillips Petroleum or somebody who purchased an actual table. And then wants to sort of buy your access is essentially what it is. The other type of source of a gift would be what they call a prohibited source, somebody who has business before or has an interest that can be affected by your action as a committee. So those are sort of -- you need to be careful of people who are giving gifts because of your official position or, sort of closely linked, people who have an interest that could be affected by the work you're doing. A couple other restrictions. And I don't know how much this will actually happen with the committee. It may happen more sort of with the staff, but use of government resources. Does the committee have letterhead or -- yes. You should not use that letterhead for personal purposes. You may use it for letters of recommendation for people that you've worked with on the committee who are seeking a federal position, but otherwise it should just be for official communications and not used in your personal capacity. A lot of these are very intuitive, very straightforward, but I want to make sure that they're out there. Also you don't want to use your title to convey an official position of the committee unless you are actually charged with or have the responsibility for communicating that information on behalf of the committee. So you want to be careful that your title is not being used for purposes other than committee business. One other thing is there are some restrictions on political activities. The Hatch Act is a law that prohibits certain political activities by government employees. It does include special government employees, but it only includes special government employees on the days that they are serving as government employees. So on those days you have a few restrictions with regard to political activity. Basically, you cannot solicit campaign contributions from the public on those days. You cannot use your official position to influence colleagues and to influence election outcomes. So you can't try to influence a colleague to vote a particular way or what have you. You shouldn't wear political campaign buttons while in government buildings -- this for this purpose is considered a government location during this meeting -- or while you're on government duty. And you should not use political recommendations in hiring and promotion decisions if you are in a position to do so. However, on those days you can actively run for office, you can participate in political management, you can solicit contributions to an employee PAC. I doubt that any of you are in such an organization, but if you would be, you can do that. You can certainly vote if there should be an election on the day of your meeting, you can sign a petition, express your personal political views, and you can make contributions. So just so that you're aware of those restrictions that do extend to you. That's really it in the way of a formal presentation. One thing that I should point out that I think was in the memo: If any of you, for any reason, are registered under the Foreign Agent Registration Act, you need to de-register. So if any of you find yourself in that situation, please see me. That is, there is a rule that prohibits a government employee from being registered as a foreign agent. And we want to make sure that that has been communicated to everybody. Are there any questions? COMMITTEE QUESTION AND ANSWER PERIOD MR. GUTTMAN: Are these the Clinton administration's streamlined rules or are these the old ones? MS. WHALEN: The standards of conduct regulations were promulgated pursuant to a Bush executive order, but they were not effective until February 3rd, 1993. So they sort of have the appearance of being a Clinton administration policy or a change. This is the first time that they are Executive Branch-wide. Previously each agency had its own standards of conduct regulations. So I'm not sure what you would have been under had you come into existence prior to February 3rd of '93. MS. KING: I have a question which would save me a phone call. There's a footnote on my form, but it may be generally applicable and I don't mind talking about that says that to the extent that IOM, the Institute of Medicine, is an arm of the National Institutes of Health, that I don't have to disqualify myself. I couldn't for the life of me figure out how the Institute of Medicine might be an arm of the National Institutes of Health. MS. WHALEN: Okay. I think we were -- MS. KING: I'm sure it must affect a lot of people because the same thing would be the National Academy of Sciences. And it was a most extraordinary statement I read because it's an independent organization completely, but it does have contracts with the National Institutes of Health as an organization to do studies. And it does studies for the Congress, sometimes pursuant to legislation. But it's a footnote, and it's the strangest footnote in the world. I don't know if others have the same footnote, but I did. MS. WHALEN: We may have overlooked the others. We didn't mean to not give you a footnote if we had one on yours, but I think that we tried to put these together to get the information out to you as quickly as possible without doing a lot of calling on individuals and finding out about the various organizations. I think it was more to say we're unaware of a connection, but if there is, this is how it would apply. So you can -- MS. KING: Well, it would apply to lots of people here. That's why I raised it because there are lots of members of the Academy or the Institute of Medicine that happen to be on this committee. MS. WHALEN: Right. And ordinarily membership in an organization or membership in a committee is not going to present a particular problem. However, if you hold an officer position or you are in some sort of fiduciary role with an organization, that's when it is more likely to present a conflict and we need to look at that. But just active participation is not as much of a concern. It is expected that there will be a large number of affiliations with professional societies, professional associations, and what have you. And that in and of itself does not present a conflict. I think that each of you was selected because of your particular expertise, your affiliations with certain outside organizations, the experiences that you have had and your knowledge in the subject area. That has to be balanced against those potential conflicts that are presented by affiliations in more of a leadership role. CHAIRPERSON FADEN: Ruth, I think. I saw Ruth and then Duncan. DR. MACKLIN: Actually, my question was answered. It was a question about how one organization of which I'm a member was picked and none of the others when I listed all of them, and the answer was given in what you just said since I'm on the executive board of that organization. But it's surely not the organization, of all strange things, that could possibly present the conflict, but the executive board. DR. THOMAS: I think a lot of us are going to have requests for speaking engagements at professional organizations and the like, some of which may, at least indirectly, turn on matters under consideration here. A two-part question. Did the standards have any implications for restrictions on what we might say? And, secondly, are there restrictions if we're offered an honorarium? MS. WHALEN: Okay. That's a great question. There is no restriction -- let me go to your second question first -- on the honorarium. There are restrictions on full-time employees with receipt of honoraria, but special government employees, that does not extend to them. The important thing, I think, with speaking engagements is that you make it clear in what capacity you are speaking. You certainly may include your service on this committee in any biographical information or sort of historically if you need to set the stage. And you should not disclose any non-public information. And I would think that you should be careful about discussing particular deliberations or particular matters that you're currently investigating or currently looking into, but I think that you certainly can speak generally about the committee and about the goals, the focus, what the intent is of the committee and certainly may refer to publicly available information that has been discussed in the meetings and what have you. So any further on that? DR. KATZ: I have a question. I am on the faculty of Yale University, and I learned that that could constitute a conflict of interest, which I find rather intriguing. But I had thought in two or three weeks to talk with people at Yale University who may be doing radiation experimental work at a fundamental level and in the medical context. Can I talk with them and find out what they're doing, even though it's my own university? MS. WHALEN: I need to know a little bit about the committee and its time period. Are current experiments a part of the -- CHAIRPERSON FADEN: Technically we go up to 1994. The focus is through 1974, but we are free to go up to 1994. MS. WHALEN: I think it would probably be better if you didn't if there is -- DR. KATZ: Why? MS. WHALEN: Well, you need to avoid a conflict or an appearance of a conflict. And if an experiment that Yale may be conducting could be a subject of the committee's review, then I don't think that you should be the person. I think there are others on the committee who could certainly talk with Yale and find out about their experiments and the study that they're undertaking, but I don't think that you as a Yale professor. You have an interest in being paid, continuing to be paid by Yale University. And a decision or something that the committee may learn about that, about experiments that Yale may be conducting or may have conducted could impact on your situation there. DR. KATZ: The university's endowment will not decrease by my inquiries. I wonder whether it's possible to think about it, but it would be so useful because I also know some of these people to learn all kinds of things that may be important to our committee work. MR. GUTTMAN: This is obviously a pretty elemental question. Could I suggest that the way this might be done is structuring it so that if we were investigating Yale or particular experiments, that Dr. Katz would be clearly isolated or sanitized or whatever, but that for purposes of freedom of discussion and inquiry, it doesn't seem useful -- I mean, this is for the public -- that Dr. Katz not talk to the people that he can most readily talk to about these things, that we talk about how we can structure it that this is done in a way that the public is -- MS. WHALEN: So that he's not -- MR. GUTTMAN: Dr. Katz I don't think would want to say that he would want to investigate. DR. KATZ: No, no. Right. MR. GUTTMAN: He's talking about just to find out about radiation experiments. DR. KATZ: Yes. MR. GUTTMAN: That's a very different quality of thing. Can we work out the particular rules. MS. WHALEN: Yes. MR. GUTTMAN: This is something that I think requires some degree of precision and refinement, and we want to make sure people can -- DR. KATZ: The investigation will be conducted by somebody with a Harvard degree. MR. GUTTMAN: Which you have as well. (Laughter.) DR. KATZ: True, true, true. on't have to disqualify myself. I couldn't for the life of me figure out how the Institute of Medicine might be an arm of the National Institutes of Health. MS. WHALEN: Okay. I think we were -- MS. KING: I'm sure it must affect a lot of people because the same thing would be the National Academy of Sciences. And it was a most extraordinary statement I read because it's an independent organization completely, but it does have contracts with the National Institutes of Health as an organization to do studies. And it does studies for the Congress, sometimes pursuant to legislation. But it's a footnote, and it's the strangest footnote in the world. I don't know if others have the same footnote, but I did. MS. WHALEN: We may have overlooked the others. We didn't mean to not give you a footnote if we had one on yours, but I think that we tried to put these together to get the information out to you as quickly as possible without doing a lot of calling on individuals and finding out about the various organizations. I think it was more to say we're unaware of a connection, but if there is, this is how it would apply. So you can -- MS. KING: Well, it would apply to lots of people here. That's why I raised it because there are lots of members of the Academy or the Institute of Medicine that happen to be on this committee. MS. WHALEN: Right. And ordinarily membership in an organization or membership in a committee is not going to present a particular problem. However, if you hold an officer position or you are in some sort of fiduciary role with an organization, that's when it is more likely to present a conflict and we need to look at that. But just active participation is not as much of a concern. It is expected that there will be a large number of affiliations with professional societies, professional associations, and what have you. And that in and of itself does not present a conflict. I think that each of you was selected because of your particular expertise, your affiliations with certain outside organizations, the experiences that you have had and your knowledge in the subject area. That has to be balanced against those potential conflicts that are presented by affiliations in more of a leadership role. CHAIRPERSON FADEN: Ruth, I think. I saw Ruth and then Duncan. DR. MACKLIN: Actually, my question was answered. It was a question about how one organization of which I'm a member was picked and none of the others when I listed all of them, and the answer was given in what you just said since I'm on the executive board of that organization. But it's surely not the organization, of all strange things, that could possibly present the conflict, but the executive board. DR. THOMAS: I think a lot of us are going to have requests for speaking engagements at professional organizations and the like, some of which may, at least indirectly, turn on matters under consideration here. A two-part question. Did the standards have any implications for restrictions on what we might say? And, secondly, are there restrictions if we're offered an honorarium? MS. WHALEN: Okay. That's a great question. There is no restriction -- let me go to your second question first -- on the honorarium. There are restrictions on full-time employees with receipt of honoraria, but special government employees, that does not extend to them. The important thing, I think, with speaking engagements is that you make it clear in what capacity you are speaking. You certainly may include your service on this committee in any biographical information or sort of historically if you need to set the stage. And you should not disclose any non-public information. And I would think that you should be careful about discussing particular deliberations or particular matters that you're currently investigating or currently looking into, but I think that you certainly can speak generally about the committee and about the goals, the focus, what the intent is of the committee and certainly may refer to publicly available information that has been discussed in the meetings and what have you. So any further on that? DR. KATZ: I have a question. I am on the faculty of Yale University, and I learned that that could constitute a conflict of interest, which I find rather intriguing. But I had thought in two or three weeks to talk with people at Yale University who may be doing radiation experimental work at a fundamental level and in the medical context. Can I talk with them and find out what they're doing, even though it's my own university? MS. WHALEN: I need to know a little bit about the committee and its time period. Are current experiments a part of the -- CHAIRPERSON FADEN: Technically we go up to 1994. The focus is through 1974, but we are free to go up to 1994. MS. WHALEN: I think it would probably be better if you didn't if there is -- DR. KATZ: Why? MS. WHALEN: Well, you need to avoid a conflict or an appearance of a conflict. And if an experiment that Yale may be conducting could be a subject of the committee's review, then I don't think that you should be the person. I think there are others on the committee who could certainly talk with Yale and find out about their experiments and the study that they're undertaking, but I don't think that you as a Yale professor. You have an interest in being paid, continuing to be paid by Yale University. And a decision or something that the committee may learn about that, about experiments that Yale may be conducting or may have conducted could impact on your situation there. DR. KATZ: The university's endowment will not decrease by my inquiries. 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CHAIRPERSON FADEN: We have agreed as a group that "guys" can be used. MR. GUTTMAN: "Guys" is an adequate collective. CHAIRPERSON FADEN: Yes. MR. GUTTMAN: Five years from now it will be "women." CHAIRPERSON FADEN: "Gals." DR. HERKEN: This morning Glenn gave me the rest of the inventory of the Division of Intelligence files that were given over to the History Office of DOE. And I haven't had a chance to go through them. Actually, they look like they're more current. They're in the '70s and the '80s, and the documents we're interested in would date from the mid '40s. MR. GUTTMAN: Gregg, if you could just comment from your perspective as an historian and Jim and Ron the actual historical importance of what we're doing here in opening these up, you know, whatever they may or may not have about the uranium/plutonium experiment, just the significance? I mean, is this the kind of stuff historians usually get to access or -- DR. HERKEN: No. In fact, the problem historians always have is that the trail leads up to the DOE vault and then stops there. So for historians, in addition to the committee's work, this is just a very exciting prospect. Historians, colleagues of mine, in fact, who have written on the subject for 20 years, are very excited and actually very interested in helping the committee, probably for self-serving reasons because it means fulfillment of a wish they've had for all these years. COMMITTEE DISCUSSION DR. TUCKSON: A quick question on that, Gregg. Help me. I think it's obvious. I just need to understand it better. The way in which historians and others get access to the material that this activity opens up, is it that it opens up the door for anyone to go and access the same information bank that we have or does the material that comes through this committee then become the vehicle and the door through which historians get access to it? DR. HERKEN: Once the committee has freed up the material, then it becomes available completely to the public. So it then joins the database. DR. TUCKSON: Once this committee frees it up? DR. HERKEN: Once this committee; right. Right. DR. TUCKSON: So we are the pathway, as it were? DR. HERKEN: That's what -- CHAIRPERSON FADEN: Right now we are. We -- DR. HERKEN: And if you want to comment on that? CHAIRPERSON FADEN: There are two things operating here. On the one hand, the agencies are and the administration in an active path of declassification. This is an initiative for the whole administration. How quickly or whether the particular documents or collections of documents that we're particularly interested in would actually be addressed in that administration-wide initiative, we have no way of knowing. Because of us, though, I mean, because of us if, in fact, we request particular collections that are currently classified and request that they be declassified, if we are successful in that, then we can at least assure that the material that we receive will as soon as we receive it become available to the public. It might become available to the public a year from now or two years from now as part of this general administration initiative. I guess I'm not making myself clear. We can't know whether or when the particular collections that we might be interested in would be declassified by the administration or whether they ever would. We can try to get declassified -- and once available to us, available to everyone -- the material that bears particularly on our charge. Does that help? DR. TUCKSON: Yes. Let me let Dan. And I'm going to ask some follow-up. MODERATOR GUTTMAN: Let me be more blunt. It's more than a pathway. Yes, we are a pathway, but we are the facilitator. Without Gregg Herken and Jim David sitting in that room with those people, those documents that relate to this highly important classified division of this central Cold War agency, nobody would have asked to even look and find if they existed. In other words, we would have been getting documents, but it wouldn't have been notes. And at the point we are now, this is what's critical to understand. We have lists of documents, but we don't have Jim David and Gregg and, I add, you all, we will be sitting looking through maybe the personnel files, instead of the real documents. So that we're not simply the pathway. We're the -- DR. TUCKSON: Got it. Now, if I'm an author, a writer who's been writing for 20 gazillion years in this field, and I've got a book that I really want to do and I want to get at it quick and I want to scoop my competition in terms of just really getting something out of a particular angle, if they call me and say "Gosh, you know, really, it would be great if I could find out" or you should ask the committee to get X piece of stuff and Gregg goes and he gets it and then he tells me and I read it and I go to a coffee break -- CHAIRPERSON FADEN: And you call your -- DR. TUCKSON: -- and somebody comes back here because it's a committee -- I mean, I don't know. In other words, are there any concerns in this regard? And I guess the other thing I would just want to get a sense of even not being so Machiavellian or pecuniary about it, it's the nature of the matter of how this stuff gets released if, in fact, it's -- because it's important to a lot of people. CHAIRPERSON FADEN: Absolutely. Pat, did you want to speak to that? And then I will -- MS. KING: I think it's important to separate classified and non-classified material because if you have access to material that's still classified, it can't be further distributed except to people who can see it until it's declassified and made available to the public. So we should keep it separate. And we have no power to declassify. DR. TUCKSON: Right. CHAIRPERSON FADEN: Now, we have the power to -- DR. TUCKSON: But, Pat, let me -- and I think you're moving in that direction. That's fine, given. That's good. My concern and inquiry is in the area of declassified material that is not generally available except through the Xeroxes that this committee gets because I don't know if the committee is taking -- Gregg, if you get a call from a historian at Duke who says, "I understand you've given the committee X piece of information. Send me a copy as well," are we opening ourselves up as a clearinghouse firm that sends it out anywhere? MR. DAVID: If I could say something in that regard? In addition to providing copies of unclassified and declassified documents to the committee, the agencies themselves are making copies of those documents available through any number of means, including public reading rooms around the country. DR. TUCKSON: That's good. That's all. MR. DAVID: And there's been some -- CHAIRPERSON FADEN: Our job is not to Xerox and mail out to people, but we have a reading room. The Department of Energy has a reading room. DR. TUCKSON: So we don't have that kind of pressure on us, and that's what it sounds like, that this is being opened up across the board. And anybody can go to other people. And I now feel very comfortable. The second quick question -- MS. KING: That's not the potential source of the pressure. I don't think anybody has any problems. That's why I say you have to separate this. Nobody has real problems getting unclassified information if you know what you're looking for. The problem that people are having is getting information declassified or released so you can do it. And, therefore, your first scenario about receiving tips about where to look is actually useful to us if it concerns our work. And it may also be useful to others. In that sense we end up being facilitators indirectly. CHAIRPERSON FADEN: And we have no problem working with the relevant professional communities. MS. KING: Right. DR. TUCKSON: That's good. CHAIRPERSON FADEN: Obviously that's what we're all here intended to represent on the committee and in the staff. So those of us on the committee or on the staff who have colleagues or contacts who have insight as to where it might be useful for us to look, we're happy to get that information. And if that assists ultimately the research of other colleagues, that's fine. I mean, the point is that this will not result in scoops, we don't think, in any sort of traditional scholarly sense because everything that we get that can be made available to the public will be made available to the public, to any historian, journalist, scholar, advocacy group, all at the same time. DR. TUCKSON: This is great. MODERATOR GUTTMAN: Let me make a couple of -- DR. TUCKSON: I just have one follow-up after that, but go ahead. CHAIRPERSON FADEN: Yes. MODERATOR GUTTMAN: No. You go ahead, Reed. DR. TUCKSON: No. It's different. It's a little different issue. So go ahead. MODERATOR GUTTMAN: Just a factual point. Just got a note from Glenn that each of the agencies is different. DOE is putting the documents that we're getting out in the public reading rooms, unfortunately, probably before we get them. But each agency is different. I don't know that DOD is doing that. Yes? DR. TUCKSON: The other question that came up yesterday in the public witness section is again this appeal for some mechanism that we could establish to spot-check compliance at the agency levels. I don't know whether or not you've given any more thought to that kind of system since this is the topic that we're now on. MODERATOR GUTTMAN: Yes. Well, it's more than spot, though. Let's just talk about that for a second because I covered that in some generality. First of all, a reason, to me the reason, but probably not, that you have people like the people sitting on the other side is because they're on the other side of the table or in the same room with the agency asking "Are you looking at this division's boxes, that division's boxes?" So it's more than a spot-check. It's your using your intelligence to make sense of this. Part of what we have been struggling with because when Ruth set this up, well, this one is sort of a kind of quality assurance question. The other is the committee's own research question. But they're both really related. Now, the quality assurance actually is more directly presented in the case of, say, the Department of Energy's going out to the field. They have teams that are going out to Los Alamos and Hanford and so forth. And one of the questions -- this is a suggestion -- in what we have here, that for the next meeting, we have an option or a memo on precisely the question of: How would we go about checking to make sure that when they've gone out to Richland or Savannah River, they've done it well? And this is an obvious question because this is the bigger than -- if they've got 150,000 boxes and they produce 1,000 documents, is there a discount? I mean, it's an obvious question. We're at a point now where we're just sitting here and wondering, saying, "Well, gee, what's going to happen?" But your question is absolutely correct. And so one of the option recommendations is that, in fact, we figure out quickly what we would do to audit those field searches. The headquarters search is kind of more hands on because there the historians are going to be working with the agency historians, saying, "Well, the archives, what have you looked at?" It's much more clearly hands on, direct. The field searches and the contractor searches, there we're going to need some quality QA kinds of questions. CHAIRPERSON FADEN: Essentially when the staff started working at the end of our first meeting, I had set up this memo so that there would have been separate sections, one on quality assurance and one on our own research and how to work with the agencies and the directions to give them. It became clear that that structure was a little premature. We weren't quite ready to divide the world that way. And also maybe the division was not as precise as in my mind it was. But we certainly have that responsibility. I mean, people are going to look to us to provide some sort of independent assessment about whether what the agencies do and produce is credible. DR. TUCKSON: I think the answer in the process is great, and I know you're being carefully diligent about documenting that and keeping track of that just so at the end of this thing it doesn't come back to -- MODERATOR GUTTMAN: Well, let me make two points. One is David Saumweber, who is not here, yesterday we were very privileged to have on staff coming from the National Academy of Sciences -- National Research Council. I don't know. It's like the IOM. I don't know what's related to what. But they're all there somewhere in that big science establishment. David as soon as he starts working is going to sit down with people who understand documents and figure out exactly how to organize and control. So when Ruth says all documents are going to be made available, I'm sitting here saying, "God, not until we find which room we're going to put them in," but David is going to get to the question. Exactly these questions of how and what and when are ones we're going to start to address first. Is that correct, David? CHAIRPERSON FADEN: Poor David. Pat? MS. KING: I guess Reed and I must be thinking about the same problems because I'd like to feel at the end of this process that I can hold my head high. And I'm sure we all feel that way. One of the things that concerns me is I don't think a committee like this can certify about what agencies have done. We neither have the staff, the expertise, the time, nor anything. We will never be in a position to say that we got the documents we asked for or we knew what to ask for because our reading about this is too big. So what I would like for the staff to think about when you come back next month is how to shift the burden of proof on these issues, which is the way lawyers would do it. And that is that the agencies have to certify to us that they have done what we have asked. And so the question becomes: What do we ask? That's very different. That's also a very hard task. You just have to figure out what to -- if they're going to certify to the answers to what you ask, then the asking becomes a critical issue. But it seems to me that's the only way that we can realistically approach this problem. We will never be able to develop a checklist. We will never be able to go to the agencies and say "What have you done?" and be able to say "Okay. This is fine." So I think that how we think about what this problem is all about is critical, and I would urge that the way we approach it is not thinking about what we're going to do so much as what we're going to have them do and the way we are going to structure what we require them, which is a good lawyerly way of thinking about things, but this is the way investigators have to proceed. MODERATOR GUTTMAN: First of all, what you're saying, from my perspective, what we need immediately is something in the nature of a subcommittee so that we can begin to work with the committee members to actually get through these difficult -- but in terms of the substance of what you're saying, a law school-like response, I think we're concerned about the difference between rule formality and rule adherence so that when we're asking for "Did you do these things?" we're sort of talking to the wind in many cases because these agencies, there's one secretary of the agency, but there are so many compartments unless we get in there. You know, you can't really not get in there. And then once you get in there, you've got this practical responsibility. And that's a very difficult -- your point, certainly it's an essential -- MS. KING: To put it crudely, it's whose ass is on the line. And I know that -- (Laughter.) CHAIRPERSON FADEN: This is great. All right. MODERATOR GUTTMAN: I'm glad we have women on this committee. MS. KING: The point that I'm making now that I've got everybody's attention is that the way to look at this is it's not ours so much as it is theirs. And what we are in a position of doing is to sort of facilitate the fact that when they stand up and sit down, you know, when they go sit down on whatever's on the line, that you have gotten us to come to the line. And this is now hostile. CHAIRPERSON FADEN: No, no. It's -- MS. KING: I'm not trying to suggest that this is -- CHAIRPERSON FADEN: Let me just get a feel of the committee because I think we're now talking about setting the philosophy or the approach for the whole committee's proceedings. I think what you've just said, Pat, is absolutely correct and critical. We have to think about what we can do and what we can't do. As a nonlawyer, I don't see it that way, but, I mean, the ass on the line stuff I can understand. (Laughter.) CHAIRPERSON FADEN: And I, frankly, think that this issue of all of us, staff and committee, being able to hold our heads up high at the end of this is absolutely essential to our personal integrity, to the integrity of the process, and the money that's being spent on us by the American people. So I would take it that -- is there any disagreement with this approach as a general philosophical approach for how we're supposed to proceed as a committee when we structure the staff's activities? This is a big question. This is not a detail. This is sort of the tone. MODERATOR GUTTMAN: I'm sure this is the second of dialogue. Pat understands this better than I do, but we're dealing with millions of layers of an onion. MS. KING: Right. MODERATOR GUTTMAN: And so to not be proactive is to sit back and accept. That's the question. MS. KING: That's why I suggested -- MODERATOR GUTTMAN: I know that. I know that. The question is: Once you get into the proactive mode, then you look like you are accepting. Does that -- MS. KING: No. MODERATOR GUTTMAN: Okay. Well, tell me -- MS. KING: It's the way you present yourself in your proactive mode. MODERATOR GUTTMAN: Okay. Okay. MS. KING: What I've tried to say is that what we have to do I think is quite difficult, and that is to find ways to structure the questions -- MODERATOR GUTTMAN: Yes. MS. KING: -- so that when they answer the questions, -- MODERATOR GUTTMAN: Yes. MS. KING: -- if things should come to light at some subsequent date, if we have done our work well and they say "We have done this. We have not done this. We have answered this question," the best way to do it is to frame the same question 10 different ways. I mean, that's one strategy. But if you get them to say that this is what they have done, if you have been astute enough to frame the issues correctly, then I think that's as much as we can do. Now, that's an enormous task. When you're dealing with millions and millions of documents out there, some classified, some unclassified, and you have no sense of what your whole universe is, to try to frame what they must do is enormously difficult and very proactive, but it is different than assuming that what you're going to do is somehow monitor what they're doing. That's not what you can do. MODERATOR GUTTMAN: Let's take this example. And this is what we're talking about with the classification stuff. Secretary O'Leary made plain to the world that she was in -- we all know that she had more than the best of faith that she wanted to get openness and wanted to get declassification. But it took us to go in there and say "Did you look at this division?" Now, we're only still at that level because now they say "Well, here are some records of that division." Well, we still have to go and say "But they don't look like there's a" -- I mean, my question is -- CHAIRPERSON FADEN: That's fine. MS. KING: We're beginning, but we need to move more systematically. For example, the expertise on the staff identifies places where you would have to look for information. The next step is: What information do you want from those places once you've now found the appropriate places? We will not be able to read every document. So that what we've got to have are techniques or strategies for requesting information that we think may be pertinent. And I think that's an enormously difficult task, quite frankly. But all we can do is start to ask for and identify ways of thinking about the information we need and place the burden on the agency to go back and do the searches and people power to do that. MODERATOR GUTTMAN: That's clear. We know that. MS. KING: Right. MODERATOR GUTTMAN: We aren't going to look at the -- MS. KING: That's proactive from my part. MODERATOR GUTTMAN: Okay. Okay. CHAIRPERSON FADEN: It's very proactive and it's also cooperative because what the agencies have been saying to us is "Tell us what you want." MS. KING: Right. CHAIRPERSON FADEN: And so I think the point here is if we give guidance that's specific enough, the agencies then have tasks that they consider feasible. And then what you mean about the responsibility is it's the responsibility of the agency when they say that "We have now" -- MS. KING: "Done what you" -- CHAIRPERSON FADEN: -- "done what you've asked." If they haven't, that's where it is. But we are expecting and we have any reasons to expect that what we ask will be answered because we have every reason to think that the cooperative/collegial arrangement that the agencies have extended to us and which we are very happy to accept is indeed the operative mode throughout here. But that's not to say that we don't have to understand our limits and our scope of authority vis-a-vis the agency. MS. KING: And my second point, basically, is the creation of a group to work on this is perhaps very important. It can't all be serendipity. I mean, one of the things as part of doing research is serendipity. Some of it, you know, you just come across things and other things. Some of the time you have to have actual strategies for where you think you may go. And those strategies need to be thought through and sort of carefully detailed. That's all I'm suggesting. And it sounds like that's what you started to do by having people who understand what kinds of questions to ask. I just want us to be more systematic and more comprehensive about it with the view in mind that the ultimate responsibility for who's -- MODERATOR GUTTMAN: I don't want to interrupt, but I moderate. So I can do what I want. Before I recognize the committee members, let me just hold it a second so these people can think about a response to Pat's question. How have you in your own minds begun to think about it? Can you begin to address the strategic kinds of questions, say, in relation to DOE to give you a sense of what they're thinking now? Then the committee members can. Go ahead, Henry. DR. ROYAL: I completely agree that we should have a more focused search of the documents. I'm a little bit concerned about the committee promising more than it can deliver. And I'm also concerned about us making departments promise more than they can deliver. We've already heard that the recordkeeping is not terrific. And, just as I would not want our credibility, the committee's credibility, to be dependent on no further documents showing up in the future, I wouldn't want the departments' credibility to suffer because they did a good faith search and something comes up later on. So we just have to make sure that we're going to do the best we can and the departments' are going to do the best they can, but that our credibility shouldn't depend on some new information coming to light two years from now. CHAIRPERSON FADEN: I think that's an important point, very important point. MR. DAVID: I'd like to just mention something briefly. Pat, I think you said something that to a certain extent answers your concerns, and that is that the agencies themselves are going to be doing the actual searches. Obviously the committee simply doesn't have enough personnel. And the committee and the committee staff working with the agencies with respect to their searches, the scope thereof and so on and so forth, has occurred already and will continue to occur, but the actual examination of documents will be by the agencies themselves. And if something is missed in a certain collection by an agency reviewer, that's just the way it is. DR. ROYAL: I think the best way that we have to assure that we're getting the information that we want is the fact that we have a number of ways to cross-check what should be available. I mean, it seems like we already know the existence of documents that we've never seen. And so one way to be more certain that the department is providing the documents that are available is by talking to people who were working at that time and finding out what they know and what they know about the documentation that existed at that time and seeing whether or not we can get at it from that way. MODERATOR GUTTMAN: But also the interagency coordination. It's a way of finding HHS doesn't have it, but DOE was on the committee, that kind of thing. Jay? Am I allowed to go on? CHAIRPERSON FADEN: If you're moderating. MODERATOR GUTTMAN: Okay. Jay? DR. KATZ: You know, that is very important, but we are still at the beginning of our inquiry. And we'll know a little bit more at the next meeting as to what the records search is doing. And I think that staff should pay particular attention also and let us know about the barriers that they encounter, note their successes, but also to give us sort of a sense where are they coming up against a stone wall where it should only be -- what is it, a gauze curtain or something? Gauze curtains can also be impenetrable, but at least it's better than a brick wall. But I want to make a more complete suggestion without going into great detail. I was going to bring to the committee's attention that we look into the Navajo uranium experiments. And yesterday we learned a little bit about these experiments. I think getting to the bottom of those experiments which are within our purview could give us a great understanding, a considerable understanding how certain departments of the government, the mining operators, the Public Health Service, et cetera, interacted with one another. And I don't want to go into that now for reason of time, but in light of my thinking about the documents we didn't get when I was on the Tuskegee syphilis study, there also were overtones of that experiment with the Tuskegee syphilis study, that I think I can at least in a few days time tell the staff assigned to it what kinds of specific things they should ask the various agencies to give us. CHAIRPERSON FADEN: Jay? DR. KATZ: Yes? CHAIRPERSON FADEN: This is a very important discussion, but we shouldn't be having it now because we're supposed to be talking about the Department of Energy, which is related. DR. KATZ: Oh, I see. Okay. CHAIRPERSON FADEN: But if we could just put it absolutely on target? And I think we should definitely bring up this issue this afternoon. DR. KATZ: Okay. CHAIRPERSON FADEN: So I'm just interjecting. MODERATOR GUTTMAN: Ruth notes we have 10 minutes. Let me suggest that -- first of all, let me just say that from the comments here, I must sound pollyannic. I'm only talking about this is a doable task because we're here. We have to do it. The problems, the pitfalls, the ways in which we can be -- you know, those are so evident that people doing this don't sleep. So the point of this is that your engagement is more than welcome. I mean, I would suggest that the options we have, we discuss those that give you concern, but that what from my perspective would be useful is to move through this afternoon's discussion to some kind of subcommittee mode by which we proceed through these options. And we can discuss questions you have about them in a kind of cooperative vein with the agency and whoever is involved from the committee directly overseeing it so that we kind of like crawl along the floor of the cave as best we can. If you have questions about the particular options, we can address those now. Our basic perspective is that we've tried to give you options that are not just "Here's a million different things." These are the ones that we think are with merit and that we think that we're in synch with on the agencies. Obviously some of them have all kinds of questions and difficulties, but those are things we've got to crawl -- CHAIRPERSON FADEN: Just so we all know what we're talking about, this begins on Page 20 of Tab G. MODERATOR GUTTMAN: One other report I want to make, Glenn Podonsky has just given me some clarifications to the memo I gave you, which relate, in particular, to two things. I'll Xerox this and pass this out. I don't want to get into it at length, but, basically, if I characterize it -- well, on the classification issue we were discussing, he says that the "Classification Department of Energy search team," which means the people working with Glenn on this issue, I think, "does not believe it currently has knowledge of all collection of headquarters records." The "records to which it lacks knowledge of location and information may include data on 'Work for Others' and intentional release experiments. "The search team said that they had not been successful to date in finding these files." On the issue of contractors' cooperation, which is Jay's point, "DOE initially appeared to encounter resistance to the search, including: Contractors at Los Alamos and Chicago initially appeared to resist the teams search, seeking a nondisclosure agreement from DOE. This however turned out to be a communications problem between headquarters and the field. "Both Los Alamos and Chicago have been extremely cooperative in this process. In point of fact, Los Alamos has been releasing documents to their public document room from the beginning of Secretary O'Leary's direction." And, finally, a certain part in our memo, which we'll indicate, "At the May 4th meeting," staff and DOE, "the DOE team said they had not been successful in finding" the classified "files." The bottom line, as I read it, is we're all working to look at these classified files. And the field and DOE are working to help us. DR. LEDERER: This leads to a question that I have about I hope that we can discuss whether or not the committee members should have security clearance and whether staffs will have security clearance to review documents that may then be declassified for us to use. I guess I would like to hear more about the progress of that. MODERATOR GUTTMAN: I think let's put that in a separate. I would like to go on, but the short answer is that we are all possessed of security clearance forms, are we not? CHAIRPERSON FADEN: I assume Susan is asking the strategic question that Ruth had raised with me privately, which is: Should everybody be cleared? Should only some people be cleared? How do we understand it? and also the sort of scholarship issue of: Knowing something that's classified that's very relevant but may not get declassified, either in time for this committee's report, I mean, how do we -- MODERATOR GUTTMAN: Let me see if I can -- there are some very fundamental issues that are actually not at all unrelated to the kinds of things that we're talking about. For example, the Smithsonian historians do not have security clearances for reasons that I'm sure they'll be happy to discuss with you. I think it's important that anybody who's in the process of filling out these forms understand what implications there may or may not be. It's something that we obviously want to address personally and collectively. Let's do that at a discrete time where it has the time it merits. DR. LEDERER: Well, will it be on the agenda for this meeting? CHAIRPERSON FADEN: It can be this afternoon. MODERATOR GUTTMAN: It can be put on this afternoon. Yes. We can talk about it, yes. Yes. But it -- CHAIRPERSON FADEN: It bears, obviously, on how we proceed with DOE. It's a methods question. MODERATOR GUTTMAN: Right. It is a method question. That's right. CHAIRPERSON FADEN: It's a methods question about how we want to approach this -- MODERATOR GUTTMAN: That's right. CHAIRPERSON FADEN: -- because we certainly don't want to have the committee in its entirety's understanding of what needs to be said be constrained by the fact that some of that critical information comes from classified documents that cannot then be made public. Obviously the whole goal would be to get the stuff declassified as quickly as possible so that we could then be able to say this all publicly. And part of everybody's concern is whether that, in fact, can be made to happen. As a strategy, one issue would be, one approach would be, to designate only a subset of people on the staff and on the committee to get security clearances who needed them. We need to have that so that people can look and see among the classified material what is relevant. And we'd specifically push hard to get that stuff declassified, rather than having everybody cleared and everybody then struggling with the same questions of integrity about "What do we do about this?" But I would think we need to have at least -- I'm looking at our staff here -- some people on the staff with security clearances and at least some people on the committee, who could then together perhaps form a subcommittee, whose role it is to make recommendations about which classified material we need to get declassified. MODERATOR GUTTMAN: The only observation, this is really a mirror of the problem we're studying. We're studying research that was in and out of classified work. MS. KING: Keep in mind, though, you cannot discuss a classified document as long as it's classified with anybody else on the committee or the staff until declassification takes place. CHAIRPERSON FADEN: Right. So we have this problem of how to figure out how this committee is supposed to -- MS. KING: Declassification is historically a very slow process. I don't know how much clout we have to get it speeded up, but -- MODERATOR GUTTMAN: These are all this kind of I call the bigger than a bread basket question. All of this is happening immediately, but over the course of 4 months, you have 2,000 documents to classify. Right? So what does that mean? CHAIRPERSON FADEN: This is key because one of the options -- I forget how many of these options under the DOE memo that we have from staff deal with this question of classified material. One conclusion the staff could reach is that we want some sort of a concrete policy discussion and maybe document from the administration about our getting expedited. I don't know enough about -- MODERATOR GUTTMAN: Here's our test case. This is what staff did to test. This is our forensic method. There's the Advisory Committee on Biology Medicine, which is the key committee. The story is the DOE said they physically had three or four boxes of documents related to that in their office. One of them is classified. So what Gregg Herken did was said, "Well, fine. How long does it take to declassify that one box?" And that is something we're awaiting the answer from. So that is at least some -- you know, if it takes a couple of months to get the answer, then, you know, we know something about the process. CHAIRPERSON FADEN: But we can't wait that long is the problem. MODERATOR GUTTMAN: I understand that. CHAIRPERSON FADEN: That would be fine if we had several years and we could wait and see how long it's going to take. MODERATOR GUTTMAN: Right, right. CHAIRPERSON FADEN: Gregg, did you want to -- DR. HERKEN: Just that anything having to do with biology and medicine, there's no particularly good reason why it need be classified. These are classifications that date back to the '40s or '50s. One would think, one would hope that that material could be reviewed very quickly and declassified. There's no weapons design information, for example, no stockpile information in there. Something like the Green Run, though, that deals with long-range detection. That's very sensitive, very highly classified, but that's probably also an exception. DR. LEDERER: When you say something could be quickly declassified, what does "quick" mean here? DR. HERKEN: There are declassifiers, certified declassifiers in the Department of Energy who have the authority to declassify by looking at the document they have -- I guess it now requires two stamps, but two people have to look at it. But it's possible, I would think, to declassify thousands of pages perhaps in a couple of days. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: My ignorance here is so great I don't even know how to frame the question, but it's something like this. Among the criteria for declassifying -- and I think Gregg just gave an example, but not stating the criteria. What are the criteria that could enable something to be -- well, the other way around. What would be the criteria in virtue of which a decision not to declassify would take place? I mean, you gave a couple of examples, but now I want the criteria. DR. HERKEN: I think that Hazel O'Leary has defined six criteria, and I can't remember exactly what they are, but it's roughly weapons design data, stockpile information, information that would be of use to a proliferant, to a nation building nuclear weapons. There are three or four others. CHAIRPERSON FADEN: Then there's a subquestion following that. Some people on the committee and the staff will have the clearance to look at those classified documents. Can portions of a document be declassified for discussion so that all that stuff with the weapons -- that doesn't have anything to do with us, but other things embedded in it that might very well have to do with us could then be declassified. Is that -- DR. HERKEN: That's right. For example, the Air Force history of the long-range protection program, we're probably only interested in 2 or 3 pages of what amounts to a 200-page document. CHAIRPERSON FADEN: Can I just get a sense of the committee? Would the committee like a memo from the committee to the relevant agencies asking for assurance that declassification requests will be probably attended to, blah blah blah blah blah? I mean, I'm not sure what it will do, but could it hurt? MODERATOR GUTTMAN: That's a good idea. Gregg, is it a good idea? DR. HERKEN: Absolutely. I'm not sure the committee quite appreciates how much classified material is out there and how difficult it has been for historians historically to get that declassified through the normal routine. Having a letter from a high authority saying "Please expedite" would certainly help. CHAIRPERSON FADEN: So is that the will of the committee? We will address such a letter, make such a request? MS. KING: And we also should get another letter about how fast they would provide security clearances. DR. HERKEN: Okay. DR. MACKLIN: Excuse me. Is this agency by agency, the security? In other words, if you draft this letter, does the letter have to be drafted to each agency head in order, then, for that process to take place within each agency? CHAIRPERSON FADEN: That's correct. That's correct. So we're basically asking for both the security clearance to be expedited for those people on the committee and staff who would be designated to have those clearances, which is a personal preference. Would you like to be among the pool of people who maybe have the security clearance? And then the second issue, which is an assurance from and maybe within a time frame that we either get something declassified or an explicit judgment that they will not declassify something that could be made part of the public record within a time frame that we'll come up with given the fact that we only have a year to do our work. DR. HERKEN: Can I ask: When you apply for a clearance, to what level does it go? Does this include top secret? MODERATOR GUTTMAN: We're going to have to ask -- CHAIRPERSON FADEN: Yes. The answer is yes. That was my understanding. DR. HERKEN: Because there's also the category of restricted data in Department of Energy. And it would be important to have that. And, in addition, there are going to be some clearances, some code word clearances, that one person might have to get. CHAIRPERSON FADEN: All right. Well, we'll need, obviously, your guidance and other people's guidance about exactly how to frame this, but we're going to make sure that there's at least one person on -- I would hope that it can't be one. There are at least two people representing the committee who have access to absolutely anything that could conceivably be relevant to the work of the committee. How many of these people, we don't know, but we know it's got to be at least two. It can never be just one person for purposes, I think, of committee functioning to make a judgment about whether a particular piece of information needs to be made available to everybody. We have a problem? And it's time. DR. KATZ: What do you think? Do you have a sense already? Because I would rather not fill out those forms if I don't have to. I would only do it if it is important for our work. But if you can get a sense of whether you are having -- CHAIRPERSON FADEN: I will do it. DR. KATZ: -- top clearance and one or two others, whether that is not really sufficient or not and whether we have to go through the onerous work to be cleared. And if it later on becomes necessary, we may ask for an emergency. CHAIRPERSON FADEN: Clearance. DR. KATZ: Clearance, yes. CHAIRPERSON FADEN: We were going to do this this afternoon. Let's just do it now, take two minutes and cut into the coffee break, if that's okay. Ruth, did you -- DR. MACKLIN: Yes. To add to what Jay just said, I think he's focusing on the onerous nature of the task of filling out the forms, but there's also a question that I think everyone should be aware of and that I'm not clear about, which are the actual implications for the future. We know they're going to root around in our past and present, but what are the implications for the future, both for our work during the course of this committee's existence and beyond? It seems to me that that's something that we have to know on the individual -- MODERATOR GUTTMAN: There are several kinds. One is the personal question. The other is the ability of the committee to function in several respects: that half of the people know things and the other half doesn't. And the third is in relation to the outside world, where you're telling the people "We're open in public, but we can't tell you certain things maybe. But we can't tell you." So there are things that are very important elementally. CHAIRPERSON FADEN: Let's do the following. We don't have the expertise here to answer the questions about what the implications are for the future. I think what happens -- and this is from the way it's been explained to me -- is that you have your security clearance, and you don't have to have it forever. You can have it for a period of time. But that may be false. We can sort of get that clear. But I think the methodological question and the process question for the committee is: Is the committee comfortable having a subcommittee of committee members cleared or does the committee want -- you know, we can't make anybody go through a security clearance who doesn't want to? It's clearly voluntary. So is the committee comfortable with only some of us having clearances? Pat? MS. KING: I think there are several tasks. One task is to find out whether classified documents are relevant to the committee's work. CHAIRPERSON FADEN: We've already established -- MS. KING: That doesn't need everybody to be clear. That only needs a relevant number of people to review. That part's easy. Maybe you want to wait until we encounter the situation, but my experience is that security clearances don't happen overnight. The second problem is that if you have a security clearance and you want to discuss something, not only can we not discuss it in public. We can't discuss it with anybody who does not have a security clearance at the same level. And I think that that is -- I won't get to the personal thing because everybody has to make a personal decision for themselves, but in terms of committee functioning, that is very hard to have to keep in mind who on this committee has been cleared and who has not been cleared when you're discussing information. Now, the problem is we don't know what we're going to encounter in the classified documents until we actually get there, but it may be too late, then, to work out those problems. So on the theory that the committee's charge -- and I go back to this. I think part of what people were concerned about is not only whether some research or experimentation was conducted ethically. Other concerns that led to the creation of this committee deal with: Those agencies that had "defense, military, intelligence" responsibilities, the whole classified group of people out there, what were they doing with respect to doing research on human subjects that might not necessarily have been therapeutic in nature or had a split purpose, both therapeutic but some military purpose? If you see that as a major part of what we're doing or supposed to be doing, then you can't get into those agencies without having to deal with classified material or declassified material. I urge everybody to start the security process, even though I find those forms incredibly onerous. The scholarship question is very different because that affects people's future lives but with the idea that we might be able to get data declassified. That will take care of the scholarship problem as well in the future. So there are some big unknowns about how people's futures will be affected. DR. KATZ: Pat, can I ask you a question here? Because I may be wrong. I come to it from a different perspective. Forgetting about the onerousness I do believe that some people and staff and chair, et cetera, maybe a few others need to get security clearances. I'd rather not have a security clearance. And the reason is what I can ultimately use in public and be part of our document, I'd rather not be under any constraints, having read certain documents that prevent me from talking. I then will -- and my hunch is I will do that as part of my nature -- raise all kinds of questions about this, that, and the other thing. But I want to do it about knowledge that I can use. I don't want to have knowledge that I've been told, once again, in secret and then have to be more careful because of the burden of secret information. What do you think of that perspective? MS. KING: As a person who's had security clearances in the past, I tend to sympathize with you because it does always make you drop a screen in front of you when you're getting ready to open your mouth. On the other hand, it seems to me that I don't know how we do our job with only the information that's already available in the public forum. So I don't know what to say there except -- DR. KATZ: We need to urge you. We need to urge to get more and more declassified. And both Dan and -- MS. KING: I agree with you about that. DR. KATZ: -- you are working in that direction. Anyway, that's another question. CHAIRPERSON FADEN: The dynamic is something like the following. Let's hypothesize that we are now looking at a classified document, and the issue that has to be made, the decision that has to be made is: How important is this document to the work of this committee and its public charge? If more members of the committee participate in that discussion in some respects, that's better. Okay? It also makes it a stronger case going back to the agencies to say it's not a subcommittee of the committee that thinks that everybody else needs to see it. The whole committee has seen it, and the whole committee believes this needs to be declassified. It needs to be in the public domain in order for us to responsibly conduct our charge. So the argument for having every one declassified goes to the essential power behind the full committee's asking an agency to declassify a document, rather than a subcommittee of committee and staff going to the agency and saying "We need to share this with our colleagues because we think this is relevant." On the other hand, it has to be remembered this is a voluntary decision. Nobody signed on as a committee member under the condition that they would agree to get a security clearance. And there should be no felt pressure one way or the other. In general, my own view is you have to make a personal decision. I would prefer more members of the committee to have security clearances than fewer members of the committee. I would like it not to be a small number. But I don't think anybody should feel that they are being an irresponsible committee member unless they agree to be cleared because that was not a condition of the terms of agreeing to become a committee member. So we should get that out. Ruth? DR. MACKLIN: Jay acknowledged his reason for reluctance to get security clearance. I think I should acknowledge mine, which has to do with the possible restrictions on foreign travel. Some countries are viewed, as we learned very early when we were given the information about security clearance, as sensitive, even in the post-Cold War era. One reason I happen to know from just reading the materials is because they haven't signed the nuclear nonproliferation treaty. I know that I go to some of these countries. I have a commitment to go to one of these countries. I'm organizing a conference in one of these countries. Since the security clearance might take up to three months and then if I make a request to go to that country, which is what you have to do is make a request and be cleared: A) they may say no or B) it may take so long to decide that my chances of going or my opportunity to go would be foreclosed, and this is a commitment I've already made. CHAIRPERSON FADEN: Can I just ask? Ordinarily we are not asking for comments from anyone outside the committee, but this is a technical point that could facilitate the discussion. Is there anybody in the audience who knows about -- MODERATOR GUTTMAN: Glenn Podonsky. CHAIRPERSON FADEN: Glenn, do you know the answer to Ruth's question? MR. PODONSKY: Yes, I do. In terms of your clearance -- CHAIRPERSON FADEN: Can you come up to the mike for just a minute? So we're departing from our convention because maybe this will get our work done a little faster. This is Glenn Podonsky from the Department of Energy. MR. PODONSKY: The security clearances in terms of foreign travel, the way the Department of Energy and the other agencies mostly operate is you inform the security element of that agency that you're going to have foreign travel. It's just because of protection of yourself, not because they want to prohibit your travel. What we have looked at in the formulation of the human experiments group is when your committee was being formed, we wanted to make sure security clearances did not prohibit you from access to information or prohibit your normal work schedule. So we've worked with the security people in DOE, and that would not be a prohibitive factor. In terms of what Gregg said earlier, we've already made arrangements for those folks who want to be cleared that you feel need to be cleared at all levels. There will be no prohibition because of security clearance. Whatever you need will be provided. CHAIRPERSON FADEN: So are you saying, Glenn, that Ruth's hypothetical consideration, her real personal consideration, would not materialize? MR. PODONSKY: It would not be a hindrance. CHAIRPERSON FADEN: She would not lose her clearance because she went to a country that was on this list? DR. MACKLIN: No. It's the other way around, that I wouldn't be prohibited from going to the country because I had been given the clearance? MR. PODONSKY: No because, remember, the clearance does not necessarily reflect what actual information you've been exposed to at the time of your trip. It's purely for information purposes in terms of making sure that the security people know where everybody's been going so that you're not put into an unfortunate situation in a hostile nation or a nation that the U.S. government has recognized as hostile. DR. MACKLIN: And, by the same token, then, past visits to any of these countries; that is, the forms that we fill out require us to say when and for how long and at what point we visited any country. So no matter how long a list those countries -- what countries those are, even in the pre-Cold War era, would that be a barrier to obtaining the clearance? MR. PODONSKY: No, not at all. Just from a personal example, my father came over from the former Soviet Union in 1917 and during the Bolshevik revolution. I have all the highest clearances. That hasn't been prohibited because of my family background, the point being that, believe it or not, security is getting into the real world today. (Laughter.) CHAIRPERSON FADEN: Thank you, Glenn. Jim? Henry? And we've got to stop. DR. ROYAL: I just actually had one more question for Glenn, and that was -- CHAIRPERSON FADEN: Glenn? DR. ROYAL: Do we have to wait for some approval when we -- CHAIRPERSON FADEN: Glenn, we have another question for you. One second. DR. ROYAL: Do we have to wait to get the approval back or do we just have to notify whoever it is that we're notifying about foreign travel? MR. PODONSKY: It depends on the agency, but they give you approval relatively -- I say relatively. What we have set up is this is a special situation. You have a President's Advisory Committee here. So it's not the same process, the same thing with declassification you were asking about before. The other thing that I was reminded of, you do get a debriefing just to make sure that no foreign agent's contacted you or what have you. It's part of the procedures. DR. HERKEN: If I can ask just a question about the prohibition upon publication of research? This would affect more historians than I think the medical people. But if you could comment on that? Would I have to submit historical articles for review? If I did have a clearance, would I have to submit them for review, even after I had lost the clearance or given up the clearance, if I had looked at materials that might be of interest to the subject I was writing about? MR. PODONSKY: I can't answer directly in terms of what the regulation is, but I know that we have people right now in the employment of the department that are exposed to classified information. And before the publish in various magazines, they ask just for a sanity check because they want to make sure that they don't divulge any information inadvertently. Whether it's a requirement or not directly, I don't know. We'll find an answer for you. CHAIRPERSON FADEN: Good question. Thank you. We need to take a break. Jim, did you want to make a comment? MR. DAVID: Just one quick question for Glenn. And that is: Can the DOE -- (Laughter.) MR. DAVID: I'll move the microphone back so you don't have to make another trip. Can the DOE grant clearances that would give committee members and committee staff access to classified materials held by other agencies? MR. PODONSKY: The answer to that is the Security Department of the Department of Energy is working with the other agencies to make sure there is reciprocation on the clearances. One of the issues in the Executive Branch is, unfortunately, all the agencies have their own security clearance process. It's very cumbersome. But the security community is working that through. So the short answer is right now it's not reciprocated from document to document from agency to agency, but there are some mechanisms where certain agencies under certain programs are recognizing each other's clearances. MR. DAVID: I just want to say why I asked that question, and that is because, in particular, two other agencies on the interagency working group in all likelihood have a considerable amount of classified material that might be relevant to the committee's work and -- MODERATOR GUTTMAN: Can you comment on the DOD/CIA situation, Glenn? MR. PODONSKY: No, I can't. MODERATOR GUTTMAN: Oh, come on. MR. PODONSKY: I can only speak for DOE. CHAIRPERSON FADEN: What we need is an answer in this letter that I'm now going to write on behalf of the committee to the agencies. We will ask specifically on this issue of facilitating a security clearance "Since the committee members and staff are completing the forms for the Department of Energy, will the Department of Defense and the CIA and so on accept that clearance? If not, can they guarantee a rapid security clearance process using their own documents?" because we need to get that started right away. So we'll just have to do that. And we'll need to send those letters out immediately. We need to stop for a break just because we need to. When we pick up, we're going to look at DHHS. I have a great sense of not having kind of reached closure on stuff. We will try to do that this afternoon. So let me just make a plea that we just stay really focused. And we'll do DHHS. We'll come back this afternoon and really get very task-specific subcommittees, who's going to do that, what should the staff do in the afternoon. (Whereupon, the foregoing matter went off the record at 10:57 a.m. and went back on the record at 11:19 a.m.) CHAIRPERSON FADEN: We're going to do DHHS. Let me do this. We're going to try to get some additional information about the security clearance question over lunchtime and try to make that information available to the committee in the very beginning of the next afternoon session, but we don't want to take up the whole afternoon session talking about security clearances or we'll never give the staff any work to do over the next three weeks. But we'll try to get more information. Please come to the table. We're going to try to get started. I shouldn't be so tentative. We are getting started. We're going to try to maybe get started if everybody would please cooperate. MODERATOR GUTTMAN: Before, Glenn Podonsky has given us copies of his clarification on the materials we gave you. I'm just going to pass them out. These are public documents. I don't know if you want to put one in the record of the committee. CHAIRPERSON FADEN: The Energy discussion was perhaps not as focused as we would have liked it to be. Some very important large questions emerged that affect our entire experience, and those had to happen. We'll revisit specific issues with respect to how we will be working with the Department of Energy in the afternoon. I would appreciate it, though, if the rest of the morning we could focus real hard on DHHS, which raises some similar, some different kinds of questions for the committee. And maybe the easiest way to do that would be as well before Dan gives his presentation, for us just to open to Tab H in our books and go be ready to talk about the options when we get to that point. Who are we missing? Jim? Is Jim coming? Is he not here? He's coming up? Okay. Here comes Jim. So we've got all the staff. So if we could just be real targeted, Dan will give us the presentation. And we'll just zero right in. METHODOLOGICAL REVIEW OF AGENCY DATA COLLECTION EFFORTS: DEPARTMENT OF HEALTH AND HUMAN SERVICES (TAB H) MR. GUTTMAN: First of all, as I said earlier, we're very privileged to have in the audience at least D. A. Henderson. I think I saw Wendy Baldwin and Gary Ellis. CHAIRPERSON FADEN: Could you stand up so people can know who you are if you're there? Gary, Wendy. MR. GUTTMAN: Those of you who don't already know these people, they would be more than pleased to talk with you. And I assume that includes the staff as well. We're all working together. So in the break or whatever. I'll try to be brief on HHS because I'm really not as comfortable talking about it. And now that I've read the history of it, I found out there are many parts of it that I really didn't know much about. And, as the case with DOE, the method that we used was first a group of people which included myself, Faith, Jim David, Gil. Ron Neumann sat in. He is with NIH, but we're getting started. He's obviously got terrific expertise. So he sat in. We didn't have him working on the report, but he sat in and provided acute insight. We met with Gary and Wendy and Kathy Hudson and then tried to follow up. And because of time compression, there was a terrific need to get a lot of information down in a terribly short time. We tried to run a draft, a description through HHS. And they were terribly, terribly helpful given their time constraints in getting back questions and comments. We tried to make the corrections, and we hope we did some rough justice to what they gave us. In particular, the history section which HHS provided was to me extremely interesting and informative. I finally understand something about what that bureaucracy was and is. You all or probably many of you are much more familiar with the HHS bureaucracy than I am. So let me try to be as capsule and hopefully adequate as possible so you can get into the discussion. It appears that we're talking about the search at HHS. We're talking about at least two different kinds of worlds. One is the NIH world. And the other is the other world. The NIH world -- and this is my characterization. And, Wendy, I trust I'm not going to be too far off base. It's a world where people apply for grants, and there are review boards, as opposed to where, you know, you're running a program and you're directing strategies and so forth and so on. They're not completely different, but they're dissimilar. And we are told that NIH has, many of you -- I must stop apologizing, but it should be a running apology -- know better than I do, there's an intramural and an extramural program. NIH has told us they've got a relatively good grip on the intramural activities, but that for purposes of this exercise is a small fragment, 10 or 15 percent of the total. I'm not sure whether it's by grants or by dollars, but something of that order of magnitude. The extramural is a more interesting, difficult case. And Wendy and Gary and Kathy spent lots of time and lots of very high-powered intelligence trying to figure out what's the way to get an elegant research grip on how to look at this. And what we're talking about, and their research I think concentrated on the pre-'74 period. The first point is that the HHS computerization didn't go into effect until the early '60s so that in the large part of the period that we're talking about from the '40s to '61-'62, we're talking about basically capsule descriptions of grants, of which there are tens and tens of thousands. And D. A. said at the initial committee meeting, sometimes you can get a glimpse that maybe these are about radiation, but you can't tell whether they're about people or bugs. So the question is: Well, what do you do from there? And HHS has tried some very imaginative things, and some of them are useful but time-consuming and require efficiency judgments. For example, they have thought about "Let's take a particular experiment and do a literature search." Faith can go into the details, but the answer is there's an immense amount of literature. And you can do that, but even that is not without time and cost considerations. So you're going to have to focus narrowly. What has sort of narrowly been suggested was that it turns out there was a Radiation Study Section by maybe one or two names that existed between the '40s throughout the period. So one thing that was suggested by HHS was looking at what was done by that section. And it turns out that when they looked at the first computerized year, there were about 400 grants. And then they hand-searched. The initial year was about 15. So we hypothesized somewhere between 15 and 400. On the other hand, that may not be the only section where grants went through. For example, the document that Jim David found with the fragment of the Saenger application in 1950 that was in the OSD Secretary of Defense files, that appeared to be through the physiology section as an example of a radiation thing. But, anyway, as a working start, what staff is suggesting is working with HHS on sort of narrowing down the radiation section grants and maybe seeing if we can begin to make sense in some way that documentation. We have two cuts on that, which I think HHS thinks are useful. One is using the AEC material of the radioisotope licensing data. We may be able to quickly determine because that's going to be more descriptive which of these experiments that, as D. A. said, even if you read the journal articles, you can't tell whether they are bugs or people -- which of the radioisotope licenses may be more quickly and adequately described as bugs or people so you can narrow the DOE and DHHS group. And, as Ron Neumann suggested, while the AEC may give us an elegant if inarticulate grasp on the radioisotope part of the world, then you've got the X-ray part of the world. And so the notion was to sort of sub-focus maybe in coordination with HHS on the radiation grant section X-ray subsection. Now, that's just working. This is not a straitjacket. This is not a directive. We're asking: Can we go back and sort of talk with them about this thing? That's sort of the generality of the HHS at one level. The next level, you say: In the other parts of the agency, which are obviously of in their own right tremendous importance, interesting things were found. FDA found that they had 15 experiments, -- they haven't yet gone through the boxes; maybe they have now -- I think 8 of which were jointly funded or sponsored. And so one of the things that was observed -- and also I think they found, in fact, there was some kind of classified work that a radiological division was doing in connection with what looks like to me the Nevada test site, but it's not clear. So that one of the observations that I think is an empirical observation on HHS' part -- and, again, this is me speaking, and you can talk to them directly to verify it -- is that, in fact, there was more joint funding. And let me be careful in what I'm saying. It's not necessarily that HHS was funding an experiment, but that experimenters were jointly funded. And that came up, as Ron Neumann pointed out, in the Saenger experiment or experiments, where the DOD funded the experiment. And it looks like HHS predecessors were funding perhaps the bed in which the patient rested or perhaps some of the training. So that leads to sort of the most important staff option recommendation is that in connection with HHS, we begin to sort of take a suggested direction sort of more both at the level of looking for higher-level kinds of information and policies, but also looking at the ways in which back in the '40s and '50s, activities that were funded by the HHS predecessors related to the activities that were funded by the DOD or the DOE. That takes us away from looking for let's find another experiment or let's find another piece of evidence about an experiment, but let's see if we can find the rules, the ways in which the world worked, what kind of connectivity. And so, again, part of it is the coordination kind of documents. Well, why was it? We now know that PHS grant documents turn up in DOE files. Well, there's nothing nefarious about it, but what was the process? What was the logic? Why did that happen? Was there an interagency review committee? If so, you know, why? We're asking questions to which we know there are answers. Maybe it's going to be hard to find them, but we know the answers today. We know that there are such and such committees. What were the answers then? A similar set of questions, for example, on the classification processes. We now know that some of these researchers -- it's not a surprise -- were both in classified and declassified worlds. This is exactly the kind of thing we're talking about. Well, when you had a researcher, Dr. Saenger, who was funded jointly, was he privy to security clearance? And if HHS or its predecessors were funding him, did they know that? Well, how did people know about where those boundaries existed? And the reason it gets, at least to me, extremely intellectually interesting is one of the things we know and we're told is that all of this is in the public literature. Billions of this is. But then is it the case that what's public is in the public literature but we don't know about what's not? And the question is not looking at a particular experiment, but seeing if we can get into a document search mode that can answer the questions about the way the world was structured. And just to complete the piece of the puzzle that is -- I mean, every day there's a new piece. When we met with the VA, Denise and Jim Moreno and I and Faith, again, they told us that in 1947, General Groves -- I mentioned this earlier -- went to the VA. And the formed a secret medical committee which they've lost the trail for. And Secretary Brown is extremely interested, he told us, and wants to know. Can we help him find where that trail picks up? So there is the question. Well, we begin to see the picture that nobody else sees, some of which, most of which may have been public. We begin to see that we can connect dots by looking at documentation of processes and structures and procedures, how things were made secret or not secret that will then lead us back into other kinds of questions about the particular experiments which we have been able to focus on through this narrowing of the radiation section. So that's sort of the overview. There are other items of the HHS options that are important but I think probably less controverted. One is interviews. HHS did a number of interviews. Our suggestion, of course, was do more interviews. But the question was: Why? What's the point if you did some? And now our question is we would like to work with them on the interviews and perhaps maybe refocus the interviews towards what we're now looking at, which is instead of asking people "Do you know of any experiments?"; not only that, but "Do you know how the world worked?" I mean, if Dr. X was funded here and there, how did that work? And there were general kind of process policy questions as well as: Tell us if you know of an experiment that we don't know about. The other is HHS -- I think Faith can address this. Now we're getting into the actual real world of medicine, which is they're also interested in confirmation. The NIH intramural program, I gather, is all experimental by definition. And so they're curious if they want us to go through all the billions of documents. And they have what seem like perfectly reasonable limiting questions, and they want to get a confirmation if they're limited. I alert you also HHS pointed out we had asked them, as we did everybody else, for Green Run-related documents. And, of course, they have had the CDC study of the Green Run. And they pointed out that that wasn't something they searched for. And we said "Well, why not? That's in our charter." And they said because it's, as either Secretary Shalala or D. A. said at the initial meeting, they define out of what we're doing their studies of somebody else's mess. And that's for reasons of efficiency, not for reasons of -- I'm not sure that's unreasonable, but I just highlight that. Oh, the other thing that's very important that HHS brought to us is that, as we know, they sent out letters to 20,000 of their present/former grantees. They have assured us that there's lots of interesting material there, that there's no question we would want to look at it, but leaving to us the next step. And obviously HHS will cooperate, but then there's the mechanics, a similar question to what we were discussing in relation to DOE except with HHS, it's everyone, not just Rochester and Chicago. That's a big question. And you may not want to answer it now, but you may want to get into let's start thinking about it. Faith, have I covered 32 percent of what I should have or -- CHAIRPERSON FADEN: Are we ready for a discussion? MR. GUTTMAN: Yes. I just want from Faith: What have I not said correctly? Tell me. MS. BULGER: A few minor details, but they're details in the report. MR. GUTTMAN: Do you have anything you want to add? MS. BULGER: Dan said the major issues there. COMMITTEE DISCUSSION CHAIRPERSON FADEN: We should go right into the session. MODERATOR GUTTMAN: Anna says I should introduce the HHS people. I thought we already introduced the HHS people. Okay. Thank you. CHAIRPERSON FADEN: We're having a note-recycling problem. If you do this long enough, every note will come back again and again. I think we should just start the discussion and try to get as specific as we can on all the points. We'll start with Pat, but let me just say that I get anxious whenever any of us -- and I do this all the time, say "I may not do this now. We'll do it next meeting." I keep thinking about the fact that we have a year, all totalled. So it is not in general prudent to keep putting things off to the next meeting that we could perhaps make a determination about today since our time is so finite. Pat? MS. KING: On Page 22 of the memorandum about HHS, in the last paragraph it says "HHS supports Options 2, 3, and 4 as valid approaches." Am I to infer from that that they don't approve of Option 1? MODERATOR GUTTMAN: No. Again, HHS is here, but we had discussed and they had suggested 2, 3, and 4. It fell out of what they were doing. One is sort of what we had constructed based on our discussions with them. And one would be in the nature of: We think it's reasonable. HHS has not said it's unreasonable, but it's something that we would have to work out. In other words, this was staff -- MS. KING: Can I ask somebody from HHS what their position is on 1 if somebody is willing to answer it for us? CHAIRPERSON FADEN: Sure. Yes, if you would come to the mike, Wendy? This is Wendy Baldwin from DHHS. MS. BALDWIN: Could I first just comment on two things about the summarization? One is in terms of Green Run, it was our understanding that epidemiologic follow-up studies were not included. This was not a question of our not wanting to get involved in someone else's project. If we, in fact, had co-funding of a significant nature, we, of course, would be involved in another agency activity. It was the definition of the epi follow-up studies. The only thing is that I was a little concerned about how -- this came up last time about what the letter to 27,000 institutions said. It said "Conserve your records." It didn't say "Look for them. Identify them. Find them. Tell us what you have." There's nothing there to be had except that we're getting mail back that says "We didn't do anything in radiation." But all we asked there was that people conserve their records. Option 1. If the committee directs us to pursue Option 1, it implies a different search strategy. We have been searching, looking for human experimentation in ionizing radiation. We have not been specifically searching for other types of memoranda perhaps that might reflect at a different level of policy. Now, we can, of course, do that if the committee so directs us. It's a somewhat different orientation. I think there are a lot of subsidiary issues that if that's the direction, that we might want to talk about; for example, what happens in terms of the co-funding, what we know about other people's funding when they get support from HHS and it's very straightforward. And we could certainly document that. We would have no reason to know if an investigator had a security clearance. And I would be very surprised if reviewers cared. They're reviewing a research project that comes to us. We wouldn't ask for it. I doubt they'd volunteer it. And I don't think the reviewers would be interested if they did. CHAIRPERSON FADEN: Does that answer your question, Pat? MS. KING: Yes. CHAIRPERSON FADEN: Thank you. MS. KING: So they're not opposing it? MS. BALDWIN: No, no. MS. KING: It's just different? MS. BALDWIN: Okay. MODERATOR GUTTMAN: I think what we're posing is not a major change of direction, but it's -- MS. KING: It's a major change. MODERATOR GUTTMAN: Well, it's an addition. It's not the world. It's a supplement or a -- right. Wendy states it better than I could. Go ahead. MS. BALDWIN: We felt that we had gone as far as we could in looking at what we had and what it would take to learn more about what we had. And beyond that, we're waiting for direction from the committee. And so that's sort of what you see there. Do you want me to just stay here while you ask? CHAIRPERSON FADEN: Maybe it would be better if you went back to the audience -- MS. BALDWIN: Fine. CHAIRPERSON FADEN: -- just so we can keep the thing going, but beyond which don't leave, Wendy. Don't leave. And we'll reserve being able to ask you to come back if questions come up, which is pointing possibly to the utility of formalizing having someone from the agencies as we have these discussions available. We're just lucky that Wendy and Glenn are conscientious and showed up so that we could get these things pursued. But what I'm hearing from Wendy is we need to get specific about what we want staff to do with DHHS and with all of the agencies. Okay. So 1 is open for us to request of DHHS if we think as a committee we want staff to work with. DR. MACKLIN: Option 1 you're talking about now? CHAIRPERSON FADEN: Option 1. Everybody doesn't have their report in front of them. Option 1 is redirecting the agency's search or adding to the agency's search a focus on essentially policy-level documentation, rather than experiment-level documentation that would bear on our charge with respect to the human radiation experiments. Is that something that the committee wants to ask the staff and DHHS to pursue? Yes? Eli? DR. GLATSTEIN: I think it might be easier and more focused if we could inquire of the executive secretary of the Radiation Study Section if we have any policy guidelines with respect to other agencies and so forth. CHAIRPERSON FADEN: This is exactly the kind of thing. That's what we mean by policy level, as opposed to experiment level. I take that as an endorsement from Eli that this is a good direction. DR. GLATSTEIN: Yes. CHAIRPERSON FADEN: And from Ruth as well. I'm not seeing anybody argue against it. We are saying to staff work with DHHS in implementing Option 1. DR. GLATSTEIN: I don't know how far back that goes, but I know they've had a Radiation Study Section for at least 35 years. I don't know when it began, but it certainly goes back until at least the early '60s. MODERATOR GUTTMAN: '40s these people say, the '40s at least. DR. MACKLIN: Just one other point. I mean, I presume this wouldn't look only at the Radiation Study Section because it could be that if there's interagency co-funding, it could have been one of the other study sections in HHS and then DOE or one of the other agencies. Is that what I heard Dan say before about the -- MODERATOR GUTTMAN: Yes. We don't know what's there. We may not find anything. But it's the connectivity of the agencies as well as the policy level. DR. GLATSTEIN: There are some guidelines. And by what mechanism is a grant that has radiation in it sent to the Radiation Study Section, as opposed to other one? MODERATOR GUTTMAN: That I think actually Wendy has been to that level of detail. And I think the problem is that's not at this point particularly -- we may find that out, but we don't yet know that. That's something they thought about, I think, looking at. CHAIRPERSON FADEN: But, Eli, I mean, we're going to work outward from that. It's starting where we know they looked at radiation work and using that to go outward to see if we can put a picture together about how research was reviewed and supported and what policies guided human subjects. So Option 1 is endorsed. Nancy? DR. OLEINICK: A corollary to that is if a grant application that has to do with radiation is not assigned to the Radiation Study Section and is assigned to another one -- and this decision is often made by a secretary in the office, where thousands of grants arrive within a few days of one another -- and if it's assigned to a physiology study section, for example, generally the executive secretary of that study section will elect to bring somebody with the expertise onto that study section to make sure that it has a fair review. Now, I don't know whether this information is available, but if one could cross-reference what reviewers -- there usually was a pool of reviewers that would be often required to review these and brought in to review these grants. If they were involved in particular deliberations on the physiology study section, it might -- CHAIRPERSON FADEN: What we need to do is look to see how far back both this procedure was used and whether there are any records of it. I mean, you -- DR. OLEINICK: I don't know. I mean, I'm only suggesting that as one mechanism for trying to root about. CHAIRPERSON FADEN: Could we move on to other options? What we'll do is hopefully set up subcommittees, again, of people who have particular expertise, either by topic or by agency, who can, just as Nancy's just done, give the staff guidance. Have you thought about looking for this, talked to DHHS about whether this would work and so on? Because we know in this committee, there's a lot of expertise with respect to NIH, in particular, that can complement the expertise, of course, that sits within NIH itself and DHHS generally. There are a couple of tough issues on this list of options. In the interest of getting to some of the tougher ones, can we spend a few minutes talking about how the committee wants to approach the access to records that are in the possession of universities as a committee matter? We have, I think, already endorsed yesterday that we are going to make a request around the plutonium experiments of the University of Chicago and at Rochester as kind of test cases, where there's targeted reason for looking at those two universities, but there's the general question of whether the committee wants to make requests of universities, whether the committee wants to make agencies request information of universities, whether we pick the universities, and for what reasons. I mean, the first issue is: Do we want to be contacting as a committee universities directly seeking information or do we want to be going through agencies, things of that sort? Ruth? DR. MACKLIN: I couldn't answer that question without hearing the arguments on either side. CHAIRPERSON FADEN: Does anybody want to argue for one side or the other? Pat? MS. KING: I would argue resources as an argument in favor of having agencies contact universities, rather than having us contact universities, but I think that agencies should contact universities after we determine some kind of priority or exactly what we want them to contact them for. I also think that universities are more responsive. All institutions are more responsive to those with whom they have continuing relationships than they are to ad hoc fly by night one-year presidential commissions. And for those reasons, I would urge that we really want the people who have ongoing relationships with these institutions to contact them. It goes back to what I said before about us providing the guidance, the questions, the designation, if we want to select universities, rather than the whole universe of universities, that we do that work. CHAIRPERSON FADEN: Ruth, did you want to respond to that? DR. MACKLIN: Just a follow-up. That's a very persuasive argument, and I'd buy it. The question is: Might there also be after the initial contact by the agency -- the committee is going to be giving directions to look at specific things. Might there after that be contact with the university, whatever it may be, or medical center by members of the committee or committee staff? That is, what you just argued, that doesn't preclude -- MS. KING: It does not preclude. DR. MACKLIN: -- subsequent contacts, inquiries, and back and forth by committee and staff, but it's the initial. We're talking here only about the initial contact. So it wouldn't be the case that everything would have to continue to go through the agency once the initial contact -- MS. KING: It doesn't preclude it, but, as my daughter gets tired of hearing me say, I believing in crossing bridges when you come to them. I was definitely only dealing with the first round sort of as an operating principle, but you're right. CHAIRPERSON FADEN: Henry and Duncan? DR. ROYAL: It's not totally clear to me what the goals are by contacting the university. We want the universities, all the universities, in the United States to provide us all information about all human radiation experiments. CHAIRPERSON FADEN: No, no. The issue, this committee would then determine whether any universities should be asked to collect records and make them available and, if so, which universities and for what purpose. But if we determined that records in possess of universities would be useful to the deliberations of the committee, that's an if. Okay? Then the question on the table was: Should we approach the universities directly initially or should the requests come from the agencies? So all we're into is if we decide we want to get records from the University of Chicago, which I understood we had already endorsed yesterday, then requests for the University of Chicago to get together all of its records with respect to in this case the plutonium experiments should come initially as the proposal on the table from the agencies who sponsored that work. DR. ROYAL: So we're only talking about the University of Chicago and University of Rochester? CHAIRPERSON FADEN: Right this minute that's all we're talking about and in specifics, in specific relation to the plutonium experiments right this minute. We're not talking about a letter to every university medical center saying "Send us everything you've got." Duncan? DR. THOMAS: I agree with Patricia that contracts with universities ought to be done through the agency, but I want to turn to the general question of what information we're going to be requesting from universities outside of these specific targeted requests towards said University of Chicago. CHAIRPERSON FADEN: Before we go to that, Duncan, let me just get closure on this one issue. And then you'll have the floor right back. DR. THOMAS: Okay. CHAIRPERSON FADEN: I take it that Pat's suggestion is endorsed that in requests for records from universities, that initial request should come from the agency or agencies that sponsored the work that caused us to be interested in that university in the first place. Good. Okay. Then I take it that that's it. Now we go to the point about what we're going to ask for. DR. THOMAS: Well, really, all I wanted to say about the general request is that it's premature for us to be talking about that until we have addressed Item 7, which is the prioritization of the search in the first place. I don't know whether the committee yet wants to move to Item 7, but let me just say that I find it very hard to see how we can go about prioritizing the search until we digest what information we already have in hand. And that has certain implications for databases and things, data which we want to organize our knowledge up to this point so that we can digest it. I'd like to put that on as a sort of high priority for discussion this afternoon. CHAIRPERSON FADEN: Absolutely, absolutely. Can we hit some of the other specific ones? Although I think that Duncan's point is very well-taken, it's hard to -- I picked the university one because it was kind of content-free. It's if we decide we want to get information from the university around this particular purpose, who's going to get it. We've clarified that. But the tougher question is: What would be the reasons for wanting to go to universities which line up with the question of priorities? Could we look at some of these other specific ones, for example, with respect to -- this is so we can give DHHS and our staff something to work with on Page 24, Item 4, which says "Limit search of clinical center documents." This is an example of where Duncan's point is so absolutely pivotal. As Dan already pointed out, obviously everyone who comes to the clinical center at NIH is by definition an experimental subject. That's how the clinical center is in a sense set up, as a research subject, an experimental subject in a narrow sense. And so many people at the clinical center have, at one point or other, been exposed to ionizing radiation we can't even begin to think about it. It's sort of busy-making and largely irrelevant. Do we want to put aside the issue of the intramural program for the moment? Do we want a subcommittee to deal with the intramural program? Do we want to think about what to do with the intramural program out loud now? Duncan? DR. THOMAS: I agree that for the time being, I think we should postpone or limit the search of the clinical center records, but I just wanted to express my puzzlement over the last sentence of this paragraph. It seems to me counterproductive to limit the search to those who have consent forms when our concern is whether or not the work -- CHAIRPERSON FADEN: I agree. It was in there because it came up, but I agree completely it kind of is sort of the cart before the horse problem. Ruth? DR. MACKLIN: Again a question of ignorance. Is there any knowledge of or evidence of any collaborative research between the NIH intramural program and any other agencies? CHAIRPERSON FADEN: I don't know the answer to that question. DR. MACKLIN: I mean, the reason I mention that is that a reason not to limit it or a reason to identify those might be because they would be of some interest. So if, for example, the use of ionizing radiation involves only medical procedures, dah dah dah dah dah, but those particular experiments were somehow involved with other agencies, then that would be a reason to look at them. CHAIRPERSON FADEN: Jay? DR. KATZ: Yes. The question of looking into the intramural work is only tabled for the moment or -- CHAIRPERSON FADEN: That's because of the previous -- DR. KATZ: No, no. We have many more important things to do now, but eventually -- and this may not take too long a time -- we want to look at what they are doing: one, because we want to find out what the nature of the research is that they are conducting and get a sense of that. And also I know from research done at the intramural center in other medical areas that a number of these patients coming to the centers really believe that they are getting the best possible kind of treatment, rather than that they're participating in experimental programs, that their notion -- and this is also supported by the general practitioners that refer them to the research center, "Look, you really ought to go there. They have nothing to offer you. You'll get the best possible kind of treatment there." And in patients' minds, treatment and research becomes equated. CHAIRPERSON FADEN: Yes. DR. KATZ: So we may want to look into that and see what's going on. CHAIRPERSON FADEN: I think what I'm hearing is that clearly there are good reasons for looking at the intramural program at NIH in line with the mandate of this committee, that we don't need to do it right this minute. We have some other things that need our attention first, -- DR. KATZ: Are more important. CHAIRPERSON FADEN: -- but we will return to how we want to work with DHHS looking at the intramural program. If that's agreeable to everybody, if we could look at Options 2 and 3, which are specific? We've got two proposals from staff that Dan enumerated. Option 2 is that we work with DOE and in an attempt to identify through the AEC records isotope distribution as a means towards flagging DHHS studies or DHHS predecessor agencies. Is that a strategy that the committee wishes to endorse? Mary Ann? DR. STEVENSON: I think it's really important, though. There were and still are specific DOE-sponsored laboratories within universities. There's one up in UCSF campus. And I don't think there are a huge number of them, I imagine 20 or less, but those particular laboratories that have been in the past, maybe continuing even now, to receive specific monies from DOE should really be identified. It would just make our work much easier. CHAIRPERSON FADEN: So this is a separate issue, Mary Ann, of the fact that there are DOE-funded labs, basically, whole labs, full -- DR. STEVENSON: That are specifically working on radiation issues, you know, maybe just at the cellular level, but at the past it may have been specifically in relation to human radiation experimentation. CHAIRPERSON FADEN: This goes to the DOE issue generally but relates to this? DR. STEVENSON: Yes. And there may be some cross-funding between HHS and DOE, but they have been always considered sort of DOE-protected laboratories. And they compete differently for funding. But I think it would make our job easier if we could identify and name those laboratories because we could focus. CHAIRPERSON FADEN: Is everyone in agreement with that suggestion? It seems like an obvious one, but it takes the expertise of the committee to bring those things out. So that's wonderful. We endorse Mary Ann's suggestion as a research strategy, again trying to connect up DOE and DHHS. But are we also on board with respect to the isotope distribution records as a good strategy for pursuit on the part of the DOE sort of narrowing the DHHS predecessor agency search in line with what we could find out from isotope distribution records? So Option 2 is endorsed if I don't hear any objection. Option 3, then, is almost the flip-over in some ways or the complement, maybe not the flip-over, that if we're going to use the isotope distribution records to try to get at research that's isotope-based, that we really concentrate in the extramural program at looking at non-isotope experiments. Can we have some discussion of that? Gil, did you want to get in on it? DR. WHITTEMORE: Just to explain briefly the logic behind that and why the phrase "for now" is in there, my understanding is at this point we don't really know how complete DOE's isotope distribution records are. From the summary sheets that are published in the annual reports, they seem to have had a fairly detailed knowledge of the research being proposed. And at this point it might be inefficient to have HHS looking in vain for records of isotopic experiments if DOE, in fact, still has those files readily accessible; so for the immediate time period for the next step, perhaps to have HHS focus on those kinds of experiments that DOE we assume does not have any record of, namely those involving X-rays. MS. KING: This, I understand it, then, is an alternative the way it's just been explained. MODERATOR GUTTMAN: Complementary. MS. KING: Complementary? CHAIRPERSON FADEN: It's been suggested that we would do both. MODERATOR GUTTMAN: The box is HHS has, as Eli said, a radiation section. We're going to focus on the radiation section. And then what's the most efficient way to focus on it? Well, instead of HHS looking for what particular descriptions of radioisotope work, we know that they're very vague. Maybe go get those through AEC. CHAIRPERSON FADEN: Or see if we can. MODERATOR GUTTMAN: Right. And then as to the non-isotope through X-rays, then focus HHS in that respect. It's a box and narrowing. CHAIRPERSON FADEN: It may not work. I mean, as Gil suggested, it may turn out that we don't get enough information from the AEC records to make this coherent, but for right now it seemed like a plausible strategy that might introduce some efficiencies into the work of the staff and, importantly, into the work of DHHS so that they would know what we're looking for. Nancy? DR. OLEINICK: I keep seeing complications in some of those. Now, back in the '40s if anyone wanted to work with radioisotopes, they would have to go to one of the AEC facilities that was producing the isotopes. There was no question. So their records to the extent they have records on it, that is definitely the way to go. And I don't really know the history of exactly when commercial organizations began to find the isotopes and incorporate them into various precursors. And then you would know, for example, that, I mean, Amersham or NEN were the ones that were getting the tritium and P32, the various isotopes, and incorporating them because many of the radioisotope experiments involve using precursor chemicals that are not completely the isotope, but they contain the isotope as one or more of the atoms of the molecule. And then that material would be fed to an animal or cells or whatever and looked for where that isotope distributed itself. So at some point the commercial operations were getting the isotopes again from these laboratories. So somebody has to be producing them and then incorporating them and then selling them very broadly. So I don't know exactly what the history is and exactly when this came in, but at some point this particular search is going to not be as revealing as you'd like. MODERATOR GUTTMAN: Can these guys comment on -- CHAIRPERSON FADEN: Ron, do you have a comment that you want to make on that point so we can -- DR. NEUMANN: I can answer that a little bit. We found in annual reports in the early years that it began by contracts between the AEC and the four or five companies that began labeling precursors, but there was a relationship that existed. The second aspect is that, even if you bought the radionuclide-labeled material, you still had to have a license from the AEC or its successor, the NRC, to be able to receive it. So, again, the strategy would focus on using that as a search strategy. The difficulty becomes apparent early when they allowed the institutional licenses to exist. And at that point one has to then go to the institutional records of its approval processes to find the individual investigators, but I think that still gives us a framework to do that. CHAIRPERSON FADEN: Thank you. We're clearly going to have to work all angles, but can we have a general endorsement of that strategy? We're now on Page 25, where we have Option 7, which is the big one, which maybe we can defer for this afternoon. But with respect to 5 and 6, 6 is the help line. Can we work with that for a minute and then hope we say something about 5 or 6 and then break for lunch? Six is the help line. Is there an interest on the part of the committee members in working with the help line? Duncan? DR. THOMAS: It doesn't seem to me that HHS has received very many referrals. CHAIRPERSON FADEN: No. DR. THOMAS: I think the hotline is important, but we should go through DOE for this purpose. My understanding is they have a database already assembled which they've expressed willingness to turn over to us. I think they should do that as soon as possible, and we should take a look at it. CHAIRPERSON FADEN: Is that the will of the committee, go straight to DOE and get the kind of master database that they have? And then we'll have to figure out, maybe get a staff analysis of how the information from the hotline might be used. And then the committee can look at the next meeting as to which of the strategies staff suggest we would want to endorse. Mary Ann was in and then Jay. DR. STEVENSON: Do we think that we're going to pick up different incidents or different people through the HHS hotline? Because it's stated that this option requires minimal staff time. And it's potentially useful, but -- DR. THOMAS: The answer to that is in there, frankly, because people count. And everybody is here because of individual human beings. And any hotline/help line thing deserves -- DR. STEVENSON: Right. I mean, it sounds as though -- MODERATOR GUTTMAN: No. It doesn't look like -- as the cost-benefit, it should be a relatively easy thing to do. DR. STEVENSON: Right. MR. GUTTMAN: And I think we should do it. DR. STEVENSON: I think we should keep the option open, even though -- MODERATOR GUTTMAN: Right. We should do it. Right. DR. STEVENSON: -- the DOE may be numbers-wise or -- MR. GUTTMAN: Right, right. I mean, this is in there because this is about people, not because we expect to find, you know -- DR. STEVENSON: Right. So I would say that we should keep that option open if it's -- CHAIRPERSON FADEN: And expand. Make sure it's a -- DR. STEVENSON: And make sure that the DOE hotline as well is -- DR. THOMAS: I would just like to establish whether or not these individuals are already logged in the DOE database. DR. STEVENSON: That was my concern. Are we getting different people through this? MODERATOR GUTTMAN: Well, I think it's a relatively small, discrete, at least -- CHAIRPERSON FADEN: I don't know the answer. Are they removed? Does anybody know? Faith, are they removed? MS. BULGER: Yes. I can just give you a brief outline of how the DOE help line is working. Any call that any agency gets, including Congress, et cetera, they are supposed to refer everyone to the DOE 1-(800) number. And everyone calls in there. And they log people in on this very short form, but they have certain information that they get. They enter every call into a central database. So they're keeping track of that, and that's taking a lot of their time. And then what they do at the help line is then refer. If they can identify another agency that they believe is the primary agency that might have had responsibility or contact with a particular person or incident, they refer that person's call or the information on that person's call. After they've entered it into their database, they refer it to the agency. So these referrals have already been logged in to the DOE hotline, but the follow-up to the callers themselves is the responsibility of the referral agency. So HHS now has responsibility for determining whether or not these calls deserve follow-up, what kind of follow-up, and how much. This is a very limited recommendation because it sounds like they've gotten 20 calls. They've made an initial decision that three or four were potentially patients at the clinical center. And they've essentially sent out letters to the other 16 saying "We don't think you've been connected or what you've described is any identified HHS activity." And that's the extent of the follow-up with those 16. With the other four they're trying to get in contact with them and do some more extensive follow-up. They believe they have medical records for three of those and maybe four in their files. CHAIRPERSON FADEN: Duncan, do you want to? Then let's close this one. DR. THOMAS: In that case there doesn't seem to be any priority for us to do anything with those at the moment. We should certainly follow up any leads, but for the time being, HHS is doing a good job on it. MS. BULGER: Exactly, exactly. The only suggestion in that option was something that came out when we were discussing with DOE about their help line. The initial month of their operation of their help line, they were taking much more extensive histories of the calls, and they were actually asking for written documentation that the callers had about anything that related to what they were describing. And they received written documentation from this first month of calls, and they said that they found that that documentation was very helpful to them in determining whether or not it might be something they wanted to follow up on. And so our only suggestion here, what might be that the agencies as we continue to look at their response to these calls, that they're getting referred, that it be consistent across the agencies and that if it doesn't require a lot of their staff effort, that they could request in a second follow-up letter, "Please provide us any written documentation you have that might help them further down the line make calls" and whether or not it was related. CHAIRPERSON FADEN: I think we need to close the discussion on the help line. We can return to it this afternoon if we want to come up with more specific recommendations. DR. KATZ: I just want to later on make one comment, but it can be this afternoon. CHAIRPERSON FADEN: So maybe in the interest of eating lunch and getting to our major task, of which this is a clear part -- Pat, did you want to say something right this section on 5? MS. KING: Option 5. Are you going to discuss -- CHAIRPERSON FADEN: I was going to table Option 5 until this afternoon. MS. KING: Oh, okay. CHAIRPERSON FADEN: But if we can handle Option 5 quickly -- I'm just wondering whether we can. MS. KING: Maybe we can't. CHAIRPERSON FADEN: Maybe we can't because I think it's tied into this sort of where do we want the whole strategy to go. And then wherever the strategy goes, presumably interviewing relevant people would be an appropriate thing to do for some strategies. So let me ask the committee. We're going to have lunch in the same spot, Anna. I don't know if they'll change the cheese or what, but it's the same buffet. Let me ask you this. I'm so concerned because I know after lunch people come, are tired, or whatever. Please take, eat, drink, whatever you need, caffeine, Coke, or whatever, to be awake. We are shortening the lunch break. I know people like to take a walk or whatever, but we're going to end at 3:00. So take your walk afterwards. We just really want to come right back at 1:00, work hard, and end at 3:00 o'clock. So eat so as to stay awake. (Whereupon, a luncheon recess was taken at 12:07 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (1:05 p.m.) COMMITTEE DISCUSSION--COMMITTEE/STAFF WORKING RELATIONSHIPS: SUBCOMMITTEE ON PUBLIC OUTREACH (TAB J) AND FORMATION OF OTHER SUBCOMMITTEES CHAIRPERSON FADEN: We need to get started right away. We have two hours and everything to do. Let me just draw your attention to a piece of paper in your huge pile of pieces of papers that was plopped on your spot if you could find it during the lunch hour. It looks like this. Pat, do you want to say a word about why it's there and what it is? MS. KING: I asked that it be reproduced because this document, which is now declassified, was given to me by someone, an historian who does work trying to get documents from the government. It was declassified in 1994. Several things to note about it. The first two sentences say "Because there's a fear of adverse effect on public opinion and may result in legal lawsuits, documents covering such fieldwork should be classified secret." You will also note I think I have two documents, but one of them exempts, as you have pointed out, this one, therapeutic protocol. Note that there are two classifications. One, this was restricted data. That's the classification that we're talking about this morning. And within restricted data, this was secret data. This was classified at the time that the Nuremburg trials were taking place in Germany. This is to give everybody a clue. CHAIRPERSON FADEN: A kind of sobering pause to realize what we're dealing with here. MR. GUTTMAN: Note also it refers to the Department of Commerce in this document. CHAIRPERSON FADEN: Great. Good. That's wonderful. I didn't see that part. Where's that part? MS. KING: It's in the last line on the first paragraph. CHAIRPERSON FADEN: Terrific. That's great. Good. DR. MACKLIN: Who is Dr. Fidler? CHAIRPERSON FADEN: Anybody know who Dr. Fidler was? MS. KING: Gregg knows, but he's not here. Do you know? CHAIRPERSON FADEN: Jim, do you know who Dr. Fidler is, to whom this is cc'd, "Attention: Dr. Fidler"? MS. KING: Gregg knows about this document. MR. DAVID: I think he was involved in extensive leading Manhattan projects for biomedical research work. I don't know what his position was at the newly established Atomic Energy Commission. CHAIRPERSON FADEN: We'll pursue it. This is not to start a substantive discussion about what was going on there, but merely as a sobering reminder or introduction to the sensitivities of the period in which we are going to try to be working and the importance to access to classified material, basically, is the -- DR. MACKLIN: Can I just ask one other question? CHAIRPERSON FADEN: Sure. DR. MACKLIN: What is the Corps of Engineers? What authority would they have had in this? Who are they? I mean, the person who signed it was a colonel in the Corps of Engineers. CHAIRPERSON FADEN: Jim, do you want to go into -- can you come to a mike, Jim, for a second because it won't be recorded? MR. DAVID: Just very quickly, the Manhattan Project, which was created in 1942 to build the atomic bomb, was placed within the Corps of Engineers of the United States Army. And many of their personnel continued working for the Atomic Energy Commission when it was established in January 1947. CHAIRPERSON FADEN: Thank you. Let me just give you my personal sense of what we have to do in the next two hours. And then as a committee, we can do something totally different. But however we get there, by the end of the two hours, we have to have very clear, very specific instructions to staff about what we want them to do between now and the next meeting. As I said in my opening remarks, the staff can only be as good as we are specific and useful in our directions to the staff. And included in that, we have to give very clear guidance about how we as individuals, either in the context of the whole committee or in formation of subcommittees, mean to work with the staff towards achieving those interim objectives between now and the next committee meeting. So we have to leave today, 3:00 o'clock, with the real specific, very careful understandings that we all agree to about what's going to happen between now and three-four weeks from now, when we meet again. Otherwise, we will lose part or all of, a 12th of, the time that we have to accomplish our tasks. I'm always mindful of the fact that we only have a year to do all of this. And while ordinarily we would wish to have more time and the time to get to know each other and kind of form a Gestalt and all that kind of good stuff, these are luxuries we cannot afford in the context of this committee. In line with that, what I want to do is take a few minutes to summarize what I think we have already said we want staff to do and then move on to areas where we kept saying "We'll do it this afternoon. We'll do it this afternoon. We'll do it." Now it's this afternoon. Looking at my notes over lunch for the past two days, it seems to me that we have as a committee endorsed, first, that the staff continue with at least two, but I think all three, of the case studies. It would bear some discussion to see if my recollection is correct. With respect to the Cincinnati experiments case study, we have endorsed the suggestions of staff, as I understand it, to try to establish whether there was an original protocol and, if so, how to get it. We have endorsed, in addition to other things that the staff has recommended, an attempt to get information about particular patients insofar as that it's possible to flesh out who they were and how they were selected and their experience. And we have endorsed that the staff try to determine the extent to which the driving force for these experiments were military in purpose, the advancement of medical management of cancer in purpose, or some combination thereof that we're still struggling to get that part of the story straight. With respect to pursuing the case studies regarding plutonium, we have, I believe, endorsed that now through the relevant agency, the Universities of Rochester and Chicago be contacted to provide us with relevant information that would bear on those, on the plutonium experiments. We might want to take some time thinking specifically about what it is we want to ask. Sure, Mary Ann? DR. STEVENSON: Are we choosing them just as -- I mean, there were other universities or institutions that were involved in the plutonium. CHAIRPERSON FADEN: We should take a minute now. Do we want to deal with all of these? At this point do we want to deal with all of the universities that were involved in the plutonium experiments? MR. GUTTMAN: The practical distinction is UC is a major contractor for DOE now. CHAIRPERSON FADEN: Right. MR. GUTTMAN: And DOE had said the committee has got to deal with what we should do with people who are -- "Tell us what to do with these nine present contractors." That is a cut, in addition. CHAIRPERSON FADEN: From the committee's point of view, are we interested in information from all the relevant universities involved? DR. STEVENSON: I think we're eventually going to need it. CHAIRPERSON FADEN: Pardon? DR. STEVENSON: I think we'll eventually want that. The question is: Do we need it now? CHAIRPERSON FADEN: We might as well start now. We might as well do it now. Okay. We might want to return to exactly how we want to craft that or leave staff some room to do that. We will do that. We also talked about wanting in the context of the plutonium experiment to follow up leads that staff have uncovered with respect to linking the experiments conducted at Cincinnati with other experiments that seemed to have been following a similar program of research with similar bases of funding, to try to get a larger picture of how that would fit. And, in particular, we want to know this issue about planned studies, this notion that there were other planned studies, but we can't tell whether they were implemented or they weren't implemented. If they weren't implemented, why weren't they implemented? If they were implemented, what happened to them? They were all part of this initial attempt to understand more about what these materials did to human beings. With regard to the Green Run, it is my understanding from my notes, but I'd like to verify it with the rest of the committee, that we did endorse staff to pursue the Green Run experiment, at least insofar as it would be helpful to get the policy documents that would help us understand where the Green Run experiment came from and how it related to other interests that were occurring at the same time, which is basically to try to get the background information as to whether anyone ever challenged the propriety of doing the Green Run experiments, what the thinking was of the people who authorized the experiment, and the kind of follow-up afterwards. Staff seem pretty confident that they know where to look for the answers to those questions. So we're not talking about a tremendous amount of sort of fishing. There's a high degree of suspicion as to where the answers to these questions sits. DR. MACKLIN: I don't know if you have the exhaustive list of questions. Wasn't there also the question there of the recommendation or the comment that this wouldn't be done again? CHAIRPERSON FADEN: Right. And why? DR. MACKLIN: And why? CHAIRPERSON FADEN: Right. This is all part of trying to figure out how this was viewed. Where did it come from? Was there any reflection about the ethics of conducting these tests and exposing a civilian population to the release? And that might follow from discussion afterwards about not repeating it or discussion beforehand about why it should be authorized. DR. STEVENSON: Just kind of a logistical question, wasn't that information within classified documentation? CHAIRPERSON FADEN: That's right. DR. STEVENSON: So either it has to be declassified or somebody has to get a security clearance. CHAIRPERSON FADEN: That's correct. That's correct. That's my memory, too. Okay. We also in the discussion just before lunch endorsed specific options in the staff's memo with respect to DHHS. I won't rehearse those, but it's very clear in my notes anyway that the committee has endorsed Options 1, 2, and 3. Which one is 4? One, 2, and 3. Four we said we'd put off, which is the clinical center, but 1, 2, and 3, namely going to the policy-level documents as well as the experiment-wise research, using the isotope records of the NRC to try to refine what we can do with DHHS and emphasizing non-isotope research for the extramural program, DHHS, for the time being and going through the record policy-level stuff for that as what we have endorsed specifically for staff to continue to work with DHHS to pursue. We didn't have as focused a discussion about DOE because we took on the larger questions, which were very important, about classification and the philosophy of the project. We may need to return to that now or go to a subcommittee. Let me introduce right away, then, the issue of subcommittees and then -- DR. KATZ: One question. CHAIRPERSON FADEN: Sure. DR. KATZ: It may come up later. I would suggest that the case studies, the uranium -- CHAIRPERSON FADEN: I'm about to -- DR. KATZ: You're going to -- CHAIRPERSON FADEN: I'm going to propose, actually, a subcommittee for that issue. DR. KATZ: Okay. CHAIRPERSON FADEN: I don't think that the whole committee is positioned to -- DR. KATZ: Yes. CHAIRPERSON FADEN: -- is as knowledgeable, for example, as you and Duncan are about the uranium experience, the uranium miners' experience, to endorse or not endorse. The staff has spent a lot of time thinking about how to profitably advance its work by close working relationships with the committee members. And the structure that obviously suggests itself is the subcommittee structure. Let me say a few things about subcommittees, and then I'll lay out some proposals for the kinds of subcommittees that we might want to endorse. First of all, we could have subcommittees of several types. We could have standing subcommittees. That is to say, the subcommittees that would endure for the life, for a good chunk, of the committee's work. We can also have specific subcommittees directed around a particular issue that once that issue is resolved, the subcommittee no longer has a reason for existing, and it would end. Whichever kind of subcommittee we would construct, standing, specific or both, subcommittees would be staffed. There would be at least one staff person and probably more than one staff person that would be assigned to provide support for every subcommittee. And it's very likely that subcommittees would be composed of members of the committee and members of committee staff. We would meet. Subcommittees can meet in person if they choose to. We have the resources to have a number of subcommittee meetings face to face. We envision, however, given how busy people's schedules are, that many "subcommittee meetings" would occur by telephone conference, which the staff could facilitate. We can manage the FACA requirements for openness as necessary either way. So that's not a problem. And some subcommittee work can obviously be done by E-mail or non-electronic correspondence. We would have presumably the kind of subcommittees that would produce recommendations or options for the full committee then to debate or endorse the option or options that seem most appropriate for the committee as a whole. And I don't think there's any way to predict how much work any particular subcommittee is going to produce for any particular subcommittee member. So I don't know that we can really invest a lot of profitable energy in trying to think through how much time this is going to take. It's hard to know. We would have to agree to be on subcommittees with a good faith understanding that if we can't really keep up with it, for whatever personal reason, we'll have to step back and say "I'm sorry. I just can't help as much as I thought I could help with this particular effort." But we couldn't in advance guarantee you that the subcommittee will only have three telephone conference calls or will only have to generate X number of memos to one another. There just wouldn't be any way to do that. So that's by way of administrative backdrop. Now by way of potential subjects around which to form subcommittees, there has been a request from staff that there be a subcommittee that deals with the general set of questions having to do with outreach. There is a memo that has been circulated for committee review for options with respect to outreach in the broadest sense, outreach with victims and survivors' groups, outreach with the general public, press, Congress, and so on. So there is a desire for people who have an interest to work with staff on questions of outreach, there be an outreach committee. And depending on how the subcommittee goes, there would be proposals coming back to the full committee, if necessary, for endorsement of a particular strategy or another. It occurs to me based on the discussion today, in particular, that it would be useful to have a subcommittee that would deal with the general issue of monitoring responses to requests for declassification, a strategy group, basically, who would deal with issues of declassification and would work with staff to monitor responses to requests for declassification and to be making assessments about the impact on the committee's work as we run into, should we run into, obstacles with respect to questions of declassification. We also in the staff discussions have addressed whether it would be useful to have two broad subcommittees, which may in the end break down into more than two to roughly correspond to the two story lines that, at least so far, kind of guided the staff's work, namely that there would be one subcommittee that would deal with the question of elucidating ethical principles, standards, and practices from 1944 through to the present. This subcommittee would really focus on those sets of questions. The immediate need is we need to start thinking hard about what we can accomplish by way of establishing practices as well as guidelines and formal rhetoric-type statements. What can we profitably do in a short period of time to establish whether and to what extent there have been -- what the practices have been and how they have changed, if they have changed at all, with respect to involvement of human subjects and in research involving ionizing radiation, in particular, and research involving human subjects generally? Paralleling that, there has been a suggestion that we have another broad subcommittee that works with the staff to guide strategy with respect to telling the Cold War story, basically the story of how human subjects and science involving human subjects was used to advance the interests of society other than interests in advancing human health or where advancing human health was a sub or a parallel interest, but there was a clear military or defense interest that lay behind the research. So so far an outreach committee, a monitoring classified material problem committee, a committee looking at ethical principles and practices guiding research involving human subjects, a committee working with staff, subcommittee on the Cold War story, and now two other committees to consider: one, a committee to address the issue that Jay raised earlier, which is the scope of the committee regarding specific areas of inquiry that have come to the committee's attention where there are questions about whether they fall under the mandate of the committee, which is essentially a subcommittee to explicate the mandate in a meaningful way to deal with how to interpret that mandate, broadly or narrowly, and whether particular additional cases would fit under it. And here we would put the issues relating to the uranium miners' questions that have been put to us about the possibility that experiments, something that would be called experiments, involving Micronesia should or should not be addressed by this committee. So it would be basically a subcommittee to then make recommendations to the whole committee, either "We should take this on" or "We shouldn't take it on," and "Here's the reasoning why we should" or "we shouldn't." And, finally, a subcommittee -- and I'm not sure whether this can be articulated as separate, but this goes to Duncan's concern we tabled from this morning about setting priorities; in particular, setting priorities with respect to case studies. Now, this is related, obviously, to the adding of case studies or the deleting if that's the view with respect to Green Run that might come out of this subcommittee. But it has more to do with: Even within the experiments that clearly fall within the mandate of the committee, are there some that we want to select for intensive investigation or what methods do we want to use for identifying those for intensive investigation? I'm not sure how that subcommittee would work separately from the subcommittees working on the substance of both the Cold War story and the ethics in science story. My guess is in the end, you'd end up all working together, but some mechanism for setting priorities as to whether the committee is going to land on specific case examples to consider in considerable detail. So I've got six subcommittees -- this may not be the right structure -- on the table for discussion. Henry? DR. ROYAL: I would suggest combining the scope of committee and priorities into one subcommittee. It seems to me that there's a lot of overlap between what those two committees might do. CHAIRPERSON FADEN: So that's the consideration of which ones we should land on would include those that are newly being brought to our consideration as well as the ones that obviously fall. Duncan? DR. THOMAS: I am interested in both. So for me it's immaterial as to whether they're one or both, but in my mind they're very clearly different activities. One of them has to do with our mandate and whether a broad substance area is to be considered by us. And the other is: Given that decision, how should we then go about targeting the records retrieval process so that we get either an exhaustive or at least a representative sample of cases to talk about? I think they're very different activities. DR. ROYAL: I wasn't suggesting that they weren't different activities, but there's a lot of overlap between the two. And I think that, rather than having lots of different committees, it would be better to have one committee address both of those different issues. DR. THOMAS: Certainly if everybody who is interested in one is interested in the other, we might as well make it one committee. CHAIRPERSON FADEN: Right. You could decide to deal with those issues serially in the order, for example, that you've just discussed, Duncan. You could start with one, resolve the one by the full committee, and then return to the other. Jay? DR. KATZ: I would suggest that we add a separate subcommittee to look into the '74-'94 research studies done. CHAIRPERSON FADEN: I was folding that into the ethical principles and practices subcommittee since it seems to me that if the mandate is to look at principles and practices from 1944 through to the present, it would incorporate the '74 forward within it, again within the spirit of not having too many subcommittees since the thinking would be we elucidated our strategies for trying to figure this out. You know, should they be different pre-'74 than post-'74? Why or why not, that kind of thing that would be all of the piece? But I'm open to either way of constructing -- DR. KATZ: Well, to the extent to which I've thought about this, if you fold it into the policy analysis, that could only come after we know more about what has happened since the federal regulations went into effect in 1974 because it seems to me that it's largely that aspect of our work that will have to make us think hard whether to recommend further changes in policies because the argument in today's world is yes, you know, I can understand why you are concerned about 1945 to the 1974 for historical reasons, but we don't have anything to worry about because things have changed so much since 1974 and everything is now in very good order. I don't believe it, but I will be pleasantly surprised if our investigations will show that the federal regulations are working. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: I agree that we need to look at that. And maybe a subcommittee is a good way to do it, but I would suggest that we might have a more focused look at that question if we defer the formation or the beginning of work of that subcommittee until after some of the other things begin to unfold. That is, it may be that there's a historical picture or a time line and that we're not likely to find a sharp change in anything at a particular time, but there may be moments in time. So, just for example, we might find that some things changed in the ethical practices, standards, and policies around 1966, which was when HHS set up its -- or not required, but recommended that committees be established, in which case there may have been an interim period in which there was informed consent and institutional review boards within HHS mandates, but not in other areas. So it may be more fruitful because this is a whole other advisory committee in a sense that you're suggesting. I mean, I think as it has a part and follows threads that we uncover in the course of the early investigations, we might be able to tackle it in a more manageable way a little later on in -- DR. KATZ: Ruth, I understand where you're coming from, but the '74 -- first of all, we're under the pressure of time. We have a limited period of time. And this will take work all its own. It's part of our charge in two ways: one, that we're specifically charge to at least "sample" '74 to '94. And we are also asked to make policy recommendations if indicated. And that's an enormous task of its own that eventually has to be tackled. And until we have some information from the subcommittee, we cannot really decide whether we can say "All the federal regulations are working reasonably well. And we only recommend" this, that, and the other thing or we may find that we really have to take a sustained look at how current federal regulations ought to be modified. So if we have an infinite amount of time, I think it's wonderful. I am concerned about our time pressure. CHAIRPERSON FADEN: It's actually, in part, because of the time pressure and also, in part, because of something that Ruth said that I'm resisting creating a separate subcommittee, Jay, and that is I don't particularly feel like I want to endorse the suggestion in our mandate that something magical happened in 1974. My own thinking about research practices, research policies, and research rhetoric about research involving human subjects, advancing our understanding of that would not be served particularly well by even implicitly in our methodology pretending as if something magical occurred, you know, and we're on a different planet as of 1974. So I'd like to see one subcommittee that deals with these as common threads. DR. KATZ: Also it's due to the fact that you know too much. Many other people feel differently. CHAIRPERSON FADEN: You know, if we set it up and thought about it all as a piece from the beginning, we might be able to advance the entire work of the committee, both more efficiently and also more coherently. We may apportion resources differently based on what the whole committee decides, but I would prefer a subcommittee that's given the whole charge. DR. KATZ: The whole charge of what? CHAIRPERSON FADEN: Of looking at ethical practices and standards. DR. KATZ: And '74 to '94? CHAIRPERSON FADEN: From '44 until the present and sort of come -- DR. KATZ: One subcommittee? CHAIRPERSON FADEN: One subcommittee that would work on -- by the way, I should mention the subcommittees can break down into sub-subcommittees or teams. I'm just looking for a structure that's not so long, really, that staff doesn't have 18 different subcommittees to deal with. If we can basically identify people by interests, then when the subcommittee meets, if it looks like really sustained work is required in a particular area, then, you know, Lois or Henry or Mary Ann or whoever can say "I'm willing to put a big chunk of hours into this" that the rest of the subcommittee members either don't have the interest or the time to do, and that would be all right. DR. KATZ: I would urge you to consider separating the time periods into two subcommittees because from what I know, it's too great a job to work with the entire period from '44 to '94. CHAIRPERSON FADEN: Let's do this. Let's do this. We'll have this full discussion. If the group wants two committees overall, we can have two committees or one subcommittee and have a whole lot invested in it. But did you want to speak to this? MR. GUTTMAN: A clarifying question because the staff has thought about it. Obviously, as difficult as it is with the old world, at least we know there were plutonium injection experiments and so forth, and they were finite. Post-1974 HHS has not even looked at its documents, not because it doesn't have them. It's because they're so immense. And so the question from the staff is: Where in this subcommittee structure -- or my question, anyway -- are people going to begin to focus immediately and how you would operationalize any search for information on the post? And Ruth's question, which subcommittee would it fit into? It could be in any number of these. CHAIRPERSON FADEN: It would be in any number of these. MR. GUTTMAN: Yes, yes. CHAIRPERSON FADEN: Pat? MS. KING: I thought Dan and I were going in the same direction, but I don't think so. I have the following reaction. I think we're arguing about pigeonholes. And when I think it through step by step, the staff probably has done it, but it hasn't been shared with us. It seems to me that we know we have to end up with something that tells a Cold War story and something that describes the policies and the documents and ethics, standards, and practices. So that part's easy. Those committees can't do very much without any data. CHAIRPERSON FADEN: Part of it is guiding the committee staff as to what kinds of data to look for. MS. KING: But the problem is if you put them into pigeonholes first, you preset your boxes. For example, the information from DOD about codifying the Nuremburg code is two pieces of information. It's a piece of information that goes to policies and practices. CHAIRPERSON FADEN: That's right. MS. KING: It's also a piece of information that goes to the Cold War story. Part of the problem is that if you start off with the priorities on the two committees that will ultimately do those tasks, the risk is that you will pre-confine part of the story to one box unintentionally. Am I being clear? CHAIRPERSON FADEN: No. It's blurry. MS. KING: So in terms of how I think through the subcommittee structure, the first structure that we need, it seems to me, is you can establish the committees, but the committees don't really have a lot of work to do except keep identifying the data that goes into their committee for their purposes. But what you need is a committee that: one, focuses on classified data and how to strategize to get it out, and you need another committee broken down by agency, if necessary, to guide the work through the agencies. That's where the work is. It's when the data starts to emerge and people start taking a look at it that you want it to be put into these other two long-range committees. I'm trying to do this in sequential order, not in terms of establishing them all today, but to think through how you do your work. And you can't do your work until you generate your data and then bring some analysis to the data. And you don't want to put it in the box too early. So instead of structuring the initial committees along these two stories, I would structure the initial committees along where we see data collection problems and trying to draw the data. And you can do that by somebody taking DOE, somebody taking HHS, somebody taking that way. That's one way of doing it. Another way to do it is classified versus non-classified. I mean, there are lots of ways to do it, but the emphasis ought to be on the subcommittees that pull out the data. MR. GUTTMAN: Pat, we may be thinking along the same line, but you had the intermediate step. The question that staff has is the post-1974 data. And so we haven't thought about even whether and what kinds of data. At least pre-'74 we know what the cutoff period is. We know. Look for everything about experiments that probably were classified, whatever. But post-'74 is: How do you even think about looking for that data that's got to be addressed? I mean, think. MS. KING: It's pulling out the data that's the most important thing for us to focus on, however you want us to divide up. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: I'm anticipating an objection here from Jay already, but the ethical practices and policies, while the policies did change, the practices are alleged to have changed in '74. We believe that the practices may not have changed so sharply or so dramatically. But the Cold War was still going on and with a vengeance. So one way that the two committees as described could do their work -- I mean, I'm really making two points. One is Pat's. And then I'm going to go on to say the other thing about post-'74. Let me say the post-'74 thing first. It makes good sense to trace out whatever we find that emerges in all of these agencies up to 1974, to continue tracing those experiments and/or researchers or whatever. I mean, those didn't stop in '74. Right? I mean, so there's a natural flow. This doesn't tell us everything about research after that, but it might tell us something about whether or not pieces of radiation research changed when the new regulations came in, whether people did anything different, whether they did exactly what they were doing before. So that's a way to track both the ethical practices, ethical standards and practices, and to see whether or not that had any -- there's going to be an intersection with the Cold War story, but it seems to me that's a focused way of looking at post-'74. Then if we want to go beyond that, if we have the time and the resources, we can, but at least it confines the study to the mandate of the committee in the radiation area. That's one observation. The other that goes to Pat's point is existing, having the two committees, one deal with the Cold War story and one deal with the ethical standards and practices, doesn't follow that you're going to lose anything. You just may not know where to put certain things. That is, if something falls into both categories, that's okay. And the -- MS. KING: I agree with those things, but I'm afraid that we will lose something. That is exactly my point. My point is to think about it in more fluid terms. My first point is I agree with the need for two subcommittees. I add an additional point to that, though. I said you don't want to focus on those two subcommittees just yet. We need them. Maybe you need in the back of your mind to be on one of the two. And we know that's going to get activated. What we need is the data that becomes the stories that would be told in both of those committees. And that's the immediate -- that's what I see as the immediate up-front problem. And I also see as the secondary problem that if you split up into groups and subgroups too quickly, sharply divided, with each of us having separate meetings, then data will, in fact, end up telling one story, where it really belongs in both stories. That is my fear. Now, maybe it's misplaced, but that was the fear that I -- DR. MACKLIN: As a very small practical matter, this can be handled very readily by staff. If, in fact, the staff working with the committee -- the structure of these committees, it can either have some overlap among the committee members or ensure that both stories are fully known by the staff who are working with it and can, therefore, work with both committees. CHAIRPERSON FADEN: Let me make an observation. I think what Pat -- this is something that I've struggled with, too, sort of: Which way do you go first and how do you connect the two? There clearly is need for staff to have continual guidance about how to deal with each of these agencies in this formative period, where we're trying to figure out how to do this as well as we can do it. And the interactions with these agencies really involve information that's relevant to both stories. This is correct. One concern I have about starting exclusively with a structure that has particular committee members working with particular staff members around -- this is the Energy Subcommittee, and this is the DHHS Subcommittee, and this is the Veteran Affairs Subcommittee, which we may want to have, is that here's one concern. The ethical practices story cannot be told largely with data from the agencies is my intuition, my working hypothesis. And that story has got to get started right away, again echoing the concern about time constraints. And most of the information for that story I don't think is going to come in some direct sense from the agency. So I worry that if we don't get a subcommittee structure starting to work on the ethical practices stuff quickly enough, you know, that that one I think needs to get kicked in right away. MS. KING: Ruth, we're not talking at cross purposes. CHAIRPERSON FADEN: Right. MS. KING: I used the term "data." I said there are lots of ways to approach figuring out how you want your data. One way is to have subcommittees divided up by types of data. One type of data may be practices data. One type of data may be: How are you going to classify data? CHAIRPERSON FADEN: Right. MS. KING: One type of data may be how you get at experiments data. But it's the data, that if you don't have the data, there's no story to tell of any sort. And so the question is to identify the data and identify how we will get there, exactly the point you posed, but knowing that there's a subcommittee that you're on when you're working on the data collection across these fields, that you end up trying to spend a lot of time telling the Cold War story. You're going to end up with a lot of time telling the policies, practices story. CHAIRPERSON FADEN: Right. MS. KING: I mean, you need to know that in your head when you're working on data, I think. But if we don't have the data, we won't get anyplace. And the data is cross-cutting, much of it. CHAIRPERSON FADEN: It sounds like there are several proposals on the floor. One is the one I put out, which, believe, me, I have no strong investment in. So it's okay. Another is we drop out the Cold War and ethical practices, one, as subcommittee structures for right now and get very particular subcommittees that are defined by data sources, one of which could be practices, but the others could be agency-specific. And another is that we keep the two that are the big story ones, but also have subcommittees right now that are agency-focused, which is kind of the one that appeals to me, but then you've got a lot of subcommittees going here. But that's okay if people can handle it and if staff can manage the structure. Ken? And then Jay. MR. FEINBERG: I like sort of a hybrid, a lawyer's love for order. I really see four or five subcommittees, just based on what I've heard in the last hour. One, there is a subcommittee on what we'll call scope. What is the mandate of the subcommittee? What is the mandate of our advisory committee? And once that mandate is sort of articulated by this committee, Duncan's point, included in the scope committee for the purpose of keeping a limited number of committees, within that mandate, what should be the case studies? What should be the detail? I like Henry's point on that. So one subcommittee is scope. Then there's a second subcommittee, what we'll call, what I call ethics, ethical practices. Let's articulate the universal principles. But I agree with the Chair that that critical committee should begin to work on articulating standards and the practices underlying the standards that go back in time, et cetera, sort of an ethics subcommittee. Third subcommittee clearly is outreach. That's easy, it seems to me. CHAIRPERSON FADEN: Right. MR. FEINBERG: That would be a third subcommittee. A fourth subcommittee probably has to await another meeting, but that fourth subcommittee to me is what we'll call remedies. That's premature. We haven't gotten into anything about remedies. But that will be an important subcommittee, I think. Then we get to the last subcommittee, and what I call as a lawyer -- and Dan understands this. I would call that the discovery subcommittee. That is a subcommittee devoted to the discovery of facts, Barbara's point, I mean, the discovery of facts. Now, within that subcommittee, we've heard all sorts of discussion about what we ought to be discovering. Look, I don't care how many people want to be on that committee and how Dan and the staff want to break it out in terms of let's focus on Cold War, let's focus on ancient history, let's focus on post-'74. How that discovery of facts subcommittee wants to go about looking for data, for data, and who wants to be on that subcommittee, you know, that's fine. I'd like to hear what the staff thinks is a realistic division of responsibility in gathering and collecting data, but it seems to me that is a finite project, which is pointed out very well, I think, earlier. That is we've got to collect data. Well, all right. However we do that, I mean, that's really what's going around. But meanwhile there's ethics, there's remedies, there's scope, and there's -- CHAIRPERSON FADEN: Two points. I like the structure with two concerns that we've discussed. Dan and I discussed this ad nauseam. The data-gathering function crosses the ethics committee function. That's a problem. There's going to be an awful lot of data gathering to elucidate what the ethical standards were. So when you separate the two, you've got an artificial -- the label suggests somehow that the ethics subcommittee can do its work without data gathering, which is impossible. MR. FEINBERG: Two answers to that. One is it doesn't mean, as I think somebody pointed out earlier, that that ethics subcommittee is up and running on day one and can do its entire task. That doesn't mean we shouldn't have it. Second was your point, which I may have missed earlier, in which you suggested that there's some ethical "work" where data gathering or agency information won't be particularly helpful. CHAIRPERSON FADEN: Here's where I want to distinguish, Ken. It's data gathering, but not from the agencies. Information about practices with regard to the involvement of human subjects in science from 1944 until whenever, until now, is going to require a lot of data gathering, but a lot of that data gathering is not going to be in the form of requests to DHHS or DOE for documentation. It's going to be in some cases original research done by committee staff. In some cases it may be commissioned work. In some cases it may be data from secondary sources, but it's going to be data gathering. Now, this is a discussion Dan and I had a long time now running about how to understand the discovery process, to use that language. MR. GUTTMAN: I gave away your argument, Ken. CHAIRPERSON FAD time at the beginning during the data gathering is going to make it very difficult for us to find some of the data and to organize it. I think what we need to do is save those distinctions for later, not for the initial data gathering. CHAIRPERSON FADEN: So that's a vote against or at least argument against. Mary Ann? DR. STEVENSON: Okay. On a different tone, I just want to reiterate and underscore Pat's concerns about this data collection because it to me still seems that we're very vague in terms of the extent and the timeliness. And ultimately that's what we have to have. I think a subcommittee might be helpful in really delineating just how much time we have. We cannot search forever, and we cannot get everything. So we have to decide when it's time to call it quits in a way. And I think, although we've discussed it somewhat today in terms of reviewing how the collection is going on in these various agencies, it still needs to be much more streamlined. And I think that's something that might, at least at the suggestion level, be best done in subcommittee. It's not that we're absolute. It comes back to the main group, and we vote on it or decide on it. But I think we're a long way from even getting close to the data, which is ultimately going to determine our scope and priorities, et cetera. We are so far from that it's really worrisome. CHAIRPERSON FADEN: It's a real concern. I agree. Eli? DR. GLATSTEIN: I feel the same way. I don't have anything in addition to that. CHAIRPERSON FADEN: Your endorsement was to what Mary Ann is saying, -- DR. GLATSTEIN: Yes. CHAIRPERSON FADEN: -- which would endorse Pat's more general structure. DR. GLATSTEIN: Also what Nancy said, too. I think that until we've got a grasp on what we really have in the way of meaningful data, I think it's kind of foolish to split it on a laboratory time scale. CHAIRPERSON FADEN: Dan? And then I have a point, too. MR. GUTTMAN: As far as we are from getting the data about the Cold War, we haven't even begun to think about this other, whatever period we're talking about. And Ruth may have suggested what may be an efficient way of doing it is follow things that we're following from the Cold War into the period that we call the modern period because they don't arbitrarily start or stop when HHS passes regulations. But the point I want to make is that in the process of setting the subcommittees, I think Jay has an excellent point. We have to start immediately to conceptualize what method to cover this modern period, whenever it starts, however you want to cover it, because we haven't even begun to ask for that data. DR. STEVENSON: I actually feel less overwhelmed by the modern era than some of the other people because at least I know from experience with NIH and HHS granting, grants that involved human subjects were flagged. I think a lot of this would be very accessible through -- MR. GUTTMAN: The data will be very accessible, but it's the volume. It's what's the research method or the operationalization of: What do you want to do with it? That's the question. It would be easier to get it, but you've got to think now about what you want to get and how much and that kind of thing. And maybe it's just an outgrowth of the earlier study. DR. STEVENSON: But I still think it will be much easier to screen because of the computer data. I really do. MR. GUTTMAN: Yes. But, as you're pointing out, the time frame we have is much easier. It means: Can you do it all in a week and a half? DR. KATZ: But, Dan, let's be careful about -- it's come up repeatedly -- the emphasis on the Cold War period and the ending of the Cold War period because that's really analogous to the defense of the Nazis that goes back to the concentration camp experiment. It was a national emergency. And, therefore, you had to do all of these experiments. And the excuse has been used and will be used that the Cold War necessitated conducting these kinds of experiments. I think that is only half or less than half the story. There are other forces at work that led to these experiments, and not to excuse it and maybe not even make too much of it, that it just happens that we are reviewing '45 to '74, that this can be understood because of the Cold War that had involved this. CHAIRPERSON FADEN: I think that's a mistaken conception of what's an issue here, Jay, if I understand what you're saying. I think we are very much concerned, at least I am -- I'll speak for myself now -- with that part of the committee's charge that has to do with looking at the ethics of research involving human subjects and ionizing radiation across time, regardless of when it occurs up until the present. That requires looking at research involving human subjects that it did not involve ionizing radiation, at least in part, because we have to make sure: A) that we don't contribute to any misguided understanding that somehow radiation or ionizing radiation is so much more worse or evil than any other kind of substance that one can investigate that it warrants in and of itself special consideration and also because, in fairness to people who work in ionizing radiation, we need to understand whether if there are any retrospective or current concerns, those concerns aren't more widely concerns for the entire community of people doing research involving human subjects. That's a very central part of what we're about. But we also are very much about the question and under what circumstances and whether, with adequate justification or inadequate justification, human subject research was used to advance interests that had nothing to do or little to do or only in part to do with advancing human health. And that's the Cold War story. Okay? And that's of central concern, I think, to the American public. The American public wants CHAIRPERSON FADEN: At least I am not in any way disagreeing with you. The only question that's on the table is whether it's necessary to have two subcommittees or one subcommittee to deal with that. DR. KATZ: Yes. In two sentences, three sentences, or four sentences maybe I'll finish this. I think that the task, the data-gathering task, is a discovery task. For one subcommittee to do pre-'75 and post-'75 is just too enormous a task. I wouldn't want to be on that subcommittee because I would have to drop everything. The pre-'74 task is an enormous task, and the post-'74 task is an enormous task. In fact, you have to figure first out: How did we get into post-1974, et cetera? So, therefore, I think for managerial reasons, we need to divide them up, but that comes from my personal views. And, of course, it ought not be subject to the decision of the higher committee. CHAIRPERSON FADEN: That's a sort of practical feasibility point for two committees, but if I fit Jay's suggestion within Ken's suggestion, which in some way fits with Pat's suggestion, that that would be essentially like two ethics committees, one dealing with pre-1974 or '75 and the other one dealing with post-'74 or '75? Is that your suggestion, Jay, if you fit it inside of Ken's suggestion? DR. KATZ: No. CHAIRPERSON FADEN: What is your suggestion? DR. KATZ: I think it's discovery, not ethics. MR. FEINBERG: As I understand it, it's a suggestion that the discovery of facts is so enormous there ought to be a Discovery A subcommittee and a Discovery B subcommittee, separate people, one looking pre-'74, one looking post-'74. My view would be if there's a large enough discovery committee. That subcommittee can decide for itself who wants to work on pre-'74 and post-'74. And it's still a subcommittee, but it's big enough so that people aren't overwhelmed with the task at hand. CHAIRPERSON FADEN: Okay. Thank you for that clarification. Pat was next, and then I see Nancy and -- no. I see Mary Ann. MS. KING: I share with Ken the lawyer's love for order, but I also have to combine my lawyer's instinct for order with what I know about some of these processes from some other committees. And that is there are both categories, but there's also a moving process. And it's trying to capture both that is giving us this difficulty. Let me suggest that I liked what Ken had to say except data on ethics is a duly artificial separation of subcommittees. The way this typically works is it's sort of like scales, that there has to be a lot of interaction between those people who concern themselves with ethics and an understanding of the data as it develops. And data plays a big role in the beginning fact gathering and then analysis, which is really the ethics part, plays typically in the committees on which I've served a bigger role as you work with the fact. But it's really an interactive process, particularly where you don't have, as we have had in past times in ethics, experts we call in to tell us what some of those facts are. This time it's one step beyond that, and we have to go figure out what the relevant facts are. So I actually propose -- and I don't know if this will be unwieldy, but I don't think so. I actually propose that there be a group that is joined that is concerned with data and ethics -- people will know who they are -- because you have to be concerned with both -- and as we go through the process, that that group split. And I don't think it's going to split, by the way, into data and ethics. I think it's actually probably going to split more along the lines that Ruth suggested in the beginning, which will be the Cold War story and the ethics practices and policy story, but they has got to be a common core of knowledge about both the discovery, what Ken called the discovery, and what he called the ethics. And so that's my fluid process development, rather than trying to pick categories. I have no other problems with the other parts of this category or any other categories he listed, and I actually think there would be some very good overlap and interaction between this sort of combined group and the group that deals with scope. But I think that that's a manageable interaction. I don't know if that makes sense, but -- CHAIRPERSON FADEN: Is everybody clear on Pat's suggestion? I'm trying to keep track of all -- I think Anna is, too; I'm not sure who else is -- of the permutations that seem to be the most different. I've got Nancy, Mary Ann, and I saw Eli, too. If we can just stay in order so that we can -- I'm sorry. It was Nancy and then Mary Ann. Nancy? DR. OLEINICK: The comment I would like to make has to do with making a distinction between pre-1974 and post-1974. Much of the data that we are looking for are long-term experiments, which began in the pre-1974 era and continued afterwards. And I think that making some artificial distinction based on some particular point in time at the beginning during the data gathering is going to make it very difficult for us to find some of the data and to organize it. I think what we need to do is save those distinctions for later, not for the initial data gathering. CHAIRPERSON FADEN: So that's a vote against or at least argument against. Mary Ann? DR. STEVENSON: Okay. On a different tone, I just want to reiterate and underscore Pat's concerns about this data collection because it to me still seems that we're very vague in terms of the extent and the timeliness. And ultimately that's what we have to have. I think a subcommittee might be helpful in really delineating just how much time we have. We cannot search forever, and we cannot get everything. So we have to decide when it's time to call it quits in a way. And I think, although we've discussed it somewhat today in terms of reviewing how the collection is going on in these various agencies, it still needs to be much more streamlined. And I think that's something that might, at least at the suggestion level, be best done in subcommittee. It's not that we're absolute. It comes back to the main group, and we vote on it or decide on it. But I think we're a long way from even getting close to the data, which is ultimately going to determine our scope and priorities, et cetera. We are so far from that it's really worrisome. CHAIRPERSON FADEN: It's a real concern. I agree. Eli? DR. GLATSTEIN: I feel the same way. I don't have anything in addition to that. CHAIRPERSON FADEN: Your endorsement was to what Mary Ann is saying, -- DR. GLATSTEIN: Yes. CHAIRPERSON FADEN: -- which would endorse Pat's more general structure. DR. GLATSTEIN: Also what Nancy said, too. I think that until we've got a grasp on what we really have in the way of meaningful data, I think it's kind of foolish to split it on a laboratory time scale. CHAIRPERSON FADEN: Dan? And then I have a point, too. MR. GUTTMAN: As far as we are from getting the data about the Cold War, we haven't even begun to think about this other, whatever period we're talking about. And Ruth may have suggested what may be an efficient way of doing it is follow things that we're following from the Cold War into the period that we call the modern period because they don't arbitrarily start or stop when HHS passes regulations. But the point I want to make is that in the process of setting the subcommittees, I think Jay has an excellent point. We have to start immediately to conceptualize what method to cover this modern period, whenever it starts, however you want to cover it, because we haven't even begun to ask for that data. DR. STEVENSON: I actually feel less overwhelmed by the modern era than some of the other people because at least I know from experience with NIH and HHS granting, grants that involved human subjects were flagged. I think a lot of this would be very accessible through -- MR. GUTTMAN: The data will be very accessible, but it's the volume. It's what's the research method or the operationalization of: What do you want to do with it? That's the question. It would be easier to get it, but you've got to think now about what you want to get and how much and that kind of thing. And maybe it's just an outgrowth of the earlier study. DR. STEVENSON: But I still think it will be much easier to screen because of the computer data. I really do. MR. GUTTMAN: Yes. But, as you're pointing out, the time frame we have is much easier. It means: Can you do it all in a week and a half? DR. KATZ: But, Dan, let's be careful about -- it's come up repeatedly -- the emphasis on the Cold War period and the ending of the Cold War period because that's really analogous to the defense of the Nazis that goes back to the concentration camp experiment. It was a national emergency. And, therefore, you had to do all of these experiments. And the excuse has been used and will be used that the Cold War necessitated conducting these kinds of experiments. I think that is only half or less than half the story. There are other forces at work that led to these experiments, and not to excuse it and maybe not even make too much of it, that it just happens that we are reviewing '45 to '74, that this can be understood because of the Cold War that had involved this. CHAIRPERSON FADEN: I think that's a mistaken conception of what's an issue here, Jay, if I understand what you're saying. I think we are very much concerned, at least I am -- I'll speak for myself now -- with that part of the committee's charge that has to do with looking at the ethics of research involving human subjects and ionizing radiation across time, regardless of when it occurs up until the present. That requires looking at research involving human subjects that it did not involve ionizing radiation, at least in part, because we have to make sure: A) that we don't contribute to any misguided understanding that somehow radiation or ionizing radiation is so much more worse or evil than any other kind of substance that one can investigate that it warrants in and of itself special consideration and also because, in fairness to people who work in ionizing radiation, we need to understand whether if there are any retrospective or current concerns, those concerns aren't more widely concerns for the entire community of people doing research involving human subjects. That's a very central part of what we're about. But we also are very much about the question and under what circumstances and whether, with adequate justification or inadequate justification, human subject research was used to advance interests that had nothing to do or little to do or only in part to do with advancing human health. And that's the Cold War story. Okay? And that's of central concern, I think, to the American public. The American public wants to know just what happened in the name of national defense and whether what happened in the name of national defense was acceptable or not so that we can to the extent it was not acceptable look back and say "Okay. We don't want this to happen anymore." And to focus on one is not to take away from the other. They will co-travel in very important respects. But we have both to do. And the defense that you analogized to the Nazi experiments are exactly the defense that we're charged to look at, you know, "Just how far did that go? And how good was it?" kind of thing. So I see them as both going on. That's why in my own head I've been thinking of it as just sort of the ethics in science story and the Cold War story. They obviously interrelate, but the one is not in my mind, anyway, not of higher priority than the other in terms of what we are charged to accomplish. Henry? DR. ROYAL: I suspect that we're focusing on a small part of the things that we disagree about, but there's probably a large part that we agree about. I would suggest that maybe we go down these committees, either as originally read or as modified, and see which committees we agree should be established. And maybe there will just be one or two committees that we can try to work out. CHAIRPERSON FADEN: That's fine. That's easy. That's easy. Susan, was there another one before we do it? That would be good. DR. LEDERER: Before we do that, I guess I'd like to, I guess, go back to your original proposal because it seems to me that the data gathering, both the strategies and the sources for telling the Cold War story are quite different than they are -- CHAIRPERSON FADEN: That was my thinking. DR. LEDERER: -- for the ethics stories. CHAIRPERSON FADEN: That's my thinking. DR. LEDERER: And so that whether you want to have a discovery committee with a sub-subcommittee of Cold War -- CHAIRPERSON FADEN: That's fine. DR. LEDERER: -- and medical experimentation I think would work. We'd just be calling it something different. CHAIRPERSON FADEN: I think that would work. I guess that's exactly what I've been trying to say. I'm not sure that it's helpful to have it be put together. The ethics subcommittee language that Ken used, I think, to rely on an old sort of distinction, there are normative dimensions to our work which we can only go to later, namely what the ethical principles really ought to be and whether there ought to be changes in public policy and what form those changes. We can't, obviously, begin to touch those yet, but then there are descriptive parts to the ethics story, which is, I think, what Susan is going to. We need to elucidate. And here's the data gathering. What were the operative standards and policies from '44 to the present? And we need to elucidate descriptively: What were the practices from 1944 or thereabouts to the present? And those are the data-gathering sides of the ethics story. I agree with you that you can conceptualize to some extent differently, strategize differently or look to different sources for that kind of information than for information about the Cold War story, but sometimes, as in the '53 memo, they will come squarely together. So how about Henry's suggestion? Are we ready to see where we have agreement? I'm going to try a safe one. The outreach committee. Do we all want a committee on outreach? Okay. Great. Do we need a subcommittee -- that was a subcommittee on outreach -- on scope? Any disagreement? Okay. That's two. A subcommittee on remedies? Although that would happen later, I think that makes a lot of sense. DR. STEVENSON: On all of these subcommittees, are we deciding whether they're going to be enacted right now or just -- because I'm not sure we can even do scope until we have data. MS. KING: Why don't we do the ones we need? We don't have to establish every subcommittee today. CHAIRPERSON FADEN: All right. Do we need a subcommittee -- MS. KING: We should accept the ones we need today? CHAIRPERSON FADEN: Do we need a subcommittee on outreach at this moment? Yes. All right. The next thing, do we need to set one up in the next three weeks? Do we need a subcommittee on scope in the next three weeks? I think we do. Does anybody want to argue against it? No. Okay. And that's the one that's going to figure out: Do we put the uranium miners in or out? What do we do? How far do we go with intentional environmental releases? What do we do with the Marshall Islanders and stuff like that, little things like that? Okay. I think that's it for the noncontroversial ones. That sort of does it for the ones that -- MS. KING: Can I make a proposal -- CHAIRPERSON FADEN: Yes. MS. KING: -- to try to make the rest of it noncontroversial? CHAIRPERSON FADEN: Sure. MS. KING: Why don't we make as our immediate target data gathering? To that end, we will create a subcommittee on, for lack of a better term, Cold War data, and we'll create a subcommittee on ethical practices data. CHAIRPERSON FADEN: That's fine. MS. KING: You can call them anything you want. CHAIRPERSON FADEN: Discovery A, Discovery B or two separate groups, whatever people -- MS. KING: That's right. But the point of this is that our immediate goal is to generate our data. The next round of subcommittees, we'll figure out what you do with the data you generate. CHAIRPERSON FADEN: I am seconding that, whatever. Is everybody clear? I don't care whether we label it Discovery A and B. For the lawyers who like to use discovery, we can do that. If not, we can also call it data gathering for the social scientists. We can call it whatever we want. Okay? DR. KATZ: Could you say a little bit more about that, what you mean by "Cold War data" and "ethical practices data" because I don't understand? MS. KING: Well, I have in mind the data of all sources as our immediate task, finding the facts as our immediate task. And there are several different kinds of facts that I have heard talked about. One can't come from the agencies, and it involves practices, ethical practices, that needs to be conceptualized, even how to get at some of that information, and the actual starting of trying to obtain some information. I've identified another problem is that we really need some additional strategies. I don't particularly think we ought to proceed by agency, but I do think that there's probably a difference between getting at data in HHS and getting at data in DOD, DOE, and CIA. So whatever you want to call those differences, the differences between an agency that uses classification and one that does not, I think are two different kinds of data problems. We started on that task, but my sense from the discussion is the strategies need to be refined for making sure we have identified the kinds of data we think we need and also for making sure that we obtain it. And one of the big issues is finding out, for example, more about declassification and what we can expect. So I'm willing to call them anything, but I think that the major thing that I think about is making sure we have facts is what our -- that's a significant task right now. MR. GUTTMAN: I think the clarifying question, which I think is Jay's question -- I'm not sure -- is a simple one. What we've talked about with DOE and HHS really goes up to what we have called the Cold War. Unfortunately, it wasn't a couple of more decades. But the question is we don't even know whether or what we should ask HHS to put together about 1974 forward. Does that fall into one of your two -- MS. KING: Yes, it does. MR. GUTTMAN: Okay. This is just for purposes of clarification so -- CHAIRPERSON FADEN: I think the year is irrelevant. MR. GUTTMAN: Okay. CHAIRPERSON FADEN: It depends on whether it's about practices of investigators, how human subjects have been used in research. That's a practices question. MR. GUTTMAN: Okay. CHAIRPERSON FADEN: Whether it was in '88 or '62 or '99, if we're in business that long, that's a practices question. So if we're asking the question about what are the practices that have governed how human beings have actually been used in experiments from 19-whatever until 19-whatever, that would go under the ethical practices data-gathering thing. MR. GUTTMAN: Just to be operationally clear, if HHS says "What do you want us to do with these billion documents from 1982?" I should say "I'm going to check with the ethical practices subcommittee?" CHAIRPERSON FADEN: Unless there's a Cold War story continuing. DR. MACKLIN: Wait a minute. I'm sorry. Could I just hear the way you phrased it again? Documents from when? MR. GUTTMAN: No, no. Well, see, I don't want to get into the cutoff. Modern documents. CHAIRPERSON FADEN: Here is Dan's pragmatic problem. Okay. DHHS comes back and says "So far we've concentrated on pre-1974. We've got a gazillion documents from 1974 forward. What do you want us to do about them?" And the answer is "We're going to wait until our two data-gathering subcommittees make recommendations to the whole committee about what they would like. If there are Cold War stories continuing post-1974 and you have relevant information on that, we'll ask you for it. If in order to elucidate what the practices were involving human subjects and continue to today are can be advanced by getting information from DHHS, we'll ask you for it." DR. KATZ: But Cincinnati and plutonium falls in both of your categories. CHAIRPERSON FADEN: Fine. DR. KATZ: Am I right, Pat? MS. KING: I started the point about there would be overlap, but I don't want to get us offtrack. The basic point is we must gather data, one. The second basic point is there are different kinds of data. The clearest delineation is between practices, ethical practices, data and trying to get documents. That's the clearest. CHAIRPERSON FADEN: Right. MS. KING: Now, within documents and within practices, there will likely be some documents that are classified, some documents that are non-classified that would take different strategies. Within practices, what I listened to, what I thought I heard was that before we do anything about practices, we must have a conceptual approach to what we're talking about in practices that we can implement. So that first what we need to do in practice is to identify what our goals are and then identify what kinds of data even fit within those goals. That seems to be the problem with the practices data. Did I pick up everybody's discussion? I mean, that's what I thought. So I don't like the -- that's what I had in mind, Jay, that that could be two committees or it could be three. But I saw two. And if I saw three, it was a division between classified data and non-classified data, which would make it three, -- CHAIRPERSON FADEN: Right. Now -- MS. KING: -- but not a division according to time and not even a division according to -- I'm sorry I used the phrase -- Cold War versus practices, but I think Cold War became the residual category after practices. But that's what I had in mind. It was no date, time lines or anything. DR. MACKLIN: There's still Dan's question about what you say to HHS. CHAIRPERSON FADEN: You say to HHS what you need specific to each -- MR. GUTTMAN: No. Which committee, I mean, whether I have a committee to go to. CHAIRPERSON FADEN: You go to both. MR. GUTTMAN: Fine. Okay. CHAIRPERSON FADEN: You go to both and say "What do you want to know from 1974 forward?" MR. GUTTMAN: Okay. CHAIRPERSON FADEN: And each committee may want different things. MR. GUTTMAN: Yes. Sure. CHAIRPERSON FADEN: By the way, the subcommittees will go back to the full committee. And the full committee then may come back and say "Okay. You have authority to make decisions of the following sort on behalf of the whole committee." But we're not ready to do that yet. I mean, in the next three weeks, we basically just sort of get going. And then the authority seeded to the subcommittees is something we would subsequently need to discuss, but for right now the subcommittees' charge, I take it, would be go back, think this out, and come back to the full committee with some options and recommendations, not make the decisions and tell us what they are. Later we may decide to cede the subcommittees, which we can as a whole committee, decision-making. MR. GUTTMAN: Can I be more concrete because we're actually further ahead? I mean, we're in the middle of going to these agencies and coming back and -- CHAIRPERSON FADEN: Point well-taken. MR. GUTTMAN: DOE, my recommendation, staff's recommendation is we seem to be working along with them. Whether it's, unfortunately, too slow or not, we're working with them. And we'd like to be working with the subcommittees, whichever ones or one. And so can we work in the -- CHAIRPERSON FADEN: How about if we give authority to the subcommittees to make a judgment between sort of operational decisions that are of not huge consequence that they can go ahead and do and policy directions that they have to come back to the full committee with? MR. GUTTMAN: We'd like to be able to continue to work -- CHAIRPERSON FADEN: Would that be all right? MR. GUTTMAN: -- with the agencies as we're doing now and want to do it through the subcommittees if that's possible. CHAIRPERSON FADEN: Would that be acceptable to give the subcommittees room to use their judgment as to whether this is an operational decision that they can go ahead and say to staff "Do it" or a policy-type decision that needs to come back to the full committee? Is that okay? Otherwise, we will be paralyzed. Dan is quite right. MR. GUTTMAN: To be further hyper-technical, we didn't technically cover the DOE options. So I guess where does that leave us? And is that an operational or a policy decision? CHAIRPERSON FADEN: In terms of where to go next with DOE? MR. GUTTMAN: Can we go ahead and -- CHAIRPERSON FADEN: I tell you what. If we resolve this, we can go back to the DOE memo if you want. MR. GUTTMAN: Okay. Okay. CHAIRPERSON FADEN: If we resolve this now, we can conclude by going back to the DOE options memo and making some specific committee decisions, just as we did with the HHS memo. But let's see if we can get this one locked down. MS. KING: Maybe I have a looser sense of organization, but I'm willing to leave a lot of stuff either to staff or the chair and staff because I think everybody else is full-time except the members of this committee. And what's troubling me is I don't want to lock you up because we're part-time. I mean, even though it's summertime, we're still part-time. So part of the way I think about a subcommittee is that we do the conceptual part or we do the approval part in a sense of "Yes, pursue that line." And I don't want you to stop working because we haven't been to CIA and DOD yet. MR. GUTTMAN: Right. CHAIRPERSON FADEN: No. They're still authorized to do that. MS. KING: Some of the questions and options maybe should come from a subcommittee in terms of further strategy. So maybe we should talk about how we think we're going to interact between staff and subcommittees because I don't think things should bog down because there is a group of part-time people. And, however hard you're going to work us, Ruth, we're still part-time. Part-time people are going to interact with people who are basically hired full-time to do certain kinds of things without tieing them up. CHAIRPERSON FADEN: For what it is worth, you should note that a large part of the staff is not full-time. MS. KING: I know, but we're making them work a lot -- CHAIRPERSON FADEN: We can calculate the number of full-time equivalents that this staff reduces to. But a lot of the human beings are themselves part-time. But your point is well-taken, and Dan's is as well. We clearly don't want to paralyze. We can't afford it. MS. KING: Right. CHAIRPERSON FADEN: So I guess what we're suggesting is not only that the subcommittees be empowered to make decisions that in the judgment of the subcommittee are not policy-significant, big deal decisions, but go ahead and do it, but also that I think what I'm hearing you say is that I, as representing the committee, should be empowered to authorize certain things in between meetings so that the staff can keep on going. I'm also not full-time, but -- MS. KING: We didn't notice that, Ruth. CHAIRPERSON FADEN: Is that acceptable to the committee? MS. KING: Yes. CHAIRPERSON FADEN: It's implicitly how I've been working anyway because otherwise we wouldn't have had anything to look at. But is that formally acceptable? Thank you. Can we maybe resolve the subcommittee question for the interim, allowing that we may decide two meetings from now we want to get rid of this one and come up with a different subcommittee structure so that we can go back and look at the DOE stuff a little more specifically since we do have some things we could look at as a committee? I am hearing now the subcommittee on scope, the outreach committee, a data-gathering committee that focuses on, for lack of something better or worse, the Cold War side of things and a data-gathering thing that focuses on ethical practices for right now. And the only two unresolved issues, one is whether the data gathering about ethical practices should somehow be split up pre-1974/post-1974 and whether the data gathering around the Cold War should be split up between classified and declassified. Okay. That's what it sounds like. I'm going to make a proposal. Let's take the Cold War side of things. Should that be one subcommittee or two subcommittees for classified and unclassified, one subcommittee, and then a group can work on the classified problems and a subgroup can say "Hey, I've got expertise or interest" or "I will work with staff particularly." Two of us will work with staff particularly around classified obstacles. Okay? Now, on the ethical practices data gathering, do we want that to be two committees pre and post-'74 or one committee and people can split up? One. Jay, are you going to be comfortable with this? DR. KATZ: No. CHAIRPERSON FADEN: No. Do you maybe need -- MS. KING: He already said he would abide by a majority -- DR. KATZ: That doesn't mean that I could be -- CHAIRPERSON FADEN: All right. We're just registering the -- MR. FEINBERG: Shall we take a vote as to whether Jay should be uncomfortable or not? (Laughter.) DR. KATZ: Right. I would vote in favor. CHAIRPERSON FADEN: All right. It sounds as if it's one committee, and then it may split up, that some of the people in that committee may want to work more on the "modern era" and others on the older era. Okay. Now, can we get volunteers? People can be on more than one committee. Let's do that quickly, and then we can go to the DOE memo, back to the DOE memo. Four committees: subcommittee on scope, subcommittee on outreach, subcommittee on data gathering/Cold War, subcommittee on data gathering/ethical practices. Okay. Who would like to be on the subcommittee on scope? Duncan, Ken, and Henry. Who would like to be on the outreach subcommittee? Reed, Ruth, Susan, Lois, Henry. This is wonderful. My greatest fear last night is that I would say this and not a single hand would go up. That was the panicked moment. We would do all of this work and structure these subcommittees. MR. FEINBERG: It's not over yet. (Laughter.) MR. FEINBERG: Again, the lawyer in me. CHAIRPERSON FADEN: Subcommittee on data gathering/Cold War, who would like to be on that one? We've got Nancy, Eli, Mary Ann, Pat. Am I missing anybody? All right. Subcommittee on data gathering/ethical practices? Ruth, Susan, I'll go on that, Eli. I'll go on that. And, Jay, you don't want to be on that subcommittee? DR. KATZ: I want to think about it over the weekend. CHAIRPERSON FADEN: Okay. All right. We've got it? Have we got it? Okay. We will figure out staff and make sure that there's staff overlap so that it kind of all hands together. And Jeff and Steve are at the table today so they can answer questions in case that comes up as we sort of round out the staff. But we'll do this; right? We'll do it. Okay. Maybe we'll have to send out something very quickly to find out when people would be available for telephone conferences over the next three weeks. We'll get that to you because if we're going to form these subcommittees and do anything between the next three weeks, we're going to have to find out when people can talk to each other. So we'll work on that right away. Ruth? DR. MACKLIN: It's a procedural question. Are the subcommittees going to be -- is this going to be the kind that will require the conference call and the public -- CHAIRPERSON FADEN: I don't know. DR. MACKLIN: All right. CHAIRPERSON FADEN: We have to work out the details. We'll work that out. DR. MACKLIN: The second question is E-mail addresses for the staff, for us to communicate to one another. You don't have it yet; right? So we may have it. MS. KING: Some of us don't use it. We have it, but we don't use it. CHAIRPERSON FADEN: We'll work on it. All right. DR. MACKLIN: Could we just make sure that before this meeting is over, that you have a list of who has it and who uses it since I have it and I use it and I like it? CHAIRPERSON FADEN: We can have categories, like "Have it, like it," "Have it, hate it," "Have" -- (Laughter.) DR. MACKLIN: And how to change your view about it if you hate it. MS. KING: The best thing to do is to publish a list, make a list for us, but only put on the list what people are willing to have us access, be that a telephone, a fax machine, or E-mail. That's the only thing that works. That's the list that's golden. You can maintain a separate list of other ways that you may be able to get at people, but you can't be sure of it because I have some phones I don't answer. (Laughter.) CHAIRPERSON FADEN: I understand. MS. KING: You understand? CHAIRPERSON FADEN: Yes. There is the operational way you can really find somebody, and there are all the ways in which someone presumably could be found. Also one list had car telephone numbers on theirs, and not everybody likes that. So you should sort of know. DR. MACKLIN: What? I'm sorry. What? CHAIRPERSON FADEN: One list has car telephone numbers on it, which raises a cost issue. We'll deal with that. MS. MASTROIANI: If you could do something for me, behind Tab A is a roster. If you could look at it and make sure of the numbers and your availability? You could just even write your E-mail address, hand it back to me, and we'll make sure that it gets distributed. CHAIRPERSON FADEN: In the interest of the next half-hour, is it agreeable to the committee to revisit the DOE memo, which is Tab G, and go back to the specific recommendations, staff recommendations? Yes, Ken? MR. FEINBERG: That's one thing we might do or the other thing we might do or, as an alternative, is have before 3:00 o'clock a very brief series of subcommittee meetings. It might be very helpful for each of the subcommittees to meet for five minutes to just talk about where they're going and meet with the staff person and maybe you run around to each of the meetings. CHAIRPERSON FADEN: That's a very good suggestion. Some people are on more than one subcommittee, but, nevertheless, that is doable. How about if we visit the DOE memo for maybe 10 minutes, real list-like? And then we'll divide up for the last 15 minutes, in some fashion or other. And, Jeff, just sort of arbitrarily assign people for right now to one subcommittee or another. Is that all right, Dan, for purposes of this getting together? MR. GUTTMAN: Sure. That's terrific. CHAIRPERSON FADEN: All right. So if we go to Tab G, which is revisiting DOE, Page 21? Could we get different people at the table in case -- we'll call you if we need you, people that are on the staff for that. Option 1, Page 21, Page 21 of the DOE memo from staff to us, their report of what's going on at the Advisory Committee, options for -- have you got it? See where we are? "Recommendations for Committee Advice to DOE." That's the first thing. So what should we advise DOE? The first option is that we should go ahead and tell them to complete the strategy that they've already embarked on. And they're not going to stop, no matter what we say, anyway, probably, which is trying to catalogue all the information everywhere that bears on this. So, I mean, I think we should go ahead and say yes, fine. Good. Two is important. That is a request from staff that we instruct DOE to immediately focus on what is referred to as high-level documents here. These are the policy documents, as opposed to the experiment-wise documents that might shed light on, as Dan calls it, the dots that connect the story. Can we get a committee endorsement of that? Yes. All right. Going over to 3, this is turning to the classified material. Can we endorse that staff advise DOE that we would like them to do what is in 3? Yes? Good. Four, this obviously has already been endorsed in the DHHS one, which is go for the isotope records. Okay? So everybody wants to get the isotope record. Five, the work for others record. Can we tell -- MR. GUTTMAN: Actually, it's just a study. Either they give it to us or they don't. CHAIRPERSON FADEN: Yes. It's a particular study of work for others that was commissioned for Secretary Watkins. Can we go ahead and ask them to give it to us? Yes. Good. Nobody opposes it. Six, we want to get all the documents with respect to the 1974 IG plutonium, Inspector General's report of the plutonium, thing. Okay? Yes. Good. Seven, we have already talked about the hotline database. The committee wants the hotline database? Yes. Eight, we have to work on efficient means of getting access to data in the control of the national archives. Is staff authorized to work with DOE on that? DR. LEDERER: Is that easily done? CHAIRPERSON FADEN: I have no idea. MR. GUTTMAN: No, but we want to work on it. DR. LEDERER: That is a noble thing. CHAIRPERSON FADEN: I don't know. MR. GUTTMAN: Yes, yes. You know, DOE wants us to sit down with them. There's a longer story. We'll be happy to get into the details, but the answer is we'll -- yes? DR. LEDERER: I just want to know if it's doable. CHAIRPERSON FADEN: I don't know. I mean, is it staff's judgment that -- MR. GUTTMAN: Well, I'll tell the story. Yes. CHAIRPERSON FADEN: Don't tell us the story. (Laughter.) MR. GUTTMAN: It's a necessary recommendation. If it's not doable, we'll tell you in two weeks. CHAIRPERSON FADEN: Okay. We want to authorize the staff to find out if it's doable. How is that? No offense, but we don't have time for stories now. MR. GUTTMAN: It's a fact, not a story. CHAIRPERSON FADEN: Direct committee action. I wonder if the direct committee action -- MR. GUTTMAN: This has already been covered, the Rochester and the Chicago. And I think that -- CHAIRPERSON FADEN: And we have already endorsed that we should go and ask Rochester and Chicago. DR. STEVENSON: But the past and present contractors to DOE. CHAIRPERSON FADEN: Right. So, in other words, we want to go to all the universities involved in the plutonium experiments. The ones that are contractors, no problem apparently for DOE; the ones that are not contractors, Chicago and Rochester, we are now going to instruct DOE to write a letter on our behalf asking for what? Any record that they have that could conceivably bear on the plutonium experiment memos, letters, everything? MR. GUTTMAN: I would suggest in the case of Rochester and Chicago, we would like to work with the staff again. We want to be broader for the reason that those organizations were at the center of a lot of the story. And we have to keep it within reason, but that we keep it open to -- CHAIRPERSON FADEN: All right. Is that your proposal, that we -- MR. GUTTMAN: Yes. I'm not just -- CHAIRPERSON FADEN: -- let the data-gathering -- MR. GUTTMAN: Right. CHAIRPERSON FADEN: -- committees, both sides of which advise staff, and I will be authorized to facilitate it so we get this stuff done? Committee-directed staff action. DR. MACKLIN: Could I just ask one question here? CHAIRPERSON FADEN: Sure. DR. MACKLIN: Now that we've formed the subcommittees and I'm already thinking as a member of the subcommittee, when you ask for information of University of Chicago and University of Rochester, how general or how specific is the information that you ask for? MR. GUTTMAN: Ruth, I don't want to get into a story. The answer is the DOE has notions of what exist. So it's a question of working with DOE. They have notions. They just don't have a mechanism to get it. For example, they talk about cutting, which is their term, a contractor with Chicago or Rochester to give them the money to do the search. And they can tell us what kinds of things may or may not be there. DR. MACKLIN: No, but my point is now you're talking to the medical centers, the universities, the laboratories, the medical centers, that may or may not have had procedures in place relating, for example, to ethics, that the DOE didn't have, didn't care about, didn't want, didn't know about, and didn't require. MR. GUTTMAN: That was a separate cut. I was going to talk about that. We also have, for example, university historians and university libraries. There are whole sources at universities that are relevant. CHAIRPERSON FADEN: But the point here is -- and this is where this is all coming to a piece -- if we are going to ask a university for something, the something should try to cover both as much as possible. So we might as well also ask that you give us a detailed history of what your oversight has been with respect to research involving human subjects generally, when you first started an IRB, who was constituted, what existed for approval before the IRBs. DR. MACKLIN: Right. I mean, there may be some things in a grant accounting office or in their records, but there may be a time when they established a record for research review or protection of human subjects or whatever they call it. So, I mean, to cover it, to make sure that -- I don't know. I mean, it's always possible to go back to them, but it seems to me we ought to be able to identify once you're not talking any more about asking the agencies, but the contact is going to be to these others, the agencies may not know what to ask for since we decided they would be the conduits. MR. GUTTMAN: Excellent point. And at the risk of extending this, that's probably best to be discussed in these committees. But there are two tracks. One is the agencies have what money they funnel to these universities, which produce whatever is produced. Then the universities, for example, may have a historian that independently studied the Rochester atomic energy program. Can we delegate to the subcommittees that both tracks -- CHAIRPERSON FADEN: I think what this suggests is the procedural importance of making sure that before data-gathering strategies are launched by one group or the other, that the staff make sure that there's enough overlap that the other group knows what this is about, "Do you want to add anything? From the perspective of what interests you, is there anything you want to add, modify?"; whatever, so that we can kill several birds with the same -- MR. GUTTMAN: Letter. CHAIRPERSON FADEN: -- letter. Okay? But that's a very good point that that raises. I think this is enough for DOE. MR. GUTTMAN: Yes. MS. KING: There is one we didn't talk about, HHS and the interviews, which concerns me. CHAIRPERSON FADEN: We didn't talk about that. MS. KING: No. We were going to put it off until this afternoon. CHAIRPERSON FADEN: That's right. Do you want to revisit it in five minutes now? MS. KING: I can say exactly what I want to say about it. You don't even have to do five minutes. I think that the list of who you interview and how you interview and the kinds of questions that you ask in the interview has to come from this committee. That's all I wanted to say. CHAIRPERSON FADEN: Should come from this committee? MS. KING: Right, that you need a reason for the people that you go out and meet, and you should have some idea of the kinds of questions that you're going to ask them before you get there because interviews are only efficient if they're kind of sought out in advance in terms of what you're looking for and somewhat flexible so that if things turn up, you can keep pursuing it. But I was concerned about that because I didn't know if all of that work had been done. MR. GUTTMAN: No. Here's the question, and this goes to all of these committees. There is now into a resource question. The interviews that we were talking about were ones that HHS conducted with its people on its dollar, so to speak. MS. KING: They've already done them? MR. GUTTMAN: Well, no. They would go ahead and interview more. The question is your suggestion that maybe this committee or its staff do the interviews, which is fine, but it's a resource question. MS. KING: We should target who should be interviewed. We should look at the questions that will be asked in the interview. We should not do the interviewing. We should structure what the interviews should be like. MR. GUTTMAN: Right. MS. KING: And in doing it, it ought to be possible to develop this for all agencies because we'll have to do it for other agencies for HHS. In fact, it's even more important to do it for agencies like DOD and DOE than HHS. And so you want to be able to know from our point of view what is likely to take place when somebody else has to go out and do the interviews. CHAIRPERSON FADEN: Fine. MS. KING: He still looks puzzled. MR. GUTTMAN: No, no, no, no. I'm not puzzled. The other point that I wanted to make, which is somewhat related to what we were discussing with HHS, is this whole useful literature search. There may be all kinds of literature that are efficiently mined; for examples, reviews of radiology. And then there's the question the subcommittees want to discuss as to who mines that, the staff or the agencies, and if so, how that gets done. CHAIRPERSON FADEN: Again, that can go now to the two. MR. GUTTMAN: Yes. CHAIRPERSON FADEN: Both data-gathering committees can think: How could we use essentially traditional literature searches? Do we want to use them? How could we use them? Towards what productive ends? Okay. So we take the last 15 minutes to break down into subcommittees, following Ken's suggestion? I think that would be very helpful. We've got four subcommittees. Some of you are in more than one. So you'll just have to choose or flip back and forth. Let's figure out how to stick people for the subs. How do we do this as a procedural matter for the FACA stuff? Do people hang around and listen? How do we do this? We're going to split up right now into subcommittees. Susan has raised the issue of security clearance and the discussion about it, whether we should go back and do that again. We haven't resolved it. We have not resolved it. I was hoping that I could get more information about security clearance stuff for people. MS. KING: What you could do about subcommittees is make sure you -- well, never mind. Maybe we can have a subcommittee conference. There are some group questions that are important. DR. TUCKSON: The only thing about it, Pat's point earlier around the security clearance is very important. And the point that she made about if some people have it and some don't, then you can't talk to each other. And so if that's correct and I mean, she knows what she's talking about, then it almost demands that everybody has to go through the process. Otherwise it's crazy in discussions where some people have to leave the room. CHAIRPERSON FADEN: I think the issue is it seems to me that there are very good reasons that Pat's articulated that others have echoed why it would be helpful if everybody had a security clearance. On the other hand, I am very mindful of the fact that no one was asked to agree to get a security clearance as a condition to being a member of this committee. So I don't want people to feel as if they absolutely have to do it or if they're being a bad citizen if they choose not to go through the security clearance. So can we leave it that people will have to make personal decisions? My personal hope is that most people on the committee will choose to be cleared, but certainly if anybody doesn't want to be cleared, that's okay and we will work with it. DR. TUCKSON: I think you shouldn't have a lot of pain about it, though, even though I don't want to make Jay mad at me. He's a nice guy. He gets over it. But the thing was that the assumption when we came on the committee was that we would have to go through that process. All the orientations said we had to do it. So, really, it's not like we should be upset. CHAIRPERSON FADEN: Okay. I've looked at that. MS. KING: The other question I would ask is: I understand as scholars right in this area, this is troublesome. I mean, I've heard those arguments before. Is there a way that -- if we get to a point in the committee where it becomes an issue that somebody doesn't have a clearance in order to resolve something, that is not the time to get one. So what I'm trying to do as a compromise, and that is: For those people who have legitimate reasons for being concerned about this, is it possible to get a clearance and not act upon it is what I want to know so that if we -- CHAIRPERSON FADEN: We'll find out. MS. KING: -- reach an impasse, it is possible at that point to make a judgment about whether you would actually look at something classified or not? But that way it can be done or is it the clearance itself? DR. MACKLIN: That's not the only reason. I mean, they may be having that file on you with information that they're going to find out that you just don't want. DR. TUCKSON: I see. DR. MACKLIN: It becomes then a permanent file in the United States government on things that otherwise are private information that otherwise wouldn't be there without security clearance. And people might have reasons for not wanting that information in, whatever that personal information is. So that's a different kind of reason. MR. FEINBERG: I think that the entire issue of security clearance ought to be put on the agenda for next meeting. And we'd better do some homework. For example, it may be that once we secure -- and, Dan, maybe you know this. I have my doubts about this, but it may be that once we get security clearance for one or more members of this committee, then the final report, which, in whole or in part, is based on that information garnered and gathered through that security clearance, our report may then be held hostage to DOD. MR. GUTTMAN: I am embarrassed that you're asking the question at this time, but I'm glad you asked it. MR. FEINBERG: And I've got to tell you if our report has to pass muster with the federal government, then right away the credibility of the whole report could be -- MR. GUTTMAN: Right. MR. FEINBERG: So all I'm suggesting is caution in the security clearance area. Let's between now and next month know what the consequences are and the implications are, and then we can act on it. CHAIRPERSON FADEN: We will proceed with that guidance. Can we now break up into subcommittees? DR. MACKLIN: Would you read the list of names to tell us who else is on the committees we know we're on? CLOSING REMARKS CHAIRPERSON FADEN: Let me just do this real quick. Anna has asked me to remind everybody that before we do that, four announcements. And then we'll break up into the subcommittees, and I'll remind people where they are. Next meeting is June 13th and 14th. It's going to be here. You have the times for the next meeting. The meetings through July, the dates have been circulated. We'll try to get the ones after that to you. We have four educational briefings scheduled for the next meeting. Susan Lederer, Jay Katz, Ken Feinberg, Steve Klaidman, if you want to put anything in the briefing book about that, please give it to us by June 3rd. And that's it. Now down to who are on the subcommittees. Do we have the list? Jeff, who's on what subcommittee? DR. KAHN: Outreach is Reed, Ruth, -- I presume that's Macklin -- Sue Lederer, Lois, and Henry. CHAIRPERSON FADEN: All right. Can that group go where Steve is? Steve, stay put. And that group will move down here. DR. KAHN: Right. CHAIRPERSON FADEN: Okay. DR. KAHN: Scope is Duncan, Ken, and Henry. CHAIRPERSON FADEN: There are two of the same. I don't know if we can do this. Well, that group will be where Duncan sits. Okay? They'll just float back. Okay? DR. KAHN: And Henry will have to move back and forth, I guess. CHAIRPERSON FADEN: Okay. DR. KAHN: Data-Gathering, Fact Discovery, I. Cold War: Nancy, Eli, Mary Ann, and Pat. CHAIRPERSON FADEN: Okay. So these three are in the one subcommittee. So it's where Mary Ann, Pat, and Eli are sitting. So move around there. DR. KAHN: And then Data-Gathering II: Ethical Practices, Policies, and Standards: Ruth, both Ruths, actually; Sue; and Eli. Well, there we have three overlaps. CHAIRPERSON FADEN: Overlapping problems. I will stay put. And whenever everybody's ready to come do that one, I'll be here. But at 3:00 o'clock, Phil Caplan comes promptly to close us. So we are closed promptly at 3:00 o'clock. (Whereupon, the foregoing matter went off the record at 2:45 p.m. and went back on the record at 2:54 p.m.) MR. CAPLAN: As the designated federal official for this meeting of the Advisory Committee, my name is Philip Caplan from the White House Office of Cabinet Affairs. And I hereby close the meeting. (Whereupon, the foregoing matter was concluded at 2:54 p.m.)