ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + + Friday, June 23, 1995 The Advisory Committee met in the Executive Chambers at the Madison Hotel, 15th and M Streets, NW, Washington, DC, at 8:30 a.m., Ruth Faden, Chair, presiding. Advisory Committee Members: Ruth Faden, Ph.D., M.P.H., Chair Eli Glatstein, M.D. Jay Katz, M.D. Patricia A. King, J.D. Ruth Macklin, Ph.D. Lois Norris Nancy Oleinick, Ph.D. Henry Royal, M.D. Philip Russell, M.D. Mary Ann Stevenson, M.D., Ph.D. Duncan C. Thomas, Ph.D. Reed Tuckson, M.D. Staff Present: Dan Guttman Anna Mastroianni Steve Klaidman Jonathan Moreno Jeremy Sugarman Agenda Item Page Committee Discussion: Recommendations for the Protection of the Rights and Interests of Human Subjects [Part IV, Chapter 19] 5 Committee Discussion: Findings--Contemporary Intentional Releases [Part IV, Chapter 18] 128 Committee Discussion: Recommendations for Balancing National Security Interests and the Rights of the Public [Part IV, Chapter 19] 129 Committee Discussion: Recommendations on Openness [Part IV, Chapter 19] 244 Committee Discussions: Outstanding Issues P-R-O-C-E-E-D-I-N-G-S (8:44 a.m.) CHAIRPERSON FADEN: It was a good morning until we read the newspaper. Actually it's usually a good morning until I read the newspaper. DR. GLATSTEIN: Oh, don't take it too seriously. CHAIRPERSON FADEN: Thank you, Eli. Yeah, but the content isn't accurate either. Okay, all right, we have a lot of work to do. Even if the Post can't get it right, we're going to try to get it right. Okay, we're going to pick up where we left off. I think the agenda will definitely change slightly, and that is -- what we'll do, if you look at the afternoon schedule, is that we've got lunch and openness and outstanding issues. What we're going to do is turn that around and put notification issue that we didn't get in on -- what's today? Wednesday -- on Wednesday's agenda after lunch is when we'll do notification. Today's Friday. So I'm saying on Wednesday we didn't get to notification. I'm not that -- I am distracted, but not that badly. I still have the days of the week, right? So instead of doing openness after lunch, we will do notification and then openness so that we had openness and -- because we can't risk putting it off yet again. We also wanted to revisit -- I'm flipping it over. I want to make sure that notification gets -- I don't want to risk at all the possibility that we don't discuss notification, because it's been put off too many times, and it's still in many respects unresolved. We also need to find time in the agenda to revisit the uranium miners' recommendation. There's a draft -- no, two drafts actually -- two alternative drafts for the committee to consider. They differ only in terms of -- one is the one that says -- well, when you get to it, you'll see. But there are two versions of the uranium miners' recommendation out reflected the two approaches that the committee simply wanted -- we wanted to consider on Wednesday. If we could march through the rest of the contemporary recommendations for human subjects quicker than the agenda requires, that would be nice. What we need to do now is turn to recommendations and continue as far as we can to get through the recommendations for the protection of the rights of human subjects. I would take us -- let us finish -- if we could get to page 12 -- 23 of the recommendations chapter, chapter 19 -- this is the set of recommendations on military personnel as research subjects. That's where we left off. But we shouldn't think we're that far ahead. If you recall, we skipped recommendations eight and nine, which we have to go back to -- the education recommendations. And even though people tend to have an attitude -- well, education, that's not going to be problematic, we still need to discuss it, and it is a real recommendation. And we have -- these are real recommendations, and we have to decide if we've got them right. But if it's all right with everybody, I'd like to pick up where we left off -- do the rest of the contemporary human research recommendations, and then go forward. Okay, if we could start with recommendation 12, which is in how many parts here? Four parts, 12A, 12B, 12C and 12D. Are there discussions, comments -- are people comfortable with accepting these recommendations? Does anybody want to take objection to any of them? Mary Ann? DR. STEVENSON: One objection. I want to probably direct this at Phil. How much of this do we know, if at all, is in place? Anything, nothing? I mean, there's -- when you read through the text, you get the feeling that some of it may have been partially implemented in places. DR. RUSSELL: Well, I think the system that's in place in the military is probably -- DR. STEVENSON: Is what? DR. RUSSELL: In the three armed services and the Department of Defense, is very comprehensive and very detailed. I think the -- and where the research is military in nature or related to military objectives rather than just clinical investigation at a medical center, there are two levels of review. So I think a substantial amount of it is in place. There's one recommendation about non-participation of leadership that is partially in place. It's a common practice, but not always practiced. I don't think there's a lot of -- a lot in this recommendation that's going to make substantial change. And I do want to have to comment about the -- that no unit officers or non-commissioned officers were present, because in the first place, because of the high level of technology in the services, there's a lot of non-commissioned officers. And in many potential studies, experiments, the participation of the non-comms would be very critical. And especially if you need to do the study as units. And so, while it's -- I think important to minimize or eliminate if possible command influence on volunteering, the -- in some instances it's absolutely essential to allow at least the mid level of the non-commissioned ranks to participate. So, we have to allow for that in here. CHAIRPERSON FADEN: How would you want to amend it, Phil? Would you want to leave it that -- we're on page 26, line five. Would you want to -- would you agree with the recommendation with respect to unit officers? Let's start with that. DR. RUSSELL: Well, I would limit it to officers and non-commissioned officers who would not be expected to participate in the experiments. CHAIRPERSON FADEN: Well, that's a -- so where they're not being asked? DR. RUSSELL: Where they're not being asked to participate, then it's appropriate that the command not be present at the briefings. But I think if we put in a statement about whether or not expected to be participants as volunteers. CHAIRPERSON FADEN: Where they're not being asked to volunteer themselves. DR. RUSSELL: Where they're not being asked to volunteer, yes. That 12D, I'm not sure that the Navy and Air Force don't have those registries already in place. CHAIRPERSON FADEN: Do they? DR. RUSSELL: Yes, they probably do. CHAIRPERSON FADEN: Dan, do we know that they don't? MR. GUTTMAN: I don't know. CHAIRPERSON FADEN: So we have to check. So obviously if they have the registries, we don't -- we're not going to ask them to do it. We can just tell them it's a good idea you have it. Okay, we'll change it from -- we applaud -- so 12D is acceptable, provided it's not redundant. Okay, 12C with a modification that Phil has introduced. Nancy? DR. OLEINICK: Can I just follow up on the response that you made, Phil? I can understand the officers needing to be there if they are part of the experiment, but the issue here is whether the enlisted people or those under their command have -- can voluntarily participate. Now, is there some mechanism by which the individual soldiers can be -- voluntarily participate without undue coercion? DR. RUSSELL: That's very common. DR. OLEINICK: I mean, given the scenario that you've given us now, if their officers are present. I mean, that's the issue. Is there a mechanism by which they could be asked in the absence of their officers? I guess that's the issue here. CHAIRPERSON FADEN: Well, the turning it around just makes -- DR. RUSSELL: Oh, I see what you mean, certainly, yes. CHAIRPERSON FADEN: I mean, turning it around just to make sure that what you're saying can't -- is a bar to the recommendation in its current form, Phil. Assuming that either unit officers or some NCO's are also being asked to participate in the research, couldn't they be asked separately? DR. RUSSELL: Yes, definitely. CHAIRPERSON FADEN: So couldn't we leave the way -- I mean, because there seems to me something to this recommendation. We know it's common practice voluntarily, so it can't be that burdensome. You could always ask them -- DR. RUSSELL: It depends on the study. If you're just looking for a group of volunteers to test a vaccine and it doesn't matter whether you -- what the ranks are, it's very common to exclude all the senior NCO's and officers from the briefing. And so, that the volunteerism has no -- on the other hand, if for example you're doing a study that requires whole tank crews, okay, then you can't exclude the tank crew commanders. You have to have the whole crew participate or nobody. And so, you have those kinds of -- what I'm trying to do is make it -- put as much volunteerism and less command influence as possible into without precluding doing some militarily essential studies that may have to be done by a unit, or at least in small groups. DR. STEVENSON: Could you use that qualifier except where militarily required? DR. RUSSELL: Well, maybe we could do that. Maybe we could. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: Let me try to understand here. We're talking about two things. One is the recruitment process, and of course closely related to that is the participation. Now, what I just heard you say, and I just want this for clarification, is there are some experiments in which the whole crew -- I think as you put it -- the whole unit, has to participate. In which case, there's no possibility of not participating. DR. RUSSELL: Yes. DR. MACKLIN: If no one does? DR. RUSSELL: But if they choose not to, they choose not to. DR. MACKLIN: As individuals? DR. RUSSELL: As individuals. But then you can't do the experiment, okay? So that has got in the way of doing a lot of studies, and -- DR. MACKLIN: Well, that's what's important to know, I think. In other words, when you say it's gotten in the way of doing a lot of studies, does that mean that sometimes there's not -- the studies are not conducted because some people in fact don't want to participate? DR. RUSSELL: Oh, yeah. We've had difficulties with levels of participation. We compromise the study. What I want to try to do is to keep it from coming administratively impossible to do some essential studies such as -- oh, you can think of a physiologic study of heat stress in a vehicle under certain conditions where you have to instrument the crew and drive it around in the desert. Well, you can't do that unless you've got the whole crew participating. And so, I would want to make it impossible - - or, I mean I would want to make it possible to recruit those folks. And you can't exclude the NCO commander of the vehicle. DR. THOMAS: It's an accepted principle that in this situation a single person who declines basically makes it impossible to do the study with that unit, is that right? DR. RUSSELL: Well, it may be possible. But you know, that's a hypothetical experiment. That one -- maybe you could do it with only two, maybe a few of the people instrumented and not all of them. Maybe it's possible. On the other hand, you have various positions in the vehicle and so forth, so you -- I don't want to be too specific about a hypothetical study. DR. THOMAS: No, no. Assuming that it were possible to do the study with -- assuming it were not possible to do the study without everybody in the unit being a participant, then it follows that if a single individual in the unit declines to participate, that means the unit doesn't participate? DR. RUSSELL: That might be true. DR. THOMAS: And then so the only remaining question -- DR. RUSSELL: If you had to do it on aircraft crews -- if the pilot refused to participate, you couldn't do it. DR. THOMAS: Yeah. But then I guess the only remaining question is whether undue coercion might be placed upon that one hold out. But I don't see that we can do anything about it. DR. RUSSELL: Well, I don't think we should put in place -- make it absolutely impossible -- CHAIRPERSON FADEN: Why don't we do the following: I think what we can do is -- I take it that the ombudsman or ombudsperson, whatever the -- is unobjectionable. I want to argue very strongly for that. I think that it's -- DR. RUSSELL: No, I think that's fine. CHAIRPERSON FADEN: Particularly in the circumstance that you just described. There has to be some independent person that is doing some sort of vouchsafing that the whole thing isn't a farce, that it really is a sincere commitment to the principle that this is not an order but a request or whatever -- however we phrase it. With respect to the first one, we could put in with some sort of a clause that says except under a narrow set of circumstances determined by somebody or other. And we'll figure out maybe with Phil who the right person -- or let the services decide the right procedure for determining when -- who should decide when an exception is appropriate, but allow for an exception. That the language we'll come up is the language -- clearly it's meant to be an exception, and the services have to come up with some mechanism for indicating it's an exception and it's certainly any that the ombudsmen could not be waived even in the circumstance where the NCO and the unit officers were there. Yes? DR. KATZ: Yes, the weakest kind of comment is that if he had this exception, hopefully it can be that -- not in terms of a person having the authority to get permission, but rather in terms of the circumstance under which they can be considered -- if the words could be found, I would feel more comfortable. CHAIRPERSON FADEN: Fine. So you would -- DR. KATZ: It's quite an exception. And of course, you know in any other areas, people have no objection to the ombudsmen, there is always the danger in some studies and have documented this, that the ombudsmen then gets -- by the institution -- CHAIRPERSON FADEN: Sure. DR. KATZ: -- in which he lives. So that's part of the fact of life. CHAIRPERSON FADEN: I think that's fine. DR. KATZ: So -- but it could be done along those lines, because it's an important exception to -- and a necessary exception maybe to an individual choice. CHAIRPERSON FADEN: Well, that would be fine. I think we could come up with some language. So with that exception -- I mean, with the revised -- the revisions that we've just discussed, I take it 12C is okay. 12D will remain if it isn't already in place. So it will remain for only those branches of the military where -- I mean, well, we already know the Army has it. So the issue is whether the Navy and the Air Force have it. I'm taking it -- because no one's commented, that let's just for the record get it clear that 12A and 12B -- DR. STEVENSON: Are okay -- CHAIRPERSON FADEN: -- are okay? Well, I don't know that they're redundant. DR. STEVENSON: Okay. CHAIRPERSON FADEN: I mean, the point is -- at least in my conversation with Phil and with the people from the military with which we've been consulting, I really don't think either are redundant. And the services are in the process of reviewing their own procedures as we speak, and I think particularly 12B is a tough one. It's really no -- for those of us who have just finished going through an accreditation process for their medical institutions know -- although this was probably hospital, I would assume, Reed, rather than the whole thing -- the whole deal -- that it's very hard to get curriculum space in a medical school -- my understanding from talking to Phil and other people is it's very difficult to get curriculum space in the training of military officers. So to say that we think -- so the 12B, which says basically officers have to be educated about the regulations governing research involving military personnel as subjects is not trivial. And you know, may not be easy to implement because there's only 100,000 things that obviously people in the services want their officers in training to know. So it would be like a medical school curriculum, which we'll go back to fighting over. You know, an hour for subjects regulations against an hour on God knows what -- but it might seem a whole lot more important to the people who are designing the officer training curriculum. So it's not -- you know, as -- as it sounds, I don't think. So I take it that 12A, 12B, 12C with the revision that we've just discussed, and 12D are okay? Ruth? DR. MACKLIN: I just want a clarification on -- with an example under number two, page 25, line six, number two, and that is -- under 12A. All right, clearly distinguish those activities that are research and therefore discretionary on the part of the member of the armed services from other activities that are obligatory such as training maneuvers and medical interventions intended to protect the troops. Now I mean, training maneuver sounds like it doesn't have a medical research component. But I'm just concerned that there are some things that could be named research that biomedical research -- or could be called training maneuvers. And my concern is whether some things that would otherwise be research, except for the fact that they're taking place in the military end up being in the training maneuvers or medical interventions -- and maybe it's a second really -- medical interventions intended to protect the troops because the context is the military. So, I'm just wondering whether that clear distinction is possible. I mean, I don't have any examples, so I can't clearly give the -- CHAIRPERSON FADEN: But the challenge is for the military to figure out how to clearly distinguish. DR. RUSSELL: I think that is -- CHAIRPERSON FADEN: That is what we're asking. DR. RUSSELL: That goes right in to 12B. There's a whole set of regulations that define what is research that has to be done under the human subjects regulation, what is equipment testing that may involve people driving the vehicles or shooting the weapons or whatever, and how that relates, and when -- what the difference is between training and human experimentation. I think there's been a lot -- a tremendous amount of work done on those regulations. Some of my concern, based on experience, is the capability of everybody concerned to understand and interpret the regulations, which is why we've put the 12B -- DR. MACKLIN: All right, well let me -- can I just ask it a different way? CHAIRPERSON FADEN: Sure. DR. MACKLIN: Because I mean, I'm obviously thinking of the only thing I know about this, which is what this committee has looked at. The regulations that are now in place, Phil, that you describe, are things -- I mean, the committee had a difficulty understanding -- you probably didn't, but I did -- what the distinction in the studies that we looked at, what was necessary for training maneuvers or for operations or for occupational safety -- all these other words that we were using to describe what went on. And it seemed to me we ended by saying sometimes you can't distinguish the two from the nature of the activity because it's exactly the same activity. So we were left with a gray area and with the understanding that for some purposes, what is a training activity or occupational safety might otherwise be a medical experiment. Now, what I'm -- I mean, and that was what we looked at and I think sort of came to the conclusion in those past -- in the studies we looked at that took place in the military. Now, my question is about the regulations you've just described. Those, I take it, were put in place after the -- all those tests that we looked at. CHAIRPERSON FADEN: Way after. DR. MACKLIN: And the question is whether they go farther towards making this kind of distinction that is clearly distinguishing what seems to be implied here and which I think you said, that the regulations are there now. Am I being clear? DR. RUSSELL: Yeah, I think yes, they have been put in place and rewritten -- or revised several times since the issues we looked at here. And I think the key issues that have to be considered are whether you're really doing experiments on the individuals or whether you're -- or conducting a military training exercise. Now a military training exercise frequently is very hazardous. CHAIRPERSON FADEN: Yeah. DR. RUSSELL: To train the troops and crews properly, the have live fire exercises, very hazardous. They -- and the atomic weapons tests were -- the military took advantage of them to basically do live fire maneuvers on the atomic battlefield. Those were novel maneuvers, but they were not -- and today would not be human subject experiments. CHAIRPERSON FADEN: They wouldn't. DR. RUSSELL: On the other hand, if in the course of these kinds of exercises somebody finds it necessary to do studies of physiologic responses or psychologic stresses or toxicologic studies or whatever, then the human subjects regulations kick in and you have to do all that under the volunteer regulations. But the fundamentally high hazardous occupational problems of training military crews with live munitions and so forth are not voluntary. And they can -- DR. MACKLIN: Well, I don't think anyone would construe those as biomedical experiments. I mean, it would be foolish opening the door to calling everything that ever exists a biomedical experiment, and that's not right. So all these things that are hazardous that don't -- that could not reasonably be called biomedical experiments except by expanding the concept beyond reason, I don't have any problem with that. I'm going back to the gray area where in one context something that would be a biomedical experiment to see what the dose of radiation is that's absorbed when you rub your hand against the fuselage or something might in another context be a occupational training or hazard training study that's required for the operation of the activity. That's the one -- I don't care about the weapons and all that stuff, because that's not biomedical. I'm thinking of exactly the ones that could be classified in either setting, depending on whether they take place in some laboratory in a civilian environment, or whether they take place in the military. Now, I mean, that's really what I'm concerned about. DR. RUSSELL: When you're doing the studies of occupational hazards, I don't -- that one is a little bit gray. But I would -- I think it was a bit of a bizarre experiment, but I think that probably would have fallen -- would today fall under human volunteer. CHAIRPERSON FADEN: The situation is clearly that there will remain gray areas. Now what we know is there's no regulation in the world capable of addressing every context or every situation. As best as I was able to figure it out, the military now has regulations up the wazoo for everything, okay? (Laughter. Now that doesn't mean -- DR. MACKLIN: I'm glad you said that. CHAIRPERSON FADEN: Right -- it really was -- set down their regulations for regulations for regulations, which sort of doesn't surprise me. But that's basically how it is. And there are very many regulations with respect to safety and risk management for all of these hazardous training maneuvers that are not considered research. So when we asked for regulations that govern protecting exposing service personnel to risk, most of the regulations and manuals and policies that we got were not for the human subjects protections but for all this sort of training stuff and use of new equipment. And then they had this other evoking of the term volunteer that's not in a human subject context, but they asked for volunteers to check out -- in some of these hazardous new things, they asked for volunteers to be the first to use the whatever, but it's in the training. DR. RUSSELL: There's a lot of volunteerism that has nothing to do with the -- CHAIRPERSON FADEN: Right, exactly. That's what I was trying to -- so there's -- DR. MACKLIN: I'm interested in the intersection. CHAIRPERSON FADEN: And the problem is that we won't be able to regulate it away. So the issue here is to tell the military to try again -- look at it and see if you've got it as clear as you can get it, okay? And in any event, work on -- the bigger problem seems to be not -- you know, refining the definitions or coming up with yet more procedures and protections. But the concern that people who are in the position to be telling other people under them what to do don't -- may not know, even the distinctions that have been made. And that's the concern that -- the human volunteer stuff is apparently well understood by the people -- or it's claimed anyway -- well understood by the people who are the scientists in the military or the physician scientists in the military. But they're not necessarily the people who we're most concerned about in terms of the message that's given to the soldiers or the sailors but their unit officers who may not appreciate that hey, this is really an activity that's to be considered discretionary. So, I don't know that there's a way to resolve -- DR. MACKLIN: No, there's no way to resolve that. I mean, I would agree you can't regulate it away. I would like to see, however, some acknowledgement, some -- possibly a discussion under 12B that captures some of these points -- CHAIRPERSON FADEN: That would be fine. DR. MACKLIN: -- in the report. So that it doesn't then look as if this committee thinks that regulations can solve everything. CHAIRPERSON FADEN: That would be very helpful. DR. MACKLIN: And that you can regulate it away. CHAIRPERSON FADEN: Okay. DR. MACKLIN: And I think it should include an acknowledgement that there are many things in the military that are not voluntary in the nature of what the military is. I mean, many things in these training maneuvers or whatever we're discussing here that are not voluntary, and that sometimes activities that would otherwise be or look like -- I don't know what the right word is here -- or could otherwise be classified as human experimentation, might be part of a training maneuver. That's what the gray area is. CHAIRPERSON FADEN: I'm not sure that's right. DR. MACKLIN: Well, -- CHAIRPERSON FADEN: We can try it. I mean, we can go back and see. I'm not sure that characterization is right. I think what you're basic -- what you're going for is clearly correct. There are gray areas that are very significant. But I don't know that the training is the right place to pick it. We'll work on the language. DR. MACKLIN: Well, maybe it's under -- sorry. Then maybe it's under medical interventions and to protect the troops. CHAIRPERSON FADEN: Yeah, I think it may be. DR. MACKLIN: If those are -- and maybe that's really where we ought to look at it, because that's medical. CHAIRPERSON FADEN: Right, right. DR. MACKLIN: If medical interventions intended to protect the troops are such that they are in the nature of the case not established medical interventions, -- CHAIRPERSON FADEN: Correct. DR. MACKLIN: -- but are the only thing that might protect the troops, -- CHAIRPERSON FADEN: That's correct. DR. MACKLIN: -- and they are authorized as mandatory or obligatory or non-voluntary because of that, then I want to see that as an acknowledgement. I mean, otherwise it makes it look like research in the military is just like research anywhere else. But I think it's not. CHAIRPERSON FADEN: Can we work on language? DR. MACKLIN: What? CHAIRPERSON FADEN: You're talking -- DR. MACKLIN: Yes. I'm just talking about putting in a paragraph that acknowledges -- CHAIRPERSON FADEN: Acknowledges that the context is complicated and raises different kinds of issues then. And each setting raises different issues. We've already discussed yesterday the complications in the context of the hospital setting and the old person, and that raises one set of issues. Now you've got a different set of issues that are raised in the context of the military with uniformed personnel, which is a different set of issues. And the different kinds of pressures and different contexts and different kinds of attention in different environments. So what you're suggesting is this report not look dumb and pretend as it there aren't tensions that are inherent to the military context, just are there are tensions inherent -- and that's certainly appropriate. And I think -- is that agreeable to everyone? DR. RUSSELL: You want to put that under the front end of 12 before you get to the -- CHAIRPERSON FADEN: That would be nicer. DR. LEDERER: Isn't that already on page 24 to some extent? CHAIRPERSON FADEN: To some extent, yes. But we can make it clearer. DR. LEDERER: About the unique constraints of the military? DR. MACKLIN: No, because those -- what's under 24 describes the difficulty of ensuring voluntariness in those activities that the regulations say are voluntary or that would be voluntary under the regulations. DR. MACKLIN: And you want another paragraph that deals with determining whether activities require volunteer and human use of rules. DR. MACKLIN: Well, -- DR. RUSSELL: That's the key issue. DR. MACKLIN: The key issue is that there are some things that would otherwise look, smell and -- DR. RUSSELL: Right. DR. MACKLIN: -- quack like research. DR. RUSSELL: Do they or do they not require a -- CHAIRPERSON FADEN: Right. That may in the military context -- DR. MACKLIN: Be obligatory. CHAIRPERSON FADEN: Right, got it. We can -- I wrote down quack like research to remind me. That will remind me what to put in. Quack like research is very good. I can do that. Okay, so with two major -- three major qualifiers, just to summarize, the addition of the paragraph describing -- acknowledging this tension and the quack like research problem, and that the military context has its own set of tensions and problems around what's research and what's not -- akin to the research and treatment situation we talked about for ill patients yesterday. With the proviso that 12D may go away if it already has been adopted by the other services, and with the proviso that there be an exception to the recommendation that officers and NCO's not be present when enlisted personnel are being recruited -- the military one stands. Is that agreeable? And obviously everyone will see the revised language, so that you're only agreeing to the context and the words will be fought out. Now we're going to recommendation 13, which is in two parts. This is on compensation. 13A is yet another call for the federal government to figure out what to do about compensation of former subjects for research related injuries. Here we are trying to think of a less vulgar phrase than the one that's coming to mind, but we are joining a long line of other committee, bodies, and groups that have called similarly in the past for some kind of comprehensive federal policy. We don't hearsay what we think it should be, but we simply point out out of the frustration of our own experience in trying to figure out how to deal with the issue of compensation retrospectively. That it would be very nice if nobody 50 years from now had to be sitting and struggling with -- figuring out how to do this. So that's 13A, and then 13B is quite similar. And I'd like to hold off discussion about it for just a minute. And it has to do with a specific call about compensation for research -- for subjects who were used as research without their consent from now on forward. But can we do 13A? DR. STEVENSON: Is A restricted to federally funded -- CHAIRPERSON FADEN: Well, this is compensation from the federal government. DR. STEVENSON: But for federally funded? CHAIRPERSON FADEN: Yeah, yeah. It should say so. It doesn't say what it should be or how it should be done. It just says please deal with it. Yes, Eli? DR. GLATSTEIN: Well, I'd like to see that -- I have no problem with reviewing that area for compensation for research, but I'd like to see -- explicitly request them to review the issue of insurance companies declining to pay for patients who go on clinical trial. That is classified as research by third party carriers, and they do not pay for it. And I think this is a serious issue that is undercutting a lot of clinical research that could be done in the country. And I think that needs to be reviewed. Specifically clinical trials, not other forms of research, but patients for whom there are no good treatments and they want to go on a clinical trial and the insurance companies won't pay for that. CHAIRPERSON FADEN: I understand the problem. I'm thinking about whether it's appropriate to bundle it with compensation. It strikes me as a separate kind of recommendation. It's about a different kind of an issue. DR. GLATSTEIN: Well, if that general area is to be reviewed, I think it comes under it. But maybe others don't agree. CHAIRPERSON FADEN: Ruth, then Phil. DR. MACKLIN: Well, first -- I mean, there is a connection, because if in fact there were compensation for injured subjects of research, then insurance companies might be more willing to pay for the research maneuvers. I mean, so there's a connection, I think, if I understand that area. But my other problem, which is a question, is what authority does the federal government have over private insurance companies in an area like this? I mean, -- DR. GLATSTEIN: Excellent question. There's virtually no authority over the insurance industry period. It's the most unregulated industry in the United States. CHAIRPERSON FADEN: States do. The states do. The states have the authority. DR. GLATSTEIN: The states do, but the federal -- DR. MACKLIN: So I mean, but my question -- in other words, what could a recommendation -- CHAIRPERSON FADEN: To the federal government -- DR. MACKLIN: -- here to review -- we can ask the federal government to review compensation for research injury under federally sponsored research, but what could we recommend that the federal government do about an area about which it has no jurisdiction? MS. KING: It goes in informed consent discussion. Because the other way you can get at it is to include in the informed consent discussion that this is a major area that is subject to -- CHAIRPERSON FADEN: You better be on the mic, Pat. I'm sorry. MS. KING: That subjects need to be informed of the economic and financial consequences of participation. CHAIRPERSON FADEN: Right. MS. KING: Not that they can be informed by the researcher, but it needs to be called to their attention that they should be sure to find out for themselves these consequences, because the researchers actually may not know. CHAIRPERSON FADEN: I have Phil and Jay waiting on this. Did you want to comment? DR. RUSSELL: I find it very uncomfortable to get into the issues of insurance coverage when we really haven't discussed those issues and there's ramifications that are far beyond those that I can comprehend at the present. CHAIRPERSON FADEN: Jay? DR. KATZ: Well, I don't know what we can do about it. It first came to -- the whole issue of -- as it affects informed consent about who pays for research injuries came to my attention when Eli talked about it briefly at the last meeting, and -- on something that I had never considered. I was puzzled in the informed consent forms that I have reviewed. And I only touched on it without confidence because it's really a can of worms that in some of the informed consent forms, it's mentioned -- the incidents as a result of the research was a 15% of collapse of the lung, and that was acknowledged. And the 5% incidents where a chest tube and further hospitalization would be required. It was also stated that the patient is responsible for payment. I think -- and there was one or two other experiments like that. Any patient who would have read this carefully would have said I'm not going to participate in this unless, you know, the -- my insurance carrier assures me that -- DR. GLATSTEIN: That's the dilemma. CHAIRPERSON FADEN: Well, I think -- but I think we're talking about two separate issues. One is the issue of who pays for the consequences when there are bad outcomes and someone who's been in a federally funded research project. And that's what this recommendation is directed towards. The other is who pays for a clinical intervention which is experimental and on protocol. Who pays for that itself? And that was the issue that Eli raised, and that's where the questions come up about whether we really have the territory. And even does the federal government have the reach to address the question of whether insurance companies should have to pay for bone marrow transplantation for breast cancer transplants. DR. GLATSTEIN: Well, it's a little more complex than that. I mean, if you have a clinical trial that has a standard treatment -- CHAIRPERSON FADEN: Right. Oh, I agree. DR. GLATSTEIN: And the third party carriers will not cover that as a -- because that's research. So the patient's off study and the patient gets the standard treatment arm. It's the same treatment. I mean, that's crazy. DR. KATZ: If I can finish, it's like -- but it goes to what Pat said, and it didn't come up. So I apologize. And let me take another 60 seconds -- is I think now -- I speculate now that one of the reasons why investigators -- the distinction between research and treatment because they would like it to be viewed as treatment, so that the insurance companies won't be alerted to the fact that they may not be financially responsible. DR. GLATSTEIN: That's absolutely correct. DR. KATZ: Okay, and I never -- thanks to you, I learned a new kind of complicated -- DR. GLATSTEIN: A new kind of -- (Laughter.) CHAIRPERSON FADEN: Yeah, and that certainly belongs in the introduction to that last chapter. MS. KING: I think that the economic issues for subjects deserve -- not only in the last chapter -- and I'm not suggesting we make this an area of recommendation. I think that this is going to be a bigger area in the future as the health care system continues to change. And I actually think that while we have focused on medical risks, for many subjects economic risks are going to be far more significant in the immediate aspect for them than medical risks. And so we should be sure to devote perhaps a substantial pointing towards the future in the prior chapters. CHAIRPERSON FADEN: Let me make a proposal. Way back on the recommendations that we discussed yesterday -- it doesn't go to your point, Eli, directly. It goes indirectly. When we talked about the kinds of -- the list of subrecommendations that was federal government find some way to fix it, we certainly have the base, based on our RPRP project where we found and people commented on confusion in forms about -- We had an item that said did they explain the financial burdens, and we found that it wasn't always done well. We can certainly add another subrecommendation that says government, find a way to fix it so that it's very clear that IRB's have an obligation to make it very plain, to investigators that they have to make it very plain to subjects -- potential subjects, what the financial implications are of their being on this study or not. MS. KING: The complication is they may not always know. But one of the things that -- what we're asking basically are two things, I think. One is, to the extent you know, we want subjects to know. But the other problem is that subjects, because they are trying to get health care usually or some access to something -- in many instances may need to be told to go find out for themselves. I mean, because I don't think that you can expect researchers to know the -- so the big issue a lot of times is that this falls between the cracks. CHAIRPERSON FADEN: I would agree. I would think sometimes the statement has to say you would need to check with your insurance company -- MS. KING: Right. CHAIRPERSON FADEN: -- to establish whether in this case, being on -- MS. KING: It's so complicated that you may not want to check. This is an area where we need people to explore. Because if you check with your insurance companies -- so what we want them to do is not so clear. What we want to call for is some of these issues have come to our attention -- we don't think that -- we didn't pursue them. CHAIRPERSON FADEN: Okay, got it. MS. KING: But that it needs to be investigated and explored, and all these many complicating factors examined. Because it is not clear cut. DR. KATZ: You need two consent forms. One to be submitted to insurance companies, and one for the patients. CHAIRPERSON FADEN: Ruth, is that on this point? DR. MACKLIN: Yeah, it is on this point. CHAIRPERSON FADEN: Okay, if we could have that, and then I'd like to close on that one and go on. DR. MACKLIN: Yeah, it is on this point. I mean, I don't know why we want to be so wimpy here in recommending that the government review -- CHAIRPERSON FADEN: Oh, excuse me, Ruth. You're on compensation? DR. MACKLIN: Yes. CHAIRPERSON FADEN: Before we do that, can we get closure on the financial thing? Is it all right with everyone that we add to the informed consent recommendation another subrecommendation to address the -- make sure that the system starts working on this financial problem. Is that agreeable with everyone? I mean, I take it then that that -- well, next time you get the informed -- the list of government fix-it recommendations that we went over yesterday, there will be that addition. I'm sorry, Ruth; I just wanted to get closure on that. Now let's go back to recommendation -- DR. MACKLIN: Yeah, I mean, there are two things in here. Compensation for research injury, and then the thing that Jay pointed out particularly, and it says here particularly reimbursement for medical costs incurred as a result of a subject's participation in such research. Now, do we just want that to be reviewed? I mean, someone gets injured as a result of being in the research and would not have been presumably injured had he or she not been in that research. I mean, we don't know presumably, but I think that's the key here. Now, I just want to add to one point that Pat -- in saying this, by way of background -- sure, calling up your insurance carrier and finding out what they will pay for in advance is going to alert them to the fact that you are going to be a research subject. In some cases, as I'm sure Pat well knows and everyone else as well, people who otherwise might not have access to medical care become research subjects. They agree to be research subjects in order to get this top flight medical care at University Hospital X Research. They don't have an insurance carrier in many cases. They don't have an insurance carrier. So the question what happens to them if they get in one of these research -- I mean, they want to be in the research so they can get the kind of care that they otherwise wouldn't get because they don't have access to the system. Then they get injured and they have to pay, and where are they going to get the money to pay? I mean, so this is a much more complicated thing. And by saying the federal government reviewed this makes it sound as if this committee is neutral on these issues. Well, I'm not neutral on these issues. CHAIRPERSON FADEN: Yes, Pat? MS. KING: I'm actually not neutral on the issue because I have long agreed with the President's commission conclusion. But before that, the national commission discussed it as well. It's not a question of being neutral. The question is, did this committee -- CHAIRPERSON FADEN: That's correct. MS. KING: -- sufficiently explore the issues so that we can make an independent recommendation that compensation be granted. I think that's what the issue is, Ruth. DR. MACKLIN: But why is this in here at all then? CHAIRPERSON FADEN: It's in there because we did enough to discover this is a big problem. We did enough -- we struggled enough on the retrospective issue of compensation to know that it's tough. We then look and see that -- and discover there are no policies governing today. So we can anticipate that 20 years from now, a committee like ours could be sitting there hitting their heads against the wall if there's a similar sort of thing. So at least we can say this has got to be fixed, okay; because we don't want another committee 20 years from now to sit there with the similar problem of trying to figure out remedies, and see that there's no federal policy or guidance or any fair system for compensation. So that's why it's there. The reason that it doesn't stipulate the form it should take it Pat's point, that we haven't collectively debated. But I too have no problem -- MS. KING: But we could do something to strengthen it along those lines. I don't see what the problem would be once we recommend the review indicating that substantial members of the committee are in agreement -- CHAIRPERSON FADEN: That would be fine. MS. KING: -- with the President's commissions recommendation which would strengthen it. But I still think that there's a problem about not having explored or discussed some of the implications. And the President's commission conducted a full exploration of the issues. They did tons of work on the issue. DR. RUSSELL: What's the text of their recommendation? CHAIRPERSON FADEN: It's on page 29. I mean, I think that's a great solution if that's agreeable to you, Ruth, would be for those of us -- some of us -- and I also personally think that the recommendation is right. One, if we can have a sense that some members of the committee or many members of the committee, depending -- or all members of the committee agree that the President's -- support the President's commission recommendation, which is not the same as saying it's our recommendation as a committee because we deliberated. But rather, it's the President's committee -- this previous committee's recommendation. They spent, you know, as much time on that as we're spending on other issues. And so we say they made a good case and we agree with them. Yes? DR. OLEINICK: Is there any information that came out of the subject interview study that would bear on this point? CHAIRPERSON FADEN: Not to my knowledge. DR. OLEINICK: Because we did ask questions about their insurance. CHAIRPERSON FADEN: I don't know. I mean, -- DR. OLEINICK: Is this something that could add fuel to the fire? CHAIRPERSON FADEN: I don't know, Nancy. And Jeremy is occupied putting out the fire from the newspaper. DR. OLEINICK: Oh, okay. CHAIRPERSON FADEN: So I don't want to take him in and ask him -- DR. GLATSTEIN: I don't think it went into any depth. DR. OLEINICK: No depth. But at least it did ask about insurance -- DR. KATZ: Do you have any practical experience with the problem or not? DR. GLATSTEIN: Plenty. DR. KATZ: And that the patient ultimately had to cough up the money or not? DR. GLATSTEIN: Well, I think the vast majority of cases where people go on this and wind up with the bill like that -- generally written off. CHAIRPERSON FADEN: By the institution? DR. KATZ: By the institution. They don't really demand payment. CHAIRPERSON FADEN: Can I do this? I really -- it is - - as compelling as it is, Pat is right to draw to our attention, this is not something that we have as a committee taken on as an issue -- forward looking. I would like to support Pat's suggestion that we include a sentence that indicates that some members or all members -- and I'll just ask a vote -- support the President's commission. What I would do though, since not everybody here is as familiar with the President's commission's recommendation, let me propose -- well, is anyone not prepared to vote yet? Because I would be happy to send -- we could easily send you -- we sent once before, but we could send you a more detailed summary of the President's commission's recommendation on compensation than just this abstracted summary. So that when you indicate whether you want to be included in the group, you can take a look at that. So what I will do is make sure that those of you who I -- who doesn't need such? Okay, so just to say -- in our reduced staff situation, anything that we don't have to do. Yeah, okay, so everybody except the people who have raised their hand, we will send you more detailed information on the President's commission's position, and then we'll circulate a little ballot that says would you like to be included in the group. And if it turns out that it will be all, many, some, a few -- okay, of the members have independently studied and support the -- have independently considered and support the President's commission. Is that all right? Okay. Now let's go on to 13B. 13B is -- comes out of our experience and basically says that from here on forward, if any person is used in a research project without their informed consent and it's federally supported, that there be compensation awarded, even in the absence of research related injury. So it's basically saying we want to send a very strong message to the research community and to the federal government that dignitary harm from now on forward warrants this level of sanctions. Well, the question is who else is going to give it? We can't -- you know, the federal government provides such compensation. The recommendation is the federal government do it. So the problem is how would you then say the federal government should be responsible if it's drug company supported, for example. That's the problem, Jay. And if we could think of a way -- there are lots of hands up, so let's get up there. Nancy, Pat, Lois, Henry -- okay, Duncan. Nancy? DR. OLEINICK: Well, one of my concerns about this is what lawyers may be able to read into it. And maybe Pat can comment on it. But I can just see a case where a person is on a protocol and the lawyer looks and says there's some little "i" that wasn't dotted in the informed consent, and then -- so that the consent was not fully informed, and it goes on from there. Now, I may be over reaching here, but I'm concerned about -- (Laughter. I'd like to hear a comment from the lawyers in the audience as to whether that is a danger. CHAIRPERSON FADEN: Pat happens to be next, and she's our lawyer -- our only lawyer at the moment on the committee. MS. KING: It would be one thing if we were saying without consent that -- but that's not what the wording says. CHAIRPERSON FADEN: All right, let's change it to without consent if you're concerned is the informed consent part makes it too -- MS. KING: This is a big shift, though. CHAIRPERSON FADEN: I understand. MS. KING: I don't want to change that -- the legal tradition is that you can't do anything to a person without their -- you can't touch a person -- would be a battery without consent. That one's always been pretty easy. Informed consent has always been troublesome because it raises questions about what the informed means. So the litigation -- you're asking the lawyer's question. I answered that first. The litigation about what is informed, of course, has got standards that say material risk, material benefits. And so they're always subject to interpretation, that kind of thing. But my problem with this is a different problem. I have that problem too, but this leaves a lot of room. But my problem is a different problem. My problem is one that says we have a preceding recommendation that says we think people who are injured -- you know, who got -- who were injured and they got costs and they got physical costs, they got medical costs, etc. -- that for 40 years we have been trying to get something through to protect those people. And now we come along and say we want to send a message that you ought to protect people who did not give informed consent. My view is I am not interested in sending the messages out into the air someplace. I really want the problem dealt with, and I want to start with what I consider the most serious. And I don't want to undermine that by then making a statement that can be used against me in trying to accomplish what I consider the goal that I immediately need to accomplish. So my own sense of this is that in the discussion about -- of the preceding -- CHAIRPERSON FADEN: 13A. MS. KING: -- 13A, that what I would have liked to have seen would have been in the text following that recommendation something about the commission's experience and a recommendation that within this, we consider as a part of the discussion, our experience which is that dignitary harms are the sorts of harms that also should be compensated for. I mean, that would be for me the way that it would be acceptable. I have a lot of problems. I'm opposed to this recommendation for those -- some of those reasons in addition. CHAIRPERSON FADEN: Lois? MS. NORRIS: Some of my major ones have already been talked about, and I think there's going to be a -- I get a strong sense that there are a lot of people who will not be comfortable with this. So I don't know how far I should go into this. CHAIRPERSON FADEN: Go ahead. I'm going to argue for it in a minute. MS. NORRIS: Okay, well that's fine then. I think if we are to adopt this in any form, I think we should specify that we are looking at from today forward. CHAIRPERSON FADEN: Oh, absolutely. MS. NORRIS: Because it's not clear it's expressed in the past tense. That's an easy one to fix. I also shared the informed consent -- and I sent that in in writing -- question. Particularly in light of some of our current projects. And it's not clear to me what we're asking to be done. It says in line 13 through 15 that we anticipate that there won't be all that many because the subject will have to legally prove. Do you mean that this remedy or compensation should be sought in a court of law? I'm not quite sure -- CHAIRPERSON FADEN: No, that language isn't good. But the idea is the burden of proof would be on the subject in this case. MS. NORRIS: Proof to whom? CHAIRPERSON FADEN: To whoever -- however this would be administered, and that's the problem. MS. NORRIS: Okay, so you're saying that these are open questions? Because it just simply wasn't clear to me. And then if you're talking about the courts of law, and I -- this is a stupid, mid-western question type thing -- where does sovereign immunity come in? MS. KING: No, I think you can already -- I haven't looked at my book, but it seems to me that the Mink case -- the Chicago case where the women were involved in research of the reproductive -- the drug -- where they recovered in battery, not an informed consent case -- a consent case, that the law already provides that if you are involved and you don't consent -- not informed consent, you don't consent -- that's a battery. So the only thing that this could do is to add the informed consent provision. CHAIRPERSON FADEN: Also, this is where the compensation comes from. Okay, that came from the University of Chicago. MS. NORRIS: I was wondering -- I guess whom did they recover -- CHAIRPERSON FADEN: Well, Lois is -- MS. KING: The legal questions then go to the question of being able to sue in the federal -- CHAIRPERSON FADEN: Well, this is why you can't -- you'd have to have a mechanism other than a suit. There would have to be some mechanism set up whereby the federal government would be -- like it probably would be folded in with whatever compensation -- MS. KING: You want to say it should sue the government? CHAIRPERSON FADEN: I don't even want to have to sue the government. I want a system whereby if a person can show that they were used -- and we can get into the informed consent versus consent -- in a federally funded research project, in addition to suing the institution, if they want to sue the institution, and they want to sue the investigator -- that there should be some way in which the federal government makes amends, and I want it to be in money. Because we couldn't do it backwards for all the reasons that we could. But going forwards, I think -- and I'm not saying a large amount of money. And we're not stipulating the amount. I'll put out my arguments in a minute. I've got -- Lois has still got the floor. MS. NORRIS: I have one more point, and that is in the text you say a clear signal needs to be sent to the research community and the federal government. It seems to me we run the risk of sending the signal to the research community that the federal government's going to stand behind their blunders. And in fact, it might lessen. CHAIRPERSON FADEN: Okay, well I think that could be corrected by making it clear that this is not meant to be an exclusive remedy. That if you were involved as a research subject without your consent and you recovered something from the federal government, you could still sue the institution. And in fact, presumably it would strengthen your case, because if the government agreed that you had been used without your consent, that would not hurt in your suit against the institution. But I don't know, I'm not a lawyer. But that's very helpful for a recommendation that probably isn't going to make it -- we'll get it much better. We'll see how it goes. Lois, do you have -- Henry? DR. ROYAL: You made the statement that although we've agreed that it's difficult to put something like this in place retrospectively, that somehow it's going to be easier to put it in place in the future. And I guess I don't see how we're going to avoid the very same problems that we had applying it retrospectively with applying it prospectively. That is, at the time that someone puts a case forward for the fact that informed consent was not obtained, they're going to have to do some retrospective analysis at that point about whether or not informed consent was obtained. And to me, and I assume to everyone on the committee, informed consent is not the signing of the piece of paper. Informed consent is this process, this interaction between the physician and the patient. And I just -- I don't understand why it's going to be any easier in the future than it was in the past. CHAIRPERSON FADEN: The reference I made to that, Henry, was not to the evidentiary problems. Although I think obviously 40 year remove is different than a six month or a year remove. But my concerns were more with the ambiguities around the clarity that the duty was there in the first place and fairness issues about how to set things up. So that the forward looking thing is if you -- you know, it's like saying well the rules of the game have to be public, and everybody knows it. And before you slam somebody for it, it's got to be clear that the rules of the game are known. So that was my reference to the past. The argument is you set it up forward looking, you say look, from now on here are the rules of the game. Okay, whatever those rules are so everybody knows them. But not to the evidentiary difficulties. That doesn't mean there aren't all these other problems people are raising. Duncan and Phil? DR. THOMAS: Well, I can be brief, because Lois has pretty much touched on my points. I support this recommendation, but as Lois pointed out, it doesn't explain that it's just prospective. And my concern is that -- assuming that the purpose is purely prospective, no rationale for why it is only prospective is offered, and that needs to be made clarified. CHAIRPERSON FADEN: And the sort of rationale I just provided would be the kind of thing you're looking for? DR. THOMAS: That's right. I mean, these issues -- the same questions could be asked retrospectively as well. And I mean, I would have liked to have seen us make a stronger recommendation retrospectively, but I understand the will of the committee. That rationale needs to be very clearly spelled out. CHAIRPERSON FADEN: Phil? DR. RUSSELL: My concerns were mostly retrospective, so I guess they've been taken care of. I think that if you -- looking back, we would open up a huge amount of problems without attending to -- where I think we need to be concerned about are the very, very large phase three trials of drugs and vaccines and so forth. And the question of the adequacy -- you could wind up with a huge number of people have been "involved" in a federally sponsored research, most of whom -- or at least half of whom may have gotten either a placebo or a standard drug. But they were part of the -- and whether -- and if somebody decides that the consent form or the process by which consent for 50,000 Swedish children was somehow flawed, then you've got a nightmare, and a lot of claims without any evidence of doing any good for anybody. DR. KATZ: Could I just make a 30 second statement about prospective and retrospective -- CHAIRPERSON FADEN: Sure. DR. KATZ: Yeah, because it goes to just -- Pat or Dan probably can talk about this very quickly, is there's a whole legal literature of -- on prospective and retrospective. And when should it be retrospective and when should it be prospective? I think if you were to argue in favor of prospective, we don't really have to explain too much why not retrospectively, because it's almost -- about many things, you just can't apply it retrospectively, because there were no rules in effect to behave in this kind of fashion. But anyway, -- CHAIRPERSON FADEN: I've got Ruth and Pat, and then I'd like -- and then Lois, you can -- and then I'm going to put myself. Ruth? DR. MACKLIN: I'm surprised to hear myself say this, but I'm actually ambivalent and leaning towards rejecting this. And the reason is as follows. I mean, some have been given, but -- it's often the case that when something's going to cost money, the people who are in charge or responsible for these things fold the money into the cost of doing business without changing their practices. Now, what we really care about is for researchers to get informed consent. Granted, from the point of view of the victim, as we're calling them, or the person who has not given adequate consent -- and this is where my ambivalence lies -- there ought to be some kind of remedy if people have been wronged. But that's all I can say about the remedy. And I'm not sure why they should get money for it. I mean, in our society, money is the solution to everything. But if in fact -- I mean, Phil's example of the nightmare or the floodgates opening -- we already know -- and I'm glad that this is not going to be lawsuits, but as Ruth said, there may be suits against the institution as well as whatever compensation scheme. We already know that there are a lot of frivolous or unjustified lawsuits in the medical arena. That is, where doctors -- where some wrong happened, but doctors were not really culpable. The reverse is true too. People don't sue for genuine malpractice where there ought to be, and maybe that's a larger category. But Nancy's concern I'm picking up on here that if people see -- ah, here's yet another area in which we can win the lottery, even though you're saying it's going to be a small amount of money -- I mean, I think this will encourage people to do that kind of thing. Now, what I really think we ought to do, and it doesn't come under this heading, is talk about sanctions against researchers. CHAIRPERSON FADEN: That was my other alternative. DR. MACKLIN: Now, sanctions against researchers, we already know and it's just beginning to come in that people who do things like falsify research -- also the scientific integrity stuff -- are now beginning to be scrutinized, and in fact, punished in ways that for researchers are much, much more serious. Namely, you take away their opportunity to get a grant for five years or two years. I mean, some of these things seem like slaps on the wrist too. But nevertheless, they are sanctions against the people who did the wrong. So Lois' point - - oh, well, so, you complain to the federal government -- who cares, they're going to take care of me. I mean, this seems to me the wrong approach to a problem, giving some people money that may increase an incentive for people to go mucking around with their consent forms and making claims that may not be justified while not touching the wrongdoers. So, that's the basis for my ambivalence, or even leaning against this. CHAIRPERSON FADEN: Pat? MS. KING: Two things, now one of them in response to Ruth. First of all, we should be clear that if this were done where the money is coming from -- you know, we're all acting like we're deep pockets plaintiffs. The money is not going to -- the Congress is -- if this were adopted, which it won't be, but -- I predict that confidently. But if it were, the money is coming out of the research budget. Let's be clear about it. We're talking about tradeoffs. This is not let us do nice things. These are hard cost benefit assessments. And in case anybody has forgotten, NIH's appropriation already with respect to research costs is -- on the real research side, is in somewhat jeopardy. So for me, this is the real world. CHAIRPERSON FADEN: Pat, can I interrupt you? And the reason I'm going to interrupt you is the interest of time. It seems to me very clear that the committee does not want to endorse this recommendation. MS. KING: Okay, then I'll go to my second point. CHAIRPERSON FADEN: All right, so even though -- MS. KING: It's the sanctions. CHAIRPERSON FADEN: All right, then let me just clarify that and then go to sanctions for a minute. I have a series of arguments, and I'm not even going to try them. Okay, we'll let it go. I am so concerned about getting through the rest of the agenda. My back up position was the sanctions one. We didn't get a chance to write it, so this is fine. I think that this could have been made workable, but it's not worth it given everything -- if that's agreeable with the committee, we will get rid of this recommendation. I am so concerned about moving forward, I don't want to have -- waste discussion on something that looks like it's not going to go anywhere. So can we now -- we don't have a written text in front of us, but we can now go to the issue if -- whether the committee wants to consider a recommendation that makes a clear sanction against the investigator? And then after some discussion, we'll try to come up with the text. MS. KING: I don't have any -- in principle -- opposition to what Ruth said. I have again a pragmatic one. And that is -- and the committee, in its own work, did not -- as we acknowledged yesterday, explore the question of sanctions and enforcement of what is currently a requirement. The requirement in the federal government is that you obtain informed consent, and those requirements are to some extent specified. So what we are back in is to yesterday's discussion about sanctions and enforcement. It would be acceptable -- we have something about that, if I recall, if you want to fold this into it. But I would also be very hesitant to go too broad. But this again is one of those areas where we didn't discuss, although we have experience about why there might be a need. CHAIRPERSON FADEN: Let me do this. I think we do have some information, I just don't have it available right now, about whether -- to what extent an investigator or institutions have ever been sanctioned in any respect by the federal government for failure to comply with the informed consent regulations of the common rule. We will check into that and see if we have it. If the answer is no or if there are no sanctions -- formal sanctions in place -- the first issue is are there specified sanctions for violations of that part of the common rule. We need to establish whether that's the case and what they are, and if they've ever been enforced, and under what conditions. We'll do a little homework and then come back with the recommendation that responds to whatever the fact situation actually is as to whether there is -- if there is a policy on sanctions for violation of informed consent duties, maybe it needs beefing up or needs teeth. And if there isn't, then we can recommend that it be introduced. Is that agreeable? Ruth? DR. MACKLIN: Yeah, just a small proviso that we look at this in this research context of human subjects. That is, I consider it a mild irony, to say the least, that all of the attention has been paid to the research fraud and the -- CHAIRPERSON FADEN: No, I meant specifically sanctions not only for the specific provision of the common rule that requires informed consent, okay? Because that's what we're trying to replace this with. DR. MACKLIN: Right. CHAIRPERSON FADEN: What I'm struggling for is some way to send a message and also to enforce this committee's commitment, okay, to respect for autonomy and the duty to obtain informed consent as rock bottom in research ethics. We need some forward looking signal to give that is strong. DR. MACKLIN: This is at least as important as a violation of the ethics of research as dropping data points on a chart. MS. KING: What it does do though, Ruth, is again to ignore the other requirements like selection of subjects and things that we also are concerned about. And I have to say I'm somewhat concerned that the recommendations really give a prominence to consent and informed consent, which I think are very important, as you know. In terms of disregard to what I think really protects subjects in the real world in addition to their consent, which is risk benefit and how they're selected. DR. MACKLIN: I'll note that in an appropriate place. CHAIRPERSON FADEN: I'm not sure it has that effect, and we can certainly look at the other provisions. And I think that one of the things that we have to acknowledge even in our own work -- harms to subjects. And as Jay pointed out, as well - - certainly the justice issues are a separate category in there. I would agree with you. But if you do look at the history of research, experiences as Jay has pointed out -- egregious harms have occurred -- that they have occurred probably way less frequently than violations of informed consent. Dignitary harms are much more common. MS. KING: I agree that dignitary harms are much more common. But they also have, I think -- never mind. CHAIRPERSON FADEN: Right, so I mean there are some disagreements there. Yes? DR. THOMAS: I agree that the sanctions route sends a clearer signal that what was originally proposed. I just want to point out that this approach does not address any remedies to the individuals whose rights were harmed. CHAIRPERSON FADEN: That's correct. DR. THOMAS: And I want to be clear that it -- is it the view of the committee then that the appropriate remedy is for individual civil claims against investigators, or conceivably the sponsors of the research? MS. NORRIS: Pat, I thought you mentioned some way that elements of recommendation 13B could be folded into 13A in such a way as to express the committee's concern or something like that. Am I right on that? MS. KING: You are, that one of my suggestions was that our concern about dignitary harms and compensation before we got to enforcement -- the possibility of compensation should be a part of the preceding recommendation in the text. That the commission's -- its work on the past led the committee to raise this as a consideration to -- for work in the compensation arena that will be prospective. CHAIRPERSON FADEN: That would be very helpful, and because we can also indicate that this is our committee's contribution to the work of the President's commission, which focused on research related physical injury. And we could say that we would -- those of us who want to -- that we endorse the President's commission's recommendations. We also want, however, for this review to include attention to how appropriate remedies for dignitary harms. MS. NORRIS: Well, that would be a way of salvaging some of 13B. And I really believe in 13B in principle. But -- CHAIRPERSON FADEN: Is that agreeable with everyone, that 13A would be amended to include that whatever scheme is developed, also address violations of dignitary harm in some way? MS. KING: But I recommended it for text. And so, people should -- not recommendations. So people may want to focus on that distinction. I did not recommend changing the recommendation. I recommended in the discussion of the recommendation. CHAIRPERSON FADEN: All right, so the difference we should get clear on, if you look on the text 13A, which is -- wherever it is -- on page 28. It says -- recognize that the federal government review the area of compensation for research injuries. So the issue is, does the committee want to add a line to the recommendation for -- maybe the word should not be compensation but remedies for right now. That -- also look at appropriate -- consider appropriate remedies for dignitary harms or whatever language we want to put in here. Not necessarily compensation, so that we leave it open. Would that be agreeable? Is that agreeable to you, Pat, as we go around here? MS. KING: I wasn't listening, I'm sorry. CHAIRPERSON FADEN: What's coming out here is an amendment to the text in 13A that doesn't specify compensation, but says that this review also consider appropriate remedies for subjects who have suffered dignitary harms, but in the absence of physical injury. MS. KING: That was what I -- CHAIRPERSON FADEN: In the text of the recommendation. MS. KING: Oh, no; I would not agree to it in the text. CHAIRPERSON FADEN: Even if the word says remedies? MS. KING: No, because I have a fundamental disagreement about where the committee is going with its placement of dignitary harms for public policy recommendations. So that's why I took it upon myself to point out that my suggestion applied to text, not recommendation. If the committee disagrees, the committee disagrees. DR. MACKLIN: I don't think the committee's going anywhere; it says the government review. CHAIRPERSON FADEN: My point is where she wants to put her emphasis in terms of her public policy recommendations. And she does not want to emphasize issues of consent and dignitary harms. She wants to emphasize research protections with respect to risk and selection of subjects. That's her priority. MS. KING: That was the way I stated it. So, if the committee differs, the committee just differs. I mean, I'm fine with that. DR. LEDERER: Ruth, can I ask you -- I don't understand why you think the committee is only recommending reviewing, because the second half of 13A is to create a mechanism to resolve. Isn't that strengthening -- isn't that more than reviewing? Isn't that movement? DR. MACKLIN: Yeah, but to say a mechanism for satisfactory resolution, if the government reviews it and says the system ain't broke so don't fix it, they have created a mechanism. I mean, they haven't created it, but they have said that the existing -- that there's no need to create a mechanism because the existing system is fine. That is, the committee in being neutral and says review this isn't really saying take a step beyond the status quo. CHAIRPERSON FADEN: Okay. DR. MACKLIN: They could fix it by saying there will never, from this time forward, be any compensation for research injuries. DR. LEDERER: Given that, it should strengthen this recommendation. CHAIRPERSON FADEN: Let me just get -- let me get a sense of whether we want -- whether other members of the committee want it in the text or the recommendation or in the text, so we know where we go. This is also one in which we -- well, you can't if you put it in the recommendation. How many people are wanting to see a reference to remedies for dignitary harms in the text of the recommendation? Okay, and how many people would rather see it in the text? All right, so we have a divided committee on this point, and we'll have to note it in the text. We'll say that roughly half -- or we can say if half the committee would recommend that this review -- the other half -- but if it's in the text, what do we want to say about what the other half of the committee wanted it only in the text but not in the recommendation? DR. MACKLIN: Look, I'll change my vote. I mean, I don't think it says anything, quite frankly. I would rather see unanimity in the committee because the -- since the recommendation says so little, I want to know what we're giving up by putting -- (Laughter.) CHAIRPERSON FADEN: Well, if it's in the text, I'm not sure what difference it makes. I really don't know what difference it makes. DR. MACKLIN: I mean, to say the committee is divided makes it sound like the committee is divided on some very important issue. CHAIRPERSON FADEN: Fair enough. DR. MACKLIN: And I think it's better for us to try to stick together if we look at what are the implications and what matters here -- CHAIRPERSON FADEN: Good point. DR. MACKLIN: -- in the text or in the recommendation. CHAIRPERSON FADEN: Good point. We'll just put it in the text. I'm not sure what the difference makes. And you really don't understand the difference, but okay. That's helpful, Ruth. Can we now go to recommendation eight? We skipped these yesterday because we went through the tough part. So now we're going -- what seemed like the tough part. You never know with this committee. (Laughter.) You never can tell where people are going to get hung up. So this is recommendation eight and nine. They are directed at education. Eight is directed at the biomedical and behavioral research community; and nine is directed at the public. I'm sorry, it's page 12, 13, 14 and 15. And a lot of this comes out of the discussion we had two meetings ago or last meeting. I can't remember when. Ruth? DR. MACKLIN: Well, this is not ambivalence as much as cynicism. I can see what has happened in the current requirements for education for trainees, post NIH fellows, and all of these in research ethics. Namely, it has spawned a small -- not really an industry for ethicists, because it's been a burden for ethicists. Well, some say that. But it's a burden for ethicists and creative ways in a Mickey Mouse format of trying to meet those kinds of federal requirements. So I get invited to do grand rounds in hematology, and although I really thought they were interested in ethics in hematology, then I hear the head of the division say well, you know, we now have a requirement -- CHAIRPERSON FADEN: There are no recommendations for requirements. DR. MACKLIN: Yeah, I understand that. CHAIRPERSON FADEN: Okay. DR. MACKLIN: But I'm saying the kind of thing that -- CHAIRPERSON FADEN: I just want to make that clear. DR. MACKLIN: But then what do you think the deans and the presidents and all these people are going to say? We need to have some more ethics teaching in here. CHAIRPERSON FADEN: I don't know. But this responds to the point Reed made. What this is saying is we've got to work at the culture. There are no recommendations here for requirements of anything, okay? This is hortatory. It may not do anything. I am also somewhat cynical, but I do believe -- and I was very moved by what Reed said -- you had done, Reed, at your institution in response to your experience on this committee. And what I really am trying to communicate in 8A is that if we had more people like Reed who were presidents of universities and deans of schools of medicine and deans of schools of public health who went back to their faculty and said you know, this is really central to our mission as a training institution, not because we're going to have federal dollars held up and because there's a requirement, so let's go find somebody to go hire. But rather, because we believe that this is what -- part of what we need to do to train people properly. Now -- DR. MACKLIN: They have to be like Reed to begin with. Doing this isn't going to make them like Reed. (Laughter.) CHAIRPERSON FADEN: And this is not going to bind anybody. It's entirely hortatory. So if we want to say no, we say no. But I think that unless -- you know, if we send a message out there, maybe the -- you know, maybe 5% but maybe 50% of university presidents are people like Reed. I mean, I would like to think that many of them are people of integrity who, when it's brought to their attention, might want to make this a priority. Pat? DR. MACKLIN: Let me say what -- repeat something I said earlier, which is I like your word, Ruth, hortatory -- because I don't like hortatory recommendations. Because I think -- I'm quite serious about this. You're only as good as your weakest link in the area in which you make recommendations. So as a general principle, I don't like them. On the other hand, I think -- and I don't know if there's time -- and so I would vote against it in this form. On the other hand, I do think that -- with respect, for example, to research fraud -- that there has been a change. There's a beginning of a change in the community. But the change didn't go this way. The way you got to deans and presidents was to address the recommendations and then to be more specific about what we want and we can do that to the associations, to the accrediting agencies. It was the AAMC, for example, and organizations like that that started some of the work that was the detailed movement work. And that's what we need to do in a recommendation like this one. That what we are basically -- and we can't use the word add to the agenda. I really need to know a little bit more what they did in research ethics. But with respect to fraud stuff -- but that is where the thing started to move. It was the associations and organizations in conjunction with presidents and deans, plus what was going on in the federal government that started getting universities to issue different kinds of codes internally. I mean, that's what we are aiming for here, I think. CHAIRPERSON FADEN: That's correct. MS. KING: And so, my view is either we spend some time trying to identify how -- a little bit how it was done before and craft a crisp recommendation about what they might consider, or do away with this altogether. I mean, I think that's more useful. CHAIRPERSON FADEN: Lois and Phil? MS. NORRIS: This is a question, but didn't education come off or come to some extent out of your inquires of the IRB? I thought that that was probably strongly supported there, and I've heard strong support of it generally amongst committee members. I don't know how it can be crafted to satisfy Pat's concerns, but I think it's important that this be included in some way. CHAIRPERSON FADEN: Are we talking about 8A or the whole package of eight now -- A, B and C? MS. KING: I was talking about -- I was talking specifically about 8A, because that was the one that was the most -- what I call nebulous -- and sort of being broadly directing university presidents and deans. And I want to emphasize it's not, Lois, that I don't think the issues are important. I think though that you have to do more than say they are important. You have to sort of give some point in some ways about where you want change -- who you want to look at it and someplace that might want to respond if you can name organizations or -- I do not think that this is not an important area. CHAIRPERSON FADEN: Yeah, the rationale for 8A hasn't been developed. There's a thing that says "insert name here" for the organizations. I agree with you about the role of professional associations. Especially those that can control accredit and things of that sort. Phil and the Sue? You've got the floor. DR. RUSSELL: I'm going to pass. CHAIRPERSON FADEN: Sue? DR. LEDERER: I guess unlike some of our other recommendations, I guess the federal government does not have a role in this set of recommendations that's recommended to -- CHAIRPERSON FADEN: The way it's set up now is in response to the committee's concerns last time around the sorts of issues that Ruth started raising. An earlier set of recommendations had -- it took the strategy that the federal government should require as a condition for research spending or financial assistance for students, or any other numbers of hooks that the federal government has into higher education and professional training. So the earlier set of recommendations did have the -- was set up -- the earlier draft was set up with the federal government hooks in there, and making it a federal requirement. The committee's discussion then went the direction of Ruth's -- where Ruth was starting to take us about -- these become Mickey Mouse requirements and people just -- remember we had that discussion and Reed went back and forth about on the other hand, you clean up the animal houses because you are afraid you're going to lose your whatever. So it's the stick/carrot problem. See, the last committee discussion, the view was get away -- let's not have stick; let's go with the carrot. This set of recommendations is the carrot. So when you have the stick, it's considered to be Mickey Mouse. When you have the carrot, it's considered to be worthless. So we have to sort of strike a balance here, folks. Do we want to say anything about education? Do we think there's an -- and education as a means towards changing a value structure or enhancing the right values or whatever language you want. Do you want to not say anything about education? Do we want to take one strategy or the other? Sue, does that -- that's a history of why the federal government's absent. There's a little throw away line that says if this doesn't work in the requisite number of years, then the committee would like to see the government adopt the stick approach. DR. LEDERER: Are we not suggesting any education to be aimed at research administrators -- CHAIRPERSON FADEN: In the government. No, that's a mistake. That should be in there. I'm sorry, so I misunderstood where you were going with your question. Yeah, that is a whole - - Phil -- I'm sorry, Reed? DR. TUCKSON: Just a brief -- I think that the text -- first of all, I think we have to do both. And I think we need to -- you've done I think a good job with the first sentence under recommendation eight in the text. I think you start to get at it. I think we can perhaps make a little even stronger statement that says, you know, that we don't always want to have to use sanctions. And we don't know the best way of doing this. That it ought to be that we're recommending that the research community itself -- the presidents -- when we name the associations and so forth, that you know, they ought to take the lead and do this. And I think that's an important recommendation. We don't say we know the answer to how to solve their internal world, but it's something that they are clearly -- we have to put the burden on them to do. And that's reasonable, and it's easy, and it makes sense. You do both. CHAIRPERSON FADEN: And when you say you do both, Reed, are you saying -- DR. TUCKSON: The sanctions -- I mean, one level we've got the tough stuff, and then the other level we're saying you come in and make these recommendations. CHAIRPERSON FADEN: Well, where would the tough stuff come in though? What are you suggesting? DR. TUCKSON: The rest of the report -- I mean, the rest of the recommendations. CHAIRPERSON FADEN: I see. But in this area here, you think it's -- DR. TUCKSON: In this area here, it's -- I think you're on the right track here. And I think it just needs to be even more clearly stated that we are -- we don't have all the answers here and it's not our job to have all the answers, to know how to reform the entire research culture. But you folks are the ones who are doing it every day and you know, these major named organizations, and you ought to take this as an assignment. It ought to be the -- CHAIRPERSON FADEN: So you would be comfortable with this provided there was more text? DR. TUCKSON: Just a little tight -- perhaps it even better explains what you articulated a moment ago. I think it's important. CHAIRPERSON FADEN: Okay. And Sue, I will make -- your proposal, somewhere or other, administrators in the federal government who have responsibility for human research need to be folded in with the recommendation. Okay, we're still on this discussion. Ruth? DR. MACKLIN: Are we considering all of eight? CHAIRPERSON FADEN: Yeah, 8A, B, and C. DR. MACKLIN: Okay. CHAIRPERSON FADEN: As a package. DR. MACKLIN: C does say required education -- required education for medical students. CHAIRPERSON FADEN: But it doesn't say that the federal government is -- DR. MACKLIN: No, I understand that. But it says schools of medicine and then it goes on. I guess my view about medical students is they're so far away from research or the research enterprise. Many view it or will view it as entirely outside their purview or what they're ever going to do. Much of the medical school teaching today takes place in the preclinical years, in which it's often raised. I mean, those of us who have a lot of experience in this in which it's often raised, whether what students are taught in the first two years is remembered or applied by the time they get to be interns and residents, that this will most likely find its way -- I mean, this kind of recommendation into the existing courses as it describes here -- generally emphasize the ethical dimensions of clinical care. So there will be a required unit on research ethics long before students have ever had any contact with a patient, and therefore have to confront the real difficulties of the informed consent process, etc. So I don't think this is effective. I mean, who can argue against good education? But on the other hand, I don't think it's going to be at all effective in what we're really trying to do. On the other hand, when you talk about what's required, if that works -- why for medical students? Why not for research fellows or -- CHAIRPERSON FADEN: Oh, it is. Under 8B, that's where the fellows go. See, there -- DR. MACKLIN: Right. 8B is -- CHAIRPERSON FADEN: Everybody. DR. MACKLIN: -- in a way replicating what now exists - - well, not what now exists -- but in some ways what exists in the research and scientific integrity format. That's what's there. And I've already exhibited my cynicism about that. This is not so much cynicism as it's just the wrong place. I mean, we have some -- the wrong time. I mean, we have some very important concerns. And I think that by -- this is window dressing. CHAIRPERSON FADEN: So ought we to -- I mean, the particular issue here is the distinction between -- as muddy as it is, clinical medical ethics and research ethics. So is the -- and is it more appropriate then to address this to house staff and turn it -- DR. MACKLIN: Well, yeah. CHAIRPERSON FADEN: I mean, that would turn it around and say that education and training of house staff should make sure that the distinction is on the grounds -- medical -- I mean, that's -- DR. MACKLIN: Yes, because where it's likely to take place for medical students is so early in their career. And those who are likely to tune out -- what they really want to do is get their hands on live bodies and start taking care of patients. And the idea that they're going to be doing research that involves this is far removed, both from their experience and from what they will later remember or take seriously. CHAIRPERSON FADEN: I've got Jay, Henry and Reed. And obviously, another way to amend this is to say medical students and house staff. I mean, rather than drop the medical students. But you're -- Jay? DR. KATZ: I have one general and one specific comment. I hate to make the general comment at this time, but I think the whole of eight is really premature. But you can't -- CHAIRPERSON FADEN: All of eight or 8A? DR. KATZ: All of eight. I'll get to 8A -- that's my specific comment in a moment. It's premature because a general recommendation that education in all these areas has really been neglected should be a finding leading to the recommendation at this point. That some kind of body or bodies really immediately and without delay begin to make proposals about what kind of training medical schools, prospective research scientists and scientists should receive. And by whom -- and who should give this training? As Ruth suggested, there are complex issues that need to be considered that haven't been addressed. As a recent -- I think report on some kind of ethical training or human training that I receive in the mail as a wonderful document, and it leaves all these issues out. You haven't seen it? CHAIRPERSON FADEN: No. DR. KATZ: I do not know, but it is -- it's buried in - - whether I have the copy available, but if I do -- CHAIRPERSON FADEN: That's an interesting alternative. DR. KATZ: -- I'll give it. And to really say this -- put this in the strongest kind of language that how come this hasn't happened yet, and that it needs to be done. And that's the direction in which I would go. I like always to be much more specific, but we haven't laid the groundwork yet. I'll just finish, because -- with my specific comment on the 8A, the last thing I think we need is to convene a meeting of presidents and deans of major research institutions. Maybe whatever meetings should be convened should include some of them, but we surely don't want to be a little bit provocative. We don't want to invite the foxes who got the chicken house to a meeting to discuss the ethical issues of human research. In terms of their record, they have failed us so far because they haven't really done very much. So we have to bring them together as a body all by themselves. It's an exercise in futility. CHAIRPERSON FADEN: Let me just see if I understand your first recommendation, because that would be an interesting alternative. You're saying step back and say what needs to happen is that some group of people need to work on how best to educate this community? DR. KATZ: All of them, including -- CHAIRPERSON FADEN: All of them, including -- DR. KATZ: And neglected -- CHAIRPERSON FADEN: We start by saying how -- that our argument. Okay, we start by showing how little attention in fact has been paid to the question of how to educate the research community on the question of research ethics. And then the recommendation would then go on to say some group or groups should be convened for the purpose -- DR. KATZ: At the moment, Yale Medical School would pass with flying colors, but they're really doing nothing. So that's the problem. CHAIRPERSON FADEN: I've got Henry and Reed. DR. ROYAL: One of the things that I'm confused about with the education issue is to me it's one of the things that we've talked about that should have a solution. And maybe it's because of the culture that I come from. And I've mentioned this before, but I think it's worth mentioning again. In order to use radioactive material in human subjects, you have to become what is called an authorized user. And in order to become an authorized user, there's a limited fund of knowledge that you have to prove that you have. And they way this is done practically is there's a written document -- I think it's probably 20 or 30 pages long, and you have to take a multiple choice test after having read that written document to demonstrate that you have some level of comprehension of what the 30 pages said. And I guess I don't understand why as a minimal sort of practical solution to the education problem that there couldn't be a 30 page document that was developed about the ethics of human research, and why there couldn't be this multiple choice question, and why, when an investigator applies to a human studies committee they couldn't have to prove to the human studies committee that they have at least a minimal understanding of what these research ethics are. It doesn't involve individuals going and holding classes and teaching people. It's just a requirement that they have to meet. So because that's a doable thing, and I think it's a step in the right direction, and it's a concrete thing, I would rather see that kind of a specific recommendation made. CHAIRPERSON FADEN: And you think you learned something from that when you went through it yourself? DR. ROYAL: Well, I didn't, because -- CHAIRPERSON FADEN: You knew it already? DR. ROYAL: Well, because my whole training was the use of radioactive materials. But there are people who don't have any training in the use of radioactive material, and if the 20 or 30 page document is written appropriately, I think that they would learn something. And it's just an accepted fact. I don't really have any good sense for whether or not people regard it as having been a valuable experience, having had to take it. But I don't know that sitting in a classroom or going to a meeting that they would necessary regard as a valuable experience. CHAIRPERSON FADEN: I've got Reed and Lois. Nancy? Reed? DR. TUCKSON: Just a very brief thing on this. I think that that's -- Henry, not the -- it's not -- these issues are changing. And if they take a test, the researcher, about the specific sub-specialty field in which they are working and send - - and then that test gets corrected by an IRB, the question is how does the IRB get educated? How do the folks that are on that committee as -- how do you again establish that culture of what is the right answer to the exam as we move into these new areas of increasingly and complex ethical issues in these fields. And so I just would again just think -- and also, I would just say in terms Ruth's earlier point about the medical students, it's true that the majority of medical students might not be, but there are always in each class a group of students who are very involved in conducting activities, even at the first and second year, particularly those that are coming in with the goal of being M.D, Ph.D's. So I guess the bottom line on this is that I don't think we probably cannot -- I don't think we need to kill ourselves on this thing. I think we just simply need to say what our intent is. It is very clear that at every level of the -- of participation in the conduct of research, and students in training, house staff, fellows, scientists, people on review committees. At every level, there is this need to make sure that this is a paramount issue. The permutations of possibilities of how to do this are beyond the range of this committee to try to prescribe. And that the best that we can simply do is to say that these issues cannot be solved with -- always with a stick, although there are recommendations in this report that are very stick oriented perhaps. But here are carrots that simply say to them this is their responsibility to do it. These are the things that are minimal that ought to be done in terms of identifying the populations of people that need to be educated. Now you guys have to come up with the best of your recommendations. If they don't do it, then that's for someone else to begin to later on -- we can't do everything in this report. CHAIRPERSON FADEN: Lois, and then I'm going to try to see if we can't get some closure so we can stay on schedule. Is that all right? DR. LEDERER: I'll pass. CHAIRPERSON FADEN: Is that okay, Nancy? All right, let me see if I can get a sense of where we are. We still haven't talked public education. I hear three strategies. It may be more. One strategy is Jay's proposal that eight be replaced with a recommendation that calls for some group -- and we'd have to then think about which group and to whom the recommendation is directed -- to work hard on trying -- after pointing out that this is a neglected area, work hard at thinking through the problems of how to educate the entire research community about research ethics -- how to do it, what it would mean, what the implications might be for training, for education. Whether it should be a carrot, whether it should be a stick -- all that sort of stuff. Basically passing it on to another group with a real focus on figuring out what the content should be -- what the content should be and how it could be done. You could have just that recommendation. Let's call it Jay's recommendation for short hand, okay? Then we could have what's called as Reed's recommendation for short hand. In addition or separately, or maybe it's the same thing, I'm not sure which -- a recommendation that says biomedical research community, this is your problem. It's our problem with you. And we're not going to prescribe how to do it, but you've got to find a way to fix it. There probably is a way to construct it so that's one recommendation, or it could be two separate recommendations. And then there's Henry's recommendation, either again in concert or separately that -- yes, Henry? DR. ROYAL: It seems that you could combine all three recommendations into one. You have Jay's recommendation as being the recommendation, and then in the text, for example, things like this should be considered. CHAIRPERSON FADEN: Fine. Now the issue is if we go -- and that's very agreeable, I think, because it would work -- to whom does Jay's recommendation go? If we're saying -- is it to the biomedical research community, to the federal government, to whom is it going? Okay, who are we saying do we want to pick up the mantle about education and ethics for the biomedical research community. DR. KATZ: Could two groups in terms of -- are we asking them for blueprint -- two institutions come to mind, but I do not know whether they are the best, is the American Association of Medical Schools, possibly. But I don't know. But surely the Institute of Medicine -- I mean, really in a sense, ask them to -- at this point to convene a committee to come up with a -- there may be others. DR. MACKLIN: Well, why not both? I mean, it seems to me in the spirit of today's world, calling for some cooperation between the public and private sector, if you -- if it's directed at the federal government, the focus will be on the regulations. They'll be on the regulations. And they may not -- and it won't be on ethics, it will be on the regulations. On the other hand, people who are concerned about education or who have responsibility -- the AAMC is one and the Institute of Medicine brings in very important people from various institutions to put on their committees. I mean, it sounds to me like a collaborative thing because you want it to go on in private institutions, and to encompass more than -- private as well as public institutions, but not only government. And you want it to encompass more than the regulations. So why can't a recommendation be addressed to educators and the public and private sector and the federal government that is responsible for the funding? DR. KATZ: Henry, and is there -- and Eli, is there a major research institution -- research group like the American College of Internal Medicine? Is there some research like that that could also -- that say look, you also -- you too ought to think about it? Is there such a group or not? Is that an umbrella kind of group? CHAIRPERSON FADEN: And they're different in the specialties. DR. GLATSTEIN: There are several. DR. KATZ: But in the spirit of Ruth's suggestion -- CHAIRPERSON FADEN: We can throw them all in, but -- DR. KATZ: Not too many, not all. But if we bring that third arm in also, that might be -- CHAIRPERSON FADEN: Here's my concern, okay? This is going to come in -- this is going to be one of these recommendations that has a very high probability of landing like a thud. Okay, now maybe what's written here would land with a bigger thud. But there are a couple of risks here. You now, one is -- is this going to sound like -- and when I think about what Ken said yesterday -- a commission recommending a commission. Okay, well you're talking about some kind of group. Whether you call it a committee or a commission or a group or something -- DR. KATZ: But if you make a strong statement about the neglect with which all of them have -- all of us have pleaded this issue, and that's really a high priority, somebody like the Washington Post may take notice. (Laughter.) CHAIRPERSON FADEN: That's not the kind of thing that makes for a gold mine. DR. GLATSTEIN: I do know that the Radiation Research Society is very interested in the actions of the committee as a whole -- the work the committee is doing, and will probably sponsor a panel after -- at their next year's meeting on this -- once the report is written. They want to hear about it in detail. CHAIRPERSON FADEN: I'm just sort of at a loss here. This is getting more and more and more -- this was hortatory, this is more, this is basically -- unless we get something concrete here, it's really going to sound like hey, they'll be wonderful rhetoric, but said it's been neglected, it's terrible and awful. And then we say do something. Now we can do that, okay? And that's fine, and have one recommendation that doesn't take up a lot of space. But I'm not sure what goes with that. I'm looking for some way to give it a political emphasis so that it's got the challenge to somebody who has to either take it up - - there's no sort of accountability issue here. CHAIRPERSON FADEN: I see Phil and Reed. And Nancy, I'm sorry. Nancy, you were waiting from before. DR. OLEINICK: I was just going to say there is an analogy of sorts in terms of the training that graduate students are now mandated to receive in scientific -- you know, ethics of conducting scientific research. But this isn't -- this is graduate students, and it's not research with human subjects explicitly, but ethical treatment of animals and -- you know, scientific fraud and those sorts of things. And this is now regulated by NIH, at least. I don't know if it goes throughout the federal government, but all graduate students -- in order for the institution to receive training funds from the federal government, the graduate students have to have this. And even those who are not on these training funds are still getting the course. So each institution arranges their own course, something like what Ruth is saying. And at our institution, there is a week in the summer that all incoming students -- you know, stop whatever lab work they're doing and they spend an entire week of intensive work on this subject. It's taught by some individuals from the bioethics community and others -- scientists who also participate in it so that they are given -- you know, real life situations as to the kinds of things that they're going to have to think about. So I mean, but it is directed -- the reason for bringing this up is that we could make the direction -- the recommendation to the federal government. Because I think it's going to have to start there even if the actual implementation is done at the local level. CHAIRPERSON FADEN: Phil and Reed. Phil? DR. RUSSELL: The one organization I think could pull the suborganizations together is the Institute of Medicine. And if there was a recommendation that asked the federal government to support an activity under the Institute of Medicine to bring together the educational organizations and the professional organizations that are -- CHAIRPERSON FADEN: Anna's just brought to my attention we ought to acknowledge that several members of the committee are members of the Institute of Medicine. I don't know if there's any issue about us sort of suggesting that the Institute of Medicine either do a study or get a study, but we'll look into it. Their funding is -- no, but if we have an interest in the Institute of Medicine continuing to have important role and get funding and stuff like that, it's a little bit of an issue. So we have to think about -- we have to think about that. It is potentially unseemly for us to -- DR. MACKLIN: Refer it to an ethicist. (Laughter.) CHAIRPERSON FADEN: So we just have to think about that. Anna is right to draw it to our attention that there is an issue about -- DR. KATZ: We are not making a recommendation that people necessarily welcome. So that's -- CHAIRPERSON FADEN: I wouldn't -- DR. KATZ: Well, I would. CHAIRPERSON FADEN: Reed? DR. TUCKSON: I want to support -- I think Phil's on the right track. And I would only amend it by just being more specific, saying that through the Secretary of Health and Human Services, this ought to be -- this ought to occur. Therefore, giving it some focus with the governmental establishment. CHAIRPERSON FADEN: Well, I think if we -- because of our mandate, I think if we were going to address it, we have to address it to all the agencies. I mean, there's an interagency working group of agencies involved in human subjects. So we could direct the recommendation to that interagency group that has -- that's responsible for the common role and all of that good stuff. But are we -- DR. TUCKSON: That's probably -- I don't mean to single them out as being more or less important, just a matter that since there needed to be some focus of activity for this, it just seemed like a reasonable place. But it's not worth beating it to death. CHAIRPERSON FADEN: Now, are we saying -- so I get clear. I mean, I'll try to write something up or Anna will write it up or whatever. We'll try to pull something together. But right now, I have a very uneasy feeling that this is just some -- you know, recommendation go and do good. You know, I'm not sure how to make it more specific. Nancy has reraised the issue of the stick, and is there no interest in the committee in suggesting that -- DR. KATZ: Could you elaborate on this? Because it's important because I really don't understand it. CHAIRPERSON FADEN: On which -- DR. KATZ: On the issue of -- that there's no -- could become a meaningless kind of statement. CHAIRPERSON FADEN: Well, I mean, -- DR. KATZ: Let me just finish. Is that if we really point out in that -- whatever we write, that this has been a neglected area of concern, even though it should have been addressed by somebody. If we make specific recommendations as to what needs to be put into with respect to -- and some of these things, people have mentioned even here about education -- what kind of -- and your general kind of way that they need to address and who should teach, etc., and what. And do that, you know, in a few paragraphs. And then say now appoint a group that makes these recommendations, maybe even that it ought to be addressed -- I do not know whether it's a possibility, but couldn't we ask the interagency group to approach -- and some other institutions and ask them to look into these matters, because this happens frequently. And so, bring the two together, and then submit a report with them, because these things -- to serve thought, but also immediate attention. Would that be that nebulous? I mean, that's what -- CHAIRPERSON FADEN: I depends on how far we can carry it down. If we're talking -- I'm sorry, Ruth, you were -- DR. MACKLIN: Well, I was just looking at what we have here so we don't lose it. I mean, I'm not sure that the -- that anyone is making an argument against including such a recommendation in here. We're worried about carrots, sticks, watering down, etc. Recommend eight as it stands before you get to the A, B, and C. I haven't heard anybody argue against having it as a recommendation, and I certainly would not argue against having it. The advisory committee recommends a multi-pronged effort to ensure the centrality of ethics and the conduct of scientists and research involving student subjects. Now, that may sound like apple pie, but I mean, that's there. Then there are the specific ones afterwards. We don't want to omit it all together. I think the discussion has been both about the efficacy and the appropriateness of the A, B, and C. I argued against A; my colleague to my left, notwithstanding as the leader of this group, but I argued against it on the grounds that I think sufficiently discussed. And I argued against C, because I think it's the wrong time, seeing as it's the education of the medical students. But A -- I mean recommendation eight as it stands can include certainly the education for medical students. And the way B is written doesn't actually say that it's required, so it's Nancy's recommendation, but it's there as a specific tool. And I think combined with what Jay is saying and with some address to those who do continuing medical education and those organizations of research scientists, we can have the education in here without being so specific that it's going to either be inappropriately specific and required and not in the right place, but still point to the lack or the things that haven't been there. So I think that the -- I'm going to suggest that we keep recommendation eight as it stands. CHAIRPERSON FADEN: Lines 11, 12 on page 12. DR. MACKLIN: Yes. And that we fold into the -- that we eliminate the A, B, and C and that we fold into the text under A what's now in recommendation 8B as one of the examples. CHAIRPERSON FADEN: So we're basically -- the recommendation is essentially this call for this. And then we're going to direct something to -- I mean, somehow Reed's suggestion directing it both to the federal government and to the biomedical research community and saying federal government, you have -- we're directing you to exert leadership in concert to make sure that the things happen. And here are the following things we're suggesting, including the commissioning of a panel or a study of how best to approach the question of the education of research ethics. Whether we mention the IOM or not will depend on the issue I just described. DR. MACKLIN: But that could be a such as if we mention the -- CHAIRPERSON FADEN: Such as the Institute of Medicine or whatever. That we explore the usefulness of extending the federal requirement that all people who receive traineeships get this course work to other sorts of things -- explore whether -- so we put all that stuff in the conditional -- explore the utility and the development of accrediting. Whatever the kind of thing Henry is describing. I just threw it in there. Is that where we're going? DR. MACKLIN: I think that's where we should go. CHAIRPERSON FADEN: Okay, so we'll try writing it that way and see what happens. But basically, the accountability is the federal government should do in a timely fashion -- should move on this and hear the various things that ought to happen in a timely fashion -- that the federal government has to do it in concert with the biomedical research community and the education community. Okay, for two seconds before we take a break -- I don't know if it will be two seconds -- public education. Lois, no? DR. GLATSTEIN: Apple pie. CHAIRPERSON FADEN: Yeah, I worry about it for that reason. It's almost nothing, right? The sentiment is important. It's more than a sentiment. The notion that the public needs to understand in order to protect -- in order for each of us to protect our own interests, we need to understand something about the research enterprise. The how is not there, and I'm not sure -- DR. GLATSTEIN: Maybe this is the place in the text that we can bring out that issue yesterday about exportation from research to the -- to practice. And maybe this is the place where that can come out. I don't know. DR. KATZ: I thought you recommend that journalists should be educated. (Laughter.) CHAIRPERSON FADEN: I don't think -- I mean, we could roll it into eight, but I don't think it works. I mean, the eight is directed at the biomedical research community. This is basically -- do we want to just drop it because it is nebulous? Or do we want somehow to -- DR. GLATSTEIN: I think the sentiment needs to be expressed there somewhere. I mean, we've got to get the -- it's more than just the government, more than just -- CHAIRPERSON FADEN: Oh, but the concern is when you make -- you mean you don't want to make recommendations that are totally throw away. You want to have only recommendations that you think have a chance of -- you know, that really should happen, okay? That doesn't necessarily mean that they -- that politically you think they will; but at least that you think they really should and you explain how. And the problem is, this doesn't go -- DR. RUSSELL: Is there a finding related to this? CHAIRPERSON FADEN: Well, our whole argument has been that people don't -- you know, we look at all that stuff. DR. RUSSELL: Is there a specific finding? CHAIRPERSON FADEN: The SIS stuff, I guess. Henry? DR. ROYAL: What about combining it with eight, saying that medical professionals in the public should be educated so that we don't have a lot of recommendations that are hortatory. (Laughter.) CHAIRPERSON FADEN: Just one big one. (Laughter.) DR. ROYAL: It doesn't have to be a big one. DR. MACKLIN: The problem though is that different institutions and agencies will be responsible for educating the public. So if you fold it all together, the public's going to get lost and the emphasis is going to go on the IOM, the professional organizations and the medical schools. I mean, unless you want to say that medical schools or those kinds of institutions should themselves take on the responsibility for educating the public, but I don't think they have the foggiest idea how to do it. CHAIRPERSON FADEN: I mean, one thing I -- Anna and I actually toyed about is whether -- and this is always that problem. It's easier to get to patients than -- it's easier to get to people once they're sick than when they're just well and walking around or at least not in anybody's care. And we all know the failures of the patient's self determination act. But there is in here embedded the notion that institutions -- hospitals in which research is done have some obligations to educate the community from which most of their patients come about the fact that we are a research institution and here are the differences between, you know, research and treatment. And here's how we look out for our interest, and just know this about us. Which is -- you know, a recommendation that could be targeted towards institutions that provide medical care. DR. GLATSTEIN: Maybe you could institute a program that would serve as an alternate for the Internet pornography. CHAIRPERSON FADEN: And be just as lively, I'm sure. Reed? DR. TUCKSON: But see, Eli's point is extremely important. I think first you cannot -- (Laughter.) Well, it's extremely important in the sense that the notion of how patients and consumers participate in the process of health from this day forward is very different -- inevitably different than it has been in the past. The sense -- because of the Internet, because of America OnLine and CompuServe and Prodigy. Absolutely because of those things, patients are so much more highly educated and are going to be more highly educated, and they're going to be much more empowered as they participate in their own care. And we cannot fail to recognize that the clock has changed. And so this notion then of recognizing -- we have to recognize that. And I think that it is a very different recommendation, this one, than number eight for the reasons that Ruth mentioned. Now, I'm not answering your question about how do you do it. But I think you have to speak to it. And I think the question merely is that I think the only way that I think we can do anything about this is to first acknowledge it and put it front and center as saying this is a major issue. I think secondly it is that the way in which we distribute this report we ought to speak, I think, to the way that the only thing that we can really control over this -- at least at our level, is to say that we are -- it is our desire that the distribution of this report be wide enough so that the American people have access to this kind of stuff. So at least that helps to prepare them to know that there is a way of participating. And then I'm going to have to think more about -- be even more specific. I can't be smart enough at this second to figure out any other mechanism. Hopefully somebody else has it. But I think even if we can't give the specific mechanism, we have to address the issue. DR. GLATSTEIN: Maybe there should be some effort made to attract the media themselves to form some of this educational -- perform some of this educational service. I'm not sure that couldn't be done. CHAIRPERSON FADEN: I don't know how to fashion this in a way that has any oomph is the problem. So there's this -- the issue of whether a recommendation format is the right form for drawing attention to an important national issue. Maybe it is, maybe it isn't. Maybe we're not -- as Reed put it, smart enough to figure out how exactly to flag the issue without having it just fall away. MS. NORRIS: Do we have any findings without recommendations? CHAIRPERSON FADEN: I don't know; I haven't done the check. MS. NORRIS: Well, we could make this a finding, calling attention to the need absent a recommendation. DR. GLATSTEIN: And maybe you have a Ken Burns special. I'm serious. MS. KING: I think I need a break. CHAIRPERSON FADEN: All right, but I don't want to promise -- after the break, I don't want to go back to those set of recommendations. MS. KING: Well, I only said that only partly facetiously because we seem not to be able to come to grips with your -- with the problem that you described very accurately. And we are at the level where we're throwing off what comes to the top of our heads. CHAIRPERSON FADEN: All right, why don't we take a break. I don't know what we'll do with this. But we're not going to come -- no, I don't think we should come back to this for a few minutes. I think we can go back to other things and see what we're going to do with this. I don't think it's going to get any better. Or not even at the end. Maybe not even in the meeting. Maybe people will try to work out something and give people some concrete alternatives. (Whereupon, the proceedings went off the record from 10:54 a.m. until 11:18 a.m.) CHAIRPERSON FADEN: We are behind schedule. Maybe we could make up time. Maybe we can't. I'd like to stay on the agenda, at least until lunch, and then at lunch slip in notification. Then we'll just have to see how much we can get done. Next on the agenda is the findings. We're switching from recommendations to findings for just a minute, going backward. Then we're going to flip forward to recommendations again. The findings on intentional releases is in your findings chapter, Chapter 18. That can be found on Page 11. There is a finding. And then I'm hoping the finding itself will be reasonably noncontroversial and we can go on to the recommendations. Did we discuss this already? I don't think we did. Okay. Then these are my notes to myself or maybe it was some reaction to a conversation with someone that in Finding 12, that the text beginning in the case of the Green Run be not folded. Didn't we discuss this? We did discuss it. Okay. Good. We discussed it already. All right. So we discussed it. So put away findings. We're going to go to forward-looking recommendations on intentional releases. We discussed it when we weren't supposed to discuss it. Good. I looked at it, and I said, "Gee, why do I have this?" This is my unedited copy. So now we're back to recommendations. And these are now the recommendations balancing national security interests and the rights of the public. This goes obviously to the very core of our charge as a committee in terms of what we were set up initially to consider. It is Page 31. There is a recommendation on classified research, which is Recommendation 14, which has a lot of background behind it which is not intended to stay there but was put in there so that it would enlighten. I hope you could tell the difference. It could enlighten committee discussion. And then Recommendation 15 is with respect to intentional releases. They're grouped together because they're both directed at national security as that interest may conflict with other interests the public may have. Lois? MS. NORRIS: We are on classified research? CHAIRPERSON FADEN: Yes. We might as well do them in order. MS. NORRIS: Recommendation Number 14? CHAIRPERSON FADEN: Yes. MS. NORRIS: I have a couple of problems, only one of which is really major. 14(b) referred to approval of an independent nongovernment panel of technical experts. "Technical experts" to me is inappropriately vague in this particular case. If you're talking about chemical warfare, for instance, a technical expert could be a chemist and a weapons design person. And I don't think these are the people we want to be -- CHAIRPERSON FADEN: We want a different kind of expertise, array of expertise. MS. NORRIS: Some more specificity, whatever. CHAIRPERSON FADEN: We want to make sure that it's not just technical, that it's not people with now a technical -- experts in other things, ethics, politics. MS. NORRIS: Right. Then we also mention -- I think this is Lines I think 17 through 19 -- that the record should be made public as soon as national security concern justifying secrecy no longer applies. I assume that you have no intention of subject identifiers releasing natural consent forms. CHAIRPERSON FADEN: Oh, no, no, no. MS. NORRIS: Just the forms themselves. CHAIRPERSON FADEN: Right. We can stipulate that. MS. NORRIS: The one that really does concern me is on Page 33, Lines 8 through 11. And this is where we are calling for security clearances for research subjects of classified research. That one worries me. Two reasons: First of all, it could create a backlash, create a new coercible, vulnerable set of subjects; i.e., military and civilian employees who already have security clearances. Therefore, they're accessible. CHAIRPERSON FADEN: I see what you're saying. They would be disproportionately approached. MS. NORRIS: Oh, yes, very accessible subject pool. That bothers me. And then also if you require security clearances for subjects and they do elect to recruit subjects who do not already have them, in order to volunteer, for whatever reason, you have to subject yourself to the personal scrutiny of a security clearance and subject all your friends, neighbors, colleagues, business history to a security clearance. And I think that places an undue burden on those potential subjects who don't already have clearances. DR. THOMAS: A commitment which may make it difficult for them to withdraw at that point. DR. RUSSELL: Why? DR. THOMAS: Because they have so much invested in the process already and -- CHAIRPERSON FADEN: Yes. Phil? DR. RUSSELL: I assume you mean a panel of nongovernmental experts, not a nongovernmental panel, because it is a government panel. CHAIRPERSON FADEN: Quite correct. The modifier is in the wrong place. DR. RUSSELL: And it's a government advisory panel of scientific and technical experts. I would argue that the Charge 1 is totally inappropriate. The responsibility for classifying or not classifying something is the responsibility of a federal official, not of an advisory panel. And I don't think that the panel should deal with the justifications for classification. That's clearly a federal official responsibility and probably by law it is. So I think the Number 1 ought to be deleted. I think that what should be added is a review of the quality of the scientific experiment, that that -- CHAIRPERSON FADEN: We replace it with the scientific review. DR. RUSSELL: Right. I think that the advisory panel should assure that it's very high-quality science, that the risks are acceptable, and that the risk to potential harm, the risk-benefit, risk-harm ratio is appropriate. And then the third one is appropriate. I see the problems in that informed consent and requiring security clearance for potential subjects, but I think it's an option that needs to be retained. I can see experiments where those aspects that are classified are irrelevant to the consent process as long as the subject would understand that the reasons, underlying reasons, are classified, that he can be provided, he or she could be provided, enough information on the medicine, the biology, the risk, and so forth, to make a good judgment. On the other hand, there may be certain kinds of experiments where the nature of the experiment would be so obvious that it does reveal the classified nature. And, therefore, you couldn't do the experiment. You couldn't do the studies unless the volunteers had security clearances. So I don't think we should make a recommendation that's too restricted here. I think you could make this an additional charge to the advisory group to determine whether it's appropriate or inappropriate for the subjects to have security clearance. CHAIRPERSON FADEN: That would be an interesting way of -- MS. NORRIS: Yes. That satisfies me. CHAIRPERSON FADEN: That would be Charge 4 to the independent panel that would address whether a security clearance was necessary for someone to give an adequately informed consent and, if so, to ensure that there are sufficient safeguards that this is no coercible, whatever the deal is. It may be appropriate to go to people who already have security clearance but in a way that makes it clear that they don't need to do this. I mean, there are a large number of people who have security clearances. MS. NORRIS: That would satisfy me. That would be great. DR. THOMAS: I guess I'm still a little uncomfortable with the idea that this advisory panel should not be charged with reviewing the justification for why this experiment needs to be done in secret. I accept Phil's point that the process of classifying information is a government responsibility which should not be delegated to an outside operation, but the appropriate ethical conduct of the study being done in secrecy seems to me to be something which the -- and the reason why it needs to be done that way is something that this panel needs to be apprised of and should consider whether or not in their view the additional burdens imposed on the subjects are justified in the interest of national security and whether or not the experiment should be done at all under their circumstances or whether or not a pitch should be made to the government to reconsider whether or not the experiment could be done in a non-classified setting. DR. RUSSELL: I don't have any problem with asking a suitably declared advisory committee to advise on that issue. I could think of potential scenarios where there would be reasons that are not revealed to the committee that because of some level of security that would make it essential that the committee might not be provided with all of the information, background information, that would require the security and conditions and, therefore, might not be able to make a fully informed decision on the security requirements. On the other hand, having them be advised to the extent that they understand it is perfectly appropriate. DR. THOMAS: I guess I have grave reservations about the notion that this committee could be only partially informed of the circumstances and based on that partial information could remain unpersuaded that the justification for the experiment under the conditions that are proposed is justified and the government could then go ahead and preempt that responsibility and say "Well, let's go ahead and do the study anyway." DR. RUSSELL: If you took a hypothetical scenario in which the human subject research was needed to develop a countermeasure against some threat, the assessment of that threat might be so highly classified that it couldn't be revealed to protect the sources of the information, -- DR. THOMAS: I understand. DR. RUSSELL: -- for all the reasons that -- DR. THOMAS: I understand. DR. RUSSELL: -- classifications are done. And so that the level of urgency of developing the countermeasure and so forth is a matter that only the government officials fully informed could make good decisions on. But if you got to the point where it's urgent to do this, then you could give an advisory group enough information to give good advice on: Is this being done appropriately? DR. THOMAS: But in this situation it seems to me we bump up against Recommendation 14(a) in this case. If you can't give your advisory committee enough information to make a decision as to whether or not the experiment is warranted, how are you ever going to require the -- DR. RUSSELL: No, no. That's not the question. CHAIRPERSON FADEN: I think it's not that it isn't warranted, but that it be classified. Okay? DR. RUSSELL: You're arguing about whether it will be classified or not. CHAIRPERSON FADEN: You give the advisory committee all the details the -- DR. THOMAS: No. I've already accepted that. I'm not asking this advisory committee to act on whether the experiment should be classified, but whether or not the experiment should be done or should be done in this particular manner -- CHAIRPERSON FADEN: Oh, I think that's okay. DR. THOMAS: -- and whether or not the experiment is justified based on the need, part of which must remain classified. DR. RUSSELL: Think about how that would play out. The committee might say that they don't have sufficient justification for doing this, you know, "The experiment's okay. And you can see why it's doing it. Why are you classifying that? We aren't convinced that it should remain classified?" That could be an interactive process. And they may -- DR. THOMAS: Well, I want to stimulate that dialogue. You see, that's why I think that first recommendation, although it does need to be reworded so that it doesn't imply that we're asking this panel to -- DR. RUSSELL: You can't empower nongovernmental officials with the responsibility for classification or declassification. DR. THOMAS: And I'm not asking them to. I'm not. CHAIRPERSON FADEN: Could we make 1 advise and 2, 3, and 4 determine, advise on? I'm just trying to come with particular language. Pat? MS. KING: First of all, I agree with what Phil's first statement was, that, I think, if I got it right, that 1 in 14(b) was appropriate. Maybe if he didn't say that, I will say it for myself. And I get at it this way. I ask: What is it that we are concerned about? We are concerned about potentially human subjects. CHAIRPERSON FADEN: Right. MS. KING: How do we best accomplish that? We have agreed to this addition. You want scientific review. You want to know whether it can be done. You want informed consent, which is a change, which we're now saying you cannot not do it. And we want risks to subjects that are acceptable. And we want disclosure. Now, one can make an argument that you can't do that because if you're really assessing risk, you need to know how important, not how scientifically valid, but how important the work is. And it seems to me that when you get -- you notice I'm not using "classification" or "secrecy" or "national security." When you want to know how important the work is, I think that you're into a different realm of decision-making. It is not that it does not relate to what you're doing. I see it as being primarily decision-making of a different sort with which government officials are properly charged. It is the work of the Executive and the Congress to determine and their officials to determine in our system what is significant to carry out our national interests. It seems to me that other groups may want to make recommendations about maybe the national interest should be carried out better or different ways. But that doesn't seem to me to be our charge. Ours is that at some point you have to trust the government. I mean, this is becoming the "Do Not Trust Government" commission. At some point you've got to trust it or we might as well forget about it. And I am willing to place the stress in this on a panel whose expertise does not go to making those kinds of decisions. Its expertise will go to science. Its expertise will go to risk. Its expertise will go to consent. Its expertise will not be in making judgments about what the government needs in order to carry on its business. Therefore, I am agreeing with Phil what I thought he understood, which is to eliminate 1 and to add science and to keep the remaining ones. CHAIRPERSON FADEN: You would add science and add the panel's reviewing about the security clearances, subjects need to have security clearances and, if so, to introduce safeguards for potential subjects. So the proposal is to remove 1 and add science and Lois' concern about security clearances. I remind you that the recommendation here is important. This is a hole in national policy. So when we talk about stuff where this committee is going to make a contribution, if they listen to us here, this is a big deal. This is not a little deal, even if they only do one study a year or they don't do any for 5 years and then there's a national threat and they've got to do 30 and we just don't know. DR. RUSSELL: I think it's important: one, that there be a mechanism for carrying out the necessary studies; and, two, that we do it in as credible a manner as possible with regard to the science and the potential risk and so forth. I think we'll make both national requirements. CHAIRPERSON FADEN: So if we hadn't discussed some recommendations this morning that we worried about being hortatory, this is not hortatory. Of course, it will be if they don't implement it, but it has a potential to be implemented rapidly as policy. And it's core to the history of this committee's charge, as the next one is as well. Ruth, you look troubled. DR. MACKLIN: I know nothing about any of this. I want to hear again what Phil said about what might still have to be kept secret. In other words, we're talking here about what can be disclosed, even if subjects have security clearances or to this advisory panel. And, yet, I heard Phil say that something still because it comes from a higher level -- maybe an example would help, some wild hypothetical example might be -- CHAIRPERSON FADEN: Henry, did you want to answer or -- DR. ROYAL: Well, yes. I mean, the more people who know about it, the more chance there is that something is going to leak out. And I can imagine circumstances where there are people who have security clearance but just because they have security clearance doesn't mean that everyone who has security clearance should know about this particular item because the more people you tell, the more likely it is that it's going to get out. MS. KING: That is indeed what happens with the Congress. CHAIRPERSON FADEN: Right. Let's -- MS. KING: They are only exposed to a very small number, not -- CHAIRPERSON FADEN: To a small number of the members. Let's imagine. Okay. We had these discussions with people when we were developing this memo. Let's imagine that the government has learned that a terrorist group of a certain sort, domestic or overseas, has developed a new nerve gas and they actually have information, intelligence information, that they plan to use it in such and such a city in six months. And that's the urgency behind developing whatever defensive anecdote kind of thing is -- the whole panel doesn't need to know. And, arguably, it would not be a good idea for the whole panel to know the name of the terrorist organization that they have the chemical, where it is. It's enough for the panel to know that there is a real serious concern about this nerve gas, this new nerve gas, that is being developed and there is a credible threat. That's the kind of scenario we were presented with. And maybe the members of the committee don't want to now that the name of the organization, the city, and the way it's planned to be done. So it's at that level that there's a concern about distinguishing. DR. RUSSELL: One of the big concerns of the intelligence community is revealing what they know in the context that if it's revealed what they know, then it's going to be revealed how they got it and that frequently would put the lives at risk and stop the source of the information. This is especially important in the terrorist arena. So that protecting the fact that this information is in the hands of the government is very, very essential, even though you have to act on it. Well, you can act on it by clearing people for certain kinds of activities, but they don't have to know all the background. And they may not be immediately convinced of the urgency of doing it unless they had that background, but -- CHAIRPERSON FADEN: They have to -- DR. RUSSELL: -- because of the level of concern you can't reveal it. So that's the example. CHAIRPERSON FADEN: Is that helpful? DR. MACKLIN: Yes. CHAIRPERSON FADEN: All right. With the amendments, then can Recommendation 14 stand? And, just so you know, the italicized stuff is not intended. That was there so that you didn't have to go back and look at Chapter 14 in order to know what was going on. Now we're on to Recommendation 15, which is a parallel kind of recommendation for intentional releases and secrecy and national security. (Pause.) CHAIRPERSON FADEN: I'm sorry. We were just conferring because it looked for a minute to me like it had changed from the last time I saw it, but it hadn't, though. Lois? MS. NORRIS: This is a question. And it may be inappropriate. But on Line 19, would it be possible or reasonable or appropriate to change that to "substances for research and development"? It seems to me that research is a little more narrow than research and development and -- MR. GUTTMAN: The intent here I think was to distinguish between ordinary everyday releases. Then you're into the world of the operation of everyday -- MS. NORRIS: Yes. MR. GUTTMAN: That was the nature of the boundary. MS. NORRIS: This may be personal and maybe I don't know the appropriate definition, but it seems to me that if you throw development in there, it's more than an ordinary release. It might catch something that would slip through a crack if we limit it to research. CHAIRPERSON FADEN: Is there discussion on that point or are people comfortable with the amendment that "development" be added, "research and development"? DR. MACKLIN: I'm not sure what development means. I'm not sure what it means. MS. NORRIS: For instance, release of materials into the environment in the course of developing a new weaponry. That to me catches something that research does not. MR. GUTTMAN: How about testing? I think the example historically -- MS. NORRIS: Research and testing? MR. GUTTMAN: -- is the safety tests that we had with the nuclear rockets and so forth, which is sort of the notion of development in that sense. CHAIRPERSON FADEN: Maybe the word should be "testing," rather than "development." MS. NORRIS: That's possible. I just wanted to catch something more than what we classify as research. DR. OLEINICK: Well, but, you know, I think what you're thinking of is research in the sense of purely basic research. I mean, you would consider it development or testing under applied research, I think. And I think it all, at least in my mind it all, is captured under that research. DR. RUSSELL: The acronym that's almost universal throughout the Defense Department -- DR. OLEINICK: Is R&D. MS. NORRIS: R&D. DR. OLEINICK: Research and development. DR. RUSSELL: R&D because research has the implication for basic and -- DR. OLEINICK: Well, okay. DR. RUSSELL: -- development has the testing and the nth stage. DR. OLEINICK: It's not a big point. DR. RUSSELL: It may overlap to a great extent, but the majority use both. DR. OLEINICK: That's fine. DR. RUSSELL: And it will be comprehensive. CHAIRPERSON FADEN: Would you be comfortable, Phil, with "research and development," -- DR. RUSSELL: Yes. CHAIRPERSON FADEN: -- which was the suggestion? MR. GUTTMAN: It's not RDT&E, research, development, testing, and evaluation? So we'll shorten the acronym. CHAIRPERSON FADEN: Unless anyone objects, the amendment is accepted. And Line 19 reads "substances for research and development purposes." Nancy? DR. OLEINICK: I'm just wondering if we're going to get hung up on the word "hazardous." What is the definition here? What level is hazardous? We say later on that most of the releases that we talked about where there really wasn't very much risk -- so in that sense they weren't hazardous because the levels were so low. MR. GUTTMAN: Here's the conceptual if I can be in the Pat King policy mode and bungle it if Pat will pick it up. One intent here was the key into the existing body of environmental laws, which has about a billion different and conflicting definitions of hazards and also have the environmental review process. So one intent was if there is under this whole system of current environmental laws this market research and provision for keeping something secret, then we don't want that to go unchecked. So one way to have written this was to say "If under existing laws governing hazard and environmental review some or all is secret, then this has got to be triggered." The question, of course, is: What happens if that body of law is changed or it doesn't exist? Then you have, you know -- DR. RUSSELL: But isn't that what you want to do? MR. GUTTMAN: What? DR. RUSSELL: You want to tie whatever -- MR. GUTTMAN: Yes. DR. RUSSELL: -- this process -- MR. GUTTMAN: Yes. DR. RUSSELL: -- to whatever evolves in the future with regard to environmental laws and -- MR. GUTTMAN: Except the question, though, of -- the committee I'm sure is of the view that that even if there were no Environmental Policy Act, we would still want a review of things that were being done in secret, I assume. DR. RUSSELL: The fact is there is. CHAIRPERSON FADEN: Yes, but it might go away. MR. GUTTMAN: But if it goes away because there are no resources at EPA or whatever. That's the question. DR. RUSSELL: Then we've got bigger problems than this. CHAIRPERSON FADEN: Pat? MS. KING: It seems to me that what we ought to be focused on is -- this goes back to research and development. It seems to me that our focus, our problem with intentional releases is what it can do to the people who were exposed. And am I wrong about that? And what this focuses on is when you're conducting research, development, we're trying to cover the whole avenue of activities that the government might take on. And that's why we're tangling with this problem of research. I guess I would turn around and write a recommendation that focused on when a substance is released that posed harm to those exposed, that is when -- CHAIRPERSON FADEN: The problem, Pat, is that what's circumvented by going in secret is the public debate about whether something is hazardous or not. In the environmental area especially, but I guess everywhere in life, you've got communities arguing with feds about whether a particular agent being released at the level posed to be released is acceptable or not and the Environmental Protection Act's requirements about publishing all that stuff that puts it out there, it's got to be out there, the public has a chance to comment, you fight. And, yet, all of that stuff is obviated when it goes underground. So the advocates for the community, the environmental activists, everybody who might want to comment and fight on the release no longer have an opportunity to do so. So what's at issue is precisely whose values about what counts is acceptable are now not open. MS. KING: That's not what my point went to. CHAIRPERSON FADEN: No. The issue is about who decides it constitutes a harm. MS. KING: I'm not arguing about hazardous. I went back to research and development. CHAIRPERSON FADEN: Well, then you raised issues about only posed a risk of harm. MS. KING: I said that the focus of the recommendation at Line 19 when we were talking about "substances for research purposes and development in cases where" dah dah dah seemed to place the trigger on the definition of research and development. And what I said was that's not what I thought we were intending to do that our focus is on anything that goes into the atmosphere that's hazardous -- I didn't touch hazardous -- that what we wanted to say was to turn this around, the recommendation around, to our focus when people are placed at risk. And I assume that now is covered by the recommendations according to what Dan and you both said about all of these multiple definitions of hazardous. CHAIRPERSON FADEN: Okay. MS. KING: What you're looking for is a trigger. CHAIRPERSON FADEN: Right. I'm sorry. MR. GUTTMAN: Yes, yes. CHAIRPERSON FADEN: I don't understand where you're going. MR. GUTTMAN: I think I understand, Pat. Go ahead, Pat. MS. KING: What you're looking for is a trigger that would call into place this process that you were outlining here. And the way this reads, the trigger is "propose environmental releases of hazardous substances for research purposes," is the trigger that triggers this process. That's not what I think that -- MR. GUTTMAN: Let me point out here's the dilemma. This is not the dilemma. This is the policy question for the committee. Take the Green Run, Hanford. You had, as Henry has pointed out, 669,000 curies that were released during the normal course of operation not for research purposes. So the question is: If you want to cover all of that, then you are talking about a committee reviewing all of the releases that somehow are implicated in secrecy without regard for whether or not they're operational. You could do that, but it's a different -- MS. KING: I guess we still haven't gotten the rest of it. But you're explaining better than I am because what I'm trying to get is the meaning of the not-hazardous. MR. GUTTMAN: Yes. MS. KING: It is certain types of proposed environmental releases are covered here. And those types of environmental releases covered here are if they have research purposes. And now we've added research and development purposes. CHAIRPERSON FADEN: Wait a minute, Pat. And if that's wrong -- MS. KING: And what I'm trying to ask -- CHAIRPERSON FADEN: Okay. MS. KING: -- is: Is that what we want to make the trigger? CHAIRPERSON FADEN: As opposed to? MS. KING: As opposed to talking about releases that pose risks to people without a focus on the characterization of the releases. CHAIRPERSON FADEN: And you want to say "for all potentially hazardous releases"? MS. KING: That's the question I'm asking. I'm asking what the committee wanted to -- MR. GUTTMAN: Let me articulate the writing. CHAIRPERSON FADEN: I'm sorry. I couldn't follow you until just now, Pat. MR. GUTTMAN: Let me articulate the drafting. There's a point that we tie it into current environmental laws. Then you could say that anything that is normally covered by these laws, but, for whatever reason, is secret, we want to have this thing reviewed by it, which includes everything. MS. KING: Right. That's one way of going. MR. GUTTMAN: Right. The reason it isn't written that way is because of the question: Well, what if we didn't have or don't have the same kind of -- CHAIRPERSON FADEN: But you forget the laws. Pat's saying forget the laws, whatever. MS. KING: I'm just asking because it seemed -- CHAIRPERSON FADEN: Forget the law. The law isn't the issue. MS. KING: Our concern about -- I'm trying to get to the: What is our concern about potential releases? CHAIRPERSON FADEN: Why the releases were released. MS. KING: Yes. Do we care more about the fact that the releases exposed people to risk and they didn't know about it and had no way of finding out about it? I'm only trying to find that out so I can figure out whether this does what we think we're doing. Phil, does that make sense finally? CHAIRPERSON FADEN: Yes. It does to me anyway. MR. GUTTMAN: But let me explain. CHAIRPERSON FADEN: You retained me, and you lost Dan. MR. GUTTMAN: Let me explain if I can add sort of a friendly amendment to the explanation is the difficulty is the current body of federal law has in it all kinds of trigger mechanisms so you're not -- just because it's a microcurie coming out of some plant, you don't have a federal environmental impact statement. If we talk about all releases and assuming the law changes, then you have this body, which is now all of a sudden an obligation looking all over the defense complex and determining, you know -- CHAIRPERSON FADEN: How many releases are secret? MR. GUTTMAN: Oh, you are talking about the question. I mean, I can tell you. For example, I used to represent workers. Uranium hexafluoride is released in some secret part of the fluorinal plant accidentally. It's leaking. Is that something that would be -- this happens all the -- we don't know. I mean, what I'm saying is a large part of the weapons complex is still operating in secret. CHAIRPERSON FADEN: You can't have a panel to review accidents in advance. DR. MACKLIN: The distinction between accidents and -- CHAIRPERSON FADEN: I know. I know. That's what I was responding to them, that you were talking about routine releases. How often are routine releases classified such that Pat's question: Why not address all the releases that are classified? MS. KING: I'm really asking what the committee intended to gain from its -- CHAIRPERSON FADEN: Its modifier. MS. KING: -- its modifier because that way it would let me know what we want to have here. CHAIRPERSON FADEN: I think that from my opinion the modifier was there because we were working at that context, but it may not be necessary. In other words, our mandate was to look at the releases for research purposes. MS. KING: One of the things that struck me from Dan's comment -- and this is -- I actually don't have my own views on this, but what struck me from Dan's comment is that one of the entangling problems in intentional releases is that the people who were there in the community who were being exposed to some form of radiation release were in a better situation as a result of that as they were of this additional release. And if I approach this from a human subjects, this sort of goes back to the old debate from the perspective of the person for whom the radiation falls. Do they care whether there's a plant or some airplane flew over in secret? And so that's why you really helped me to get it -- MR. GUTTMAN: No. Of course they don't. I don't think this is a drafting problem in terms of -- CHAIRPERSON FADEN: It's not a drafting problem. It's a substantive problem. Pat's quite right. Do we want to say that this ought to be the case for any release that's hazardous, whatever the law defines it? It could be secrecy is what we want to say. The trigger is when it's done in secret and there's no public federal environmental impact statement and all that kind of stuff. But Phil has been waiting patiently. DR. RUSSELL: It doesn't make any sense to have a different process for research versus non-research if you're talking about intentional release under secret conditions. It ought to be the same process. So if we're going to make the recommendation, we probably ought to just take out for research purposes. CHAIRPERSON FADEN: Right. DR. RUSSELL: Now, that would make it a fairly global kind of a recommendation. We'd need to think fairly carefully about it. CHAIRPERSON FADEN: But the important -- DR. RUSSELL: But I think that it doesn't make sense that if -- CHAIRPERSON FADEN: It would be as if this had been in place, the Green Run would have had this panel. And everything else that had been going on at Hanford would not have had a panel, which does seem nutty. That's the force of Pat's concern. DR. RUSSELL: Right. That's why it makes no sense. DR. MACKLIN: Phil just said "intentional." Now, I mean, intentional means deliberate in contrast to knowing. But set aside accidents. I mean, the routine releases are not intentional in the sense that someone deliberately did. I'm just trying to understand now what we're talking about. CHAIRPERSON FADEN: They are deliberate. They are the intentional -- I mean, it didn't really go into an action theory kind of thing, but they are planned. Do you want to say "planned"? They are planned? I mean, the plant has to release every six weeks X amount of gunk into the air. It's part of the operation of the plant. I don't know whatever language you want, but it is purposeful and planned and if we don't want to say "intentional." I don't know, Ruth. Do you see what I'm saying that it's something that some human beings decided should happen? It didn't just occur. DR. MACKLIN: Well, but it's necessary for the operation presumably. CHAIRPERSON FADEN: Right. So if you want to do a double -- you know, we don't mean to do this. What we mean to do is have a good running plant. It happens that stuff comes out. I mean, I don't know. DR. ROYAL: But in terms of the affected population, at Pat was saying, they don't care whether it's necessary for the operation of the plant or whether it was -- CHAIRPERSON FADEN: It's a planned release, as opposed to an accidental release. We obviously can't have an advisory panel advise in advance of an accident. After an accident, maybe, but before the accident -- is that okay? We can work on the word, but the word is -- MS. KING: Even I understand some problems with the standard version, but it seems to me if we're going to discuss about hortatory, that one of the places where we can do not something that I put in the category of hortatory is this is a way of calling attention to something that I do think is important. And that is that it didn't make any difference to the people who were under the Green Run where they got the radiation from. And if part of it is in secret and you've got a trigger, a mechanism, then one of the things that I hope will be the outcome of that because I believe there are responsible federal official around is that people will start asking the same kind of question that we're asking. Well, we need this process. Will there be some trickle down to those releases that involve exactly the same thing that we sort of haven't paid that much attention to because it's sort of just coming out of the factory? But where there were releases that were routine, I would hazard a guess that what was going on in the plant was not generally available to the public because of the nature of the plant that was at issue. So it wasn't secret in the same way that Green Run was secret, but if the overall goal is that the communities get to fight their own battles and it's more openness, then in my way of thinking, those operations were closed or not out in the open. So that was the guise of this question. Why lay all of this on research, in other words? CHAIRPERSON FADEN: No. I think that's right. Let me just, to move us on, unless I hear otherwise, 15(a) is amended. Line 19 just says "releases of hazardous substances." We'll come up with a word for planned, intended, other than accidents. "Other than accidents" may be the right thing, although that's sort of self-evident, the reason I just gave. So is everybody accepting of that? Then we're moving on to 15. I'm sorry. Henry? I'm sorry. DR. ROYAL: Some of the checks on Page 37, Lines 5 and 6. CHAIRPERSON FADEN: Thirty-seven, Lines 5 and 6. Yes. DR. ROYAL: It says "Actions will be taken to measure the actual effect in the release of the environment in health and safety." I'm not sure what that means. A lot of times the protection levels that are exceeded are small enough so that it's not possible to measure a statistically significant increase in anything in the environment. And it's just I don't understand. I guess I wouldn't want this to be interpreted as forcing agencies to undertake unnecessary expensive studies when there's no reason to believe that you're going to find anything. MR. GUTTMAN: The intent was to provide what we've seen as the bookkeeping things, that we don't have the problem 10 years later of people said "Well, what happened?" CHAIRPERSON FADEN: That's 2, "Records will kept in the nature and the purpose of" -- you want -- MR. GUTTMAN: This is after the fact. It could be in the form of Henry's statement that the scientists have determined that there's not anything that is worth a major effort at measuring. CHAIRPERSON FADEN: Would it be sufficient to say that records should be kept about the level, the amount of the release, how much is released without necessarily stating it's a fact? I mean, would it be reasonable to require that records be kept about -- MR. GUTTMAN: Well, it's something that's sufficient to be able to explain to 10 people 10 or 20 years later "We didn't take a big set of measurements because it wasn't necessary based on" -- DR. THOMAS: But there may well be other circumstances of where the release is of such a magnitude that you would wish to take measurements downstream that you would try to understand about the -- CHAIRPERSON FADEN: Why don't we just put "whether" in front of 4, "whether actions should be taken," "The panel will advise about whether"? All right. We've got it. Thank you, Henry. That's one of the charges to the panel. Is this a big enough deal that there should a follow-up study? And if not, we'll know it in the minutes of this advisory panel that says "It's not a big enough deal for the following reasons." Can we then move on? Thank you. 15(b). DR. MACKLIN: Just one thing. CHAIRPERSON FADEN: Yes, Ruth? DR. MACKLIN: Just one small point. And that is the text in light of the changing of the recommendation itself and eliminating the word "research," the text under 15 -- CHAIRPERSON FADEN: Line 4 on Page 37? DR. MACKLIN: Well, it's later on, too. CHAIRPERSON FADEN: Okay. DR. MACKLIN: The findings were not only that the government sponsored numerous intentional environmental releases for research purposes but also that there were all of these releases. CHAIRPERSON FADEN: Right. We have to change the rationale. DR. MACKLIN: So the text has to be changed. CHAIRPERSON FADEN: We now have to give a rationale why we as a committee charged with looking at intentional releases for research purposes are saying we should go to all secret releases. And our Green Run example is, of course, what motivates us to say why we think it doesn't matter whether it was for research or not. The fact that it's secret is what's of concern. Thank you. Reed, are we on 15(b)? Okay. Reed and then Henry. DR. TUCKSON: Just a quick question on just the EPA itself. Is that one of the agencies slated to be -- MR. GUTTMAN: Not at present. DR. TUCKSON: Thank you. MS. KING: It kind of waxes and wanes. DR. TUCKSON: So they're not being that specific about EPA. MR. GUTTMAN: It's an important message here. I don't want to take -- CHAIRPERSON FADEN: No. Go ahead. MR. GUTTMAN: It's extremely important here, and this is the whole of Pat's comment that we're now in a "Don't trust government" theme, that we've got to be very, very careful for reasons that are self-evident to anybody who reads the papers that we aren't construed as saying that you can't trust the people in government. This is EPA's responsibility. EPA when it gets the resources should be able to do a good job. We're adding another level for other reasons. But you want to reinforce the notion that you're not trying to say "Let's get rid of government and put another level of government." And so it's critical to be able to say that there are people who can do jobs and should do the job and we want to make sure that they've got the resources to do it already in the government. That's the point I mentioned because we get constant comments from a lot of people saying "Well, you're not really saying 'Get rid of government,' are you?" And the answer should be clear that we're not. CHAIRPERSON FADEN: Henry? DR. ROYAL: I was wondering if the second sentence of the recommendation on Lines 6 and 7 says anything useful because I'm not sure that I know what "critical records in perpetuity" means. MR. GUTTMAN: What that means is when Mark queried EPA, they said they couldn't tell us what prior secret releases had been reviewed by them because nobody had any records of anybody reviewing. Is that correct, Mark? So the critical means enough to be able to tell an advisory committee what it's been doing for a couple of years. DR. ROYAL: Isn't that taken care of under 15(a)? CHAIRPERSON FADEN: We're saying that that panel is going to keep records. MR. GUTTMAN: Right. That's a separate -- CHAIRPERSON FADEN: So the issue is -- MR. GUTTMAN: That the oversight agency, which is formally -- DR. ROYAL: And I guess I don't understand. Has EPA formally had oversight of classified programs in the past? MR. GUTTMAN: Yes. Mark? DR. GOODMAN: Formally the requirements to provide oversight are there. But the mechanisms haven't always been in place. For reviewing environmental impact statements apparently they have on at least some occasions, but that was a specific question where we asked them "Well, how many times have you done it?" They couldn't say. They didn't keep environmental impact statements. For review of substantive compliance; that is, not just what do you do, but does what you do comply with environmental laws, they have only recently put in place, begun to put in place, a procedure for review of classified programs. And for many years they had the mandate to do it but were not doing it because they didn't have people with appropriate clearances. DR. ROYAL: So I'm wondering whether or not critical records needs to be -- CHAIRPERSON FADEN: Rewritten? DR. ROYAL: -- defined in some way. It sounds like what we'd like them to keep are maybe the minutes of this advisory committee. CHAIRPERSON FADEN: That should be kept separately, I think, or whoever holds it, maybe EPA, should hold it. DR. ROYAL: Well, who is going to hold it? CHAIRPERSON FADEN: I don't know. We have to think about that. DR. ROYAL: I mean, it sounds to me that if we're saying the EPA does the oversight, that the EPA should -- CHAIRPERSON FADEN: Hold the records? DR. ROYAL: -- maintain those records. And I don't know what the legal meaning is of "in perpetuity." Like if the EPA were to go out of existence, does that mean that no one else has the responsibility? MR. GUTTMAN: The government. The sense of it is that we don't want another situation where someone tells us "We used to have a record of this, but we destroyed it 10 years ago." CHAIRPERSON FADEN: Right. Yes. I think we know what the sense of it is. Henry is asking for how specifically to craft it. DR. GOODMAN: I think there are two categories of documents that clearly need to be in there. One is environmental impact statement. The other is permitting documents that are required under the substantive laws. And I don't know. That's how they're referred to in jargon. Environmental impact statements is a clearly defined thing. I don't know how the permitting documents -- CHAIRPERSON FADEN: Permitting? DR. GOODMAN: -- permits are referred to specifically in the legislation, but I think those are the kinds of things -- MR. GUTTMAN: So we should probably -- the key legal documents, basically. CHAIRPERSON FADEN: Would you be comfortable with the stipulation of a few documents if the names were stipulated of what they are? DR. ROYAL: I think if we maybe gave some for examples or something, that that would be helpful. CHAIRPERSON FADEN: Okay. DR. ROYAL: And then I think we should explicitly, given the current environment explicitly, talk about that someone else needs to be given the responsibility for these records should the EPA go out of business. CHAIRPERSON FADEN: Instead of EPA oversight, you could call it government oversight, indicate here that an appropriate government agency, such as EPA. Okay? DR. GOODMAN: I should point out that there haven't been proposals to get rid of EPA, but there have been proposals to fold it together with others in some larger entities. So it might not have the name EPA. CHAIRPERSON FADEN: So why don't we just say "government oversight" and then say "an appropriate government agency, such as the EPA, be obligated to"? And that would take care of the problem, indicating that right now it's the EPA, but whoever the EPA goes into would inherit the responsibility. Mark, I just want to while we have you here make sure that the tense is correct. The first sentence suggests -- it just says "recommends that EPA establish a program." Are we sure it doesn't have a program? MR. GUTTMAN: When this was originally drafted, Mark, it might have been a prospective. Is it now retrospective? CHAIRPERSON FADEN: Because we could simply say "recommend that the committee maintain a program," "that an appropriate government agency, such as the EPA, maintain a program." DR. GOODMAN: Let me put it this way. I think, yes, that it should probably not be "establish" since some part of it has been established. But it shouldn't be simply endorsing what's there because what's there clearly they haven't yet determined the scope of what needs to be done. CHAIRPERSON FADEN: What it would read is something like "The advisory committee recommends that an appropriate government agency, such as the EPA, maintain a program directed at," and then we specify what the program is. Are there other questions or comments on this? (No response.) CHAIRPERSON FADEN: Okay. Then 15(d), again, substantive suggestions, is the recommendation that -- we don't have 15(c)? Henry? DR. ROYAL: I have some idea of what the intent of 15(c) is, but I'm not sure that I totally understand it. Right now my understanding of how the regulation is done is the government makes very conservative assumptions about what the maximum exposure might be to an individual and sets limits based on that maximum possible exposure. As I read this recommendation, what I understand it to mean is that not only should the maximum exposure to an individual be considered, but the number of in the case of radiation person rems to the surrounding population also be taken into consideration. So that if there would be conceivably an instance in which the maximum individual dose was not exceeded but that based on some person rem trigger, that that might be regarded as too big of a release. Is that what the intent of this is? DR. THOMAS: That's exactly the intent. I mean, it should be self-evident, it seems to me, that a risk of 3.5 per 10,000, for argument's sake, to pick up a number that's in the text here, might be viewed as an acceptable individual risk. And if this plant were located in eastern Washington State, where there's a total population potentially exposed to that level of maybe 1,000 people, that would be deemed to be quite acceptable. But you take that same release and you set it off in the middle of Denver, where the population -- I don't know what Denver's population is. Let's say a couple million. And suddenly you find that that leads to an expected cancer incidence of a couple of hundred cases. So that's quite unacceptable, the same release but in two different population settings. So that's why we decide to site things like Hanford in remote areas. But there is presently no formal mechanism. Although this advice has been of use and population exposures have been suggested in various circumstances, it's our understanding that it's not formally enacted at the moment in legislation. CHAIRPERSON FADEN: Duncan, let me introduce a problem that I see with the recommendation. For one thing, it doesn't belong under the "national security" heading. It's not in any way specific to national security or anything. So that was a mistake. I'm not sure how it got in there, but it shouldn't be there. The other issue is I'm wondering if this isn't one of those topics that really isn't a topic that as a committee we've debated or discussed. I know very little about this area. And what you've just said to me right now makes a lot of sense, but I don't know how it's a recommendation of the committee. DR. THOMAS: Actually, I think that has come up enough in our discussion of the whole chapter on intentional releases. And there's a discussion of that in the chapter. CHAIRPERSON FADEN: It's not my sense of it, but I am sympathetic to what is written here. So I'm sort of struggling with it. Phil? DR. RUSSELL: I have no way of assessing the impact of this on the regulatory process. I'd be very uncomfortable with it simply because if ignorance. CHAIRPERSON FADEN: Sue? DR. LEDERER: Is there a finding related to this recommendation? I mean, that would help focus our -- CHAIRPERSON FADEN: No, I don't think we have a finding with this. Well, let's see. That would certainly help. It's a good point. Where is "Findings"? DR. ROYAL: Duncan? DR. THOMAS: Yes? DR. ROYAL: We said one of the things that might happen based on this recommendation is that a release which might have been deemed acceptable based on the maximum individual criteria might be deemed unacceptable based on the population exposure criteria. Would the reverse also be true? DR. THOMAS: Oh, absolutely. DR. ROYAL: That doesn't come across clearly to me in this recommendation because it says -- as a matter of fact, in the recommendation it says "but not replace current regulations based on maximum individual exposure." So the committee members know, I do think that a population-based risk estimate makes some sense, although it's a complicated issue. So I'm not necessarily opposed to the concept or to this recommendation. DR. THOMAS: Both the individual and the population-based criteria would have their own thresholds for action or permitting or whatever. So it's quite possible that any release might be acceptable under one criterion but not the other. And it could go both ways. The issue which society would have to debate -- and I don't think it's the job of this committee to do it -- would be whether or not a release which posed an acceptable population risk but an unacceptable individual risk would still be permitted. But the wording at the moment is taken to imply that we would not relax existing standards based on maximum acceptable individual risk if the population were deemed acceptable. What I could well imagine might well happen, though, is the presently extremely conservative levels for maximum individual risk might well be relaxed to a somewhat more generous level if the secondary level of protection were added. CHAIRPERSON FADEN: Pat, we're on 15(c). I checked on the findings. We don't have a finding that bears on this. Now, our findings bear on the secrecy issue and then the risk of harm from the intentional releases, but not on standards for evaluating. DR. THOMAS: Peripherally the risk of harm historically bears on this one, though it doesn't do it explicitly. CHAIRPERSON FADEN: Right. Are there other comments, reactions? I don't have a sense of the committee here on this recommendation. MS. KING: I feel like a broken of record. CHAIRPERSON FADEN: I think I said what you were going to say. MS. KING: Yes. That is why I'm silent. CHAIRPERSON FADEN: So I take it from that that you would not support the recommendation? MS. KING: No. I have problems when we don't have a record built up, but I would not be averse to trying to work this discussion into an appropriate place in the report. CHAIRPERSON FADEN: Into a chapter? MS. KING: Into a chapter; right, where it is in part discussed, rather than making it a recommendation. DR. THOMAS: It is actually in the chapter. And, although I would still like to see this recommendation personally, having it in the chapter helps satisfy me. DR. GLATSTEIN: Phil mentioned that he was uncomfortable with it because he thought this would impair. That's exactly why I'm in favor of it. I like the idea that the releases wouldn't be made impossible but would be made more difficult, additional consideration, additional check. I don't think there's been much of a check on this in the past. And I like the idea for just that reason. CHAIRPERSON FADEN: I have the same sentiment with you. My concern is simply that we don't have whatever in the experience of this committee to speak to it. I just don't think we are the right forum for this one. So that's my concern. I'll just hold it up, see where we are. How many members of the committee would like to see this recommendation met, favor the recommendation? DR. MACKLIN: In this place or in some place? CHAIRPERSON FADEN: No. As a recommendation, not under "National Security," actually. That would have to change. But as a recommendation? (Whereupon, there was a show of hands.) CHAIRPERSON FADEN: And how many people would not like to see it as a recommendation? (Whereupon, there was a show of hands.) CHAIRPERSON FADEN: Okay. So it doesn't go in as a recommendation. Now, we can look at the discussion in intentional releases and see if it ought to be beefed up more and maybe take some of this language if it's not there. I don't know if it would fit. My recollection of that chapter now is not clear enough. But I gather in line with it's already in the chapter whether it can be led to highlight it more or not. I don't know. We are essentially on schedule again, which is rather remarkable. We're going to break for lunch. But before we go to lunch, this is the other wording version of the uranium miners' proposal. And so what I would like to do is call for a brief discussion of it right when we come back from lunch and then go to notification after that. We are going to come back from lunch. Please come back no later than 1:30. We're only five minutes off. We should be able to get back here. I'm going to start the meeting at 1:30, even if I'm talking to myself, in which case I'll get the uranium miners' proposal that I want. Okay? So how's that? We're going to start at 1:30. So those of you who care about uranium miners had better be here. (Whereupon, a luncheon recess was taken at 12:22 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (1:39 p.m.) CHAIRMAN FADEN: I'm trying to reconstruct the discussion of -- Was this Wednesday? This was Wednesday. I'm trying to reconstruct the discussion of Wednesday, and we don't have, obviously, everybody here who was there on Wednesday. So this is a little bit of a problem. Here's what we're going to do. We're going to very quickly discuss the uranium miners -- revisit the uranium miners' recommendation, and then go right on to notification. So what you should have in front of you now are two versions of recommendation 6. The only thing -- The second one, alternative proposal, does not have the supportive text, but it's intended as an alternative to the bolded recommendation statement. Let's wait until everybody gets the two documents, and the issue is whether there is sufficient Committee support for either version of this recommendation. It would replace the recommendation currently in the draft report. MS. KING: What was the recommendation in the draft? CHAIRMAN FADEN: Six. I believe it was 6 in the draft, but let's go back and check. I didn't verify that. I believe it was 6, Pat. It's one of the ones that's on that separate mailing. Okay? It's one of the ones that came on that June 19th. It is number 6. I'm sorry, it was 7 in the mailing. I don't know why it's six on this, but it's recommendation 7 on the mailing that went on June 19. So it would replace the bolded text here. The debate on Wednesday was this is too weak. Some members of the Committee wanted to strengthen the recommendation. The most directive recommendation is the one -- The new version that is two pages long is the most directive, and the one that's just got the bold thing on the top is -- MS. KING: You mean, we're supposed to have three pieces of paper. CHAIRMAN FADEN: No, we're forgetting -- unless you want to see the old one. The old one is not at issue. MS. KING: Forget that? CHAIRMAN FADEN: Right. Unless you want to see the old one, there are two pieces of paper, one that looks like this. I'll give you another one. Don't even look for it. Here, that's it. MS. KING: I have that one. CHAIRMAN FADEN: That's it. You just need that one, and the other one is the one -- Okay. You need one of these? MS. KING: Is this dated 6/17? CHAIRMAN FADEN: No, 6/22. Give Pat this one. MS. KING: I got it. I got it. CHAIRMAN FADEN: You can give it back to me, please. Thank you. All right. DR. KATZ: There's just one word that's different, isn't it? CHAIRMAN FADEN: Well, the difference is that the two- page one is a straight recommendation to the Congress. It's directive. It says, Congress, we recommend that you do this. The alternative one recommends that Congress review the Act to consider the specific change, and then argues why the Committee thinks it probably would be a good idea to make this change, but it's one step removed from saying, Congress, do it. It's, Congress, review the Act to consider whether this change is appropriate, and then the rationale would be why the Committee thinks it's a good thing to do, but it's one step short of saying, Congress, do it. Henry and Phil? DR. ROYAL: I'm thinking that we should delete the phrase "after some minimum duration of underground employment such as one year" and just leave "without required." My rationale for doing that is I would think that, if you're a uranium miner, that there is only a very small fraction of people who might be uranium miners for less than one year, and I would think that that would be their profession. As I understand it, they would basically have to prove that they were a uranium miner, and I would think that that proof would be sufficient to meet the criteria for having a plausible cause for their lung cancer. CHAIRMAN FADEN: So if I understand it, regardless of which form it is -- obviously, those words are the same -- you want the sentence to start, "Miners who develop lung cancer," period. DR. ROYAL: You could say "without requiring a specific level of exposure." CHAIRMAN FADEN: Yes. Yes, comma. All right. DR. ROYAL: Because exposure actually is dependent on the level in the mine and how long they were there. CHAIRMAN FADEN: I presume this is timed then to before 19-so-and-so? We need to make sure that's in there. Either way, we have to put it in. DR. ROYAL: It needs to have a date. It's probably in the mid-Fifties or something. DR. THOMAS: All the regulations came in about 1966-67, I believe. CHAIRMAN FADEN: So uranium miners before. DR. THOMAS: So that that would be a convenient cut-off point. CHAIRMAN FADEN: Before 1967 or whatever. DR. THOMAS: Levels were gradually declining over that period, but I think the point about which we have ethical concerns continues up through the enactment of Federal regulations. CHAIRMAN FADEN: Okay. So we put in the regulation date. DR. GLATSTEIN: But the cancer may have come up afterwards. CHAIRMAN FADEN: Exposure prior. I've got Phil and Eli and Nancy. Phil? DR. RUSSELL: To borrow a phrase from Ruth, the one recommendation is very direct, and if we really believe this, I think we should use that one rather than use the wimpy one. It has all the same context except it doesn't say it very strongly. CHAIRMAN FADEN: Well, it says it less strongly, but -- DR. RUSSELL: It recommends that they review it, not that they do it. CHAIRMAN FADEN: That's right. That's the difference. DR. ROYAL: Yes. I actually would prefer also that we recommend that they do it. Again, the uranium miners are really exceptional in the experiments that we've looked at. They clearly are at higher risk for lung cancer. CHAIRMAN FADEN: Eli? DR. GLATSTEIN: Yes, I'd like the second one. Henry just said that this group really is exceptional. I cannot help but feel a great deal of analogy between this group and the events of Tuskegee, with which many people around the table are far more knowledgeable than I, but as I understand it, the folks at Tuskegee under study for a particular disease which they had contracted were denied access to a cure for that that came out during the period of the study. Here, we have people who are under study who are denied information about their own risk from their employment that basically let them go on to a very high risk, an extraordinary risk, for lung cancer. I see a lot of analogy here, and I believe that this group has suffered a real invasion of their civil rights, a real deprivation of civil rights. I think this group -- I think that point, I think, needs to be brought to the Congressional attention, because I don't think it has. We've exchanged notes through the E-Mail on our estimate about, you know, what's the epidemiologist supposed to do. I think we need a very strong signal on this one, because that shouldn't be an area of controversy, in my opinion. CHAIRMAN FADEN: I've got Nancy and Pat. DR. OLEINICK: I certainly want to underscore what has been said before. I think that, if we are going to come out with a very strong statement recommending compensation for any group, this is the group, because it's so outstanding in terms of the exposure and the government role. I would just like to make one very small change in the wording. This is on the fourth line or something. I certainly would say the word amend rather than review, but under developed or will develop, because some of them will still be developing lung cancer. CHAIRMAN FADEN: Who develop or will develop. DR. OLEINICK: Yes. It's a minor point, but I think that ought to be in there. CHAIRMAN FADEN: Yes. DR. ROYAL: Just going to say to compensate them? You can't compensate them because they will develop it. CHAIRMAN FADEN: No, no, no. That's right. "Who develop." Then a period. Get rid of the e-d and to say "who develop." Okay, Pat? MS. KING: I'm going to pass. CHAIRMAN FADEN: Do you want to argue for the other recommendation or not? MS. KING: I'm just going to pass. CHAIRMAN FADEN: We don't have Ken here, who was also strongly arguing against the approach that's adopted here. We don't have him here to hear his argument. All right, is there anybody else who wants to speak to this. Ruth? DR. MACKLIN: Are you open for just affirmations? I have no further thing to say. CHAIRMAN FADEN: Are we ready to vote? Does anybody want to argue or otherwise go for it? I have confessed to not having read carefully the text that is underneath. I haven't had a chance to do it. So I would just point out, if there are minor things that need to be changed in there, I just don't know. I don't know if everybody else has had the chance. I got into a bunch of stuff, so I didn't get a chance to do that, but we're voting primarily on the recommendation. DR. THOMAS: I'm the only person that probably has read it carefully. DR. GLATSTEIN: I'd just like to see that civil rights point emphasized in the text. CHAIRMAN FADEN: I'll try to come up with something. DR. GLATSTEIN: I think it belongs. CHAIRMAN FADEN: All right. Are we ready to call? I will just call the two-page -- the current operative draft of recommendation, which is really recommendation 7 for purposes of the way in which this goes in. Just replace recommendation 7. How many people are in support of recommendation 7 as it stands right now, the two-page one. Let's take -- Put your hands up for a minute so everybody is -- No, down for a second. I think people are still looking for it. It's the one that was circulated yesterday. There are two versions out. The first one, the stronger one -- Shall we just try it one more time here? -- recommendation 7. Change it to 7 everywhere. The two-pager says the Advisory Committee recommends that the Act be amended. MS. KING: Can I say something again? I would ask people to think about what is more important, feeling good or conveying to Congress the strength of your beliefs in language that members of Congress cannot tear apart. If the goal is to try to get the Congress to do something, is the issue the strength of which we feel it or is it the appeal that we make to them, and is the appeal in the recommendation or is the appeal in the justification? It seems to me that what Ken and I were saying the other day didn't have anything to do with the merits of what we were talking about. It is the how. So I see this issue as what I call a "feel good" issue. We feel better saying, Congress, do it, in our recommendation rather than putting it in language that might be more amenable in trying to explain the strength of the conviction that we have that this should be done. So I don't see it as a substantive question about which we are about to vote. I see it as a strategy question about which we are to vote, and reasonable people can have different views about strategy. I am well aware of that, but I see it that way. Some of the comments that I heard -- I heard it as a substantive issue, and I don't think that that was the debate. CHAIRMAN FADEN: I think you're right to point it out, and let me say that when I changed the language, I changed it as little as possible for that purpose, to try to make it not a substantive change in terms of the position of the Committee about what the right thing is to do, but to send the message to Congress in a slightly softer tone strategically. Now I am not a wise political hand. I really don't know -- What I want to say is I agree with Pat, that what is at issue between these two recommendations is largely a matter of political strategy. I agree completely. My dilemma is I am not a wise political hand, and I do not know how much difference it will make which way we do it. I have to say that Pat and Ken are more experienced and are wiser than I am in that arena, but I think Pat is right to point it out. I personally just don't know. I mean, I wish I did, but I don't. DR. RUSSELL: My instincts tell me that the stronger language will get more of a reaction, but I may be wrong. CHAIRMAN FADEN: I've got Ruth, Jay, and Duncan. We should just know what we're doing here. DR. MACKLIN: I don't think the weaker one, as we're calling it, conveys the Committee's view about the recommendation. The weaker one says, Congress, review the provisions to consider whether compensation should be provided to miners, et cetera. So it's not only weaker because it says review rather than the Committee recommends, but it doesn't even say that the Committee thinks that ought to be done. CHAIRMAN FADEN: Let me just point out, the rationale would stay identically the same. The text that follows is the same, and the arguments are put out. DR. MACKLIN: I mean, to recommend that Congress review in the recommendation itself leaves it entirely up to Congress to determine whether, without expressing the Committee's view about that. CHAIRMAN FADEN: What we could do -- Let me just pose this as an alternative -- is after the sentence in the bolded version that says "without requiring a specific level of exposure," we could have a sentence that says, "The Committee believes there is good grounds for such an amendment." You could put that in, and that would convey -- I'm just putting that -- I'm just responding to Ruth's comment to see if we could address it. Yes, Jay, you have the floor now. DR. KATZ: I disagree with Pat that this is done for making ourselves feel good. That, I think, in this instance puts it badly. I have read most of the Congressional Record on the prior review by Congress. Congress had the same information, by and large, that we are having here in the transcript of the hearings that I reviewed; maybe not everything, but they had an awful lot, and they came to the conclusion that they did. We cannot -- It's not a matter of predicting what will sit better with Congress, because as one scientist once said, the problem with prediction is that we cannot predict, and nobody can predict what Congress might do in whatever language we put it, one way or the other. At least speaking now for myself in this instance, and what happened to the uranium miners in a variety of different ways is so outrageous that we should be entitled as a group who have deliberated about this that this is not a matter for review. This is a matter -- Congress, in its infinite wisdom, may disagree with us, and that is their prerogative, but in terms of our review that we are asking for an amendment. CHAIRMAN FADEN: Do you want to respond quickly? MS. KING: The discussion the other day and a point that Duncan made -- My memory is getting all muddled, but the point that Duncan made the other day is that there is scientific information available now that was not, in fact, available to the Congress when they passed this original Act. The problem with both of the recommendations is -- I do think this -- The issue here is how to persuade Congress to do something that you think should be done. That is the bottom line. What's the best way to persuade? The best way to try to persuade, to put your best foot forward, is to make your argument. So if you're going to have a recommendation that says, Congress, you must -- which, you know, fine; they'll do what they want to anyway -- is the recommendation should say changed scientific data -- CHAIRMAN FADEN: That's what the rationale does. MS. KING: Not the rationale. The problem is the recommendation -- The persuasiveness is our rationale. That's the first thing I get to. We have a problem. You all don't like to realize it is outside of our mandate, but it is outside, to a large extent, our mandate. That, in itself, is a substantive problem. You have to be careful when you make these kind of recommendations outside your mandate. We have a strong case. I don't believe in blowing it, and you all think I'm talking about little quibbles. I'm talking about being persuasive, and either your recommendation has to go with why you're -- It has to be in the recommendation that why you're willing to do this or you've got to at least say you have to have some -- I mean some sense of where we fit in the political structure when we're trying to do this. If the bottom line is to put our best foot forward to say, Congress, this is serious, we really believe this -- You don't accomplish that by the word you use necessarily. You accomplish that by the reasons you put forth and what your bottom line is. So my suggestion is: The Committee wants to use a stronger language. Then put something in it about in view of changed circumstances or something like that. CHAIRMAN FADEN: Whichever way it goes, it should say the Advisory Committee recommends that, in light of scientific information now available -- okay? -- or the other one, the Advisory Committee recommends the Congress review, in light of scientific information now available, so they can see that there is a reason that -- This was the point Ken was raising, too -- this is not an old Act. This is 1990. Congress has lots of things to worry about. Why should they look at something that they addressed only in 1990. So we have to lead with -- I think Pat is quite correct -- lead with the reason why they should revisit the issue. Now there may be other -- Maybe we think they made the wrong decision in 1990 as well, but that's a separate consideration. Duncan? Is that all right, by the way, that in either formulation we add "in light of scientific information now available"? No one objects to that. So whichever way it goes, that contribution -- that change will happen. Duncan, you have the floor. DR. THOMAS: Well, I think maybe Pat has now explained herself to my satisfaction. I was delighted to hear her earlier say that this is an issue of strategy, not of the substance of the message we're trying to communicate. MS. KING: But that was all that Ken and I were trying to say the other day. DR. THOMAS: No, I appreciate that, and I have infinite respect for Pat's and Ken's political savvy in this area, but I still remain puzzled, I guess, as to accepting this changed wording that we've just added, why it should be politically savvy, politically more effective, to word it as we recommend that Congress consider than simply to say we recommend that Congress do it. MS. KING: I can actually turn that around and ask you why it matters, too, because in terms of where we're going, it doesn't say anything. It does not say that -- My concern -- Ken will have to speak for himself. My concern is mandate and how much time the Committee deliberated on this issue, on the science issue and the science findings to make this recommendation. My concern all along has been tying together what the Committee did, what it reviewed, what it deliberated as a committee with its recommendations, because it is one thing to have one an extensive job on that and make a recommendation. It is another thing not to have done an extensive job, but to feel strongly about something, and to be able to feel strongly that you are right to do it. Part of what I was trying to say the other day was strategy. Part of what I've been saying all along is to keep in mind that the credibility of what you recommend is also a function of the process that you have gone through. In your mind, Duncan, it may be different, but I'm the lawyer, and you are the scientist, and that may explain the difference. My attendance at the Committee meetings do not lead me to believe that as a committee member -- and I've tried to be faithful -- as a committee member that we deliberated those kinds of issues well enough to make a stronger statement; but on the substantive issue, because you do have substance expertise and so do others on the committee, it certainly seems to me well within what the committee -- where we are now doing, to say we've got enough to say that this needs to be reviewed again. That's sort of where I come out as my bottom line. CHAIRMAN FADEN: Ruth. DR. MACKLIN: Unlike the other examples that Pat keeps bringing to our attention on which the Committee did not adequately deliberate, and I agree with her on most of those others that we discussed, this received extensive deliberation in a flurry of E-Mails -- and those who are not on the E-Mail get all the E-Mail correspondence, if I'm not mistaken. They get it in some form, in a FAX form -- and in FAXes and in revisions of the chapter and queries to the Committee members. So although we may not have sat in this room and deliberate, as we have on some other topics, the information about the chapter, about the changes, about the suggested changes and all the things that went on about trying to find out what the various departments and divisions were doing about those miners and what was kept secret and what could be kept secret -- All of that, it seems to me, was amply communicated. Now if that doesn't count as deliberation, Pat, I guess I can understand it. MS. KING: For a committee under the Public Advisory Committees Act, I would be very careful about those statements. CHAIRMAN FADEN: Mary Ann? DR. STEVENSON: I'm speaking for Pat here, but I think what you're referring to is that the Committee did not debate or examine at length the new piece of data that we are presenting as rationale for asking for this review. CHAIRMAN FADEN: I'm sorry. Could you repeat that, Mary Ann? We just had a little sidebar conversation on the point that Pat just raised. DR. STEVENSON: I think -- I'm sorry. I'm speaking for Pat. Pat can speak for herself, but I think the point is that we as a Committee did not debate or look at the validity of this new piece of data as a group at length with whatever scientific expertise we think we do or don't need, because that's what we're presenting. I mean, the Congress had all the data that we went back and forth about as a committee in the chapter when they did their own Act, but they didn't have that piece of scientific data -- CHAIRMAN FADEN: There were two pieces of information that the Committee did not -- and we went through this on Wednesday. The other is the problems that people are getting. DR. STEVENSON: Well, the other thing is the complaints. CHAIRMAN FADEN: So there are two things they could not have known in 1990: One, the new analysis that suggests that you can attribute a much higher proportion of lung cancers to exposure in the mines, and that's by a very credible context. So even if we haven't debated it, it's not so bad for the Committee, on the basis of the recommendation of the Committee who are expert in this area, to assume that the data are valid enough to be considered seriously. The other, of course, is the testimony which we did hear in Committee on the record from people who complained about how difficult it was to recover under this Act. Now that they couldn't have known in 1990, too, for obvious reasons. So I would -- You know, that's where we are. So there are really two pieces of information that we need to signal, although I think the scientific information is the kind that ought to be signaled in the recommendation. The other can be signaled in the supporting text. I think we need to call for the question. We have two versions. I want to read the alternative proposal. Either way, we are adding "in light of scientific information now available" into the recommendation, which I think is a very good suggestion that Pat highlighted, whichever way it goes, so that in the recommendation we provide Congress for a reason why we think, even that they just looked at it in 1990, they should look at it again. Then in the one that is the one-pager, there was a proposal to add "The Committee believes.." after the sentence that says "Congress review the provisions" a sentence added that says, "The Committee believes that there are good grounds for making such an amendment." In other words, pulling into the recommendation a sense of the Committee's conclusion, but still falling short of what is in this one. DR. GLATSTEIN: Good, new scientific grounds. CHAIRMAN FADEN: Right. Yes, exactly. DR. KATZ: Ruth, I just have to express one brief reservation, though not to change anything. I don't mind to put in "in light of the scientific information now available," but the reservation I have about this -- Yes, we now know that the incidence of lung cancer is greater than the Congressional committee knew in 1990, but the Congressional committee knew in 1990 that there was a significantly higher incidence of lung cancer, startling so, in uranium miners because of their exposure to radiation, and at least to this person whether it's 40 percent or 60 percent ultimately doesn't make any difference. Forty percent is enough, but anyway I just wanted to express it, and then leave it in there. To that extent, I bow to so called political pressures, but I wouldn't go any further than that. CHAIRMAN FADEN: Ruth? DR. MACKLIN: Well, no, it's just a very small point. I don't think the statement "in light of scientific information now available" is sufficient, because the other relevant thing is the provisions of that Act that -- CHAIRMAN FADEN: My personal view is I would put that in the supportive text underneath. I think that's -- It's a different kind of a problem. MS. KING: Also, the Committee did not call for public testimony -- CHAIRMAN FADEN: From the other side. MS. KING: -- on the record on the other side. CHAIRMAN FADEN: Right. See, we don't have established that, in fact, that's an accurate or full picture of how well the Act is working. So it's a different kind of evidence, and for that reason, I would write -- So if that's agreeable, there will be reference to that in the text, but not in the recommendation itself -- the testimony. All right, we're ready to call it. Okay? Let's just do it. I'm going to hold it up, the two-pager versus the one- pager. Everybody knows which is which, and everybody is clear on the amendment to the one-pager which has the phrase "the Committee believes that there are good grounds for making such an amendment"? How many people want the two-pager? DR. KATZ: You mean the Duncan version? CHAIRMAN FADEN: The Duncan version with the amendment on the -- Okay. I'm sorry, I've got to do this now. So it's going to have to be one of these. One, two -- DR. KATZ: Eli? How come? DR. GLATSTEIN: I'm persuaded by Pat. I want to get something done. CHAIRMAN FADEN: Four. One, two, three, four, five. How many people want the other one? Six. DR. ROYAL: See how easy that was? CHAIRMAN FADEN: I told you I stopped predicting. I'm not sure exactly how to handle this. MS. KING: I'll make a personal statement. Whatever we do, we should not have a vote on the record. CHAIRMAN FADEN: That was a show of hands. It was not a vote on the record. I'm trying to get a sense of the Committee. Okay? MS. KING: It's on the record. CHAIRMAN FADEN: All right. All right, Pat. I'm not sure about that, though, but let's just go. MS. KING: The reason is a vote on the record won't -- will be interpreted many ways, because it is a vote, and a part of the vote on the record is not worth having it interpreted in any way. DR. RUSSELL: I think everybody wants to accomplish what we -- the maximum. So I think we need to come to a consensus, and I'll go with 6 rather than hold out, because I don't think we ought to go on record as having a split on the committee on this issue. CHAIRMAN FADEN: It's not worth it. The point is we all have the same goal here. DR. RUSSELL: It's not worth it. It's a lose/lose issue. CHAIRMAN FADEN: Right. It's so important that this be done. I think we're all in agreement that it's so important that this be done. DR. RUSSELL: Right. We don't want to split on how. DR. KATZ: I was going to ask Pat a question. It was mentioned by a number of Committee members, and they were persuaded -- seemed to be persuaded about this with respect to you and Ken, but Ken isn't here. Do you consider yourself an expert of predicting what works better with Congress and what does not work better with Congress in a political sense, because that -- MS. KING: No, I don't consider myself an expert, Jay, but I do say this, and I don't think it requires political expertise, just how people -- If you are trying to be persuasive, the goal is to be persuasive, changing a word one way or another that might do harm is simple, in my mind. You can be equally persuasive in another way and not give any adverse ammunition which says that, in light of -- and I keep saying this -- in light of mandate problems -- I'm going to try this one more time -- in light of mandate problems, in light of evidentiary problems which are the weaknesses, the strength is what we believe we are doing is right; but in conveying what we think they should do, we should not be unmindful of the fact that others might be able to drive holes in our cases. Put it in the best foot. That's really all I'm saying. I'm not trying to make this a big issue anymore. CHAIRMAN FADEN: I think we've got to get past this here. I don't know which way to swing it. MS. KING: I'm not going to object -- I'm not going to write a dissent to this, no matter what you do to it. DR. KATZ: We'll keep that in mind, depending on which way it goes. CHAIRMAN FADEN: I don't think -- I mean, you can, Jay, or you can't. I don't think it's a big issue. I really don't think whether there's a dissent on this one -- The dissent is going to be I would have preferred the word in, I would have preferred the word out, but whatever it is, it's going to come to that. It's not going to be I disagree, the uranium miners shouldn't get money. MS. KING: I'll abide by the judgment of the Committee. CHAIRMAN FADEN: Okay. It's not -- What I'm saying by that, Jay, is that we're not anticipating dissent saying we disagree with the inference that the uranium miners ought to have their compensation. So I don't think we should worry about whether there are or are not dissents. I think we're just trying to figure this out. MS. NORRIS: I do abide by the judgment of the Committee, but I think that Pat has very strong instincts about these things. Therefore, it's based upon Pat's persuasiveness and experience that I chose the other route. DR. MACKLIN: Phil had a different instinct, but he didn't talk as long as Pat did. DR. RUSSELL: I bow to Pat's expertise at being persuasive to Congress. CHAIRMAN FADEN: I suggest we do the following. I'm going to rewrite both of these and then we're going to -- I'm going to deal with it. MS. KING: You're going to pluck one out of the hat. CHAIRMAN FADEN: I'm going to pluck one out of a hat and put it out there and run it by you, and you're all going to say, fine, and then there will be a dissent or there won't be a dissent, and that's it; but I think that we can't hammer this one down. DR. GLATSTEIN: I can live with it either way. I'm not unhappy with either choice. CHAIRMAN FADEN: I think we can all -- I'm sorry, sue. DR. LEDERER: The only plea I would make is that the explication for this be made clearer. I think that it's somewhat embedded in the text that is now provided, so that we provide the best case that we can in order to accomplish our ends. CHAIRMAN FADEN: I think that's, obviously, important. I mean, that's the whole weight of it. All right. So we had an interesting discussion. Okay. We're going to go on now to notification, which is yet another piece of paper that we have to find or a couple of pieces of paper that we should have. Regrettably, we're not at the point that it would be nice to be at. We don't have the recommendations per se about whether or not any particular groups of subjects should or should not be followed in order to protect their health, but we do have a very carefully thought through presentation for the explication by Mary Ann and Jeff and then Duncan on how we ought to proceed. That has been, as we all can recall, a subcommittee that has been working away on this issue. The hope is, if we can basically agree to the proposals as they are outlined here, that the rest of the work can be done quickly in the consultation context, and then the specific recommendations sent out -- the particular findings of that then brought out and turned into a recommendation. So the floor is open for discussion, while I go look for my copy. DR. THOMAS: It might be helpful to think about what brings -- for a moment about the type of recommendation that might well emerge from these documents. What occurs to me is that it's almost certainly beyond the scope of our expertise to make specific recommendations for particular studies, rather that -- and it's my understanding that the -- Oh, well, wait a second. Yes. There is a proposal that we farm out to a panel of consultants the decisions as to what specific studies might meet the criteria, but the recommendation should basically lay out -- as a minimum, the criterion ought -- the recommendation ought to lay out the criteria, either Mary Ann's wording or my wording or some iteration thereupon, for the studies, if any, which would meet these criteria. CHAIRMAN FADEN: No, I think -- Let's go -- if we could go to page 3 of the memo, and I would defer to you and Mary Ann and Jeff; but my understanding that what is proposed here is, first, a set of criteria, Mary Ann's and then your revision of it, then the proposal that the Committee apply those criteria to the two or three studies -- sets of studies indicated on the last paragraph on page 18 where a lot of work has already been done, and our whole rationale for looking at children in part lie on the fact that we had this mandate to make recommendations about medical follow-up. Then there is a further proposal which we can jettison that the remaining studies be contracted out for a similar analysis. Now those we could -- That recommendation, we could jettison. Failing to comment on these studies puts us in a very awkward position, not untenable but awkward. So I think that's what's at issue. Is that correct? Okay. Henry, I saw you wanting to speak. DR. ROYAL: Yes. I'm not on page 3. I had -- I thought this was quite good. There were just a few comments on the third paragraph on the first page, the fourth paragraph, fourth line beginning with "Although the risk of leukemia..." -- I think if you deleted those two sentences that you wouldn't lose anything. CHAIRMAN FADEN: Where are you? I'm sorry. DR. ROYAL: On page 1, paragraph 4, line 4, beginning with "although the risk of leukemia." CHAIRMAN FADEN: Just get rid of that sentence. DR. ROYAL: All the way through "fifty years after exposure." It just doesn't make any difference what the details are of the latency period of cancers. CHAIRMAN FADEN: Is anyone objecting to that? No. Okay. DR. ROYAL: Then on page 2 this whole one in 1,000 -- Let me tell you what the problem is with the one in 1,000. First of all, it includes incidence of disease, and then it also includes mortality in the detriment due to disease. I mean, I might get -- I don't know -- some relatively -- some disease that doesn't really cause me any big problem, and I might have a one in 1,000 chance of having that disease. That's very different than having a one in 1,000 chance of dying tomorrow. So it's not clear to me that, because the detriment due to -- based on when you are going to die or based on your morbidity is very different. It doesn't seem to me that you could have one number for both. I would like to finesse this somehow as opposed to somehow making this one in 1,000 be some magical number. CHAIRMAN FADEN: Do you have a suggestion? We're in desperate need of -- DR. THOMAS: I have another problem with that one in 1,000 figure as well, which is my point number 3. That's that the only reason I can see for having that one in 1,000 in there or any number like it is to indicate that any endpoints which materialize have some reasonable probability, and I don't mean like 50 percent. I mean some nontrivial probability, having had something to do with the radiation experiment which is our mandate. If that's the purpose, then it should be expressed relative to whatever the background rate is, and again it would depend on the particular condition being studied. It should be a proportional -- some nontrivial proportional increase in risk. CHAIRMAN FADEN: And this is where your ten percent came? DR. THOMAS: That's where that was suggested. CHAIRMAN FADEN: This is on page 1 of Duncan's memo, point 3, which is attached. So this is a proposal to substitute for the one in 1,000, whether it's morbidity or mortality. DR. THOMAS: See, I think we're rolling two quite separate calculations together in this one number, and that's the problem. CHAIRMAN FADEN: The one in 1,000. DR. THOMAS: There is a rationale for one in 1000 as well, the absolute risk, and that's that you don't want to waste your time screening for diseases that you're almost certainly not going to get. So there has to be some reasonable probability that the person is likely to get the disease or you're wasting your time screening for it, in the first place. For that, a statement of absolute risk is sensible, and it makes no difference from that perspective whether you're going to get that disease as a result of a radiation experiment or as a result of other factors, but it's not our business to be concerned about general recommendations for population screening in the absence of a particular experiment. For that reason, we have the second rationale, which is that the radiation experiment increased your risk, to some extent. That's better done in relative risk terms. CHAIRMAN FADEN: So what if the relative risk approach says, yes, screen, but then it turns out that the condition itself is so rare you're not going to find -- I mean, you don't have the absolute risk. Do you want both? DR. THOMAS: You should have both, I think. CHAIRMAN FADEN: You should have both. So the proposal is -- DR. ROYAL: One in 1,000 and ten percent. CHAIRMAN FADEN: Increase over -- DR. THOMAS: Without committing ourselves to either of those two numbers, but the principle is, yes, that both of those factors are relevant. CHAIRMAN FADEN: We'd better commit ourselves to the numbers. DR. THOMAS: But, I mean, at this stage, not. CHAIRMAN FADEN: All right. So the notion would be you would need a threshold of an increase -- a relative risk of 10 percent or greater, and then the condition itself has to have an absolute risk of one in 1,000 or -- DR. THOMAS: Some number like that. CHAIRMAN FADEN: Then you would kick in. Then is it one in 1,000 -- Then we don't care whether it's death or -- DR. THOMAS: No, I think we do indeed. Henry's point is well taken. A one in 1,000 increase in death might be very severe -- you know, might be a very important one, but -- DR. ROYAL: The ideal thing would be something like days of life lost, but I don't know how to get there. Sorry. CHAIRMAN FADEN: Well, I know. We can't get to a decision theoretically. DR. THOMAS: It's quality of life loss. CHAIRMAN FADEN: Yes. DR. ROYAL: A simple lie is always easier to believe than the complicated truth. CHAIRMAN FADEN: But if we took -- If the issue is thyroid cancer -- let's get concrete. Right? Is not the issue thyroid cancer that we're talking about? Okay. So let's take thyroid cancer. That's one of them, and the risk of the testicular, but let's just take thyroid cancer as concrete. So we say that there has to be -- The relative risk has to be 10 percent or greater, and not death from thyroid cancer but thyroid cancer has to occur with an absolute risk of greater than one in 1,000. Would that be okay? DR. ROYAL: I don't know. The reason I don't know is it then depends on how you're going to calculate the risk of thyroid cancer. For example -- I mean, I know you want this to be simple, but -- CHAIRMAN FADEN: I want it to be done, simple or complicated. I want it done. DR. ROYAL: If you were to calculate it the way some of the calculations have been done -- that is, based on the maximally exposed person using the maximal risk coefficient, then one in 1,000 would mean that you would have to go through a lot of these experiments. If, on the other hand, you did it for the average risk, and you used some more reasonable risk coefficient, then not many experiments would reach the one in 1,000. So stating the one in 1,000 without stating the methodology by how you get there could make an enormous difference in terms of a number of experiments that would need to be reviewed. DR. THOMAS: Let me add another subtlety as well. For the purpose of deciding whether screening is meritorious, all we care about is the future risk. CHAIRMAN FADEN: That's correct. DR. THOMAS: Not the risk up to this point, and that's not the way we've done the calculation up until now. CHAIRMAN FADEN: So ought it to be a 10 percent relative risk of yet getting the condition? DR. THOMAS: Yes, but I was actually thinking -- referring to the absolute risk figure, the one in 1,000. CHAIRMAN FADEN: Oh, an absolute risk. DR. THOMAS: I suspect even those experiments which attained a one in 100 risk, the future risk may well be below one in 1,000. DR. ROYAL: That would be an interesting-- CHAIRMAN FADEN: No, it's okay. I mean, that's all right. I just want to get it right and done, done and right. DR. ROYAL: But to say one in 1,000 future risk is more relevant. DR. THOMAS: Absolutely. CHAIRMAN FADEN: Right, because we're talking about -- But would that work? DR. ROYAL: That would be much more acceptable. CHAIRMAN FADEN: Remember, we're only talking about more or less 18 studies for what we will do. DR. ROYAL: If you're talking about one in 1,000 future risk, you're talking about one in 18, no matter how you do the calculation. That's theoretical. CHAIRMAN FADEN: Right. When you say -- No, I'm putting aside the proposal whether we're going to farm this out to be done for anybody else, but -- So what I'm hearing is that the criteria that would be used is a 10 percent relative risk or greater that would be attributable to the exposure that's inherent in the experiment, and then a one in 1,000 future risk, risk yet, of the condition occurring -- materializing -- for everybody who is still awake. Okay? Is that agreeable? DR. GLATSTEIN: Yes. CHAIRMAN FADEN: Okay. DR. ROYAL: The concept of this one in 1,000 future risk is not that complicated. Basically, if you're going to be at risk for 40 years and 30 of those 40 years have gone by, and if the risks are evenly distributed -- CHAIRMAN FADEN: You would know how much is left. DR. THOMAS: To be a little bit conservative here, the assumptions -- We made a reasonable assumption for risk calculation, that risk was a plateau of constant intensity from five to 45 years after exposure, but that's certainly wrong. We don't know what it is. So we should probably calculate assuming some reasonable figure for lifetime risk, inasmuch as far as we know, risk of thyroid cancer remains elevated at some level lifetime. CHAIRMAN FADEN: So we're just going to keep it flat? DR. THOMAS: No, I wouldn't keep it flat, but I think we should review what's in the BEIR V model. CHAIRMAN FADEN: Okay. So that technical point, the subcommittee could resolve, whether it's the BEIR V slope or whoever else's. Okay? All right. Now there's a slight difference between Mary Ann's wording and Duncan's wording on the other conditions that would have to be met. That just gets you into the discussion. If you pass the 10 percent relative risk and the one in 1,000 future risk, that just gets you into the discussion about whether we're going to recommend follow-up. So it's like a screen for the studies. Now let's assume we have a study that passes that screen or more. On page 2 of Mary Ann's memo there are five conditions, and on page 1 and 2 of Duncan's there's a slight reformulation of those conditions. DR. THOMAS: Just to be clear, in defense of Mary Ann's five, they are taken word for word out of the literature. So there is already a citation for this particular wording. My quarrel was, therefore, not with Mary Ann. It was with the fact that the way it was expressed in the literature didn't seem to be entirely logical. It was an attempt to sharpen it slightly, but I have no particular vested interest in this particular wording. DR. ROYAL: I like Duncan's wording better. CHAIRMAN FADEN: Can I get to how you would operationalize these in Duncan's approach, which I liked. These screening methods must be acceptable to patients. Do we need these particular people, because if so, that means we have to notify them and let them know. DR. THOMAS: Well, they are, obviously, going to have to be informed and consent to this procedure. CHAIRMAN FADEN: What I'm suggesting is, if that gets factored in, when does it get factored in? Let's assume that D and E don't apply. Do we still do C? Should that be the last one is what I'm trying to say. How many of these are made objectively by us versus the last one, which is obvious, which is that people have to decide they want it? DR. THOMAS: A good point. From that perspective, just get rid of the first half of C. They certainly have to have high sensitivity and specificity. That's a judgment for us to make. CHAIRMAN FADEN: And what I'm saying is then, of course, in the end, obviously, we're not going to make anybody do this. We then say there's an obligation to notify, and then the person decides whether they want to avail themselves of the screening or not. DR. THOMAS: This wording about acceptability to patients derives from sort of the standard screening literature. You know, there are plenty of very unpleasant procedures that would not be considered acceptable. So in the context of population screening, that's a relative thing to put in here. CHAIRMAN FADEN: So we pull that out and then say, obviously -- I mean, it's sort of self-evident. We don't kind of need it. We're not going to recommend that people be forced to have follow-up. We're only recommending whether or not anybody should be notified that it would be a good idea for them to be followed-up. So the proposal is to take Duncan's rewording minus the first part of C as the next level. First screen is this formula that we discussed, and then the next screen are these five criteria, the edited version of Duncan's. Is that agreeable to everyone? Then if we could turn to page 3 of Mary Ann's memo -- Mary Ann and Jeff's memo. I wanted there to be ratification that the studies to which we will apply this set of criteria are the children's studies -- They're just listed here. This is the group about which we have -- where we have been pursuing these issues. Okay? DR. ROYAL: So this is making the recommendation that the Committee make the decision on these three instances whether or not they should be notified or not. CHAIRMAN FADEN: These three sets of studies. Correct. That is correct. Then I'm going to hold in abeyance what we want to do with all the other studies. DR. STEVENSON: Or considered for notification, because we don't know -- CHAIRMAN FADEN: We're going to actually do the work. We're going to do the work based on the criteria that the Committee has just agreed to and make a recommendation in these studies, the ones that fall under categories 1, 2, and 3 -- Okay? -- about whether anybody who was a subject in these studies 1, 2, and 3 should be notified, and our rationale for why we picked these studies we have rehearsed 100 times. We don't need to go through that again. Then I would like to leave it to the subcommittee with staff to work out that -- to actually do that work, and then the rest of us will receive their recommendations, which would then become Committee recommendations if the rest of us buy it. Is that agreeable with everybody? DR. THOMAS: Number 3 has a question mark in front of it, and I wrote in my piece that I would say the a priori justification for including that one is as strong as the others. So I would remove the question mark. Then I went further and suggested that we should include the submariners who are participants of a particular medical experiment. CHAIRMAN FADEN: Okay. So that's -- DR. ROYAL: Why don't we wait until we do the children? If the children don't meet the criteria, the adults won't. DR. THOMAS: That's fine, but I don't want to exclude them in advance. CHAIRMAN FADEN: Excellent. So if the children cut in, then the adults would go forward. Very good. DR. THOMAS: Then we do the adults. DR. ROYAL: Then our justification about not having done the adults will be there if the children don't meet the criteria. CHAIRMAN FADEN: So good. So reasonable. All right. Now the last proposal is the proposal whether the Committee ought to commission consultants to go to work on a whole slew of other studies that the Committee has partial information on. My own -- Henry, do you want to speak to that? DR. ROYAL: I don't think there's any reason to do that. Basically, we've picked out the studies which we think would be most likely to qualify. I mean, we could revisit this question if it turns out that, after our analysis, there are a number of studies that we do think need follow-up, but if looking at these most likely candidates we were to decide that none of them need follow-up, then it would be silly to -- CHAIRMAN FADEN: I would even go further, Henry. I would say that, if it turns out that, based on these, it looks like it might be a good idea to look at some others, we make a recommendation that somebody else look at these others. I mean, not even under our aegis. DR. ROYAL: I see. Not being an ACHRE recommendation. CHAIRMAN FADEN: Right. A recommendation from us to whomever, because I really think, given the amount of work that we have to do under the next couple of weeks, that we cannot undertake anything. DR. STEVENSON: So it's beyond the scope of this committee, too. CHAIRMAN FADEN: We picked out the experiments that we thought were going to be the most likely for this concern to materialize, and if in fact our examination of these studies suggested there are people who need to be followed up, then we could say now there's a reason to go look beyond the children to other studies, and we would hope that the government will pick that up, Public Health Service or somebody else, but we can't. DR. THOMAS: Realistically, there would be no point in having consultants start work until we had completed our work, and then it's too late. CHAIRMAN FADEN: Then we're out of time. Okay. So as a practical matter, it can't be done. So we have done notification except that the work is still left to be done, but for those of you on the subcommittee, you can -- the endorsement of the Committee to use these criteria to work with the consultants to get the results, and then we will have a recommendation for the July meeting that is specific about which ones, if any, of these former subjects need to be contacted. Okay? DR. ROYAL: Could I ask that someone from the staff contact those of us who are on the subcommittee to arrange a conference call for early next week, so that we can see what is left to be done? For example, some of the things -- I'm not sure if anything more needs to be done. The testicular radiation, for example -- I don't know if anymore needs to be done. We need to identify what the tasks are. CHAIRMAN FADEN: We will -- DR. STEVENSON: I actually do have a procedural question. CHAIRMAN FADEN: Sure. DR. STEVENSON: In terms of getting outside experts' opinion as to the validity, sensitivity of screening tests -- I mean, can we -- I don't think we can do that as a committee. I don't think there is anybody on this committee that can say the screening -- you know, that can actually give an opinion of that. CHAIRMAN FADEN: I think at this point, it would be a matter of calling up and asking for free advice. Okay? We certainly can always do that and, hopefully, we have enough of a network so that we can find -- DR. STEVENSON: So, hopefully, we'll find somebody that will give us free advice. CHAIRMAN FADEN: Yes. For a complex of reasons, we are restricted to that. DR. STEVENSON: I've not gotten very far with School of Public Health at Harvard. CHAIRMAN FADEN: I want to acknowledge all the hard work the people on the subcommittee have been doing. Everybody has been working very hard. I just never know when to stop or when to start when I start acknowledging everything that's been, being done, but for a complex of reasons we would have to rely on free advice at this point. But we certainly should avail ourselves of free advice, especially if it's good. Okay. We are then leaving notification. The next agenda item is recommendations with respect to openness. So we're back into recommendations. Let's see where that is. It starts on page -- I've got the wrong draft always. Forty-one, is it? Recommendations on openness, start on page 41. I think you have a later draft. That's what I was struggling with. Recommendations on openness. The floor is open -- Let's see how many we've got to deal with. This is recommendation 16, and it's 16(a), 16(b) -- It goes up to (i)? Okay. MR. GUTTMAN: A quick comment. With the exception of the first recommendation, each one of the recommendations is discrete. You can be for them or against them discretely. The first one on the ombudsman, and Pat -- This is in anticipation of what Pat is going to say -- is in the vein of, as I understand the Committee's discussions, what was discussed about what you do about the deficiencies in current administration of the Common Rule. Do you create a new public board? Do you have a new layer of bureaucracy? The sense of it is that what we have seen in the whole process of getting the documents from the agencies, the Freedom of Information Act is not adequate for historical records, because people don't know where the record are, because records are in different government agencies. There is no central actor, and because there is no proactive force helping people, in some respects, the way the Committee is. So that the sense is that there's a vacuum. In crafting the recommendation, we were also keenly aware, as per the discussion yesterday, that any solution will immediately meet with the objection of, what, another this, another that, another Federal this. So that in the discussion -- I just want to make clear -- The thrust of that is that there is a problem that needs to be addressed. We don't want to throw out that notion by focusing on a particular mechanism and people will say, oh, you want to create another bureaucracy or something like that, because people have asked what do you mean by an ombudsman. CHAIRMAN FADEN: We have -- we, meaning me. MR. GUTTMAN: I had a nice conversation with a Canadian ombudsman. He's a wonderful guy. You get him. He talks to you, but he isn't exactly what this is. CHAIRMAN FADEN: We have A to I, and we have an hour. Okay? We've really got to march through A to I. Dan has started us on the ombudsman. Susan? DR. LEDERER: I just have a question of clarification. Does this recommendation -- Are we going to specify the records collections that are in the National Archives or is this records collections in general that are possessed by the Federal government -- MR. GUTTMAN: Yes, Federal government. DR. LEDERER: -- or those relating to the Cold War period or -- MR. GUTTMAN: Well, the notion is Federal government in general. To me, from talking to people like Jim David, for example, the experts, what is an extraordinary insight of this is that, really, there is no practical, coherent governmentwide sense of all the records. People don't know, you know -- The agencies didn't know -- Some of the agencies had a problem knowing where even to look at the beginning. So if you as a citizen filed a FOIA request, the poor person getting it would say, well, I looked around me, and I don't know where to go. So that there's a sense that on the governmentwide level we've let this system develop and, while there are plenty of wonderful actors in each crevice of the system, there is no central person or individual that's looking out and saying where can we -- The other sense that is very important is that one of the things I think the Committee has discovered is that there are plenty of collections of records which don't have to be inaccessible to the public, and you want to be able to say in today's climate we can tap the energy of lots of all these citizens out there and say, we'd love to look through these records; why do we have to have a FOIA, and then sit back and wait. Why can't we go in and look? One of the things the Committee is saying is, yes, there are a lot of indices that you could get that would make this work easily -- more easily done -- or that there are collections which you can't get into because there's one classified document. That's why you can't get into it. So the role of the ombudsman, in some respects, would be to push and to implement on the kinds of issues that we've identified, in some way analogous to the way, in the discussion yesterday, as Ruth was saying, we've identified a couple of issues, somebody has got to take those issues and push with it. There is no -- CHAIRMAN FADEN: What if the recommendation said that? MR. GUTTMAN: Fine. CHAIRMAN FADEN: Rather than recommend an ombudsman, what if the recommendation said we've identified a series of problems. They need to be fixed. Figure out how to fix it. MR. GUTTMAN: That was the sense of the Committee. CHAIRMAN FADEN: Rather than propose an ombudsman when at least some of us aren't really persuaded that that's the right way to go. You can put in "such as an ombudsman" or something like that. MR. GUTTMAN: That would be fine, if that's the -- Yes. CHAIRMAN FADEN: Is that -- DR. MACKLIN: But I thought Dan's comment just embraced both A and B. A is the ombudsman or equivalent mechanism. B is all that stuff about the finding aids, the inventories -- MR. GUTTMAN: Those are particulars you can either throw in as examples. CHAIRMAN FADEN: They're standing as a recommendation in 16(b). That's what we're confused about. You got this whole thing here. DR. MACKLIN: There are two separate things that just fell under this comment. CHAIRMAN FADEN: I think you can combine them. Is that your proposal, Ruth? No? DR. MACKLIN: Sounds like it's yours. No. I mean, the problem is, if we have a difficulty with the ombudsman as a particular mechanism, then I think we can combine them; because the heart of it is to enable citizens to gain access. I mean, the point of 16(a) is to enable 16(b) to be realized. MR. GUTTMAN: B, et cetera. DR. MACKLIN: Well, yes, et cetera, but they go in different directions. CHAIRMAN FADEN: Pat? MS. KING: Do we have findings on this in this area? MR. GUTTMAN: They were in the trust thing that we now are -- CHAIRMAN FADEN: We're not going to pull it out, but one set of the trust findings dealt with how hard -- the records that were lost, the records you couldn't find, blah-blah-blah- blah. MS. KING: Okay. I think this is an important area. I mean an important area based on the Committee's experience where the Committee does, in fact, have something to say, because we know from our experience not only the problems with classified documents but with documents -- trying to access to documents. So we're doing it last. So we're probably not giving it the attention that we should, but this is actually, I think, what should be one of our big things, because this matters in terms of a whole range of activities. So I would agree that what we want to do, what our primary goal is to build the case for something needing to be done and being very careful and lengthy about the Committee's experience on this, and then summing it up by saying that we think some attention should be made. The point that Dan makes about indices, for example, is really quite important, that people who want access could do lots better jobs if they could even get access to indices, which they often cannot do, not to mention nobody can find the documents. So it's one of those horribly dry and boring recommendations, but I think it's a really critical recommendation, and it is us. This is one of those things that we should be doing, pushing this kind of area and talking about our experience. CHAIRMAN FADEN: Phil? DR. RUSSELL: It's a little unclear to me exactly what action agency is targeted here. MR. GUTTMAN: All of them. It's a separate question about the CIA, because -- Well, all of them -- It's a general finding, the same way that our experimental findings are not radiation specific, I guess. DR. RUSSELL: The records are diffuse. Is there a central solution? If so, who is going to carry it out? MR. GUTTMAN: That's the question. Presently, there isn't. DR. RUSSELL: Who are you going to aim the -- Is the Office of the President? MS. KING: Yes, it should be. One of the first points made should be -- and I would make a second recommendation. Classified documents and general documents ought to be distinguished. They do present different problems, but there are problems with access to both. It would be useful, so that those who classify could focus on that, and we can talk about it. The first point being made ought to be the point about no central responsibility. The closest we would have would be the National Archivist, but that doesn't really satisfy some of the problems that we ran into in doing this Commission's work. So the first point is that the responsibility is scattered, as far as we know. Now I haven't discovered anything else differently, Dan -- that the responsibility is agency by agency, and given the agencies' missions, it is the natural inclination of an agency to put its mission ahead of its recordkeeping. It makes a lot of sense to me. So this is a way of calling out the attention that there is an important overall public good to be served. CHAIRMAN FADEN: This is very akin, by the way, to what we did find with respect to human subject stuff in the sense that we had -- all the agencies had problems. It wasn't that one agency had perfect records and the other agencies' records it was variation, but all the agencies had difficulties, and they all worked very hard, and it was a huge problem, and there wasn't one source. So we can make that kind of argument and basically have a recommendation that says that this is a governmentwide problem, as best as the committee can find out, that needs high priority for the following reasons. Here are the sorts of things we would suggest. It's kind of like the human subjects thing. We can make it very analogous to the human subjects one. MR. GUTTMAN: Who is going to say we don't find any gross human rights violations in the recordkeeping practices? CHAIRMAN FADEN: Well, is that -- All right. Rewriting it in a way that combines 16(a) and (b) would then -- MR. GUTTMAN: There are a couple of them that fit in there, yes. CHAIRMAN FADEN: That would -- 16(c) does not. 16(d) does not. So transfer of records to the National Archives -- Can we go to some of the ones that don't fit? Let me just take a simple one. I assume that recommendation 16(i) is agreeable to the Committee? I'm taking it out of order. DR. STEVENSON: My understanding was that, as a FACA committee, all that would be done as a matter of course. That's -- MR. GUTTMAN: Not in resource -- Actually, it's happening, but it's not a given. CHAIRMAN FADEN: It's a good idea for us to say it. Lois? Oh, no? So 16(i) is agreeable to everyone? Good. We think we are important. All right? Okay. DR. TUCKSON: Even though it is straightforward, just make sure. People that need to have access to it -- is that a convenient place to do that as opposed to where people now go? MR. GUTTMAN: The answer is, no, but these things -- Oh, yes. All those things we're trying to work out with the -- DR. TUCKSON: This doesn't mean to imply one place only and not the accessibility -- MR. GUTTMAN: No. These are resource questions, you know. DR. TUCKSON: I agree. CHAIRMAN FADEN: 16(h) is cover stories. MR. GUTTMAN: Yes. There was some E-Mail about this. CHAIRMAN FADEN: There was considerable E-Mail, actually, about this. MR. GUTTMAN: Right. I wish Gary were here. CHAIRMAN FADEN: Does anybody want to speak to 16(a)? Do those of you who commented on E-Mail want to share your comments? Henry? DR. ROYAL: I suspect -- Do you want on cover stories? I guess this apparently requires the Presidential waiver, and whether or not that's too restrictive of a criteria -- I don't know. Phil was talking about, you know, a terrorist attack, and I suppose under those circumstances the President would be involved; but whether or not he always has to be involved is unclear to me. DR. MACKLIN: Well, this is not a question of the President being involved in every declassification decision. This is false or deceptive information. I mean, this is much stronger than it would be to say that the President has to be involved in every question of waiving Secrecy or classification. This is can you be lying all over the place to cover up something without a Presidential involvement. DR. ROYAL: Let me -- DR. GLATSTEIN: You only want the President to lie. DR. ROYAL: Let me say it in another way. I've never found the government to be particularly honest. I mean, what you call a cover-up or a deceptive statement is very unclear to me. If one has a low threshold for calling something deceptive statements, there might be a lot of deceptive statements out there. I do think that's one of the fundamental problems with people trusting the government. I guess I'm really questioning whether or not this is a realistic recommendation, that maybe it's both in terms of the definition of what a deceptive statement is and the fact that it would have to go up to the President. CHAIRMAN FADEN: I just don't know what this means. I mean, it has all the failings of apple pie. MS. KING: I know, and I would have a different question. What do we have to tell us that we should make a recommendation in this area? CHAIRMAN FADEN: The only thing that -- The area where this -- I mean, I asked the same question, and the rationale comes from the -- DR. ROYAL: Project Sunshine. CHAIRMAN FADEN: -- Project Sunshine, where there was a cover story put out for the collection of body parts, the body snatchers. MR. GUTTMAN: Also in the Hanford data -- I mean, there's plenty of instances of deception. CHAIRMAN FADEN: Yes, but this is a little bit more than -- MR. GUTTMAN: I mean cover stories. I don't mean things where people say let's have a cover story. CHAIRMAN FADEN: We had several of those. We've had several of those in the historical record. In some cases, we don't know whether the cover story was ever used or not, but we've got transcripts where there are discussions: Can we tell them this, you know, instead of telling them that. So we have come across in the historical record instances in which either we have evidence that a cover story was used or we have discussions of cover stories like, you know, can we tell them we're from an insurance company when we want to do an exam on them, when in fact we want to do it because they are living near a whatever-it-is. We don't know if they actually did it or not. It's just a discussion in the transcript. Somebody is saying this. So in that case, we don't know if they ever did it. The one where we know they did it was the Sunshine thing, and maybe one or two instances. I, personally, am not comfortable with this recommendation. I am very uncomfortable with it. I feel like we don't know enough, and I don't know what this means, and for all of those reasons I would encourage us not to. Okay, does anybody want to argue for it? You know, the awkward thing is who could be against it? I mean, I'm sorry it's here, because in a way -- DR. ROYAL: But we shouldn't have that feeling that if we don't -- if something is not a recommendation of our report, that that means that we're against it. It just means that we can't address every problem in the world in this report. CHAIRMAN FADEN: Thank you for the -- You're right. It's what I have to keep remembering. DR. RUSSELL: That's collateral damage. CHAIRMAN FADEN: I'm working backwards to get to some of the other ones. 16(g) is the CIA one. MR. GUTTMAN: A brief explanation: We actually had a nice conversation with the CIA who is going to pick it up. The confusion about, first, why is the CIA being singled out -- there are two respects. One is the MKULTRA records where it's being singled out, because there was an admitted story whereas the CIA -- and it's declassified -- document they gave us, the history, they end up by saying we can see the public would still have questions about whether we did human radiation experiments, because we destroyed all these documents. So there we're saying make whatever about MKULTRA. You still have -- CHAIRMAN FADEN: Gary has submitted, in response from queries from several Committee members about why -- This gives the impression that all the stuff about the CIA remains as unsettled as it was when we started with respect to radiation experiments, which is not the case. He has the following text, which we should have Xeroxed, but okay. "The Advisory Committee has found no evidence to indicate that the CIA conducted or sponsored human radiation experiments. However, numerous documents, some of which remain partially classified, make reference to possible CIA interest in this area. Although Advisory Committee staff has reviewed all of the available classified information concerning human radiation experiments and requested that it be declassified, the public does not have the benefit of such access. Accordingly, this recommendation seeks to foster greater public access to and accountability of CIA records." DR. THOMAS: Can you just clarify the situation regarding that thing in the February briefing book in which the staff memo says, here is a project which is referred to or there's maybe a couple of projects in that briefing book which were never funded. Then we have this other letter courtesy of Ruth which says was indeed funded. CHAIRMAN FADEN: We're pursuing that. DR. THOMAS: Do we know this? We don't know whether it was done, but according to the letter, it says it was funded. CHAIRMAN FADEN: We're checking on that one. MR. GUTTMAN: Our understanding -- Ruth doesn't say that this is funded. DR. MACKLIN: Not that it's funded, but that this is the information about something that was sponsored -- No, it was funded, but not carried out. Funded but not carried out. CHAIRMAN FADEN: We are checking. DR. THOMAS: It didn't say not carried out. He said he didn't know. DR. MACKLIN: Not known. Not known. CHAIRMAN FADEN: And we are checking. The answer is we are checking. Okay. That was new information, and we are checking. This is a reference to an experiment that came to Ruth's attention when she was traveling that may have -- that appears to have been CIA supported, that may have -- that seems to have involved radiation that we haven't ever heard about before. So -- Oh, we have heard about it? Oh, it's the same one? Okay. I'm sorry. I'm confused. Anyway, we're checking. That's a scary thing, isn't it? DR. ROYAL: This thing that you're talking about, this experiment, this was using radioactive material to identify people. Why is that an experiment? CHAIRMAN FADEN: If it was an experiment. If they were trying to see if it worked. DR. ROYAL: It didn't make any sense either, because they were talking about they were going to use the half-life. MR. GUTTMAN: That's why we need an independent oversight board for these things. CHAIRMAN FADEN: That's a side issue. I want to go to the recommendation. Do we want to single out the CIA and, if so, for what reason? Pat? MS. KING: That's my question. I'm still listening for the reasons. MR. GUTTMAN: Let me list the second one. The first point is that MKULTRA has got a special significance. The second point is that it's not a singling it out, the way at least the staff used it. It's a leveling of playing field. In the case of all the other agencies, including some like the Defense Nuclear Agency which conduct terrific amounts of Secret work, there is some accessibility to the public of the structure of their records collections, that Jim David knows that DNA records are record group blah-blah-blah or here, there and that. Lots of them are classified, but he knows that. In the case of the CIA, by contrast, virtually none of their records are in the -- a very small amount are in any kind of outside CIA- National Archives accessible form, and there is no way when we go around trying to even have a sense of what we get that we know that they've looked in all the places. When we ran this through the CIA, I had an informal discussion which is now going up. I don't think that they -- Well, at the level that we were talking, what we're asking for is some independent review of their records by appropriately cleared people to make sure that the records are accessible to whoever needs them for legitimate purposes, including the government. One of the things we cite here is this investigation related to one of the bank scandals where a deputy of, I think, Janet Reno said, well, they couldn't get the necessary records for us, in response to our -- It took them a while to locate their own records. That's part of the question that comes up here, because of the work we've done with the Joint Panel in 1950 where we found examples of their records in the public files, in Department of Defense files, and they couldn't find them. Now maybe there's perfectly good reason. MS. KING: With respect to your second point, that's not what the recommendation -- I mean, it's not what this recommendation recommends, that there be a level playing field. What it recommends is that we go into the CIA and make sure that what's classified is classified -- is properly classified. What you just said is that the other agencies have publicly accessible -- not indices; that's not the right word, but you can tell what you're doing, because you can tell that there are records there, whether the records are classified. What you said was that with the CIA you can't tell that the records are there and classified. You can't tell that the records are there. That's the difference in the playing fields. Did I get that right? MR. GUTTMAN: What we found, to go back to the first point of the discussion, is that there is a mass of Federal records out there which is in varying states of organization, and the country doesn't have access in a practical sense to large chunks, because they are not even sufficiently organized. So that DOE has now gone out and done a roadmap because of this project, which is beginning to just identify the basic collection, so that that is happening in the case of DOE. You can sort of get some sense in the case of the other agencies, but the CIA --there is not even the level of organization. It's not got to do with the classification, but there's not the level of organization and assurance that there's an organizational structure by which these records are accessible to whoever needs them, and that there is no independent -- We can't say that. Nobody else in the public can say that. It's not clear that any Congress or -- MS. KING: Sounds like what you're saying is that we can't tell one way or the other whether there is within the CIA a mechanism for getting to the records of somebody that the CIA wants to -- MR. GUTTMAN: That's right. When the government -- I the B&L thing when the United States-- MS. KING: But we don't know either way. Is that what you're saying? MR. GUTTMAN: Right. MS. KING: What you're saying is that - - I'm just trying to understand what you're saying. MR. GUTTMAN: Yes, that's right. MS. KING: So in this respect, the CIA is different from other agencies. DR. ROYAL: I don't understand this. I thought when the CIA guy came here, he was talking about how they were in a unique -- had a unique situation for finding documents, and a lot of it was electronically accessible. It doesn't make any sense to me that the CIA, which is supposed to be a manager of information, can't retrieve anything. MR. GUTTMAN: Well, I don't want to give too many -- but -- That's the question. CHAIRMAN FADEN: The issue here is whether we -- I think that the recommendation has to be made more explicit than in its current form, the first part of it. The second part of it, to declassify all of the remaining MKULTRA stuff -- MS. KING: Now what is -- That was my second question. What's the basis of that recommendation? Let's be clear about why we are recommending declassification of all documents. MR. GUTTMAN: MKULTRA. MS. KING: MKULTRA. MR. GUTTMAN: The reason being, obviously, if there are documents that, for presently valid reasons, merit classification, that's a separate issue. CHAIRMAN FADEN: It doesn't say that. MS. KING: It surely doesn't. That's one of my questions. MR. GUTTMAN: We are not -- We haven't been -- There is no -- I don't think the CIA has told us if there are any documents. They haven't pointed out any documents that they say merit classification -- to my knowledge, and it's subject to check. CHAIRMAN FADEN: Have they refused to declassify records, and we responding to that? I mean, what is the issue here? MS. KING: Why is it here? That's what I'm trying to figure out. MR. GUTTMAN: I'll have to focus it with Gary. That's a good question. CHAIRMAN FADEN: We don't know why. MS. KING: What it sounds like is -- and this is what would concern me, because I think we have to be careful here. It sounded like a part of your explanation was that we had access to some documents because some of the people have clearances that are not otherwise available to other people at this point -- CHAIRMAN FADEN: That's correct. MS. KING: -- and it is our belief that those documents should be made available to everybody. This is very sticky. CHAIRMAN FADEN: Yes, and I think what happens is that the language from Gary, basically, says that. I think I have an idea of what he has in mind, and I'm not sure that it's comfortable. MR. GUTTMAN: Can I suggest something? MS. KING: At least, it's sticky for a committee itself that has not reviewed all of these documents. MR. GUTTMAN: Pat, could I suggest something? We actually had a conversation with the CIA about this particular recommendation, and the person we're working with has been away for a week and is going to get back with us. Can we try to work this in the interim? CHAIRMAN FADEN: I think we are not going to approve 16(g) in its current form. Whether we approve another recommendation that's specific to the CIA remains open, and another possibility, of course, is to fold the CIA into that first recommendation with maybe even a special mention, if their record system is more opaque even to the public than other. So we will do that. Let's keep rolling backwards here. We're on 16(f). MS. KING: I don't mind being filmed; honestly, I don't mind being filmed. But it's disruptive when the person taking the pictures is right down in front when we're trying to interact. So if the people who are doing the filming can somehow get to the edges I'd appreciate it. Thank you. DR. FADEN: Thank you, Pat. But I guess there are certain issues, invasion of body space if not privacy, still hold to have a claim too. Duncan. DR. THOMAS: Can somebody educate me as to whether present document destruction practices include any public notification of the intent to destroy? MR. GUTTMAN: No. We're talking about a very very routine. Pat will tell you. This is not like -- it happens everyday. This is routine. DR. THOMAS: No, that's what I'm talking about; just routine destruction. But records which may seem routine to one person may be important to somebody else. MR. GUTTMAN: There has not been historically a great ground swell for public notification of intent to destroy documents. DR. THOMAS: I wouldn't think so. And we don't want to create one more bureaucracy for that purpose. On the other hand you start off your first sentence here with reference to important data collections, record collections somewhere here. Here it is, line 21. MS. KING: There's a problem with this recommendation though, and that is, the government generates so many tons of papers not to be believed, and keeping a lot of these would be a problem, and I would feel more comfortable if the committee made recommendations about records in the areas that we're concerned about. So there should be some limiting, and we should be able to justify why we need it. If it's records pertaining to human subject research why we can show that -- I know exactly what Dan is trying to get to here, but it's one of those recommendations that the cost benefit part of it is -- MR. GUTTMAN: That's fine. The principle once established will either fail or succeed. DR. FADEN: We will keep going. Again we're obviously are going to have to see all of these, but we will see them in the mail and then have our final sign off on them at the last meeting. 16e. Transfer Records to the National Archives. DR. GLATSTEIN: Who appraises these? MR. GUTTMAN: The archives. DR. FADEN: Is this a problem? MR. GUTTMAN: Well, it's in some respects hortatory, but useful because of the committee's expertise in this area. DR. ROYAL: Which records are you referring to that have been appraised as being permanently valuable? Records that we've discovered? MR. GUTTMAN: No, no. This is a general -- DR. FADEN: Whoever does these appraisings determines that a record is valuable and should be retained it ought to be transferred to the National Archives. MS. KING: Well I have the same problem. This one I had with the one before. I mean the committee's basic charge is protecting human subjects or openness issues; and openness. And this is a nice thing to do but it's also got huge cost benefit kind of assessment attached to it. If there's already a federal law maybe if we say anything it should be directed at why we think the federal law's inadequate, or why it's not working in the areas that we think are important rather than a general recommendation then. DR. RUSSELL: I can't tell from this whether we say that they aren't obeying the law or whether the law's inadequate. MR. GUTTMAN: No. It's a case whereas I understand it, it's resources and priorities and neglect, and all the things that you would suspect. MS. KING: It's by cost benefit analysis. DR. RUSSELL: Are they not obeying a federal law because they can't afford to? Is that it? So then they've got two problems; both the law's inappropriate and we don't have enough money to do it. MR. GUTTMAN: Well, no. The gist of, I think, for of a lot of these recommendation everything is trade off in today's world, but the point I think we're trying to make is that for practical purposes they're inaccessible to the public and of no use to the agencies in their present forms so that you've got an asset that's of no value but just sitting in a warehouse without being organized by the archives. You're right; nobody expects a large amount of money to be devoted to this overnight. DR. FADEN: Ruth. DR. MACKLIN: When we were talking about a and b I think Ruth you made a comment; I think that e falls under this too and maybe these could be combined in some way. These are different from the ones we just looked at, so 16a through e could probably be condensed. DR. FADEN: No, not c and d. We've got to look at c and d. But you're quite right; let's go to c and d now. DR. MACKLIN: So e would go with the a and b. DR. FADEN: As all things that we are suggesting. DR. MACKLIN: Because it's all the same problem. DR. FADEN: Right. It's all the fix it problem; make the records better available, organized; all that kind of stuff so that people don't have to go through what we have all gone through. C and d are different. They speak to different things. Shall we take -- I don't care which one we do first; we should look at both. Recommendation 16d. MS. KING: I don't know if I'd be in favor or not in favor of that. I am convinced that there's not enough justification here why we should go to this enormous expense. Maybe there's some justification why we should ask them. We should ask the government to go to this enormous expense. Perhaps there's some justification that we can think about for doing this and maybe it should be time dated; maybe it should be lots of things. But I think the fact that you want to look at records 50 years later as sort of what we have been doing here is sufficiently unusual that to ask for these permanent registries for every type of research project has been much. So either it should be limited in some ways by dates, by types of research, by something, and we should give a good reason about why these data are needed for something other than the possible creation of another committee. DR. FADEN: Are we talking about d or c? MS. KING: I'm talking about d. DR. FADEN: Anna has something there. MS. MASTROIANNI: It's my understanding the National Library of Medicine is already evaluating the issues related to creation of registry for clinical trials. I don't know what the status is at this very moment, but they are doing that. DR. FADEN: And there are arguments for registries and they usually are field specific or they are related to the cryptic references here to justice questions and selection of subjects, adverse outcomes and things like that, but it's a massive undertaking. MS. KING: It's a massive thing and if we want it it should have limits. I mean maybe we want it for a certain period of time or something like that, or certain kinds of research. DR. FADEN: Ruth. DR. MACKLIN: Well it seems to me that this is related to something we talked about this morning which was documentation about consent processes and things like that. That is we talked about in a different context, not in the context of openness, but in the context of -- it started out with ethics education, but of course we were also talking about compensation and compensation for dignitary harms and other harms in which it happens. There was a whole set of things that had to do with how people might be able to find something out. Now the federal government wouldn't have control over what kinds of records are in hospitals, doctors' offices, etc., but the federal government is in a position to keep some kinds of central registries so that if things come up in the areas where people are looking for information about something like was there adequate informed consent; we were looking at compensation and debating that but it may go back to the question of investigators. There may be other purposes here that could be served that don't have to do with the possibility that forty years later someone's going to raise some problem. But if we're urging in other sections of this report the importance of things like ensuring that informed consent and the ethics of research are carried out then this kind of record would seem to me a way of being able to document and get at that. DR. ROYAL: How is this going to document that adequate informed consent was obtained? DR. FADEN: I think it doesn't document; it just provides you -- DR. MACKLIN: It doesn't document. It has some evidence that might not otherwise be available anywhere. Henry, it could protect the physician researcher. If a patient says, I never signed a consent form. I mean, I don't know. I'm just saying we talked about things this morning that might require records for being able to do it. DR. FADEN: Here's a possibility. If the NLM is already looking at feasibility of a registry and a rationale for clinical trials we could recommend that the National Library of Medicine broaden its current inquiry to consider the merits and disadvantages of creating a central registry for all research involving human subjects. We're not going to be able to work it out here. There are arguments why it would be a good idea; there are arguments why it wouldn't. And it's in that category of we haven't had the time to hash the whole thing out. So if we sat there and said if NLM is already in the business of figuring out the feasibility and the clinical trial arena last ask them to take a look at the other arena as well. It seems to me they are an appropriate agency to him to direct this recommendation under the openness heading. DR. TUCKSON: I would agree with that, and I think the main thing is just to articulate what it is that we seek to accomplish as opposed to trying to dictate the way of doing it. DR. FADEN: I think that that's going to the problem here. If we're not clear about what it could accomplish then we shouldn't even be asking NLM to take a look at it. DR. TUCKSON: That's the critical language. DR. FADEN: So that is part of it. Obviously in suggesting it I think that there are arguments that could be made for registries in this area, but I don't know. DR. TUCKSON: But given the realistic notions of cutting back on government bureaucracy, and given the real notions now of cutting back on the money available to conduct research to put in a bureaucracy, I mean I just can't imagine anybody would do this. DR. FADEN: Let's do this. I will take 16d; try to think. If we can't come up with a very persuasive argument, why even NLM should take a look at it, it will not appear again. But it will either be in the form of we'll contact NLM and see what's going on there. DR. ROYAL: And remember the kind of information that you need in the database to be useful to ethics is very different than the kind of information that's likely to be in there. DR. FADEN: The IRB stuff. I'm sorry, I didn't mean to interrupt. DR. ROYAL: They're not going to have the IRB stuff, what you just said, yes. DR. MACKLIN: Why not? DR. FADEN: If NLM right now is thinking about doing a registry on clinical trials it's unlikely that their registry will include the IRB documentation and the consent form. This recommendation includes that in order to increase the likelihood that the registry would be useful for subsequent reviews or the ethics of research along the lines of what we did in the RPRP. Basically what's suggested here is, there would be a central registry that would contain all the information on funded research projects that we had when we did our RPRP review. So that one argument is, if every five years somebody wants to do an RPRP, instead of having to go to all the institutions they draw a sample from the registry, look at the stuff, and it goes back. DR. ROYAL: Maybe that recommendation then should be part of the recommendation that they do the RPRP study every five years. DR. GLATSTEIN: We could build that in. DR. FADEN: The issue is I'm not sure whether that's the most efficient way to do it. Maybe it is more efficient not to have a registry and just request the materials every five years. Unless there are other reasons for the registry it probably is more efficient to draw your sample from the list that the agencies keep of their funding. That's the problem. I'm just not sure, but that was part of the thinking behind throwing these ones in. Let us work on this a little bit, because I think 16c is something that while we still have the committee here there's some collective debate in the next 10 or 15 minutes. 16c is directed at recipients of federal funds; grantees and contractors. MS. KING: Well, I have the same problem with this one as I did before. I don't know whether I'm for it or against it. I was looking for a reason for it. I mean I'm looking for what we know, what we don't know. For example, there's a sentence that says, "The purpose of the review is to determine the legal rights of citizens in the records." I didn't quite understand what that meant. It meant that maybe it wanted OMB to say what it thinks; that the legal rights are; but OMB's not going to do that. Or whether citizens have legal rights in their records in which case it says so. It's more a question of confusion. MR. GUTTMAN: Yes, the gist of this is that basically you've got a situation from the respect of the citizen, they don't care. This is like whether it's Green Run or the 699,000 other curators. If there a human subject or if they're just a member of the public who's interested in that subject. If it's done on taxpayer dollars, whether it's done by the AEC employee, by Oak Ridge or by the University of California on Oak Ridge money, it doesn't matter. A reporter from Spokane we talked to is calling up and saying they've been trying to get information at Hanford. General Electric had some information about experimental stuff that went on in the 60s and GE he doesn't want to turn it over and the DOE says it's nothing we can do about it. We asked the DOE; maybe it is something. But it's a notion that it's a difference, depending upon the fortuity of whether that happens to be something that is in the contractor's hands or the government's hands. And the general point here is that there should be some -- especially with so much more work and the government going out to these contractors and grantees -- some clear statement that you don't immunize the public taxpayer dollar from access by the luck of who's doing the work. Now Ruth's point; for contraries, you don't want to tie up the university system and all kinds of -- that's true. That's why we're talking about parity. MS. KING: My problem with this is, you can't discern what we're doing here. If what the idea is to do is of the same rights of access that a citizen has to x kind of records. The federal government is what you want to give a citizen access to with respect to contractors and grantees. This doesn't do that. And so, one, I had trouble trying to figure our exactly what the goal of it was, but I assume that that's the goal now the way you just explained it. So if that's the goal it seems to me that's what we want to recommend OMB that they review. And I do think it should be a review because there are in fact -- from a citizen's point of view I quite agree with you; it doesn't matter who has the records. However, from the holder of the records point of view they are not in the same position. The universities are not in the same -- grantees are not in the same position as the federal government. So there is a way in balancing questions here. So I would have a recommendation that would say that a citizen -- We should review whether the citizen should be on the equal footing with respect to access to the citizen's medical records, because I assume that's what you're talking about. And maybe it's more than medical records. MR. GUTTMAN: No, it's more than medical records. MS. KING: Okay, then specify. MR. GUTTMAN: Because medical records they technically should have wherever they are I assume, right? DR. FADEN: In any event you fill in the parentheses. MS. KING: Fill in the parentheses, and then what you want them to do is to review this, because what you want to see is there any reason for maintaining this that makes any sense. And I would have the recommendation read that way. MR. GUTTMAN: I wrote it all by myself, but I would like to say it was written by a committee. DR. FADEN: All right. So that your revised one makes explicit the agenda behind the recommendation, says, OMB or whomever is the right agency, review whether a citizen's right to access. And it's intended as I understand it not only to be your access to information about your own medical participation or participation in research, but just if somebody wants to find out about -- MR. GUTTMAN: Dr. X's research reports. DR. FADEN: Right. Something; anything like that; allowing for privacy protections and things of that sort. MS. KING: Is this then real equivalency? DR. FADEN: The issue is first, I don't take the committee should call for equivalency. We should call for review to see the extent to which there is not equivalence and then in the examination of whether the absence -- where there are not equivalences whether it is justified as a matter of public policy to have those differences. Because we have to acknowledge the argument that we've been having for a while. You expressed it better that the holders of the records are not similarly situated even though the people who have an interest in the records may be similarly situated. And we can't begin to resolve that. Okay. We have a few more minutes, but I think we sort of did it. Ruth. DR. MACKLIN: I want to make sure we weren't promised anything in the proceeding three days that we didn't yet get. I don't mean things we have to now. Now, what is that over there? DR. FADEN: I'm scared to tell you. DR. MACKLIN: I think one question we had was, which of the chapters that we now have are considered final, meaning that there is no ongoing revision. DR. FADEN: The term I believe that staff -- is near final or something like that because they were afraid to put final on it. Anna, could you describe what's in the packet for everyone? MS. MASTROIANNI: You will have final reports status, a yellow sheet that would stand out, and there's a box that says near final and there will be a check mark there. It also identifies the dates in your notebook so when you're cleaning out your notebook and looking to make -- for those of you who still have your notebooks intact. When you're cleaning out your notebooks you'll be able to go back and look at the date to see if it matches. We would appreciate any comments you would have on any of the versions that say last revised; or anything that's not near final as well so that we can incorporate those in. The mailings will go out -- You will have a complete start to finish, near final, best staff effort version of the final report by July 10, and we're going to deliver those to you on a staggered basis. MS. KING: So I'm getting a new notebook with the first set of the documents? MS. MASTROIANNI: Pat, we will tailor it for you. DR. FADEN: But the point is, it's going to come in dribs and drabs and you'll have to keep -- MS. MASTROIANNI: You will have to keep updating, and every time we send something out we'll just keep updating. DR. GLATSTEIN: And that's the first drib? MS. MASTROIANNI: And this is it. So you're getting I think four chapters that are in near final condition. And we're also be getting out a calendar explaining when the publication dates and final comments are due; all those sorts of things, early next week. DR. FADEN: And a deadline for additional statements and all that kind of stuff will be in there. So we'll fold it in and people can know what they're up against. Lois. MS. NORRIS: Have you worked it out yet whether you anticipate July will be a two or three day meeting? DR. FADEN: No. I think we should leave it as three. DR. GLATSTEIN: Leave it as three; I can't imagine it will take less. MS. KING: Don't even worry about it; you don't have a chance. DR. FADEN: Can everybody come back for one second? The minutes were distributed two days ago. Are there any amendments, corrections, dissents on the minutes anyone cares to make? Seconded for the approval. All in favor? The minutes are approved. Thank you. I forgot all about it. MR. GUTTMAN: I hereby close the meeting. Whereupon, at 3:24 p.m., the proceedings went off the record.)