ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS PUBLIC MEETING VOLUME III APRIL 12, 1995 APRIL 10, 11 & 12, 1995 ATTENDEES: Ruth R. Faden, Ph.D., M.P.H., Chair Kenneth R. Feinberg, J.D. Eli Glatstein, M.D. Jay Katz, M.D. Patricia A. King, J.D. Susan E. Lederer, Ph.D. Ruth Macklin, Ph.D. Lois L. Norris Nancy L. Oleinick, Ph.D. Henry D. Royal, M.D. Philip K. Russell, M.D. Mary Ann Stevenson, M.D., Ph.D. Duncan C. Thomas, Ph.D. Reed V. Tuckson, M.D. P R O C E E D I N G S DR. FADEN: Good morning. We are ready to start. If I remember correctly, our agenda is so askew -- I don't know if that's the right term, but our agenda has been rearranged given the important work the Committee has done collectively on issues of process and direction and so on. So if I remember correctly from the discussion yesterday, we have decided we want to go right to what is actually the agenda item for this morning, and we will not try to recoup, unless we somehow breeze through this, which I doubt it, the agenda items that we missed, both on Monday and Tuesday. We're going to start with the recommendations looking back at the section of the final chapter, if that's agreeable to everyone. First, everybody has to find their massive copy. Let me just start by explaining kind of what has happened here. If you recall -- how could you forget, right? -- at the last Committee meeting we were talking the recommendations looking back, were divided into four situations: Situations 1, 2, 3 and 4, where 3 was this complicated question of notification. 4, we never got to, which was the sort of "everybody else" category. Situations 1 and 2 dealt with proposals for providing an opportunity for a remedy of compensation in two defined contexts. Situation 1 was the context in which the government had requested information about involvement in experiments from subjects and their families. Situation 2 was a context, essentially of compensating people if there had been a radiation-related injury or what would be judged to be a radiation related injury that was in the context of participation and human experiment, without reference to the ethics, for a complex of reasons that were laid out in that situation. So we have this armful discussion of Situation 1 and 2, as well as situation 3. What is before us now is a revision that is attempting to capture some of the discussion and kind of move us forward a little bit, taking people's comments. So here's what we have in front us. We have, first of all, what's here labeled the Preamble which is almost I think literally word for word from the March draft, and the Preamble lays out the Committee's view that there are three main recommendations with respect to the remedies that the Committee endorses, and they are: First, preserving the history; Secondly, taking steps to minimize the likelihood that there will be problems with the ethics of human research in the future; and, Finally, a national public apology. The Committee did endorse those three, those being our three major recommendations that remain standing. We'll obviously work on the language and get people's sign-offs on whether these are the exact words that you would like to use to express these three recommendations, and there was also a discussion about whether this was the right order, or whether we should reorder these three, and we can work on all that. Just to refresh everyone's memory and hopefully so that no one has had a change of heart but if you do speak now, these three major recommendations receive the endorsement of the Committee on the March meeting and they will stand. So that's what's now called Preamble, but that's not really the right term for it, because this is where we represent what we take to be the three major responses that the government ought to take in the face of the histories that we have uncovered together. Now that we have, in response to the Situation 1 and 2 mess, last time, is the Situation 1A, which didn't exist before and a Situation 1, which is the old Situation 1, and then a Situation 2A, which didn't exist before, and a Situation 2. What I thought might be useful is, if we spent sometime perhaps to the break on the Situation 1, 2, 1A, 2A, after the break go to Situation 3 and describe what's happened to Situation 3, which is really an accumulative process of almost kind of Talmudic back and forth; one persons's commentary and another person's commentary and somebody's commentary and then the commentary on the commentary, but it shows how this exchange among committee members and staff actually can advance the discussion and maybe can get us somewhere. So if it's agreeable to everybody, we'll do Situation 3 after the break, the notification one, and we'll concentrate on the 1A, 1B, 2A, 2B, right now. If we get through it more quickly, great, we'll move on; if we don't get to it -- if we don't finish it all the way through, after the break we need to go to Situation 3. So the floor is open for the discussion of Situation 1A and its relationship to 1 and 2A and its relationship to 2. Can somebody here summarize what's going on here or can we just launch right into the discussion? DR. MACKLIN: Just clarify for us when you say "the relationship." DR. FADEN: What the relationship was, in my mind, and how this came about, in the discussion in March, and I think Pat primarily pushed this, but others as well, seemed to say that behind both the old Situation 1 and Situation 2, were some suppressed assumptions for commitments or positions that were not articulated and the Committee needed to articulate them, lay them out, and make them public. I reread the transcript, as did Dan and Jeff, and I'm not sure who else, but at least the three of us re-read the transcript. I think Gary reread the transcript as well of that part of the discussion, so for the person who's transcribing and the notetaker, we actually do look at the transcripts ourselves from time to time and try to learn from the discussions. I must have reread the transcript of this part of the March meeting three or four times, trying to figure out what was behind people's concerns and questions about Situation 1 and 2 as they existed before and tried to pull out one proposal, basically, for getting out the assumption. Some of the suppressed commitments that might be behind the rationale for Situation 1 and 2; this is by no means as analytically neat as it should be, and I began to generate a whole list of variants to situations and commitments that looked very much like what we had before us in the February meeting, if you can recall, that nobody liked, which was not completely exhaustive but a detailed list of 8 or -- I don't remember what it was -- 16 different situations and identified, there were at least four or five missing cells if you wanted to have a complete matrix. It obviously got unwieldy. Short of going back to a complete laying out of all of the various whatevers, that was the relationship, to sort of see if we couldn't make more explicit how it is, and also -- I'm not being very -- I'm interrupting myself, which is inappropriate -- but also in the March meeting, the strategy was taken that, let's not address situations that we haven't found. Let's just deal with fact situations that have come before the Committee. Situations 1A and 2A say okay, now respond. What I heard some of the Committee members saying is we have to say something about these situations, even if we haven't found them, because they may exist and because our belief about what also happened in those situations informs what we are willing to do in the situations that we have confronted. So that's it. 1A is the instance where -- well, take the language as it is. I don't have to summarize it. Duncan. DR. THOMAS: Two questions about 1A: The first is, I'm finding difficulty seeing what distinguishes that from our General Recommendation 3. General Recommendation 3 is that we issue a national apology. Everybody who -- DR. FADEN: Basically -- DR. THOMAS: -- was harmed. DR. FADEN: -- basically, it says all you get is three. DR. THOMAS: Who was wronged. Right. Okay. DR. FADEN: What it says is all you get is three. DR. THOMAS: Okay. Then the second question, there is no language in here about a public and individualized apology. I just want to clarify what's meant by an individualized policy. To me, it assumes that the government is going to write letters to people. DR. FADEN: In other words, the general recommendation is just in general, we apologize to those people who have been used wrongly without proper consent. This one says all you get in this situation, Situation 3, but because we know it's now Mary Smith, we can write a letter to Mary Smith or Mary Smith's family. DR. THOMAS: Okay. The reason for bringing it up now is because it's peripherally, at least, related to the question of notification which we will get to after the break. DR. FADEN: I see what you're saying. The notion is only that the person knew, and so it would be in the context in which everybody already knew -- the family members. DR. THOMAS: So we wouldn't be sending out letters to people who don't even know that they're radiation experiments? DR. FADEN: No. That's important. No. The 3 is the general to the world; we apologize to people out there, to whom this may have happened, it was wrong and we're sorry. This says if it turns out that there's an identifiable person or family member of someone where it's known and, of course, the model here is if this is the judgment that people take with respect to some or all persons who served as subjects in plutonium experiments, for example, where it is known, who they are. It's been already identified. Then it would be proper under Situation 1A or the government to send a letter to the surviving family members of that person by name as opposed to the general recommendation. Nancy. DR. OLEINICK: I just have a little discussion about a word that's troubling here. We were talking about identifying persons who were subjects in these experiments without their adequate consent. I would like to see something besides the word "adequate", because I think that's going to get us into trouble without saying something. For example, we spent time yesterday on a chapter which discussed the evolution of consent policies and the distinction between healthy subjects and patients, and the consent standards and policies in these years were different, so what is adequate? I would like to just see something that would spell it out a little better. DR. FADEN: Let me say an iteration of this, and I'm not exactly sure how this even got this way, had an alternative either without their consent or without their adequate consent leaving it for the Committee to decide how strong a position you wanted to take here because if you do say "adequate consent," we are going to have to explicate what we mean by adequate consent. DR. OLEINICK: What we mean. That's all. DR. FADEN: That's quite right. DR. OLEINICK: That's all. DR. FADEN: Which means another level of Committee debate about what we would want to take to be adequate consent. DR. OLEINICK: Certainly for healthy subjects what was considered adequate consent was different than what was -- there was no consent that was required in the early years for patients. After all, they were supposed to rely upon their physician and patient-physician interaction and trust and so forth, and what did we need consent for, and that was adequate. DR. MACKLIN: The problem with that is it wouldn't cover the plutonium situation. I mean we still have to distinguish between people who were patients where the intervention was believed, hoped, or expected to benefit them, and the circumstances where it was not. DR. OLEINICK: Right. DR. MACKLIN: So even though the plutonium subjects were patients, if the belief in advance and the knowledge was this was not going to benefit these people, even though patients were not -- that was not normally done for patients, I would argue -- DR. OLEINICK: You're correct. It's more complicated than I said. You're absolutely correct. DR. MACKLIN: All right. DR. OLEINICK: I don't know. If everybody else on the Committee is happy with the word "adequate" and you want to leave it vague, that's fine. DR. FADEN: No. DR. OLEINICK: That's all I'm saying. DR. FADEN: I think we are obligated if we use it to say what we -- to give some working definition based on whether people knew whether it was there or not. There are two alternatives. The Committee could be very narrow and simply say, without their consent, which is the very harsh situation, where there is literally no consent, and that would be easy, or if we want to say something like without their adequate consent, then we will have to work out what the Committee wants to operationally define as adequate consent. The word informed consent purposely was not used, so that we would not be evoking necessarily the fully-formed modern notion unless we chose to. We can choose to expicate adequate consent as informed consent in the special sense in which people use it now, but we don't have to. That's an issue we should discuss if we like this recommendation. In general, if we want to accept it, we have to decide which way we want. The tough road is to go with adequate consent and give a working account of what we mean by adequate consent for these purposes. Duncan and then Ruth. DR. THOMAS: Ruth, are you considering this, because I have another point. Why don't you go ahead. DR. MACKLIN: It's definitely on this point. I guess the question is, could we try. I mean, the wording is difficult but we have to agree on the circumstance, the situation, so I would like to hear what people think. I mean, for me the plutonium is no problem because although there were patients, they're being injected with some substance that has nothing to do with them. I think the TBI case, I would like to hear what people say about what would be adequate consent, whether we use that word or not. In other words, what might be left out of informing those patients that would lead us to say it was not adequate consent, whether we know or not what actually was told to them? DR. FADEN: There's another level of complication here, to go to the practice chapter, that Nancy was invoking for the comment that she made. The recommendations here speak to the duty of the government, not to the duties of the investigators, so we're not talking about what was standard practice for physicians and researchers. We're not necessarily saying that we are obligated or committed to judge adequacy in the light of or in the context, necessarily, of how consent practice or the absence thereof played themselves out in the day to day practice of research and medicine at the time. The issue here is the government and whether the government, given that it had articulated, the language we used yesterday, were principles and standards, what sense of adequate consent do we want to hold the government responsible for not ensuring that it's federally funded or conducted research satisfied? What that suggests is that one of our charges, one of our major charges was to identify the relevant ethical standards for judging these experiments, and what's emerging here is that there may be different standards that the Committee wishes to suggest for judging the government as opposed to evaluating the conduct of particular investigators and physicians, since we now know that the principles and standards articulated by the government in those early years were not communicated and did not filter through to the practice of the investigators and the physicians who the government supported, which is one of the things that we are criticizing the government for, thereby suggesting, in a long-winded way, that there might be one standard for judging the conduct of the government and another set of standards, rules, criteria, for judging the conduct of the investigators. So this is directed at the government not at guidance for evaluating the conduct of investigators or extracting remedies from investigators, just to throw that in to make life more complicated. DR. MACKLIN: Well, Ruth, that makes perfectly good sense, as you describe. DR. FADEN: Exactly. DR. MACKLIN: Well, except that we're now talking about remedies for the patients -- DR. FADEN: From the government. DR. MACKLIN: -- from the government where the consent, whether we use the word "adequate" or not, was not in some direct line between the government and the patients or subjects, but rather -- DR. FADEN: No, there's no question. DR. MACKLIN: Yes. DR. FADEN: If the investigators failed to obtain adequate consent, what we want to say here is we want to hold the government accountable -- DR. MACKLIN: For failing to communicate. DR. FADEN: -- for failing to communicate, for failing to monitor, failing to educate its investigators, the people that the government funded and employed, okay? They didn't have the 1966 apparatus in place. They had the standards and rules but they didn't require IRBs and they didn't require auditing of federal records, and they didn't say we have to see your consent form before we can give you the money, and whole bunch of things like that that they didn't do then, but we now know they had the language and they had the rhetoric, and they didn't do it. So that's the nuance here. It's very difficult. The issue of adequate consent, if we wanted to go down the route of saying "adequate consent" in the context of the TBI experiments or anything else, the issue is not how we would be looking at the conduct of the investigators, which would be a separate discussion, which will come out a new chapter, but how we want -- what do we want to hold, in this case, the Defense Department, the government through the Defense Department for funding the TBI work, accountable for, with respect to quality of the consent or the lack of the quality of consent that was obtained from the patients in those studies, just to make it more torture. DR. OLEINICK: As I said, if nobody else is troubled and there is some type of -- DR. GLATSTEIN: No. DR. OLEINICK: -- reason for leaving -- DR. GLATSTEIN: No. We are, we are troubled, and there's -- DR. OLEINICK: -- there's sometimes a reason for leaving it deliberately vague and letting the next -- DR. ROYAL: But it's the key issue. DR. GLATSTEIN: It is the key issue, but there's a lot to this one. I have a major concern that given the congressional climate about budget cutting, that this kind of compensation could be a stimulus to markedly reduce the NIH budget. DR. FADEN: There's no money, Eli; this is just an apology. DR. GLATSTEIN: Apology doesn't bother me, but it's the part when we get to compensation. DR. FADEN: All right. We're going to get to 1 in a minute, but let's just, right now, we can say on this one, this is no money. This one is an apology. DR. ROYAL: But it still is deciding who it is you're going to give the apology to. DR. FADEN: Apologize to. Right. That's exactly right. DR. OLEINICK: And it follows because the same language is used. DR. FADEN: Right. We've got this problem of how you want to deal, except it becomes a non-issue in 2, because we're not going to make a fact-finding on that issue. DR. OLEINICK: Right. DR. FADEN: Here, you're right, Henry; we're deciding who deserves an apology, and it's turning on who got -- DR. ROYAL: There's something that we said that we couldn't -- that we don't have any information on. That's about adequate consent, about how -- DR. FADEN: No, this is what was not there before. This is in case there is an instance in which whoever -- we're not going to sit there and say: And it's Mrs. Smith in this experiment and Mr. Jones in that experiment. Why the administration or the Congress, in its wisdom, may decide the evidence before it is, in other words, let's say that what we're doing here is, here's what we think ought to happen. If there is an instance in which there is evidence that adequate consent or no consent at all was not obtained, then we may conclude in the case of a few -- DR. ROYAL: So someone else, some other group, is deciding whether adequate consent was obtained or not? DR. FADEN: We would have to explicate what we mean by adequate consent. That was our charge. Now, we may conclude or we may not conclude in the context of one or two of the chapters, that this situation found itself. We haven't debated that yet. Once we figure this out, we will say -- Ruth has already articulated a position with respect to the plutonium experiments or some of the subjects; when we get to that chapter, and rip it apart, the Committee may or may not decide it's there or somewhere else. This fact situation has, in fact, come before us. This is written to say, look, we could not have looked at every piece of evidence, every experiment that ever happened and fell into this; so we've been asked to give guidance. Here's our guidance. If there is a situation out there in which consent was not obtained or adequate consent was not obtained, we think this is what that person is owed, and you ought to give that person a personal apology or that person's family a personal apology that that person is no longer alive. For us to have done our duty, we ought to give some guidance as to what we mean by adequate consent, if we keep that language in here, so that somebody else -- we're the Committee that's supposed to have expertise to figure that one out. We don't, we don't. Reed. DR. TUCKSON: I think Henry is onto something. For the purpose of this discussion, there is the philosophy and there is the mechanics, and then there are the implications. I think what I think your answer to Henry is, for the moment, we should suspend worrying about mechanics of implementation for the moment and just deal with broad philosophical -- because I keep doing the same thing Henry is doing, saying, now does that work on the individual case and so forth. I think at some point, we really need to give, I imagine, some attention for all of it, in terms of what is the recommendation about who does it. Is this something that the court does on an individual basis? Do you petition the agency, the Congress to do it? Similarly -- and not to presume some of the other sections, it's a matter of when we talk about compensation to people, I'm starting to say to myself, now, how many people is that? How much money is this? So we should divorce those things. DR. FADEN: Can we do this, in the interest of moving forward. The general principle that is being put forward for the Committee to endorse is, assuming the Committee can agree about a working definition of adequate consent, which may will take a lot of work. I don't think anybody is going to have any trouble saying there was someone out there who was used without any consent, that that person isn't owed an apology. Zero consent. That would be the fallback position if the Committee cannot agree as to proper language for adequate consent. The general principle here is if there is a person out there who is used in an experiment without adequate consent, assuming we can agree to that language, that person or that person's surviving family member is owed an apology. What is important to get out on the table, which is what we pushed ourselves to acknowledge is, what we are saying here is, that person, we do not believe, is owed anything other than an apology, because there's no harm. The notion is the person has not been physically harmed, but the person has been wronged, and we are saying what that person is due or that person's family member is due, is an apology. We are not recommending financial compensation in this situation, and the reasoning is laid out here. That's what's important about getting this position out. Okay? If we can agree to that, and the reasoning here is not as good as it can be; we need to get it better. But if we can agree to that, we can then move on to the next and the test between now and the next meeting is to come up with different formulations of adequate consent for the Committee to look at and debate. Henry. DR. ROYAL: I'd like to talk about two implications, as we refer to them. One possible implication is by having any criteria for what we mean by adequate or inadequate consent, that that somehow is going to be decisive. Someone, somewhere is going to say: Oh, you're on one side of the line and you're on the other side of the line, and having this line I think is always troubling, so that's one potential problem; problematic implication. The second thing has to do with other government- sponsored and federally-sponsored medical experiments. One would assume that this would apply to all government-sponsored, and I think we need to think about both of those implications and think about whether or not that's what we want to do. To me, it gets into a particular problem, because I certainly want to do the latter. It doesn't make any sense to me to apologize to people who are in radiation experiments without consent and not apologize to people who were in non-radiation experiments without their consent, so I see this broadening. Then you run into trouble with the first part because that can also get fairly broad too, because if you don't want the burden of proof to have to be on the person who believes that they participate in an experiment without their consent, then that has to be a very broad definition. DR. FADEN: Again, what you say is right, but in this case, all we are talking about is an apology. Now, it gets more problematic when we get to the next one, but in this case, I think the inference is that anybody who is used as an experiment in any kind of research funded by the federal government, without their consent, should get an apology; I don't know that a whole lot of people are going to be upset about that, but it seems to me that that's clearly right. You know, that ought to follow from this, and it should be fine. I think -- DR. ROYAL: I'm sorry, because I'm going through the mechanics. DR. FADEN: Right. DR. ROYAL: Someone calls up the DOE and says: I call the hotline and says, I was involved in a radiation experiment. We're not suggesting, for example, that if they're not in our data base -- I guess I just don't understand what -- DR. FADEN: How a person would get involved. DR. ROYAL: How the experiment is identified, first of all. Then once it is identified, this whole question of whether adequate consent -- I mean, we're making it sound like -- DR. FADEN: This is just going to happen in the air. DR. ROYAL: This is not a problem, but it seems to me that it's an enormous problem. DR. FADEN: Well, I think if we can get the principle out, we can work on the mechanics between now and the next time and come up with it; because, you're right, there are all different ways you could burden. And the way it should be implemented is, at any suggestion, the government should then designate a bureaucrat who should be the person's personal investigator to track down whether, in fact, through traumatic extreme to the extreme of saying, if you can come up with the documents, Mr. Citizen, that you were in an experiment and that there was no consent, and you can show it to the satisfaction of X agency, you will get a personal apology from the President. You're right. The mechanics could range from being very resource-intensive on the part of the government to being very not resource intensive on the part of the government. DR. ROYAL: Not only that, in terms of whether or not the sincereness of the policy, it seems, sort of depends on how you do it. If you just say, well, send us a note, and we'll send you a note -- [Laughter] -- that doesn't sound -- DR. TUCKSON: E-mail. DR. ROYAL: -- very -- yes, E-mail -- that doesn't sound very sincere. DR. FADEN: These are all well-taken points. I've got Reed and Mary Ann. We clearly can work on that next level and have different proposals for the Committee to consider. DR. TUCKSON: I think, Ruth, I now see why you responded to me like that. I think if we could be free to just think principles for the moment and then knowing that agreeing on principles now gives us time to come back and revisit the mechanics of them, then I think we can feel more intellectually honest. At this point, I think it's probably too many -- DR. FADEN: What I'm asking for you, is if we can agree to this approach, between now and the next time, we'll work on -- and they'll be tough; deciding if we can agree about what to call adequate consent is not going to be easy. Then we can put out a range of mechanisms and the Committee can decide which implementation mechanism the committee wants to recommend to the administration, be adopted for this. DR. ROYAL: That's a great principle. DR. FADEN: All right. So everybody is all right with this, but Mary Ann still is not. DR. STEVENSON: I'm having the same problem as Henry. I keep trying to find the example in my head. I can agree with it in principle, but I almost feel like it could never have any practical implications, because when it gets down to it at the end of the day, how could you prove -- I mean, unless there's -- DR. FADEN: Well, you see, that's exactly why this wasn't there the first time around, because it isn't a very real time thing, unless you -- DR. STEVENSON: All right. It seems to me the only instance that it could actually hold up is if you found -- which we may well; we can. I can think of one instance, if we find government documentation that states consent was not obtained for X, Y, and Z. That's really the only case that it will ever hold water because it's a self-admission. DR. FADEN: You're right. So it may end up this way. Duncan and Ruth. DR. THOMAS: Earlier, Ruth had raised the Cincinnati TBI experiments as a test case, and I would be curious to know what her thoughts on this one were, but isn't this one instance where we have, after the study has been gone for, I don't know how many years -- six, eight years -- of internal review by the University, who recommended disapproval specifically because subjects were not informed of the 25 percent risk of fatality and morbidity and various other things? It would seem to me that that was one of our clearer cases. DR. STEVENSON: Actually, I think that's one of our less clear cases, if we get into the situation of what the government was funding. Under the strict letter of the law, the government was funding blood draws and urinalysis, in their mind, I think. I think that's an important thing that the Committee has to address is whether or not the government can get away, in essence, with drawing the line for their responsibility to just their portion of the piggy-back experiment, or do they have a responsibility to look at the entire experiment and decide what the ethics are, or whether they're ethically acceptable. I think in the strict letter of the law, the government consent would have been directed towards the government's experiment, which was blood draws and urinalysis, so it gets very complicated with the TBI. DR. FADEN: What I would like to do is, we will have TBI on the agenda again, as we go through it, and obviously now if we have these in place, we have a sort of reverberation between the implications of what we might conclude in this particular chapter for the remedy that would be. They are starting to emerge what we were struggling for, which is an interrelationship between the analysis and implications in the analysis as we work out the dynamics here. I don't want to squelch the conversation on TBI, but I think we ought to have it -- almost everybody has read the most recent draft and remembers the details, and some people have been working on that draft and some people have not, so I think it would be unfair for the whole Committee to take it on today. When we revisit it, we could be visiting in the light of what we're working on today. I take it that 1A is acceptable in principle, and both the mechanics and the guidance with respect to interpretation will need to be a major project between now and next time. We'll be circulating stuff for people to react to so that when we discuss this in May, it won't be as if no one has looked at it before. Okay, Duncan. DR. THOMAS: Lois had her hand up, too. DR. FADEN: I'm sorry. I didn't see her. DR. THOMAS: I just wanted to know whether she's still addressing the same question because there's one different point I want to raise before we leave it. MS. NORRIS: This is a very small thing, but under the rationale in a couple of places, and the same is true in 1B, you refer to respect for individual privacy. I'm not entirely certain that to a non-ethicist this would be recognized as a privacy question. To an ethicist, it may mean something; to a non-ethicist. DR. FADEN: That's helpful. The rationale here, I am not by any means entirely happy with. The key thing we're agreeing to, and this is not trivial, is we're saying an apology is relevant but we are not recommending compensation in this instance, in the absence of harm. That's a tough bullet to bite. Some people will feel it's not obvious. It's not self- evident. The rationale that's provided here is not as strong as, you know, talk some about it, and we will try to work members here and other people with whom we can get this straightened out. DR. MACKLIN: What if it said bodily integrity? DR. FADEN: Instead of privacy? MS. NORRIS: That means more to me than privacy does. DR. MACKLIN: Yes. It's the privacy of the person, I take it? I mean, it's not informational privacy. MS. NORRIS: That's what I concluded, but I had to work that out. DR. MACKLIN: Yes. It's the intrusion of the private space, but perhaps the words are better captured if we say bodily integrity; we are here talking about using people's bodies. DR. FADEN: Okay. DR. THOMAS: Mine I think is also a minor point. Page two, that paragraph, from 10 to 19, has some good language about the right of the descendents to receive an apology and not applying to compensation. Then it goes on, where there's a peculiar sentence on lines 16 to 17: Upon the death of the subject, dignitary harms would cease to exist. It doesn't seem to be the dignitary harms cease to exist; perhaps the rights to compensation cease to exist. DR. FADEN: We'll work on that, yes. DR. THOMAS: Page 2. DR. FADEN: Yes, I see it. Yes. There's a lot to improve in both the argument and the crafting of the language here, an infelicitous phrase. Ruth. DR. MACKLIN: Yes. I just wanted to go back. Yesterday, a few times I said what I was about to say wasn't controversial. Today, right now, what I am going to say is probably controversial. As a way of thinking about what's going to happen between this meeting and next meeting, and I don't mean mechanisms narrowly, but I mean a principle for thinking about the mechanics, how are we ever going to find out how are going to identify subjects, how are we going to know about the consent; I want to propose this way of looking at it. I'm using this legalistic language, so the lawyers will have to forgive me. It's a burden of proof question. The burden of proof for demonstrating that someone was a research subject should fall within the subject. That is, someone should have some evidence - - and I don't mean proof in the strictest sense -- some evidence and documentation, some reason to believe, something to put forward to make a claim, and say I or my family member was a subject. However, for consent part -- adequate or whatever language we choose -- the burden of proof should fall to the government or its contractors or the institutions. In other words, whether it's old hospital records, documents that talked about the research and how it should be conducted or whatever, just as today one would look to physician's records in order to demonstrate what is documented in the chart, even though we're not going to find a piece of paper that's an informed consent document. That we know, in virtually all cases. However, the question of oral consent or what one informs the patient, one might reasonably expect, could have been or should have been in the medical records or the charts. So I'm just making this a general -- I'm not talking about mechanics, so let me back off from talking about charts and records, but I'm talking about where the burden of proof should lie. DR. FADEN: I don't understand your use of the term "burden of proof," because for me that's sort of the presumption. Is the presumption that the -- DR. MACKLIN: The presumption is that adequate consent was not obtained. Unless the government or its contractors -- or how is it put in this language, the government or its contractors can demonstrate or show or indicate that a consent was obtained. DR. FADEN: All right. DR. MACKLIN: It's a principle. DR. FADEN: Yes, I understand. That helps me to understand what you're arguing. DR. ROYAL: Ruth, what troubles me about the proposal, it has the potential for devaluing the apology. Let me tell you why. If the government has the choice of Xeroxing the record, Xeroxing a letter and sending it out to someone or trying to find the medical records, you know what they're going to do. Fine. Send them a letter. DR. MACKLIN: Again, that gets to the whole problem of devaluing the apology. But maybe there's no concern about devaluing the apology. I appreciate that, Henry, and I think in a way that's right, but it goes to a deeper question of the value of an apology. I mean, there are apologies and there are apologies. Although I think you are right in making that observation, how would we know or what is the indication that apologies are deep and sincere otherwise? I mean, it goes to the question of how the apology is to be valued and the adequacy of that, but I think that's going to be a problem anyway, even though it may be a special problem if we put things in. DR. FADEN: Okay. I've got Reed and Nancy. DR. TUCKSON: First, I'm concerned if we try, at this moment, to cut these things too fine. I want to, first of all, celebrate the point she's making as being important. I still think it gets us over towards mechanics. If we could phrase for this part of the discussion, adequate determination, how ever arrived, that such a thing happened, the consequences ought to be the following. Because what worries me is that it's going to be hard enough I think to get agreement and consensus on the stepwide sequentialness of the philosophical constructs. If we caught into the subdetails, I worry that we'll never get agreement at the end of the day, and at least we ought to get the principle squared away. Even though Ruth says we're not a mechanics, if we could just keep it for the moment, it says, as best -- you know, you've proven it, how ever the best way to prove it is, the principle is the following. DR. FADEN: All right. I have a suggestion in line with what Reed has just said, and I appreciate Reed's backing me up on my need to sort of march through here. If we march through 1, 1A, 2, 2A in a timely fashion, we can then go back and begin the discussion and this kind of thing, and that would be great. That would be very helpful. My guess is we're going to slow down considerably as we move forward here, in which case we've got to use the time to see if we can't work our way through this because of the problems in getting the basic structure right. So get the basic structure right in a timely fashion, which translates into before the break, then we will come back. On the other hand, I thought your suggestion was extremely helpful. It gives me something to work with even if we never go back to it, because that is one way of setting up, and Henry's response points to the trade off. If we're going to have tradeoffs, how ever, whatever we end up suggesting for implementation of these, there will be tradeoffs, and the best we can do is articulate what you're trading off, if you go one way or the other. Ease of getting an apology against the significance of the apology in this, and the Committee will just decide which trade off they think is the best trade off, all things considered. Great. Now we're into 1B. 1B is what used to be 1, and is the situation where the government took steps to make information not available with the consequence of making it difficult or impossible for people to seek redress for a wrong they may have experienced. The difference here is, the argument is, essentially because of the cover up, compensation is now appropriate, whereas, previously it was not. Moreover, the recommendation is compensation, we're down to surviving family members in the case of the death, precisely because the person couldn't have sought compensation during her lifetime. Okay. I've got Ruth, Reed, Duncan. Ruth. DR. MACKLIN: Coverup. The language of coverup seems to imply an after the fact attempt to cover up. Is this meant also to encompass prospective secrecy -- DR. FADEN: Sure. DR. MACKLIN: -- or prospective -- DR. FADEN: Sure. It's -- DR. MACKLIN: Right. I think it should be clear that it's prospective or retrospective attempts to keep it secret or not to have it be discovered. DR. FADEN: Sure. The whole idea is that it's kept secret from the person who otherwise has a right to know. The person, him or herself, who was the subject. Thank you. Cover up was just shorthand. DR. MACKLIN: Yes. I just think it should be explicit -- DR. FADEN: You're right. DR. MACKLIN: -- that it's prospective and retrospective. DR. FADEN: You're right. You're right. Reed. DR. TUCKSON: I guess now I'm going to get caught in my own dilemma about the mechanics. [Laughter] DR. TUCKSON: Now I'm really in a dilemma. The issue is -- and let me just again say I am trying to think this thing through. DR. FADEN: Sure. DR. TUCKSON: I don't have this yet. I wondered, as I looked at the various hierarchy of response, that this notion of going straight at this point to compensation as a way of expressing a higher level of outrage and condemnation as opposed to how do people view the notion of other expressions of higher forms of outrage and condemnation as in, literally, instead of giving the apology you say, the agency screwed up. In other words, it's was wrong done. There's a clear sense of saying that there were people who behaved poorly. Whether it's a generally named group of people or, where it's known, an individual person named. Is there a way of saying to that agency there is a -- and this where I'm caught -- that through some administrative responsibility to facilitate the relationship who feel wrong, that by interacting with them, which has associated with it a cost, which tries to address their opportunity to redress or petition or conversation or records or whatever, which has its own cost, therefore causes a disincentive for others to want to do it again because there is an expense associated with it. DR. FADEN: This is important to get out. You are quite right that the situation, too, is intended to signal that this is worse. On the scale of wrongness, this is worse, and we want to express that in our recommendation for how the government ought to respond, and we could consider alternatives to compensation or additions to compensation. DR. TUCKSON: Let me rephrase it this way, then, just so I can get off the sword. I did like Ruth. I got too detailed about the records like she did. Let me just say, in a general philosophical discussion, causing more, being able to specifically designate with greater specificity badness, how ever we do that, and some implied sense, how ever the mechanics worked out, of administrative responsibility to deal with such persons, which implies some inconvenience to the agency, without getting too detailed about what that means mechanistically. DR. MACKLIN: Could I clarify by asking if it's just a -- DR. FADEN: Yes. DR. MACKLIN: -- could we put this under the heading -- I mean, the way this is focused and the way these remedies are focused is on remedies for victims. I think what Reed just said falls into a different category, which is blame or burden imposed on agencies. DR. FADEN: Right. DR. MACKLIN: So it's another category. It doesn't give anything more or less -- it may not give anything more or less to the victims, but it imposes a burden, because I think we did something about deterrence so people won't act that way again, so it's a two-pronged thing. It isn't designed to give a benefit of some sort to the victims and also, in some way, to burden those who are culpable. DR. TUCKSON: She's accurately summarized it. DR. FADEN: I think, though, it's importance to recognize that from the perspective of some people who would see themselves as victims or their family members, if you think of this in a general ordinary sense of justice being done, that this is doing something for the people who have been wronged, and sometimes what people want most is that the people who have wronged them be somehow -- DR. TUCKSON: Accused. DR. FADEN: Punished. If something should happen to that agency or person who did this to me, so there's a way in which it's -- it's the ordinary sense of justice, justice being served. It's the concept behind all of the victims rights bills, that you have a right to pronounce, make a recommendation to the judge of what the sentencing should be if the family member has been harmed and the person has been convicted. Then you're asked as a family member to say what you think should happen to that person. It's all part of society's attempt to give the victim some sense that justice has been done by doing something appropriate. I don't even know that I want to make it one is for the victim and one is for the whatever, but it's all of a piece, but it's right to identify the particulars in different ways. So this could either be alternative or supplemental. You could either say compensation and some sort of direct something at the agency or agent responsible for the cover up or the remedy ought to be justice. DR. TUCKSON: I'm curious, like the other members of the committee. I'm putting it out there. Again, I want to be very careful for the transcript and also just because I've had enough reporters already calling me trying to presuppose what people are thinking, so I want to be very clear in these public meetings. As an individual person, I am struggling to think through, so I am not making a recommendation. What I am asking is a question. DR. FADEN: Like other people feel. DR. TUCKSON: I'm saying, can we think of it right now -- I'm suggesting us not going straight to compensation at this level but a step before you start going to financial compensation. DR. FADEN: All right. Duncan, you were next. Is it on this point, because I thought Mary Ann -- DR. THOMAS: It's other points. DR. FADEN: All right. How about reactions to Reed, then we'll do Duncan. I've got you, Mary Ann. Eli, are you on this point? DR. GLATSTEIN: Yes. I think the idea is very good, although I think there's a bunch of problems with this one. First of all, from the standpoint of a person who has been wronged, I think you want the range of reaction for the bureaucrat to go all the way out to public execution. I think also, in many instances, the person who is responsible for this coverup, whether retired or died, and somebody else pays the price, so it's the wrong person being -- the wrong individual, at least, being pressured, although I suppose that's better than no pressure at all from the standpoint of the victim. I'd like at least one more step in between compensation and apology, and I think this is right conceptually, but I think it's got a lot of headaches with this one too. DR. FADEN: And there would be the issue of what the -- I'm thinking, in my mind, I'm using the language of some sort of censoring of the agency or the bureaucrats responsible for the cover up, for lack of another word. That's my place holder for this at the moment. Ruth. It's on this point, I gather? DR. MACKLIN: Yes. Yes. I want to argue for -- I guess this is a follow up of Reed's -- for retaining the compensation part regardless of what goes on in the censure or other category. The reason is, what this situation is saying is that because of the secrecy or the cover up, people were denied what might then have been or become a legitimate claim and been able then to have some redress. So if we deny them the compensation now, we're saying, well, they were denied it before, and we're saying, ahh, it's not even important to give it to them now. I think the very point of why it was worded like this was precisely that they were denied an avenue, the secrecy or the cover up denied them an avenue that otherwise would have been open to them, and not to recommend compensation now, would be to continue to deny them what they were originally denied, which is why this was a serious wrong. I argue for retaining the compensation. DR. TUCKSON: Can I, Ruth, on this? DR. FADEN: Sure. DR. TUCKSON: I like what Ruth is saying. Again, back to the mechanics for just a second. What I meant to imply by the administrative responsibility was a facilitation of the processing, because once it's been covered up and now you can start to show that that was covered up, then that administrative agency has the responsibility for facilitating all records and so forth and so on, such as the person can pursue their grievance in the appropriate places. I think, and again, we really are again mixing the philosophy with the mechanics, but I agree with Ruth, and where we may disagree -- well, at least for this analysis, perhaps. Where I agree is that there definitely ought to be some responsibility for facilitating the individual, to be able to get their own sense, to pursue their own sense of what they're entitled to through the legitimate mechanisms. Without, I'm saying and I think she is saying also, there should be a dollar figure associated with that a priori of the legal investigative training events. DR. FADEN: Let me see who's on this point, because I'm still holding Mary Ann and Duncan on other points. Henry on this point; Nancy on this point, and did I see either Sue or Lois on this point? MS. NORRIS: No. DR. FADEN: Henry and Nancy. DR. ROYAL: Yes. I'd like to hear more of Ruth's argument about compensation, that they might have been entitled to compensation had they known. As I understand this category, it says highly unlikely to have been harmed, so presumably the compensation had to do with the consent side of it not the harm side of it. In Situation 1A, we're also saying that those people did not have adequate consent. I assume that the reason they did not get compensated, if they were entitled to it on the basis of adequate consent, it's just that they didn't understand what the rules were and that they might have been able to be compensated for it had they known the rules and had they been able to fight for their rights then. I'm having a little bit of trouble understanding why 1B gets compensated for a violation of their rights of not getting consent and 1A doesn't. DR. MACKLIN: That's a good point. I guess what I'm thinking, and I don't know, because we have to think counterfactually what would have happened, and I'm really out of my element to say what would have happened. If the premise is -- and maybe it's a premise of what you're saying, Henry -- that people never get compensated unless they're harmed, then I'd have to accept this. If, on the other hand, there are times when people get compensated if they can show that their bodies were used for some other purpose, and even though there was actually no harm, people were injecting plutonium into them and they might then be able to show, or would get some kind of a response from a court or some form of redress that would compensate people even if there were no harms, but if their bodies were used egregiously -- see, this is counterfactual. DR. ROYAL: I'm not against compensating 1B. I just didn't understand the thrust of your argument because the thrust of your argument seemed to be related to their inability to have gotten compensation at the time. I think 1B can be compensated just because of the cover up itself, that that is an additional harm in and of itself. DR. FADEN: If I could, if you look at the text on page one, that's how it's justified. Be mindful of what -- Nancy just let me know that her point was the same as Henry's -- mindful of what Henry has just identified; the rationale provided here, that the major point is on lines 14 and 15: The offensiveness of the coverup by the government warrants a remedy of compensation. It's not the argument that they could have gotten compensation before or at least they should have had a crack at it. Now, you could add that on the grounds that, look, at the time, it would not have been known if they were going to be harmed or not, so there's a subtlety that could be introduced there; if someone in 1954 had found out about this, and sued and been before a jury, if you think about it would have not yet been established if they had not been harmed, and the powerful impact before a jury of saying we don't know what's going to happen to this person. This person has to live with this horrible thing of knowing that the substance is coursing through their veins, blah- blah-blah-blah, it's conceivable -- it's certainly conceivable -- that they would have gotten an award of something, because the harm issue would have been unresolved, and so I think we can strengthen it by saying that they had contemporaneously an opportunity to seek redress before the verdict was out about whether harm was, in fact, was going to happen or not, they might well have received some sort of compensation. That would be an additional bolstering argument. DR. MACKLIN: Actually, lines 15 and 16, just after the ones you read, that sentence doesn't speculate as to whether or not they would have received compensation but they were denied the opportunity to seek redress. DR. FADEN: Right. Right. DR. MACKLIN: That's the justification. DR. FADEN: The reason why I think you've got to land on the coverup, but that's not the main justification, though, because there's a way in which the people in the first category - - Dan and I have kicked ourselves over this one and Jack and Gary, because all those people in the first category probably couldn't have known either, even without an explicit attempt to hide the fact, which is where Henry's going; even without an explicit attempt to keep secret the fact that this was going on, it would have been pretty hard in some cases for people to have figured out what was happening to them just because of the culture at the time. When you go to lines 17 and 18, the rationale goes further and says, look, there's just something -- in addition to the sought upon, the whole policy itself, the government intentionally kept information from people on purpose. Even if the purpose wasn't to prevent suit, to manage public relations, is something that the government shouldn't do. It's an assault on all of us, and we want to signal that to the government, that that's outside the bounds of what we expect from a civil government, in any respect. So it really is turning more on the cover up than the denial of opportunity to have sought redress. That becomes like a secondary justification, because if you start thinking about it too much, the people in the first group, similarly, could argue, how could I have known. In the culture at the time, how could I have known that that treatment wasn't a treatment but a research treatment or something. I don't know. Where are we on the situation. Mary Ann and Duncan, are you on Situation 1B? DR. STEVENSON: Yes. DR. FADEN: Okay. Mary Ann. DR. STEVENSON: My point certainly becomes on-point a little bit. I'm just wondering whether or not we want a temporal or conditional qualifier for the word "coverup" because it doesn't seem to me the committee has yet reached a consensus of whether or not national security interests could ever override. Do we want to put some kind of qualifier? DR. FADEN: Do you want a qualifier that says an unjustified keeping the secret? DR. STEVENSON: Right. Or for a short time for national security, and we haven't decided what we think national security interest is, so it's even more difficult than that. Have we reached a consensus that we could never allow that under whatever past or future national security incidents might occur. I'm just throwing that out because I think we have to discuss it. DR. FADEN: Well? DR. ROYAL: The obvious example is the Green Run. DR. STEVENSON: Exactly. That's why I think there needs to be a temporal qualifier, something that -- you know, there may be a -- DR. FADEN: I think it's some other kind of qualifier that you're wanting. Not temporal, but it's an important one. DR. STEVENSON: Temporal to some degree, because it may be okay to keep it secret for a while but for 50 years. DR. FADEN: I see what you're saying, so that you're defeating -- DR. STEVENSON: It sort of has to be defined as a true national security interest and at a time limit. DR. FADEN: Only kept for the time period that it's necessary to keep it. DR. ROYAL: So maybe justifiable? DR. FADEN: That's what I'm struggling for. I now understand the course of the temporal that surely a national security interest couldn't go on -- DR. STEVENSON: For 50 years. DR. FADEN: -- forever. DR. STEVENSON: Right. DR. FADEN: So at some point, in other words, if they say, we can't tell you it was plutonium during the war -- DR. STEVENSON: Exactly. DR. FADEN: -- later on, when we're coming to get your body samples and the war is over, plutonium is not classified, but we cannot tell you. DR. STEVENSON: Exactly. DR. FADEN: Okay. That's going to take some craft, some thinking through about it. That's important. Does everyone agree that we need something like that? DR. ROYAL: Yes. DR. FADEN: Okay. Duncan? DR. THOMAS: Yes. That was one of the three points that I wanted to make. I was also picking up on the subtle wording change from what I remember to be the March draft where it said: Government officials covered up the incident for the purpose of preventing people from seeking redress. That latter qualifier had disappeared in this draft, and I was just wondering whether that was conscious or not. DR. FADEN: It was conscious because there was a discussion of well, what if it had been done for public relations purposes, not for litigation, still not right? DR. THOMAS: Right. And then there was the national security question. DR. FADEN: Right. DR. THOMAS: Based on yesterday's discussion, I figured we probably had actually decided that even national security wasn't adequate. DR. FADEN: No. That was not -- I think it hadn't cut through well enough. DR. THOMAS: Right. DR. FADEN: Now the issue is reemerged, and we're saying, theoretically, there could be a justified national security, but it would be tightly constrained and would have to be very special, and only for the very short period of time that it was necessary, blah-blah-blah-blah-blah. But, you know, the problem with that is it implicitly is saying that we are agreeing that there will be, that there could, in theory, be an instance in which it's okay to use a person without their consent. DR. STEVENSON: Right. DR. FADEN: I'm not so sure that we are ready to say that. DR. STEVENSON: Right. We have to discuss that. DR. FADEN: We need to think about that. DR. STEVENSON: That's why I raise it. DR. FADEN: We can either do it now or maybe we should do it -- in other words, the structure of this recommendation can stand a decision whether or not to add that qualifier, turns on whether this committee wants to conclude that we want to allow that there can be a circumstance in which it is justified on national security grounds, to use a person without their consent and knowledge and keep it from them, as a research subject. DR. ROYAL: The big area where that's going to happen, both literally and figuratively, is with environmental releases. DR. MACKLIN: Exactly. DR. STEVENSON: Sure. DR. FADEN: If you think of the people as research subjects. Arguably -- DR. ROYAL: Well, at least they are in our package. DR. FADEN: They're in our package because the charter gave it to us, not because of any -- we've already identified -- DR. ROYAL: You said yet another option would be to say that they weren't an experiment. DR. FADEN: Right. The Green Run was an experiment but that they weren't subjects of the experiment. They were people affected by the experiment. They were not subjects of the experiment. DR. ROYAL: I see. So it actually does say that: subjects in human radiation experiments. DR. FADEN: Right. It would be one way of conceptualizing the intentional releases unless that was the whole business and the debate and the discussion and the intentional releases is, was part of the intentional release -- research part of the intentional release to study human health effects, or responses of humans. If it's not a research project, whose research questions include how the human beings are affected by this, then the human beings are affected but they're not subjects of the research. They may be harmed by the research, they may be benefited by the research, but they're not subjects of the research. You say the Green Run was an experiment, but not a human experiment. It was an experiment that didn't have human beings as subjects, but where human beings were, in fact, affected. DR. THOMAS: You may recall that last time we decided to pull out the intentional releases and have a separate category of responses for them and that this first batch of recommendations was just for the biomedical. DR. FADEN: So if we return to this biomedical, the issue that Mary Ann raised and Duncan was going to raise as well, I think it's a big discussion, and that we should either come back to it or not, but then realize the way we decide that general thing will affect whether we want a clause in here or not. DR. MACKLIN: About the national security? DR. THOMAS: We need an entire discussion on this. DR. FADEN: In the future we say, if it's conceivable that there might be a justified instance doing all of these procedures and protections, but we want to say that there might be a time in which it's okay for the government to use human subjects without their consent and keep it secret from them for national security purposes in a biomedical experiment. Think about biological warfare experiments in the future, now or whenever. Then if it's going to be all right in the future, arguably it might have been okay in the past if the circumstances had been right. DR. GLATSTEIN: See, I'm not sure I wouldn't want to take a very strong position on that and say -- DR. FADEN: No. DR. GLATSTEIN: -- say bloody no, and make it damn clear that the committee -- DR. FADEN: That's what I'm saying. DR. GLATSTEIN: -- doesn't want to have that. DR. FADEN: I think that's why I'm saying it's a big issue. If the Committee says no, we don't think that's ever permissible in a civil society, period, end of story, then you don't need an exception here either. DR. MACKLIN: Right. But the trouble is, you've got an "and". You've got two parts of it. Is it ever acceptable for the government to use people without their consent as subjects -- DR. FADEN: Oh, I see. DR. MACKLIN: -- and keep it secret or cover it up. Let's just look at the first half of the clause because that's really the operative one. Even if we decide that, for national security reasons, it is permissible for some period of time to keep it a secret, it doesn't follow that we are endorsing using the subjects in the first place because, in fact, that's what Situation 1A is. DR. FADEN: Right. DR. MACKLIN: In 1A, we are saying these people were wronged, no harm, and no secret, no coverup. DR. FADEN: And there's no national security. DR. MACKLIN: Yes. So maybe we need to say right up front something like this, but just because we put in the clause about the national security, it doesn't follow from that that we say, well, it was okay to do it in the first place. It was still wrong to do it in the first place. The question then becomes, what about keeping it a secret during the period once it was done for this period of time, as Mary Ann is saying, for national security reasons. It may require us to say right up front, though, using people without their knowledge or consent for biomedical experiments, for whatever purpose, is wrong. DR. GLATSTEIN: Yes. DR. FADEN: All right. I think that what we should do is -- and we don't have all of our Committee members here -- this may sound simple. I think it's such a big issue and we have to get clear on what the position is on that. We should try to do it when we have everybody here, or as close to everybody here; get out there, and that can sort of begin the whole deal and spell out the implications of what that means. Duncan, you had two more points? DR. THOMAS: Yes, I had two other points. The first is, I'm still having difficulty with some of the subtle nesting of the alternatives here. I see it reflected in two ways in this one. First of all, this recommendation doesn't use the word "apology" anywhere. So the implication is that 1B is a special case of 1A, and that if you default here, you're still entitled to the apology which you would get by virtue of being in the larger set, 1A. That needs to be made explicit either by saying that this is a special case or by adding the word "apology" in here. DR. FADEN: Sure. DR. THOMAS: Similarly, 1B excludes those people who were harmed. The implication again being, if you were harmed, you are then entitled to whatever you would get under Recommendations 2A or 2B. If you're harmed but you can't prove that you didn't give informed consent, you fall into 2B; you, therefore, are only entitled to coverage of your medical expenses but not for your harms, which you might otherwise have been entitled to. You see the problems I'm having? DR. FADEN: Yes, I see what you're saying. This is where I started working out all of the different things, and we're going back to that 16 to 20 different situations and scenarios. One way would be to say: If you have been both -- and I know Ruth is right not to use the word "coverup" -- but for a shorthand, whether it's prospective or retrospective, if you or your family member was used without adequate consent and there was a coverup, and you were also harmed, you could have a choice between -- you could put yourself in 1B. Harm is really irrelevant here, if that's where the greater compensation came, as opposed to whatever it is. DR. THOMAS: I don't think they should be asked to choose. I think we should make it clear that these aren't mutually exclusive alternatives. DR. FADEN: Or they can get both. DR. THOMAS: So what this one addresses is coverup, and if you fall into this category, you get this remedy. DR. FADEN: Regardless. DR. THOMAS: But it is not denying you any other remedies which you might be entitled to under the other. DR. FADEN: Okay, fine. And what it should say is, were not harmed, regardless of where their harm was. DR. THOMAS: That's right. So you just strike out that. DR. FADEN: Just make it regardless, so that either way you can claim yourself under 1B if there was a coverup, regardless of whether there was harm, there wasn't harm, it was likely harm. Thank you very much. DR. THOMAS: The other point I wanted to make relates to the rationale, and I commend the crafters of this one for their ringing language and the paragraph that starts on line 17. DR. FADEN: Unfortunately, these were not numbered sequentially, which is a problem. DR. THOMAS: I strongly endorse the premise in lines 17 to 19, and I also strongly endorse the conclusion in line 20, but the word "therefore" implies there is sort of a logical connection between the premise and the conclusion, which is not immediately obvious to me. DR. FADEN: Yes. DR. THOMAS: Also, while I'm at it, let me commend the drafters for their ringing language at the end of the last one. DR. FADEN: Ringing. Thank you. Several hands. I guess there are usually several hands in every document, and more than one committee member has done something on almost everything you get. My sense of the Situation 1B, I don't have resolution on the issue that was rebrought to us about whether we want to pursue, as Ruth put it, a direction that looks towards -- I'll use the word "censure" of an agency or not, as something to be included under the coverup situation. Is there an interest in pursuing that? There is an interest in pursuing that? Should we then, just between now and the next meeting, try to think of what that might look like and if we're working at implementation kind of things, can we have proposals for what that might mean? DR. MACKLIN: We need a rationale, though. DR. FADEN: Too. Yes. DR. MACKLIN: Yes. The rationale seems pretty straightforward. That is, in several places, including here and elsewhere, we talk about deterrence. We want to be making the point in this whole report that secrecy in government is a no-no. To hide behind it or to get away with it on the kinds of grounds that have been used, with this exception of our category of genuine national security, which we'll probably have to come back to; but for all these reasons, the liability in the public relations is just not acceptable in a free society. DR. FADEN: So we need a rationale for censured deterrence. We need the implementation stuff, alternative implementation stuff for all of these, so that wouldn't flow through that as well. The national security issue will be pulled out and treated separately with the proposal that the committee endorse that there be no justified exception for research without consent in the biomedical context, and we can debate it, make sure we really think hard about this. We'll also run it against Wilhelmine and just check to see whether what all the current regulatory constraints are, and looking to see how that concords, whether the implementation of that recommendation would remove any exceptions that exist in current statutory authority for agencies, to see what it would -- where that stands against what the law is, so we can know what the practical implications in the reg are. Maybe that's already law. DR. MACKLIN: Would that be in the Code of Federal Regulations on use of human subjects? DR. FADEN: I think it might more have to do with specific provisions of agencies that might be thought to do such work. Might have. So are there any exceptions that the CIA has, are there any exceptions that the DoD might have, or the DOE might have to the applicability -- now this is something that Wilhelmine has been pursuing and I think we sort of know the answer; but let's put it together in the context of such a recommendation. Does the secretary of the particular department have some authority to waive the applicability, which is a separate issue from the question of whether you can have classified research. So we're going to work on that one, and in the case of this -- am I hearing that there is general agreement that in situation 1b, compensation is okay? That the proposal, the sort of practical proposal for compensation D, either -- in addition to the apology and with Duncan's very correct changes so that these are not mutually exclusive and people who could fall in more than one category could claim. Reed, do you still want to think some more about it? DR. TUCKSON: Yes. I'm not there yet. DR. FADEN: Okay. DR. TUCKSON: I think I'm going to have to -- I'll be able to get there as I go. DR. FADEN: I think one or two things should happen for people who aren't there yet, try to formulate what your concerns are so that the rest of us can hear it and perhaps we'll all move that direction. One way or the other. So I'm taking that, there's a sense that most of us present are comfortable with this; obviously we don't have everybody here and Reed wants to think some more about it. So that's where we are on this one. Can we move onto 2a, then? Since these are short, maybe it would be worthwhile taking a minute to read the rationale. MS. MASTROIANNI: I also wanted to mentioned a typo in here which we sent around. It mentions situation 3 and it's really intended to be 2a. So in your reading, it shows up in two places. DR. FADEN: The first, line 18 it says 2, it should probably should be situation 2a. MS. MASTROIANNI: Right, and page 2, line 1. Should be situation 2a, just so we're not confusing it. [Pause] DR. GLATSTEIN: I have some troubles with this one. DR. FADEN: Okay. Let's start. Has everybody had a chance to read it? DR. GLATSTEIN: I think there are various ways in which the government has sponsored research. Some of this is NIH pure research, where we are supporting the work of individual investigators. The primary link to which the individual is exposed is a doctor-patient relationship with the individual physician at the institutional level, not the government. And I don't think it's right that the government should pay for medical expenses in that sort of situation. Some form of compensation is appropriate, I think, but I'm not sure it should be governmental. I think that's passing the buck, and I don't think it's really where the link should occur. Now some of these investigations are sponsored by non- peer reviewed things, DOE and DoD, where the purpose is to generate information in some instances, at least, that will be used by the government. Maybe there it's okay, but for NIH-sponsored work, I don't even see that that's the right connection here. And I am very concerned that this could be used as an argument to reduce the NIH budget. And that's certainly something I don't wish to see at all. DR. MACKLIN: I just want to understand what the relationship is between your argument against the medical expenses and the conditions under which this occurs. They were used as subjects of research without adequate consent, and they were harmed. So we have here a worst category that we've been discussing so far. DR. GLATSTEIN: That's true. DR. MACKLIN: So you're not questioning, clearly -- DR. GLATSTEIN: It's where does the responsibility lie? For peer-reviewed research, and I'm questioning whether the responsibility lies at the governmental level; I believe it lies at the individual investigator at the institutional level. DR. MACKLIN: What's the relevance of the peer review part of your statement? DR. GLATSTEIN: Because it has been reviewed by several people who were trying to look at this from a broad-based point of view, of making sure that what has been done is reasonable. DR. FADEN: How does that speak to the issue of consent was not obtained, or adequate consent was not obtained? DR. GLATSTEIN: Because at the time that consent wasn't obtained, then the standards were still thought to be appropriate. I mean, we're trying to make retrospective judgments here, which I think are complicated and on this particular subject, I've got some problems. As we get closer to today, it's one thing, but going back 30 or 40 years is a real bag of worms here. DR. MACKLIN: Eli, can we just for a moment separate -- I know what your model is which is what leading you to say this, and it's the NIH model. What about the DOE and DoD or the AEC studies of 40 years ago? DR. GLATSTEIN: As I say, those are different, because those things are designed to generate information. DR. MACKLIN: Well, so is all research. DR. GLATSTEIN: Yes, but the information being reviewed at the NIH level is basically oriented around disease. Not normal controls, not normal people in for a variety of purposes. I think we've got apples and oranges together here under the same heading, and that's the basis of fruit cocktails. I think we're mixing things up. DR. MACKLIN: Well, when we look at the contemporary research, and our research -- DR. GLATSTEIN: Oh, there's need for improvement; I don't wish to argue that. DR. MACKLIN: But those distinctions get blurred; that is, they're peer-reviewed and they're sponsored by the DOE or the DoD. DR. GLATSTEIN: Personally, I take the point of view that DoD and DOE shouldn't be doing medical research. [Laughter] That's a different issue, but I understand it that way. DR. FADEN: But the fact is they are. DR. GLATSTEIN: They are, indeed, and I wish they weren't. DR. FADEN: Okay. Can we get other reactions? This clearly didn't show up the last time, for the reason that you see it in the second paragraph. It seemed like we had to figure out what we thought about this in order to get to what was old to you. Henry? DR. ROYAL: I like the principle, but despite all of the admonitions, I'm going to talk about a better understanding, what the implications are. It seems to me the hard part of this is the harmed part, because not only is there a sort of severity of harm, there is the probability of harm. So I'm having a hard time, but that's going to come during the implementation stage. DR. FADEN: That's going to be a problem if we want to offer anybody -- that's the thrust of the last paragraph in this sequence after 2b, is the recognition to capture the --. It's the second page two you're going to reach in this, it's a thing called: Note on Causation. I was trying to capture that discussion last time with the help of others, that if we're going to give anybody anything based on harm, we're going to have to come to grips with this probability causation issue. So either, the choices are, and this is where I think Duncan was pushing last time -- either you just conclude "forget it. It is so impenetrable that we're not going to give anybody anything based on harm," because of the causal issues and the probability issues, and moreover, the value judgments about where to draw the line and how much evidence of causation or how strong an association. All that is, you know, the rational mind cannot deal with it. If you take that deal and we throw out any structure in which compensation is linked to harm, and just say forget it -- or you've got to come to grips with it. DR. ROYAL: Let me express my concerns in a slightly different way. I can imagine an experiment that's done without adequate consent easily enough. I cam imagine an experiment that results in harm, let's say death, easily enough. I can imagine one experiment that results in death where adequate consent was not obtained, where the experiment itself in terms of its risk-benefit ratio, its scientific value, its importance justified doing the experiment. DR. FADEN: But without consent. DR. ROYAL: Yes. I'm saying that there are two different types of experiments that could result in death. DR. FADEN: A bad accident. DR. ROYAL: One experiment is, which I've described, and I'll just for shorthand, go to legitimate scientific experiment. And another one might be poorly conceived, and I think that has to enter into it somehow. DR. FADEN: Well the issue is, and this may speak a little bit to Eli's, whatever fortune you want to have on the peer review, but the issue is there, even if it was -- you get into the means-ends problem, the ends justified the means. You've got to turn back to the fact that consent was not obtained, or adequate consent was not obtained. So even if it's a perfectly wonderful scientific study that really needs to be done, that has a very good chance of advancing the field in a way that hundreds of millions of people will benefit in the future, you still have the problem that the person was used without consent or without adequate consent. And does it make a difference, because the prospect for humanity's benefiting is greater in the good science because the bad science; but it's more less awful or more okay to use somebody without consent because the science was better. That I have problems with. DR. ROYAL: That all sort of hinges on what our definition of adequate consent turns out to be. DR. GLATSTEIN: Sure does. DR. ROYAL: If our definition of adequate consent is quite liberal, then I agree with you, we're quite strict. DR. FADEN: If you went to no consent. Let's take the most egregious situation. If it's no consent. DR; ROYAL: I agree. Absolutely. DR. FADEN: There's a study out there -- we also have the option of separating this and saying at situation 2a the showing must be no consent. You can always do that; or you say the adequate consent really has to -- it will be here defined as consent that bears no basis to the actual risk through the nature of the experiment. "Yes, Doc, I agree to this operation" and that's it. Either no consent or consent that's totally, with a conception of what the person is consenting to, bears no family resemblance to what in fact the person is getting to. So I'm not suggesting it, that you could even have a mechanism where you changed your definitions, so you could try everything. But the point is here if you make it no consent, I don't care who funds it, Eli, I don't care if it's peer-reviewed; I don't care what. If you've a study out there, I don't care how good the science is; my own personal view is if you had a situation where somebody was used without consent in an experiment and they were harmed, they ought to get something, and they ought to get it from the government if it was government-funded research, even if it was mediated through and ultimately an interaction between a doctor and a patient. Now what I think I'm hearing Henry say is that we shade away of the egregious case of no consent. How we would be feeling and how would this play out, as a practical matter. Eli. DR. GLATSTEIN: Hard for me to conceive of somebody who is going to go through one of these major treatments without having some idea. Some kind of assent, verbal or otherwise. I don't know how long it's been since people went to the operating room without having it done for them, without having a signed consent. DR. FADEN: Plutonium. DR. GLATSTEIN: Well, at one time obviously they did, but I don't know when that was. DR. FADEN: A long time without a surgical permission, yes. MR. GUTTMAN: Certainly with radiation treatments, it's been 30 or 40 years since -- DR. FADEN: But Eli, that's exactly the period that includes the period we're talking about here. You said 30 or 40 years. Now again, it may be that for the kind of research you're thinking of, maybe the situation, if it's restricted to no consent, is a null set, I don't know. DR. GLATSTEIN: Let's assume somebody has a poor consent. DR. FADEN: All right, now we're going to the tougher ones. DR. GLATSTEIN: They have something that was said. Probably couldn't document it. Patient is treated, patient benefits. Cancer goes away. DR. FADEN: And then they die later. DR. GLATSTEIN: Thirty years later that patient comes up with radiation-induced cancer, in the radiation field. The patient is 30 years older, probably wouldn't have been without the treatment, probably. I'm just saying, there's no question that patient's been harmed, but that patient has also been benefitted. DR. FADEN: You have to have language in here -- DR. GLATSTEIN: Now you're getting into a very complicated issue. DR. FADEN: You'd have to have language in here. I don't know, but I think you can respond to that. But you had mentioned this before, and I agree that it's a problematic issue in therapeutic research. But I think there's a way to -- DR. GLATSTEIN: Well, it's the therapeutic research that has the biggest risk associated with it. It's the one that's associated with the greatest probability of having a serious complication. I'm not anxious to see that kind of research undercut, and have that being used as a pretext for cutting the NIH budget. I can see how that can be manipulated, and I'm not anxious to see that at all. DR. FADEN: I see Henry wanting to say something, Sue wanting to say something, and then welcoming everybody else to join the discussion, this is very tough. Henry, did you want to say something. DR. ROYAL: Yes. The net harm is an interesting issue not only for the individual but for all of the experimental subjects. You can imagine a study that benefitted 50 percent of the people greatly, and also harmed 50 percent of the people greatly, and that would be very different in a study that -- DR. FADEN: Everybody. DR. ROYAL: Everybody. DR. FADEN: Or harmed some people and benefitted someone. DR. ROYAL: There's something about net harm that's important. DR. FADEN: There's also the course of the consent. If it's no consent, even if it benefits some people -- DR. ROYAL: No consent is the easy -- DR. FADEN: Is everybody okay with no consent? DR. GLATSTEIN: No consent is not a problem. DR. FADEN: Let's start with that. Is everybody all right with 2a if it's restricted to no consent, the pure use of a person. DR. STEVENSON: I guess I struggle with the mechanics. If you don't, I mean you have to be able to prove there was no consent. By documentation. DR. FADEN: I don't know; we'd have to get that through. We'd have to -- that's the burden of proof question; how much would you have to show to show that there was no consent. This is crafted to be tough; I mean this notion here is presumably the burden of proof would be on the person trying to show that there was no consent. It means we're talking about giving people money. Whereas the next one relaxes the presumption with respect to evidence concerning the consent issues. But you're right. So Mary Ann, you're saying that you would have difficulty if it was no consent, if all you had to do is say in other words, "I had no consent." DR. STEVENSON: Exactly. DR. GLATSTEIN: Well, I have trouble with that. DR. STEVENSON: I think, to be perfectly honest, that's going to be the largest category of people that I deal with, because it's a verbal consent, no consent, if there's no document, documents or anything, complete, lost or otherwise -- it means no consent. MS. NORRIS: And able to show harm as well. DR. STEVENSON: Right. That's easy to do. Although not entirely easy, as Eli was pointing out. DR. FADEN: We'll again work on the mechanics, but what I'm hearing is, it would have to be a tough standard to show no consent in order for people to feel comfortable with this. DR. STEVENSON: Sort of related to that, but not entirely, the language seems to explicitly not mention benefits going to family. Although in the narrative, they talk about the MKULTRA experiments -- DR. FADEN: In the case of death. DR. STEVENSON: Right. But that's not in the language. DR. FADEN: So we have to make it clear. DR. STEVENSON: Or decide whether we mean that. I mean, if it's not going to go to family, and most or many of these patients have long since been deceased, then the whole discussion is kind of a moot point because there's no one to receive the benefit anyway. But if it does accrue to family, then it is extremely important. DR. FADEN: All right, so we're going to make it explicit, and certainly if a person died as a consequence following the analogy of the Olson family's experience, and there was no consent, we're saying the family members should -- DR. ROYAL: But died when? DR. FADEN: As a consequence, which is what happened in the Olsons -- as a consequence of -- if the research-related injury is death. DR. ROYAL: I think you run into Eli's problem about that -- DR. FADEN: Well, you run into it -- DR. ROYAL: -- 30 years later. DR. GLATSTEIN: Yes, but there's another problem with this: you have a patient who is incurable, disseminated cancer, and they die sooner than you might have predicted. In close proximity to the treatment. Is it treatment-related, is it cause and effect, or is it just one end of a bell shaped curve. These are not easy things to dispute. DR. FADEN: But wait a second, Eli. If there's no consent and there's a high standard of proof -- DR. GLATSTEIN: I don't have a problem whether that's - - but we have problem with, if in another era, if there had been a verbal assent. DR. FADEN: Okay. I want to peel this away, and Sue is Ruth is waiting and Dan was waiting. Let's hear from Sue. DR. LEDERER: Actually, the point I wanted to make about, the families are the ones who are going to be the recipients of this. That will be clarified, I gather. DR. FADEN: I think the thinking behind this is that family members would recover for all the standard kinds of things that family members will recover in other areas, in which there are harms to diseased family members like death, loss of earnings from the person, the kind of thing; that if the person who was the subject suffered a disability and couldn't work as a consequence, now the person's now dead but there was a loss of family income that resulted, we'd work out the kind of thing that would make a claim, but we would draw a sort of standard, let the lawyers figure this out, and see if that would make sense. But it would be drawing on standards sort of situations in which a family member could recover. I want to emphasize that one of the reasons we didn't deal with it last time is that we don't have a fact situation that fits this before us, but the notion is, let the committee bite the bullet because there might be one out there, for the reasons that are articulated in this -- in lines 18 to 23, we don't have it because we're not situated to delve into the facts of any particular former subject's case and establish whether the fact, you know, a harm occurred and no consent was obtained. Ruth and Dan. DR. MACKLIN: I hate to say this, but I'm going to have to say it: I think this isn't going to work in this form. And the reason it's not going to work in this form is that we have three distinctly different classes of cases. Everytime Eli talks, and I can understand where he's coming from, he's thinking of patients, and in particular, cancer patients who were being treating. Then we have other sick people like the plutonium subject, or injected with something that nothing to do with their disease, was not intended to benefit them, they were patients. Then we have the third case, of perfectly healthy people who were used as subjects. The reason I am saying this is not working is as soon as you start talking about net benefit or net harm, net whatever it is, it only works when you have the sick people. DR. FADEN: The sick people for whom there is a prospect that they might benefit from this. DR. MACKLIN: That's right, where the intervention, where the experiment is related to their condition. DR. FADEN: And not only that, though, because phase one wouldn't necessarily offer that, it would have to be where there is a prospect of -- you could be a cancer patient and this could be a phase one trial, and I think they're in the other category. DR. MACKLIN: I don't see that we can deal with this globally if we're going to have to -- we can certainly deal with consent issues globally; that is for all classes of individuals. DR. FADEN: So you want to tease this out and look at it for those three situations. DR. MACKLIN: As long as we got As and Bs -- I think that's the only way we can really address the kinds of concerns that -- DR. FADEN: Why should there be any distinction between that healthy subject who doesn't stand to benefit, and no prospect of benefit, and a sick subject? It seems to me we only have two categories. DR. MACKLIN: Right. But the problem -- here's the problem: the problem of the death from the disease. In other words, the kind of problem that Eli is bringing up with the cancer patients can also come up with the patients where the experiment is unrelated to their disease, but they're sick enough, and then their -- DR. FADEN: But that's a causal issue. It's a causal issue; did they die sooner because of this drug they took which has no chance of benefiting them, okay? DR. GLATSTEIN: Well, even in a phase one there's a chance, albeit small, that they would benefit. That's how it's rationalized. DR. FADEN: Are you comfortable with putting Phase One research in a therapeutic category? Would you say -- DR. GLATSTEIN: Yes, I do put it in a therapeutic category. I have difficulty doing it, but I do it. To tell you the truth, it's easier for me than most because when I'm looking at a drug it's usually a radiation sensitizer drug and the patient is still getting radiation. And we're escalating the dose of the agent, because we're not demanding that the agent be effective in order that the patient benefit. I have a distinct advantage over the average medical oncologist in that regard in a phase one study. But I'm not a medical oncologist; I'm not using cytotoxic agents, I'm using radiation sensitizers. So for me, the agent that I'm studying is essentially a substance which we hope will enhance radiation effects. They're still going to get radiation effects that I think will be "beneficial" in some sense; pain relief or stopping seizures or what have you. DR. FADEN: So I don't know whether we're dealing with two categories or three categories. But you want to propose that we try to break this out and deal with three or two categories and see whether the views would be different. DR. MACKLIN: I don't want undue complexity, I want clarity. And -- DR. GLATSTEIN: I want simplicity. DR. MACKLIN: Well, I guess Eli's points are enough -- we probably have to through it a little further -- enough to convince me that if the experiment is related to the patient's condition, whether it's phase one, phase one/phase two, phase two or whatever, at least we're talking about agents that are believed or expected in some dose or other eventually, once you pass from the next stage, are going to benefit that person. So I would for our purposes, lump together these different -- DR. GLATSTEIN: Benefit that group of patients, because it's a probability issue. There's always going to be some degree of failure. DR. MACKLIN: Of course, but it's related -- the experiment is related to the patient's condition and the study is a study on that condition, and these treatments for that. DR. GLATSTEIN: Yes. DR. FADEN: We've got to put in prospective benefit. What if you have an Alzheimer's study, you're studying Alzheimer's, and you're doing something to the brain of these people. There's absolutely no -- DR. MACKLIN: Biopsies, yes. DR. FADEN: That's got to be in a different category. So it's not merely that it's related to the patient's condition; it's about Alzheimer's disease. DR. MACKLIN: No direct benefit is -- DR. FADEN: No prospect of benefit. DR. MACKLIN: No prospect of benefit, but what I'm suggesting is that the phase one through three drug trials or whatever not be, that's all in the potentially therapeutic. DR. GLATSTEIN: -- consent assumption? DR. FADEN: Nothing yet. We haven't gone to the consent assumption yet. Ruth is just suggesting that we need to think this through differently. DR. MACKLIN: Because we cannot talk about net harm or benefit -- DR. FADEN: Where there's no prospect. DR. MACKLIN: Where there's no prospect. DR. FADEN: So there are two categories, basically. There's subjects where is no prospect of direct benefit to the subject, whether the person is healthy or sick, it's irrelevant. The second category, there are sick patients where there is at least some prospect, even if remote, where the person might stand to directly benefit medically from being in the study. And now you want to look -- DR. GLATSTEIN: So you can just include first category, the exposure is not going to be related to disease and not going to benefit the patient, that will include intentional releases. DR. FADEN: Well, right now, we're into biomedical research. DR. GLATSTEIN: All I'm saying is, if you're covering it all. DR. FADEN: I can't, no, because it's biomedical experiments. DR. THOMAS: After this is decided, then it will. DR. FADEN: The reason for that, it has to do with consent, where consent in the context of intentional releases is not --. Dan? MR. GUTTMAN: I think you're talking about two -- you've got two categories you're doing. One is the risk- benefit. The other is, what are the decisional principles that are issued? And as I think Ruth and I have discussed, -- I can't imagine what we haven't discussed, so I assume we would have discussed this. But basically I see three decisional principles. The real question is in what the economists called the Free Rider problem or, you know, or what Henry might say is trivializing justice by giving too many people -- so how do you narrow down to the people that really deserve this? That's kind of a problem. You've articulated three alternative ways, decisional principles. One is, the ethicists are saying "Well, let's assume everybody didn't get consent," because the scientists can then figure out the -- DR. FADEN: We're in 2a. MR. GUTTMAN: I understand, but I'm talking about the difference -- DR. FADEN: We're not assuming people didn't get consent. We're saying they didn't get consent. MR. GUTTMAN: I'm trying to articulate the underlying reason that you're -- in this area. One is, the ethicists are saying, Well, let's assume that it's easier to figure out causality than it looking backward -- DR. FADEN: Not in this one. That's 2b. We're not to 2b yet, we're on 2a. MR. GUTTMAN: You've got your causality, you've got your consent. The only thing I want to add in, though, that's a hidden premise, it's that in fact at the time this happened the AEC said we've got to keep a written record, because it gets to the question -- another way to decide is strictly speaking, just to throw it in there, is to say if the government had a principle saying there had to be documentation, you take that seriously. Now people are saying "Well, we really can't take that seriously because it's a long time ago and because people throw out their records and -- DR. FADEN: This is the next situation we're noting, though. MR. GUTTMAN: It adds certainty to the questions; if Eli is saying that if he knew there was no consent, that he could see a remedy. We wouldn't get into metaphysics here. DR. GLATSTEIN: Yes. MR. GUTTMAN: Right? So that -- DR. GLATSTEIN: If I knew there was no consent. MR. GUTTMAN: If he knew no consent then you wouldn't worry about the risk-benefit and the 30 years and all that kind of thing. All I'm saying is that just to lay out the table, another principle for deciding that would be the record, which is something that's supported. DR. FADEN: It's not a principle, and nobody's going to buy it --. MR. GUTTMAN: I'm just stating it. DR. MACKLIN: What did you say? DR. FADEN: I think the question is, Dan's moving to the point that we've been trying to sort of avoid but we can't avoid, which is, "How are you going to prove?" "Where's the list of presumption going to be for proof that there was no consent?" Is it going to be simply no consent form in the chart means no consent? In which case lots and lots and lots of people would fall under 2a. Tons of people would fall under 2a for the time period we're talking about, because it was not conventional in many instances to get written informed consent from people, for a lot of work under this period. If you don't have that category. you go somewhere else. So we'll go back to this issue of, there are two different -- and we're putting that one away for the moment. So your suggestion is that we think about this differently for these two categories, for a moment. We now have a practical problem. It's time for a break, but I had said we were going to go like all the way through this situation 2b before we took the break, and then we were going to do situation 3, the notification. We have two choices now: People are sort of taking a break anyway. Are we comfortable with taking a break and coming back, or do we -- and just not breaking, breaking. The thing is we're going to 1:00, so the notion was, we're not having lunch until later. Do people want to take a more substantive break or just work while -- do you want to take a break, Reed? DR. TUCKSON: [mouthful] DR. FADEN: Some people want to. No more than 15 minutes. Come back at a quarter of 11, okay? [Recess] DR. FADEN: Okay, guys we should start. MS. MASTROIANNI: All right, why don't I tell you what's on your chairs or in front of you. A couple of things were handed out. The one thing that was handed out, purely administrative I believe, is your time card. Some of them have security reviews attached; they need to be faxed back by Friday. You should sign the security review. It's a security review. It's the only note I have. Once you've read it, sign it. If you have a question, call Sally. This is a message directly from Sally. You've also received a handout titled Status Report on a subproject of the research proposal review project: Review of Selected High Risk Radiation Studies Reported in Scientific Literature. This was in response to a request by Eli and Duncan to have an update at this meeting. So if you want to take some time and read that. You can follow up with Jeff if you have any questions. There's a final report, Committee Chapter Review Schedule. Our intention is to get a full draft, start to finish to you by around April 28 or 29 so that you can go straight through, but to give some of these chapters a once go-around, for time and to get some comments circulating, I have distributed a chapter review schedule similar to the one that was distributed at the last meeting. If you could just indicate which chapters you're planning to review, which ones that you're particularly interested in and the ones that you plan to get detailed comments back to us on, and either give it back to me or Jeannie or Jerry; we can compile that and we'll keep track. The due dates are Friday, April 21 for some, and Monday April 24 for others. In addition, you will find blank calendars for the months of May, June, July and August. Just in preparation for the possibility of another meeting. If you could indicate on the calendars the days that you are unable to attend a meeting, then we can do some preliminary planning and research. There has also been some discussion, and essentially a point that was raised by Mary Ann, that if we had a little bit more time to review the chapter drafts prior to the May meeting, we would probably have a more productive May meeting. Because as it stands, you may only have a week to ten days to get through the whole thing. So if you would at least give us a sense of whether there is any flexibility in your schedule for changing the May meeting that would be helpful. It may not be possible, but we thought we would at least try. You also have the two chapters that were scheduled to be delivered to you that were left on your desk. I think that's everything. DR. FADEN: That's everything. MS. MASTROIANNI: If you would rather have anything mailed back to you rather than carrying back -- DR. FADEN: Absolutely. MS. MASTROIANNI: Let us know. Briefing books and other stuff. DR. FADEN: Okay. Duncan reminded me that we need to get through situation 5, forget situation 4 because I think it's going to disappear anyway. I don't know that we can resolve 2A, but we ended with this recognition that we needed to distinguish and think through differently, to use a shorthand, the therapeutic from the nontherapeutic research, where people stand to benefit medically, even a remote prospect, to where there is just no way the person could benefit medically from their participation. I'm afraid if we take time to break out -- what we're going to with that we're not going to get any further. We take a little look at situation 2 and see where people's intuitions go with situation 2b. The idea in 2a, what I think I'm hearing, is in the situation where, in the context in which there is no prospect of direct medical benefit to the subject; whether the person is ill or well it's irrelevant, just no prospect of medical benefit; That there is a stronger sense or sentiment in the committee that it's clear to endorse situation 2A; that is to say, provide a remedy of compensation where there is no consent or inadequate consent, and physical harm, and there was no prospect of benefit to the person in the first place. That is an easier case for agreeing about the issue of compensation as the appropriate remedy. Does that seem to be correct? Correct. Now in the situation where there is a prospect that the suspect might benefit medically by his or her participation; which generally means the person is a patient. But the person could be a patient in the first case as well. What I thought I heard was, if there was no consent and net harm; however that would be articulated, that compensation also was an appropriate remedy. What we were struggling with was what to do when there was some kind of consent, and there was a prospect that the patient could benefit. Remember, this is compensation coming from the government where we haven't figure -- is that a clear characterization of where we were? And that's a lot of research, obviously, during this period. So rather than try to figure that one out now collectively and never talk about anything else for the rest of the meeting, I would like to put that away and some of us do some thinking and come back to the committee, ideally before the next meeting, so people can start correspondence and sort of thinking through different situations in which we might want to address that situation; a situation where some sort of consent was obtained; there was a chance the person could have benefitted medically from participation, and the person was harmed. It was not a good consent but it was some consent. Not an adequate consent, but not no consent. In adequate consent, there's no issue. With an adequate consent, the person is harmed, that's the risk of being in research. So we're dealing with the particular case where there was an inadequate consent obtained against whatever the standard of consent is. Ruth? DR. MACKLIN: I just want to ask whether -- I am going to identify one element of the consent, not the adequacy on a scale of adequate to inadequate; but one element, and ask whether we want to single this out if it was omitted; and that is the purpose. Either the purpose or the second purpose in a multiple purpose -- DR. FADEN: The person doesn't know what the purpose is. DR. MACKLIN: Yes. That is, if that is the element or one of the elements that renders the consent inadequate, and I'm especially thinking of the purpose as related in an experiment that might have had some consent, might have been an experiment using patients, but where there is one of what we have been calling the dual purpose experiments, and the purpose that had nothing to do specifically with the patient, but rather with the other purpose, the DoD's purpose or the DOE's purpose. Whether we want to single out purpose and the omission of that as something that is especially a feature that would make it inadequate. DR. FADEN: Okay. I will put that out; that's very helpful, and we'll try to lay out different ways of doing this. Now can we take a little bit of time to go to look at 2b, which what was 'plain 2' last time around. I want to acknowledge, as I mentioned earlier, that the causation problem hovers over both versions, 2a or 2b; either way you've got to figure out somebody about the standards for when you're going to conclude that indeed an outcome is going to be attributed to the research rather than to something else. And that's a problem, period, for both of these. So now we're into 2b, and 2b as I said was 'old 2' and maybe we should take just a second to read it, because it's again so short, and get people's reactions to it, in light of the discussion we had on 2a. [Pause] Now again the proposal might be put forward that situation 2b also should be distinguished between the therapeutic research and the nontherapeutic research, this being a nuance that is potentially relevant here as well. Open for discussion. Henry. DR. ROYAL: What is the meaning of the phrase "cost of relevant medical care"? Is it intended that that phrase refers to the specific disease that was caused -- DR. FADEN: Right. DR. ROYAL: Does it include things like routine hospital, doctor visits? DR. FADEN: No. It would be to care for that problem. It could be; I mean, we could do whatever we want, but it was meant right now to be the costs associated with whatever it was that is judged to be a result of the research participation. So if the person got a thyroid problem, it's for care of the thyroid. DR. THOMAS: Well along those lines, there's care and then there's care. If the person had gotten compensation early on and soon after the process had essentially unlimited funds to spend, he would have gotten deluxe care; and if many years later he's to reimbursed for his actual out-of-pocket expenses, which might have been pretty minimal because that's all he could afford, there's an element of fairness there that troubles me. DR. FADEN: Yes, I think we're sort of stuck with that. I don't know, unless you want to change it, make it a flat sum. DR. THOMAS: I don't know how to solve the problem. DR. FADEN: We could say it's a flat sum; it's estimated that lifetime care for X condition is Y, and you'll get Y; if it's that, but it would be attached to or a schedule based on some health economist working out what the reasonable cost would be for the care of the condition. DR. THOMAS: That seems to me more equitable than out- of-pocket expenses. DR. FADEN: It's also easier than keeping bills. But we can certainly modify that. That's fine; we can have some sort of schedule that somebody out of HCFA works out that says, -- that would be the recommendation; we're obviously not going to do it. DR. ROYAL: I just would like to say a word about probability of causation. I spoke against probability of causation the last time we were here and maybe spoke too forcefully against it. In some circumstances I think probability of causation is the best approach; and the reason I think it's the best approach is because it's what has traditionally been done, so there's fairness to probability of causation. Now the reservations I have about probability of causation have to do with when the information that you need, in order to use the probability of causation tables don't exist, then we're in a whole new arena. I just wanted to bring that to people's attention; that I think if the information you need for -- probability of causation tables exist, then that's a reasonable way to do things. The problem is when that information doesn't exist. DR. FADEN: I tried to capture the distinction on the second page; page 2, the lines 10 to 15, realizing that in that instance again it's going to be a value -- somebody is going to have to attach some sort of a value and set a presumption, as if the data are poor or the records are poor, which way is it going to be cut. Is it going to be cut to benefit the patient's claim, or is it going to be cut to make it tougher? DR. ROYAL: But then the danger you run into is -- there's an advantage to not finding the records. DR. FADEN: That's right. You will have a tradeoff, and either the committee will come up with a recommendation on how to slice that presumption -- I didn't want to do that before we decided that we generally thought 2a made sense. If we didn't think 2b made sense, there was no point then having the committee debate which way we would recommend it be sliced, if there was inadequate information about what the person had been exposed to or that kind of thing. DR. THOMAS: The proper solution to Henry's problem is to essentially average over the distribution of all the unknowns. Implementation of that principle if of course easier said than done, but it does address Henry's concern about the advantage to losing the records. Because in principle, you would be trying to reconstruct the expected value of whatever it is that record might have said, averaging over these things. It's a principle; it's a useless principle, but it's the right principle. DR. ROYAL: Duncan and I agree that what he just said was useless. [Laughter] DR. FADEN: But you're trying to impute the value? DR. THOMAS: Well, more than impute; average over. So that if there's a 50 percent probability that he had 1000 rads and a 50 percent probability that he had nothing, you would consider those two possibilities and weight them equivalently. DR. FADEN: I see. I'm sure that would satisfy no one. [Laughter] Well, reactions to this: do we need to consider it as it is, do we need to again split it in light of the discussion we just had about the differences between the two contexts; the prospect for benefit context and the non-prospect for benefit contexts, or do we not care here? Any help? DR. MACKLIN: Sometimes we have to think. DR. FADEN: Good point. Ruth. DR. MACKLIN: Will you give me permission to raise something not directly related to this but certainly related? DR. FADEN: Sure. DR. MACKLIN: Another reason at least for thinking about, and not that we want to necessarily make a distinction for remedies, but thinking about the distinction between patients and non-patients, just to put it that way for a moment, or direct benefit to patients; is with reference to those policies that we spend so much time in the very beginning of this report talking about. Now what doesn't appear in any of the rationales here is any reference or relation to those policies. But what's the relevance of talking about those possibilities in this report unless some of the culpability, the government culpability and some of the remedies, such as they may be, are related to failure to do what at least some people said ought to be done and there were policies in place. So I think the rationale should include that in order to come full circle, reminding leaders and providing part of the justification for why the government should be doing these things in the first place. DR. FADEN: Because it is the government we're talking about. DR. MACKLIN: Because it is the government we're talking about. So that's a point about the rationale and the justification. Now that raises, then, the troubling prospect that taking a closer look at the culpability in relation to what the policies were and failure to implement those policies, it provides a further reason for separating the classes of subjects. In other words, it may provide less of a presumption where patients are involved if indeed particular policies were meant to apply only to non-patients. I think there's a tension here between trying to relate both the justification and the schema and the government culpability to the existence of those policies on the one hand, and the prospect that there may be some unfairness if we try to make too great a -- put too great a reliance on the features of the policies that distinguish between subjects and non-subjects. I hope I'm being clear; I mean, I'm speaking generally. DR. FADEN: I think what you suggest requires -- and again this is yet another reason why we need to look at this document from beginning to end. I've lost track of the numbers, but I think it's chapter 5 of part 1, which is the chapter that summarized the committee's conclusions with respect to what we took to be the relevant, how we were going to understand what these policies and memos and so on from the AEC and the Department of Defense meant; and we had a lengthy discussion several, maybe four or five meetings ago at this point, and reached the conclusions about the value we were going to attach to those documents in terms of what role they would play in our ethical analysis. We need to take these remedies and go back to that and see if they fit as they should. My recollection of that is that we did say then that we would take the AEC exchange of letters, which did speak to requiring the consent of patients as holding the entire government to that criterion as articulated in that exchange between the AEC. At the same time that chapter acknowledges that the DoD's development of ethics policies with respect to consent and research emphasized the nontherapeutic track of development. That Wilson memo --. DR. MACKLIN: So that's the prospect for unfairness, right? That's where it comes. DR. FADEN: So we have to think through the position that we adopted, then, and have it fit here. That's important. We have to make sure we have a circle or square -- circle it or square it, I don't know what the deal is, but we -- DR. MACKLIN: The question is how we make it fit. MS. NORRIS: Right. DR. MACKLIN: We could certainly make it fit on grounds of culpability; finding the government culpable. But whether we have to make it -- suppose the application of an AEC policy and a DoD policy which say somewhat different, which apply to different classes of individuals results in not treating similars similarly. That would be on one reading, an unfairness. So do we derive, or should we be deriving the compensation that is owed or the remedies that are owed as we're here doing without reference to the policies, which is an attempt to treat similar classes similarly. Or if we try to use our own analysis and go back, we may end up not treating similars similarly, and since that may be more undesirable than trying to derive this from the policies, we can still look at the policies from the standpoint of some culpability without tying those results directly to what people are owed. DR. FADEN: We should all take a look. And that chapter, I don't know where it is; I guess it will go in that packet that everybody gets from beginning to end. I think it's 5 in part 1. That is the operative chapter where we had approved that chapter and gone to it, except not necessarily every word in it, but the long discussion about it said that it was acceptable. We obviously can revisit it. On 2b itself, are there reactions? No? Fine. Do you want to go on to situation 3 and think about this one? We can do that. It's an important one, obviously, because it would capture, potentially capture more people than any other category we've got. It strikes me that we have to make a distinction if only because -- between the therapeutic and the nontherapeutic situation, because you don't get into -- as we went through last time, you don't get into analysis of net harm unless you're in the prospect of benefit situations. So if nothing else, this has got to be separated out, for that reason. DR. ROYAL: I think that would help. DR. FADEN: So why don't we, rather than angst over this right now, we'll revisit it, breaking it out into the two versions and come up with some speculative alternatives that could be adopted where the committee stands and start that process and we'll pick up the discussion again. DR. LEDERER: Together with Henry's earlier suggestion about defining what relevant medical care would be in the situation? DR. FADEN: Yes. We would change that and we would also go -- I think we would go to some language that suggested some schedule would be developed for the projected reasonable cost for care of such a condition. A flat rate, something like that so they wouldn't have to sit there collecting their bills. DR. ROYAL: The reason that it's important to separate this out into the two groups, the therapeutic and nontherapeutic, is because of Eli's concern about benefiting from the treatment and then years developing cancer. DR. FADEN: Exactly. So there has to be some way -- it's easy in the nontherapeutic context, because there's only a potential for downside for the subject. When you get into the therapeutic context it gets complicated, and it's a rightness, it's right that we need to -- we follow both of these. It's differently and presumably the 2a, 2b thing we're trapped. With that, we're going to move on. We need to revisit situation 3 and then we also wanted to get to situation 5, which is really a placeholder for remedies that had been proposed for population experiments or population-related research; and we had not discussed that at all so we probably reserved a fair chunk of time. It's 11:15, and we're going to want -- so if we could spend no more than maybe 35 minutes on situation 3 and then go to -- do you have a suggestion, Duncan? DR. THOMAS: I have a question. In the briefing book at tab E, there was material on the nasopharyngeal radiation which we were told was going to be rolled into this discussion. I'd sort of like to know before we launch into this discussion what your plan is for, partitioning the discussion between -- there are philosophical principles here which are certainly important, on this other issue. DR. FADEN: I think at this point we're not likely to get to this other issue. DR. THOMAS: Okay, that's what I'm afraid of. Let me give my take on this question. DR. FADEN: Sure. DR. THOMAS: This is an unfortunate example of something that's sort of fallen through the cracks. We have something that I can't say by any stretch of the imagination is not a human radiation experiment and for which, in the class of biomedical experiments, has the potential -- although certainly not the certainty, but certainly has the potential for having caused a great deal of harm, more so perhaps than any of the other categories of biomedical experiments that we've considered. So it would be a shame, I think, if we just happened to ignore it. DR. FADEN: Oh, no, we're not going to ignore it; it's an issue of when it comes here. DR. THOMAS: So the question is how are we going to deal with it? DR. FADEN: Here's the context: There are two ways in which the nasopharyngeal situation is going to come up and we're going to address it. In Situation 3 there is both the issue of notification, but then there's a related issue that some things that -- it has been raised and put before us, and committee members have raised whether recommending epidemiological studies, which is different from notification for the purposes that we have here, if there's any situation in which the committee wants to recommend that an epidemiological study be done for the reasons that one does epidemiological studies. And certainly the nasopharyngeal situation is a context in which that has emerged. It also is the case that one of the nasopharyngeal experiments or research projects involved children, and it's to be in the children's chapter. So it's going to emerge there as well. DR. THOMAS: So we should just leave it to the authors of these respective chapters to work on for a while and we'll discuss it at the next meeting? DR. FADEN: For the first crack. Well, if we can get to it today we'll get to the discussion of what's in the document so that people that are working on it and staff have an idea of what the committee is thinking, but if we can't get to it today, we'll get to it. DR. THOMAS: Okay. I just wanted to make sure it isn't lost. DR. FADEN: No, no. Those are the two clear ways where there's a structure in place to address different dimensions of the nasopharyngeal situation as we received it. The epi follow-up question, the follow-up for epidemiological purposes is a natural extension of situation 3. It's a different purpose. DR. THOMAS: It is indeed, and I think it is something that I'd like to see discussed today. But it's not what we have now. DR. FADEN: No. So the issue is, that's why I thought we might get to it today, is that side of it --not the children's side of it because we're not doing the children's chapter at this time; but the pediatric part of it insofar as it raises particular pediatric research ethics questions will be handled in the context of the children's chapter, and we'll debate it next time. Situation 3 is where we had our running dialogue. There was the discussion in March, which was very rich, and which transformed -- the reasoning that started out based on the language in the charter of notification for purposes of protecting the health of, to a discussion about whether a notification had something to do with a general right to know and what duties might follow from the committee's acknowledging that people had a right to know that they were research subjects. So then there was a redrafting; they tried to capture that discussion, and that was circulated to people and it prompted reactions. So the memo that we have here that Gary put together is kind of capturing what happened in this dialogue and then we just provided everybody with the various memos and E-mails that responded. So there's the draft and then we've got -- an outline. So we've got Jeff's and Pat King's response and Duncan's response and Ruth's response. Now, what do we want to do. The second paragraph of the memo captured whatever consensus there seemed to be, so let's start with that first, which is the paragraph that says: Based on these responses, there seems to be a developing consensus. There's an experimental subject's right to know. What it confers is an obligation on the part of governmental bureaucracies and private sector bureaucracies to make a good faith effort to respond to inquiries from people who are trying to find out if they were research subjects. And a notification requirement. That's where the consensus is. DR. MACKLIN: Well, not in individual -- the thing that's not clear -- I mean, it's certainly not a notification of individuals that would require notifying all those for whom there are now records, and then searching for records, et cetera. But the uncertain, the part that was not resolved in the exchange was whether some form of general notification -- that wasn't spelled out; Pat King addressed it and -- DR. FADEN: Well, we can discuss that now. DR. MACKLIN: Like a public notice of some sort which would still leave the burden on individuals to try to ascertain or determine whether they had been subjects; but it would not eliminate the responsibility to have some general rather than individual notification. DR. FADEN: Anybody want to speak to that? DR. ROYAL: You mean a general notification above and beyond what has already been done? For example the DOE hotline. Is that what you would -- is that what you would envision as a general notification process? DR. MACKLIN: Well, I want to get to the level of process. What's already been done was prior to this committee's work in the identification of all these areas and all these experiments and all these different things that were not identified and specified and spelled out before. I don't know what form -- maybe we should go to the relevant portion of these memos here in which it was discussed. Pat King raised it her memo and I responded. Where is her memo? DR. FADEN: D. She's attached to -- right before Duncan's. Pat King, attachment D. DR. MACKLIN: Here. It's on her second page, just in the paragraph before number 6. And she says: This draft assumes --I think because of our focus on autonomy -- that notification must always be personal. It would be possible to do a more public type of notice at less cost. Pat says "I'm not advocating this, but if there's a desire to do more notification then I would personally like, this possibility might be explored." Among all the things that I said, -- I simply say on unnumbered page 3 of my memo: Pat addresses more general -- this is the third paragraph up from the bottom or fourth paragraph up -- Pat addresses more general public notification. She gives no reason for her statement -- I'm sorry she's not here -- that somehow would not advocate it, but I find the idea quite attractive. I'm at a loss to say what form this would take, but why would we recommend against some general public notification? DR. FADEN: You could argue that when the database that we have generated lists of experiments, which admittedly is quite skimpy in terms of specifics about most of these experiments -- it's publicly available and will remain publicly available. That's a form of public notice that there's out there, and presumably DOE has also collected some parallel kinds of things, that there is at least some place where you can -- hopefully this will be available through Internet, to which you can log on and scan a list of experiments; and in some cases we even know where the experiment was done, in some cases we don't; and if you happen to have been at St. Luke's Hospital in 1953, it's a start. That might be as far as we could go to public notification, and it's already done. It's not done as well as it might be liked, and it could be added to if the government decides to continue in some way to update the database. But that's there. Duncan? DR. THOMAS: I like the suggestion a great deal, and I also support it. To me, it's a more attractive alternative than the suggestion Reed made at the last meeting, when we had that discussion about whether or not the right to know conferred an obligation to inform. And as I recall, Reed made the clever suggestion that, why don't we send a letter implying that perhaps you might have been a subject, and if you want more information, why don't you write back to us? To which Jeff replied: Well, but then the cat's out of the bag. Why would they -- and the person would immediately want to know: "Why would you send me this letter if you didn't have some reason to worry?" And that to me seems to me a real problem with that option. This one neatly gets around that problem. Of course, it's not a personal notification, and we can always wonder whether or not people saw the notice, so it doesn't completely address the obligation to inform question, if we think that there is an obligation to inform. To me it's a reasonable compromise. DR. FADEN: Ruth. DR. MACKLIN: I think, Duncan, the consensus as described in the April 7th memo in the second paragraph does not -- I mean the consensus is that there should not be individual notification. It's silent on this general notification, but it does identify or explicate the right to know as the right to be told if one asks. So the good faith obligation, which I take it as some kind of term of art, good faith obligation, because Pat addressed that; you know, it can't just be "Well, I looked and didn't find it." There has to be some good faith obligation for institutions when asked by individuals or families to make the requisite cert. So the right to know is now being interpreted here as the right to be told the truth and not shunt it aside and to make a good faith effort, if one asks, but not to -- DR. THOMAS: It's actually a public policy statement that this right to know exists and will be honored by the government. And to have it appear in every newspaper on page one, such that people could be reasonably presumed to now know that they have this right which they can now go exercise is absolutely appropriate, it seems to me. DR. FADEN: So are we comfortable with it? DR. ROYAL: No, I was going to speak in support of it and I was going to ask whether, how much work would be involved in the database to identify the location of the experiment --. DR. FADEN: Dan, how often do we have location? MR. GUTTMAN: It's by institution. In two seconds. DR. ROYAL: The reason I think that would be a good idea is once you know the location, and either we can send the names out to the appropriate public media, although I definitely don't -- DR. THOMAS: I don't think you want to do that, necessarily. DR. ROYAL: No, because it's too much. But if it's accessible on the Internet, and if some -- DR. FADEN: People can get help. DR. ROYAL: -- person wants to find out what happened in my area -- DR. FADEN: They can go to their local library and get assistance, get on the Internet, and presumably try to get somebody -- if they had difficulty with the technology, the issue would be finding assistance in your local community through your library. DR. ROYAL: But I'm also thinking the news media would find it much more newsworthy if they knew the location of the experiments. DR. FADEN: Did you -- MR. GUTTMAN: Oh, yes, it's instantaneously accessible. The institution is -- DR. FADEN: Do we have location in every case? MR. GUTTMAN: Well, not -- in every case we don't have anything. DR. FADEN: Most cases, then. MR. GUTTMAN: We have a million VA locations and Harvard and Yale, and all kind of stuff, yes. DR. FADEN: So is that congenial? MR. GUTTMAN: Yes. DR. FADEN: If anybody has any other ideas about putting general notification -- it's not so much general notification as a mechanism to make meaningful someone who wants to decide if they want to make an inquiry. DR. STEVENSON: It's really accessibility. DR. FADEN: Yes. You can all it general notification, you can basically say it's the first step towards if someone is saying, "Gee, I don't know if I was or I wasn't, or "I could have been or I might have been" this is the first place to start. Is there any indication that an experiment was done when I was in this hospital during" and then maybe sometimes it even has the year, right? MR. GUTTMAN: Yes. In fact, I think we're already on the Internet with that. DR. FADEN: Henry? DR. ROYAL: Do you think it might also be useful to go through that database, identify the institutions that are listed in that database and send them a summary of what experiments are listed for their institution. MR. GUTTMAN: Very easy to do. DR. ROYAL: Just sort of give them a heads up on, the fact that people may come in making inquiries. DR. FADEN: "You may be getting inquiries because you're on our list for the following notices." Okay, John is shaking his head: "We can do this," I can see that. It's doable. Can we go on to the next page? DR. MACKLIN: Just of this? DR. FADEN: Of the memo. DR. MACKLIN: I just wanted to make sure that someone addresses to Pat specifically the question of whether this is okay with her, since she was the one who said she personally wasn't in favor of it; maybe she didn't -- DR. FADEN: We obviously have to do it again; you're right, Pat especially because it was prompted by her, but kind of in the negative. But obviously also by Reed and Jay and Ken, since they're not here. But yes, thank you, that's appropriate. Duncan? DR. THOMAS: Before we move on to the second page, I just wanted to raise a question about good faith inquiries to persons who believe they were subjects. We don't say anything in here about the family members. DR. FADEN: Should we extend this to family members? This was an interesting question. We had long internal discussions about extending it to family members. DR. THOMAS: I wrote something in my memo on this subject -- oh, here she is -- which specifically addresses that point. [Professor King arrives] DR. FADEN: Do you want us to find it in the language, or do you want to just read it? DR. THOMAS: It's very brief; let me read it: I tend to feel that family members should inherit the right to know upon the death of a subject. While the subject is alive and mentally competent -question mark- privacy would seem to imply that only the subject himself can exercise that right, unless he authorizes someone else to act on his behalf. After death, I see no compelling reason to deny a family member access to this knowledge and compelling reasons why access should be granted, if only to heal psychological wounds and permit redress. And then a question: Is there any law on the subject of a continuance of privacy rights after death? I have no idea. DR. FADEN: Mary Ann? DR. STEVENSON: It seems to me you have to let family members know; otherwise, they can't access situation 1b and the other one -- 2a. DR. FADEN: Right. DR. STEVENSON: And you're including family members as beneficiaries of those situations -- DR. FADEN: You've got a point. DR. STEVENSON: -- we have to let them -- DR. FADEN: I'm all in favor of incorporating Duncan's language. DR. ROYAL: You said that this had been discussed before. DR. FADEN: This is what I meant; there was an exchange with -- not publicly. DR. ROYAL: But I was interested in hearing what the reasons were for excluding family members. DR. FADEN: It's not in here because it was decided to exclude them. It just wasn't in here. DR. ROYAL: I see. There had been no negatives. DR. FADEN: Well, there were negatives; but this is the tradeoff of the privacy issue and, you know, what if it had been AIDS research or something. There are certain times at which even after -- then there's the issue that Duncan pointed to, that the whole question of the extent to which -- you know, what are the rights of dead people and how does that extend, and all these sorts of questions always come up. But you are balancing a bunch of interests and a bunch of rights here, and I think the way Duncan has articulated, and Mary Ann reminding us that it is necessary to make meaningful any survivorship benefits from the remedy side of things, that it kind of answers it for me. DR. ROYAL: It brings up the other issue about, are we going to limit the relationship at all? What descendants are we talking about? DR. FADEN: How about if we leave that to -- we'll look and see how this is generally played out and come up with some alternatives, but that's a good point. Thank you. That was important to add, and an oversight not to have included. So that's great, Duncan. And please always stop me, because I am in such a single minded rush to march through this that I'm very liable to forget some of the details that turn out to be quite significant. So if we are agreed now to go to the second page of the memo? We're on the other area, where there seems to be some kind of consensus emerging from these exchanges, of some committee members and staff. That is the consensus that the government should actively notify persons whose health could be protected, or who are entitled to compensation. I'm not sure how much consensus there was on both of these, but the point of the end of the paragraph -- the point of that, to each other on numerous occasions, quasi-ironically, is that we're sort of back where we started from because if indeed the committee does believe that anybody whose health could be protected should be notified, we're back into that memo that we never marched through before because we got into the right to know issue, about how are we going to operationalize an understanding of who might benefit, and so we're back into the analysis of the pediatric studies and the studies involving pregnant women and the prisoners and everybody else. So if we do think that somebody should be notified who could stand to benefit from the notification, we have to back and revisit the question of what counts as a benefit, a benefit against -- a net benefit, all the other downside issues, what to do with it although the risk estimates, thresholds, all of that stuff comes back. If we do want to make a recommendation that relates to protecting people's health. And again, I remind everybody that it's in our charge that we're supposed to comment on this. So we either have to say we don't think this is worth doing or we have to say we couldn't think our way through it, which would be embarrassing, or we have to say that nobody -- we don't think anybody really in sizeable numbers stands to benefit, or we don't think it should be received, but we have to say something. DR. ROYAL: Is there someone on the committee who wants to argue that at this point in time, that there's a group of subjects that we can clearly identify as someone who would benefit from medical follow-up? I personally don't have any proof in mind. DR. FADEN: Eli had argued for the prisoners. But you've got to remember the issue there is really follow-up; they know who they are. It's not so much notification in the case of the former subjects in the prisoner studies; it's not that they don't know that they were subjects. The issue for them is twofold; whether what the committee should recommend in that particular case is medical monitoring and/or the second fold, and epidemiology is a follow- up study, a systematic investigation or merely clinical follow- ups. Eli has made the proposal for the prisoners. The children one, the proposal is not really notification, it's more -- because they know who they are, okay? It's doing something. The pediatric one remains -- DR. GLATSTEIN: In which the analyses are still being done. DR. FADEN: The analysis are still being done, so we're not certain yet about the children one. The nasopharyngeal case emerges, but with respect to the pediatric situation, my understanding that we have to nail it down is that most of those children who are now adults who have been located are participating in the follow-up study that's ongoing, but we have to get more details about that. DR. GLATSTEIN: In fact on the prisoners, if they had offspring after their exposure, I think the offspring should be counted, too. DR. FADEN: They should be followed as well, because of the nature of that irradiation. DR. GLATSTEIN: Yes. You could have the germ cell mutation. DR. ROYAL: But the prisoners had vasectomies. DR. FADEN: Not all. DR. ROYAL: Supposed to. Supposed to do. PROFESSOR KING: Even if they had it, it doesn't necessarily work. DR. ROYAL: I'm confused; we're suggesting a medical follow-up study for the offspring of the prisoners? DR. GLATSTEIN: Prisoners, and if they had offspring after -- DR. ROYAL: Or --? DR. GLATSTEIN: Yes, in this instance. Find out what the heck took them, because they may well have mutations related to that exposure. DR. ROYAL: I think that from other data that we have, that would be extraordinarily unlikely. If you look at Hiroshima and Nagasaki, there have been 75,000 offspring of the survivors of Hiroshima and Nagasaki and BEIR V concluded, after looking at that data, that they were unable to demonstrate any genetic effects in that population. DR. GLATSTEIN: Well, that's probably true, but I don't think they had anybody whose gonads were directly exposed to the exclusion of the rest of them. I think that it isn't a global issue. DR. ROYAL: Dead cells don't reproduce. DR. GLATSTEIN: Well, that's dose-related. DR. ROYAL: What is the radiation therapy literature? I would think that there would be some study of the follow-up of people who had been -- DR. GLATSTEIN: Actually, there's very little, because about the only time you radiate the testes directly is it's part of leukemic treatments; otherwise, we don't do it. The test is run; if there is a malignancy in the testis, this is a testis that is usually excised on its own. DR. FADEN: I was going to suggest that we step back a little bit and figure out the different situations that we're in and then decide how to attack each of those rather than debate, start getting into many debates. The first issue is, does the committee -- if we can find a situation where someone might benefit, we would want to recommend notification. So now the issue is, have we found such a situation? But that benefit, we get into that, or not in that benefit, which is part of the debate when you get back, when you connect it back to the right to know issue. But here the justification is beneficence and not right to know. DR. ROYAL: I don't have any difficulty at all with notifying people who are -- I think it's in their benefit, the notification. I think there are two problems; one is, there are complicated tradeoffs. And the second is that historically, medicine has always perceived what they do as being good, so more is better. There are people who have special expertise about all these issues, and if we identify a potential candidate, and I would think that there would be relatively few, I would be in favor of having this public health consultant kind of person, list out the benefits, list out the harms, and then either we could make some judgment or that person could make some judgment. DR. FADEN: I think we need to make the judgment, but that person could give us a little bit of his or her recommendations. DR. ROYAL: My experience with this is it has to be done very explicitly, because many of the things which ultimately get counted as harms, people wouldn't merely leave. It doesn't ordinarily come to mind. DR. FADEN: But we are back, full circle again, to the discussion we had last time, which is how this links to the in principle right to know business. If you've got somebody who falls potentially under the notification for beneficence purposes, do we -- if it's purely and only beneficence, then it is right that we do the calculus for them and decide -- not maybe right, but it could be argued that it would be appropriate for the committee to do the calculus for them and decide whether they should be notified or not. Another control is we would say we shouldn't do the calculus for them, we just let them know and they decide. Let me suggest the following, because I don't think we can work our way through this now. We're finishing up the risk analyses on children. We can then see what emerges from that and see if we can find a consultant, the kind of people that has the expertise that Henry has in mind in terms of people to do screening, kind of decision-theory, cost-benefit stuff on screening programs. We could get such a person to take a look at the data that we have on children, and we can see how that person displays it; and then we can have a debate as a committee as to how relevant we think that analysis is in the light of whatever ethics position we want to take about how to situate this particular problem. Is that okay? And that would be how we would handle the children's issue. The prisoner one, I think we did. Now we might move to nasopharyngeal as well, and the other situations where we're talking now about notification, of people who know who they are, and do we want to recommend anything else with them. I see Pat and Sue. PROFESSOR KING: Can we do all this by next month? DR. FADEN: Yes, I think we can do all this by -- the consultant is the part I don't know about. Maybe we can line up somebody quickly enough who will be willing to take a look at it. But everything short of the consultant I think we can produce. DR. THOMAS: Well, I can make a suggestion. Because we've had some consultations previously, Henry and I had this exchange approximately several months ago; and I pointed out the existence of this U.S. Preventive Services Task Force. They published this book of 100 medical interventions and their -- DR. ROYAL: Utility or lack of utility. I know someone on that public health task force. DR. FADEN: We will work it. The only issue is find a human being who is willing to take this on at short notice. DR. ROYAL: In Washington or close to Washington. DR. FADEN: We can get this done. That's not even a factor; the person could be anywhere and get this done. The material we could get to the person; the issue is somebody who is willing to do us a big favor. So the answer to Pat's question is, except for what we can't control, which is somebody outside of us, yes. Sue? DR. LEDERER: My question goes to the top of page 2 when you say the government should actively notify persons whose health could be protected or who are -- DR. FADEN: That was the next thing I was going to try to march us through. We are not sure where the committee is on that one. So maybe we should do that before we go the epi follow-up studies, so stay with notification. Thank you, Sue. That's useful. I was trying to separate those. So on the justification to protect the health of, we think the only likely candidates are going to come from the pregnant women, children's category; then we'll see what happens with that along the change you just described. From the from the flurry of memos there was some appearance of a consensus, but that was a limited number of people, as was for this one; that perhaps also there should be notification of people who are entitled to compensation; and once we figure out, finalize our position in the situation 1a, 1b, 2a, 2b that we talked about earlier this morning, the idea obviously being here that what you're going to get is an apology; we're not going to try and find you. But if what you could get is compensation, medical care costs covered, should the government try to find you? Behind that is a huge problem, because it means the government has to be marching through experiments to find ones that meet it. DR. OLEINICK: And there's also the probability which was also mentioned in the flurry of memos about notifying people who did not fully -- false positives, essentially; people would be notified and worry about something that wasn't probable. DR. FADEN: Well here you'd only be -- in our other analysis, you're only entitled to compensation if you'd been harmed. It's kind of a circular thing, because you really can't know until in some cases you've got the person in front of you. DR. LEDERER: But didn't we agree to compensation for people who -- DR. FADEN: The coverup. DR. LEDERER: With the coverup, who would also not know that they had been exposed? DR. FADEN: You're right; I'd forgotten that. Let's separate this and talk about the coverup people versus the harmed people. So if the reason for compensation is coverup, that's different than if the reason for compensation is harm, in terms of notifying. Because if you've been harmed, you know, and then you can try to track and find out if you were part of an experiment. But if you've been covered up, you've been covered up. DR. ROYAL: Well, being covered up doesn't necessarily -- if you don't know you were part of an experiment. DR. FADEN: You might or you might not. Or you may no longer be living and your family members may not know. You were hospitalized in 1948, and nobody knows what happened. Ruth. DR. MACKLIN: One way of trying to think about this is whether the general notification, that is not the individual notification but the general notification will be powerful enough and sufficiently widespread so that it will -- anybody who might think or suspect --. In other words, since we're not any longer talking about a right to know, this is a right to be compensated if you fall into these classes. DR. FADEN: Right. DR. MACKLIN: If the right to know, as now interpreted, is a right to be told the truth or when asked -- I mean when given the truth, in a sense we've already answered the general question about notification. So now we're pulling out a subset and asking whether a different concept of right to know applies to that; namely, a right to be notified because they fall in the class of people who are entitled to compensation. So one way of thinking about it is then to ask whether being entitled to compensation gives one a higher order right to know; namely, the right to be notified, in contrast to what we have already more or less arrived at consensus and what it means to have a right to know. DR. FADEN: Henry? DR. ROYAL: I wonder if a solution to this problem might be on our friendly Internet, to flag the experiments which we identified as being -- DR. FADEN: Coverup? DR. ROYAL: Well, as being compensatable. DR. FADEN: You'd have to march through and do that analysis for all these numbers. DR. ROYAL: Potentially compensatable? DR. FADEN: Yes. DR. ROYAL: Well, I actually wouldn't mind if it were a limited list, so that it wouldn't necessarily be in all --, just so that the word does in fact get out that there are some experiments, and as long as it clearly said that there were some experiments for which you would be compensated, I would suspect that that would provide considerable incentive for people, independent people to find the persons who were involved in these experiments; and in fact they may do it better than the government might do it. DR. MACKLIN: Who are the independent people? VOICE: Lawyers. DR. FADEN: Lawyers. [Laughter] DR. FADEN: What we're envisioning here is, we've got this database. The database is already on the Internet. And then as the release of this report comes out, and there's some general public notice, the Internet is out there; the report is also out there with whatever we recommend with respect to compensation. Compensation in limited situations in which we suggest this might be appropriate. We've got to remember, of course, that whatever we recommend doesn't necessarily mean it's going to happen. We're just recommending to the government situations A, B, C and D, whatever they turn out to be; and they may or may not decide to act in the direction that we recommend. So it doesn't follow that because we recommend something that in fact an entitlement is going to be created. But in any event, we'd set it out there. The database is out there, and what I'm hearing you say, Henry, is that -- I'm a little uncomfortable about saying we should flag the ones that are potentially compensible, only because I don't know that -- there's a tremendous amount of work in doing that, and so many that -- we might err in either direction; there's so little information on so many of the experiments in the database that -- DR. ROYAL: What about the ones that we just know are going to be compensated? DR. FADEN: If we had such, then I think that would be fine. I also think that if we had any, and particularly those that fell under the coverup category, those are easier. So I have no trouble saying -- DR. ROYAL: So if we know that an experiment is going to result -- participating in that experiment has a high probability of resulting in compensation according to our recommendations-- DR. FADEN: Assuming our recommendations are implemented, yes; and the coverup one is the most. DR. ROYAL: I guess you want to tell people that? DR. FADEN: We can certainly -- VOICE: After notified --? DR. ROYAL: No. They didn't clear publicly. DR. FADEN: That these are the two that we already know about that where a coverup occurred, where -- it's going to be like two. It's not a whopping number that would fall under the coverup category. But whatever it turns out to be, it will be a small number, and you can indicate that that small number falls within the category where a recommendation of compensation has been made, and people can do with that information what they want. Would be one way of dealing with the second. Another would be to hold out a higher standard -- your analysis, Ruth, or the way you were suggesting that we analyze it. My intuition goes towards if there is any affirmative obligation that we ought to impose to notify under this compensation, then it should go just to the coverup. Because of the same argument that warranted a higher government response, the wrongness of it, the fact that you can't know; in some cases it could be so varied and people are no longer living, that in the small number -- in fact, most of those people have been notified, we think. But we could put down that there should be a notification in those instances. Ruth, Pat, and Duncan. DR. MACKLIN: It seems there's another reason, too. What we finessed earlier this morning were a lot of questions of implementation under 2a and 2b, under those particular --. So we're not going to have classes of people, that is what's going to come out of that kind of analysis is individuals that can only be determined after these efforts at implementation. So unlike the coverup situation where the entire experiment was covered up, these other situations, in 2a and 2b, are on an individual basis. So even if we knew who was in them, we wouldn't know whether they were the individuals who would be entitled to the compensation -- DR. FADEN: That's correct. DR. MACKLIN: -- because of the further analysis that needs to be done. So there's a practical impossibility that -- DR. FADEN: That's not harm-based. That's harm-based. Okay, so we're working towards something. Pat and Duncan. PROFESSOR KING: I certainly hate to undermine your momentum -- [Laughter] DR. TUCKSON: But -- PROFESSOR KING: I always get concerned that under the guise of doing good, that we actually do harm. One of the things, listening to this scenario, none of which we have any control over, it risks, because of the increasing specificity that I hear, potentially doing more harm than good in terms of raising people's expectations. I actually think what works best in the long run is be very careful about what we think a coverup is, what constitutes a coverup in our view. And to give an example of coverup, and hope that what we persuade, whoever comes after us to do, is to adopt our view of what we mean by coverup. I guess I've been around a long time to know that when you see this kind of specificity coming out of the court when you now have to convince a Congress to pass legislation, it does nothing to say that if anything comes out, it will bear any resemblance to anything that we say here; and I just put that in as a real caution, because I think that that's a real problem in this area. DR. FADEN: It's right that we have to exculpate an example as the best way in some respects to do that. PROFESSOR KING: And then concentrate our attention on why we think -- what is coverup, why we think coverup warrants certain kinds of treatment, because this is our only opportunity to be persuasive. DR. FADEN: For what it's worth, we've will do that, completely and -- PROFESSOR KING: It's terrible to come in at the last minute. What I just heard in the few minutes since I've been here gets us more and more down that line. DR. FADEN: I am teasing you. PROFESSOR KING: I want to tell you, these days I'm not even teasable. Things go right over my head. DR. FADEN: I'm sorry. PROFESSOR KING: That's all right. DR. FADEN: Duncan. DR. THOMAS: It's not obvious to me that we will be able to reach everybody; so my question is, Do we need to have some mechanism -- I have no idea what mechanism -- to ensure that some sort of reasonable equity is, so that the people that, for argument's sake it may well be that the poorest people are the ones that are the hardest to reach, and the ones that are the least likely to be informed of their right to compensation. DR. LEDERER: And lack access to the Internet. DR. FADEN: That's why we direct them to the library. DR. ROYAL: But the concept is not that the individual would be doing the legwork; it would be someone else. DR. FADEN: We'll have to think about it as we write this up, because it is an important point. DR. THOMAS: A query from me, is there any precedent in the literature on class action suits --. I don't know. DR. FADEN: We'll look. It's noon and we have a choice here. One is to go to the nonnotification situations to follow up for purposes either of medical monitoring or epidemiological research, but not the notification for either of the purposes mentioned here. Or we go to the compilation population -- and I need to hear from the group what the preference would be. We have had no discussion, collectively, of recommendations, looking backward, for the population context. Obviously my bias is that we have at least some discussion about it. So is that okay? That means that we will have to defer until next time -- we do have the nasopharyngeal materials in your briefing books for this time, so we'll probably ask you to carry them over, and maybe we'll be able to provide you with some more information between now and then. We're now at what's called situation 5, somewhere in this big thing. DR. THOMAS: This is a disclaimer for people who work in the program. This was something that was never intended to see the light of day. The hope was that staff was going to turn this into something presentable, other than than my airplane ramblings. It didn't happen. DR. FADEN: I hope somebody asked you. DR. THOMAS: They did ask. In the interests of moving things along, I said okay. DR. FADEN: Thank you. I wish that I could ramble that well. DR. FADEN: What Duncan has done is very interesting. It's a little out of sync with the way we've changed it before; but it's basically the idea of taking the same kind of categories and moving them over and using it as a conceptual vehicle for thinking through what we would like to say in these other areas. But isn't there also in here, Anna -- we've got Ken Feinberg's comments and then we have the atomic bomb test as well. So that is attached. MS. MASTROIANNI: But we have comments from Lois. DR. FADEN: So we have Duncan's preliminary thoughts, and then responses from three other committee members? MS. MASTROIANNI: Right. DR. FADEN: Duncan's preliminary thoughts; Ruth, Lois and Ken. And then we have a separate attachment which concerns subjects of human experimentation in the bomb test. Hopefully, we can split our time between the two areas. PROFESSOR KING: Is it on the table to talk about the question of appropriateness of making any remedies, recommendation with respect to what we're calling here "population exposures"? DR. FADEN: Sure. Absolutely. that's the idea. PROFESSOR KING: Well, I would be so bold as to ask, what is the case of why we should make any recommendations here at all? DR. FADEN: Anybody want to answer? I think, as I said yesterday, we cannot afford the hard questions -- we cannot afford to avoid the hard questions now. Excuse me -- [Laughter] DR. FADEN: I'm glad you asked that question, because we need to get it out there and we need to debate it, and we have to see where we are on it, and we really cannot avoid any tough questions any longer. DR. THOMAS: It would seem to me that the rationale is obvious; that if people were exposed as a result of bad government activities and if people were harmed as a result and especially if there is a coverup, the situations for which you have already called for compensation on the biomedical side, it would seem to me be perfectly fair that those same principles ought to apply in the mass exposure situations. Those are three very big ifs, of course; and it is not evident to me, and we didn't have any examplies which qualify. But let's try to separate the principles from whether or not we have examples any of this. DR. FADEN: Ruth. DR. MACKLIN: We don't have any that qualify, but we do have analogs. I think the uranium miners provides a kind of an analog in that although as your memo points out, there's no evidence that the failures to warn the miners was motivated by an intent to deprive the miners of their right to fair compensation, it's abundantly clear that they were not told and there was a directive not to tell them about the risks that they were undergoing which, had they been told, might have enabled them to do something. We don't know what they would have done, and we know that there were harms, there was an incidence of harms. So maybe this is better taken case by case or area by area rather than asking the global question that Pat asked, and try to look at what were the cases, what were the population, were people not told was there actually or a high probability of harm; and I think the uranium miners falls into that category. DR. FADEN: Is that where you --? PROFESSOR KING: No, that's not where I was going. DR. FADEN: That's not what -- PROFESSOR KING: Where I'm going with my question is in part raised by Ken's memo, and that is that -- we make a series of justifications again to the remedies questions and biomedical experiments to begin with. That case becomes more attenuated, not at the level of principle but the level of practicality as far as I'm concerned, when we moved from biomedical experiments. So what I'm really trying to say is, if we can make those arguments, because I think this requires a lot of work to justify. And I am not clear at this stage whether I want to spend a lot of time on principle unless I am going to confront the practical questions. Ken points out, and I agree with him, that this is an area where Congress has acted. This is not like some of these other areas, so we have to be clear here what we're doing. My second concern is, having marched through those chapters that are at issue with respect to this issued yesterday, going through those chapters made me more uncomfortable with talking about remedies in this question because the chapters are so ambiguous. I mean, we haven't worked on them, we don't have them there in my head. You only have them in your head, but in my head, no. Ken's idea of where to pick up in terms of being appropriate to point out inadequacies of what currently exists with respect to compensation is acceptable, I'm not saying, I'm not concluding that I'm asking the bigger question of, what are we doing with these population exposures? This is almost a question that went back to those first one or two meetings of the committee where we agreed to delay and put off, that's why the group is sending the hard questions back with us, where we agree to avoid this question because it was raised early on. And the question is: Could you take these population exposures and cases, and feed back into our biomedical experiments? So that's the question I'm trying to confront, or should we march down this road at all. If we're marching down this road, to what end; because it would be nice to develop a principle argument, but at this stage of the game I would have a hard time starting on that, to develop the principle arguments unless I knew I was doing something more than just stating --. Am I clear now? DR. FADEN: Yes. Well, you're clear to me. There are two ways to approach this, and one is to start -- there are more than two ways. One is to approach it in the abstract, and sort of think things through. The other is to start as I think in part suggested by Pat's comment, practically and case by case and think about where we are in relation to, where the world is in relation to who we are. And you have -- when you say that the Congress has spoken, that's true for atomic vets and for -- PROFESSOR KING: Uranium miners. DR. FADEN: -- uranium miners, and downwinders, and Marshallese. Now that doesn't mean that there's nothing else perhaps this committee can comment on, but to act as if those laws don't exist and to start afresh would be a waste of everybody's time. Mark that in your memo as well, Pat. We have to be mindful of the fact that there have been responses by the government to these four situations. Now the issue is whether the government wants to say anything differently. In the atomic vets, the experimentation in relation to atomic vets' attachment, there is a proposal for what the committe might say is the context of the fact that the law exists, which is just getting very case-by-case and saying "Look, here's where the law is, here's what we've heard, here are some recommendations the Committee would like to make in the way of recommendations in the light of the atomic vets legislation. DR. THOMAS: While Ken does cite, the committee should not be interfering in areas preempted by Congress. He then goes on in the next sentence and says: I have no problem if the committee wishes to make recommendations to Congress concerning the minimum exposure levels for compensation, changing methodologies for recovery, et cetera. And it seems to me that's all that's being proposed here anyway. DR. FADEN: Right. That's what I'm saying; you start in the context of the existing legislation. It's about recommendations we might want to make, if any, given that Congress has taken a position. PROFESSOR KING: Well, I wouldn't start where Duncan started; Duncan started taking off of biomedical -- what does that mean, it carries back --? DR. FADEN: That's what I'm suggesting. It's a different way to --. PROFESSOR KING: And I think that if the focus is what Ken talks about, you'll start where Duncan started. DR. FADEN: That's what I meant to say about the two different ways to set it up. I'm sorry, I wasn't as clear -- you just start with what the reality is, and then how the committee can contribute in the face of that reality, rather than theoretically and principally and all that sort of stuff. DR. THOMAS: There's another point I want to make here, and that's that we can make -- Ken seems to have reopened the door to some fine tuning of the recommendations for the groups in which it's already spoken. But in some of them, the question of whether or not we are precluded in making recommendations in areas that Congress has not addressed. Now, there may not be any such that we wish to make recommendations for; but for as I said, downwinders of nuclear plants might be an example, and there is language in here relating to Green Run, which seems to me precluded by anything that Ken has said; inasmuch as far as I know, Congress has not made a conscious decision not to include them. DR. FADEN: And Green Run is a special case, because we did get the intentional releases as a category. So that isn't important to acknowledge. DR. OLEINICK: Can I say something? DR. FADEN: You certainly can. DR. OLEINICK: Acknowledging what Pat said and setting it aside for the moment, although Congress has spoken, Congress has not specifically spoken to the issue of the experiments. It has spoken on the issue of the exposures of these populations. And if we can use an analogy to biomedical, one of the significant harms is the dignitary harm of the absence of consent to the experiment. So that may provide us with the rationale for suggesting just what we're saying, or even adding to it in certain specific cases if there are cases that we think we'd like to single out. Because we haven't really done that in any of these issues. We're saying that Congress has spoken, there were exposures, and "Let's just make it easier for people to gain access." But we haven't really talked about the issue of the experiments, per se, which is what we were asked to address. I'm not sure I have a solution to that problem; I sort of bring them up, usually, but don't solve them. I leave it to my colleagues to solve these problems. But I think that since we were asked to address experiments, we ought to at least comment on them. DR. FADEN: So the issue is, is there anything in virtue of the fact that some of these people, in some cases in all of them, were subjects of experiments in addition to having been exposed. DR. OLEINICK: Being exposed, exactly. DR. FADEN: Or as part of being exposed, is there anything additionally that we would want to recommend. DR. OLEINICK: Well, they will be getting an apology. DR. FADEN: Of sorts, because -- DR. OLEINICK: Well, they got an apology for the exposure. DR. FADEN: Well, there's another apology. PROFESSOR KING: I hate to tell you what I think about -- but go ahead. DR. FADEN: So you're right. We put the Green Run away because there is no legislative response to the Green Run situation itself. DR. ROYAL: But what we did with dignitary harms in the individual case was, we did an apology for the dignitary harm. So, conceivably, where compensation programs are set up, you could send out this additional letter. DR. OLEINICK: Yes. That might be all that's required here. DR. FADEN: Duncan. DR. THOMAS: We're sort of jumping back and forth here, so I'm going to make another jump here; just looking at the atomic bomb test memo, this again appears to me -- it says two things, in summary. One is -- DR. FADEN: Let's everybody get there first. It's right before the yellow, the next yellow thing? By Attachment 2, in this sequence, is that where you're turning? DR. THOMAS: Yes. It says at page one, lines 17 and 18: Experimental subjects who were covered by these statutes should avail themselves of the existing remedy. So that's certainly well within the limitations that Ken has imposed on us. And then page two, it goes on to make a number of specific recommendations, both in the items you want to fall at the top of the page, and the items 1 and 2 at the bottom of the page, and both of those seem to me to be within the category of fine tuning of existing statutes, which is also foreseen by Ken. I think some of these fine tuning recommendations certainly need some considerable discussion by us. DR. FADEN: This issue is do we want to -- this was the time set aside to do that if we wanted to do that, or we need to start generating serious dialogue between now and the next meeting about whether these are the specific recommendations; but this is a model. One model we do is where there is existing comments, existing remedy, the two guiding approaches would be: Is there anything that has to be done in virtue of the fact that some of these people covered by this existing remedy were experimental subjects. If that only means an additional apology, so be it. If it means more than that, fine; and then is there anything the committee wants to recommend in addition in the way of modification or a change to the existing statute in light of what we had been hearing in public testimony or from our own examination. PROFESSOR KING: What I wanted to ask was, what does our own examination consist of? I mean with respect to -- DR. FADEN: Was there a basis? That's correct. PROFESSOR KING: What is our evidentiary basis for this set, or any other set, and I'm going to put to one side public testimony because I think public testimony provides a basis for asking -- it minimally can provide a basis for asking that others examine the issues that were raised, so I'm not putting that question on the table; I think that's easily done. DR. FADEN: How about if we use the atomic vet just as an example? What you're asking is, what is the committee's independent evidence based on which this document, this draft document that Duncan drew our attention to, makes these recommendations for changes in the legislation. Dan, do you want to add to that? MR. GUTTMAN: Yes. It's simple and straightforward. We've heard the atomic vets, quite a few of them, and they've got several things that they're consistently saying. One is that the list of diseases -- DR. FADEN: Pat just stopped you. PROFESSOR KING: I said that what seems perfectly in order is to say as a part of our responsibilities, the committee has received testimony that goes to whatever we want to say; they seem to have serious concerns we can do all of this, and we can recommend that these concerns be investigated and somebody cut loose of them. What I want to know is, do we have any independent sources that say that the committee should stand behind a recommendation to do X versus a recommendation to do Y? MR. GUTTMAN: Yes. I think this answers the question: We're saying two things that are substantial. One is that there is a law that the table of diseases; Duncan pointed out it hasn't been updated. So that's relatively straightforward. DR. FADEN: The law says it has to be updated. MR. GUTTMAN: Right. DR. FADEN: So we're saying, please do what the law says. MR. GUTTMAN: The other one, which unfortunately is very, very unsatisfying but nonetheless necessary is that everybody said the system is not adequate -- in terms of processing. This is a better management recommendation. We have people who are telling us, one person who testified in Cincinnati said "I got my appeal, can you help me out?" He sent me a letter he got from the VA. It was a form letter -- DR. THOMAS: She's asking -- not public testimony. Is there anything like a GAO report? MR. GUTTMAN: No, no. That's what I'm explaining. And so it says in this form letter, you will even begin to get your decision in less than 24 months. So we sent it to the Secretary of the VA and said "What's the story?" He said: Well, that's the reality. We don't have -- the way it works now, you've got a veteran who is going to take at least 24 months to get the -- now, I don't know whether we saying anything could do anything about it, but that's something that exists as a real world problem. DR. FADEN: So if I could, the evidence is that the official from the VA confirms to our staff that indeed, it does take the 24 months -- PROFESSOR KING: The processing time is too long. DR. FADEN: It takes 24 months. MR. GUTTMAN: Yes. DR. FADEN: So it's not really that people have said to us it takes too long, we check with the VA and they acknowledge that's that long; and then we make the judgment that it's too long. DR. STEVENSON: Is there a way to find the original guidelines for the compensation for these veterans? There must be something written along that would qualify -- that we could go down and say, have you met the very prescriptions that you've put out, whenever they did this. I mean, just go down the list and check it. MR. GUTTMAN: I'm sorry, could you ask that a little more clearly. DR. STEVENSON: Whenever the compensation law for the atomic vets came into being, there's a written document. And whatever the VA was going to do in terms of that compensation and remedied the qualifications that -- MR. GUTTMAN: Yes. DR. STEVENSON: -- qualifications that would require, criteria that would require -- and the fashion by which these claims were going to be processed. There must be some document in the VA, of all places. PROFESSOR KING: The rules and regulation for -- DR. STEVENSON: They can't even cross-check -- MR. GUTTMAN: This is a complex subject, but I think I can make it simple, maybe erroneously simple. But there are three concerns that we've heard again from the vets; putting aside -- some are experimental, most are probably nonexperimental. One is that the list of how you get a presumptive -- how you get an automatic benefit is too narrow. Well, the answer -- well, scientists should study the list and see if it should be expanded. That's already provided for, it should be -- as Duncan is saying, it's got to be done. And we don't know here whether it should be expanded or shouldn't be. The second is everybody is saying that the system is broken down, it doesn't work. The good news is that the VA agrees, it's true. The bad news is that, having said that, you know -- DR. FADEN: So we recommend that they should fix it. MR. GUTTMAN: Right. The unfortunate news is that it's a valid recommendation, it seems to be unexceptionable; it's got to deal with the real world, with the money and all those things, okay? There is a third level that I understand I'm not probably articulating; it's this question, is a second category of eligibility getting into the system. One is if you get a certain kind of cancer; and the question is, do you restudy that and broaden it? The second is, other things where you may have to prove your case, and that gets into the dose reconstruction and all that kind of stuff. And that's the one that is, Henry and Duncan, that's a very difficult, murky areas. Obviously it goes to 99 percent more than the experimental. DR. FADEN: Can you do this, Dan? Is there anything in this document that speaks to this working area, this draft document? Do you have a recommendation that speaks to the -- MR. GUTTMAN: No, we don't, directly. One other thing I want to mention, just to be completely clear: The other problem that the vets have -- and I hope I'm saying clearly, there could be a lot of things -- the one that's come to our attention is that the current was "Don't cover everybody, they only cover atmospheric exposures." They have people who are cleaning up radioactive messes in some of these tests. Now we have not found any of these so-called experiments, to use the term, in those situtations so that that wouldn't be tinkering with something within our jurisdiction. But that's something that we point out here. There are four areas -- DR. FADEN: So we could say it should be reviewed. MR. GUTTMAN: Yes, right. Two of them seem unexceptionable, and the other two is a very difficult problem which requires attention but it isn't clear what -- DR. FADEN: What we can do about it. MR. GUTTMAN: Not what we can do about it, what the solution is. If we had a solution, people would think it's terrific. DR. FADEN: Nancy wants to comment. DR. OLEINICK: Dan, I don't know as much about the workings of the government as you do, so you can correct me, but it seems to me that in this case, the atomic vet as well as some of the cases which are not going to be handled by the VA and some of the biomedical experiments which are clearly not going to be handled by the VA, what is needed here is an ombudsman, somebody who can assist the citizen who needs to gain access, because most citizens have a very hard time; they fill out the form and it disappears in the system for 24 months. Is there any way, is there anything that we can recommend that would help these folks to -- MR. GUTTMAN: Yes and no, and I defer to Pat. Because this is your -- everybody that we -- DR. OLEINICK: Pat immediately looked pained when you said that. So evidently, this is not a good suggestion. MR. GUTTMAN: Right. The difficulty with all this is once you go into any agency they say "Oh, we have an ombudsman, we have such-and-such." You call 800 --- and you get a subcontractor on the phone. DR. OLEINICK: And you get a voice mail where you press 2 and it takes you to a dial tone. MR. GUTTMAN: Right. So it's like they recommended informed consent 40 years ago; right? So that's the answer to that one. We can recommend it, yes. DR. OLEINICK: Well, it's come up in a number of issues. How does the citizen gain access to the system that is supposed to be for the benefit of the citizen who has already suffered some harm as the -- MR. GUTTMAN: Let me give you a more serious answer. I think now the problem is, as I sense in talking about this with Harold Gracey, who is terrific as the chief of staff for Jesse Brown, is now you're getting the confluence of the government resources problem; with the good intentions problem. So that people run around and say "we'd like you to be more efficient" and the reason that Harold Gracey says they're not processing these claims is due to administrative logjams. I think that's what he said. So this is the -- I may have misstated what he said -- so he can state it for himself. PROFESSOR KING: The reason I asked this, I think this poses a real world question for us. It is one thing to feel good. You can feel good by pointing on anything that is wrong with the government, not only in this area, but in all others. So that's why the pain, there's a lot more government. The strategy question is, at some point we have to decide where we're putting our marbles, and I've always been on the side of, you decide where you're putting your marbles, and it may be a sacrifice sometimes of the more general kinds of recommendations you would like to make. That's a committee strategy call, that's not my call. It's a collective call; but it seems to me that that is in part why I seem to be so -- I guess I'm just tired, but why I've asking such tough questions I think because it is a real question about whether you do a scatter gun approach or whether you decide that there are some issues that are so serious that what we want to have happen, we take so seriously that we don't want to get aloft within the broad range. That's what I want people to keep in mind. That's why I'm being real hard nosed about some of this. DR. FADEN: It's true and it also turns, not only in the context of looking backward, recommendations looking backward, but the looking backward recommendations against the looking forward recommendations, and how we're going to say, if someone turns to us and says, Well, there are three things that you want to have changed in the world as a consequence of this committee's experience. What are they? That doesn't mean don't speak to other things, but what are the committee's top two priorities when we're finished here with respect to how we'd like the world to be different? PROFESSOR KING: I'm not suggesting we answer it, either; but we need to keep this in mind as we're doing some of these things, rather than -- DR. FADEN: I thought a lot about it, too, and I don't mean to say that you are restricted or we should restrict ourselves to two or three or any particular number; but you can't have 36 things that you want to have happen as a result of this committee's experience. Because it won't work that way. Duncan? DR. THOMAS: Pat, it seems to me there is some carefully crafted language here on page 2, line 15 through 16, which at least partially addresses your concern about the marbles. And it begins by acknowledging that these concerns do not bear exclusively or in some cases directly on human experimentation. And it goes on to say: But nevertheless, the committee believes that it merits serious attention. It then goes on and says: Since our focus here is on human experimentation and we recognize there is some human experimentation with the bomb tests, that therefore anything we could do to improve this system for vets generally, we'll work to the benefit of those whose claims we are justified in saying something or other about, but from the point of view of equity, we see no reason to distinguish the vets and not elaborating a little bit about things that aren't quite in this text. From the point of view of equity, we think that any benefits which we managed to win for the experimental veterans should apply to the atomic veterans generally, and these are our two specific recommendations and we want to emphasize. PROFESSOR KING: That is precisely the problem. It was those sentences and those words you read that made me say "What are we doing?" Because if you put in language which says "As a matter of principle, everybody should have access to this." What you're really doing is offering a way for people to say "do nothing." That is a part of the -- DR. FADEN: At least there's a risk. PROFESSOR KING: There's a risk of that. That's the only thing I'm talking about. DR. FADEN: Can I step back just a second? If we're going to take it to the country, Dan summarized two recommendations in the context here of experimentation in relation to the bomb test that nobody seemed to have problems with. Okay? The language here can be tightened up to reflect that. I'm just trying to get to quasi-closure on something. One was a recommendation that the government do what it says and take a look at its list, and the other was that somebody do something to try to shorten the horrible process. It's like crying in the wilderness, but at least we can add our voice to the chorus. Does anybody have any trouble with those two recommendations? Obviously you have to pass on the exact language. DR. THOMAS: I support the language. Particularly I like the words "all of them merit serious attention." Actually it's stopping short of making a strong recommendation, saying "the government must do this." But it is saying these are justifiable complaints that really ought to be thought about. DR. FADEN: The other two areas that Dan made reference to the murky stuff, we really can't endorse murky stuff without stuff in writing. So it's only partially written -- since it's not here in this draft, can we get some murky stuff written down and then we can see if there's something that the committee generally can be okay. Unless you see it there already done. DR. THOMAS: No, no, I don't see it here. I specifically wanted to add a bit of murk to your item 2. DR. FADEN: What page are you on? DR. THOMAS: I'm on page 2, line 7 and 8. Standard of proof for those -- blah-blah-blah -- was impossible, and given the questionableness of the exposure records where -- inappropriate, I have a picture of what I want to add. MR. GUTTMAN: Actually, I'm not sure -- I don't know how that got in there. I didn't recall seeing it. I think that was -- that was a different draft. But in any event, there it is. So go ahead. DR. THOMAS: Well, the concern I have is what some people might call inappropriate stewardship of records in the first place, and so on. The loss of records in a fire. Nobody is saying that this was a deliberate attempt to preclude coverup, I mean preclude redress, but it certainly has that effect. It puts veterans in an untenable position, where they have to prove the existence of records that don't exist. MR. GUTTMAN: It seems to me that what this does is focus again on this question of record keeping which a couple of people, I talked with Reed and -- that one of the essential questions of all of this, looking backward and forward, is who bears the burden when the government doesn't keep -- it's that policy question. And this obviously is another cut at that question. DR. FADEN: It's the same as you were discussing earlier. MR. GUTTMAN: This one, I frankly don't know how it got in there. I think Anna must have put it in there. MS. MASTROIANNI: Personally. [Laughter] MS. MASTROIANNI: No, I don't know where it is. MR. GUTTMAN: There it is. I know those things -- I'm not standing here arguing for number 2. DR. FADEN: Here, I think we may not be able to do too much more on the -- maybe we could try. I would like to get a sense in the other two categories -- I thought we once had language with respect to intentional releases. Other than in addition to Duncan's approach. MR. GUTTMAN: The thought would be intentional releases. The generic question in intentional releases was sort of -- if the downwinders get such and such, and the atomic vets group, why not, then what was establish the conceptual -- Duncan, was that not it? It wasn't a biomedical analogy, to advance on - - DR. THOMAS: What are you referring to? MR. GUTTMAN: The intentional release remedy concept is that it's statutory -- for the -- DR. FADEN: Can we get Gary to join us for a minute? Just get Gary to join us for a minute. I know we had - - it wasn't circulated to the committee, but the general structure was a long one, Dan described. MR. STERN: Right, there was a proposal, or a draft suggestion that with respect to intentional releases, that if -- well, there's a dual analogy. One was, like with the atomic vets, that intentional release might have only been a small subset of a total release from or accumulated release from a particular site, and if -- DR. FADEN: The Green Run relative to everything else that was all the routine releases. MR. STERN: Right. And therefore we can't just focus on the Green Run, but if the accumulated site, the accumulated releases were determined to be of -- you know, cause problems in the same way that they would to the downwinders, then those people in those sites at Hanford, Oak Ridge, or any of the other facilities should be treated the same as the downwinders are treated now. DR. FADEN: The basic structure was a sort of argument from fairness, that the health studies that are being done show that there's a concern of the same order of magnitude of other communities that have received congressional relief, then the people who are in that category ought also to receive similar congressional relief. Some language like that. See, here's the problem: The problem is exactly what we have with the atomic vets. The atomic vets, we got technically as territory only the human experiments and relation to the atomic vets; but as a practical matter, it's almost peas in a pod. With the Green Run, we got the Green Run, but to separate the health effect as we discussed yesterday in the chapter, if there are any, from the Green Run, from all the other routine releases that occurred at that site that did not fall under the charter, is impossible. So if you're going to say something about the Green Run, it's all sort of folded in. You start to work with it, it just evaporates; you can't do anything with it because of actually what happened. So the notion is just to acknowledge that; to say that what we were given is, you can't from the perspective of thinking through have the government respond; you just can't isolate the effect of that release from everything else. I don't know what the term is, but it certainly doesn't work, doesn't make sense as a human matter and also as a logical matter; you can't tease it apart. So the argument is, we're not saying what ought to be done in the specific way; we're simply saying when the health studies are finished, if it looks like they're in a situation paralleling other contexts in which there has been congressional action, that there should be a parallel action done for these folks. The health studies aren't completed, right? So when they come in, if it looks like it's the same kind of a picture, as a matter of basic fairness, they should get whatever else Congress has done for people who have similar exposures of that sort. Does that general approach seem -- now you'd have to see the writing. I'm not asking you to vote or anything like that. PROFESSOR KING: Also, it's not only a question of writing, it's also a question of where it is. We haven't seen the full report yet. We see a lot of reports, they are in the bodies of chapters, lots of things where you make the points that you want to make. Some of those become recommendations, some do not. DR. FADEN: Good point. PROFESSOR KING: So the heart of the question is what you say; the second question is where do you say it? DR. FADEN: All right. What is your thought on that? PROFESSOR KING: Actually, you're going to hate me, but I'm waiting to see the development of the chapters we discussed yesterday; because I can go to those people who are prisoners of how well the argument is made in the basic chapters, in terms of where it leads me. I think if people will read it, that's what they should have in mind; whether you want this to be at the level of recommendation as an executive summary and highlight it, or whether you want it to be as part of your chapter discussion, I think that people here feel strongly about that. So that's one of the things we should keep in mind. So we haven't gotten to, you haven't seen the full report yet. DR. FADEN: It can also be in both. PROFESSOR KING: Well, it would be in both -- DR. FADEN: Right, it's got to be in the chapter and then -- so you're seeing some things only in the chapters. Depending on how you want to feature it, is really what you're saying. Depends on how you want to feature it, it appears more than one way. So that's the general approach that now would be blank and people could look at it, in addition to this issue. DR. MACKLIN: Say that again? DR. FADEN: The approach that Gary and I just laid out, obviously it's a sketch, but it's laid out -- seems to be generally worth pursuing, and we would get the language down and leave aside for the moment Pat's point about whether these things are featured -- anything is a featured independent recommendation, in addition to a conclusion drawn in the chapter, or both. Or neither, or whatever. PROFESSOR KING: As a practical matter, that's the way reports look. Not everything that's in chapters makes its way to recommendations, but nothing that's in a recommendation that wasn't first in a chapter. And it is often a major discussion about where something goes. DR. FADEN: Right. Which gets to this issue of what are you featuring. PROFESSOR KING: Where do you put your marbles. DR. FADEN: Thank you. DR. MACKLIN: I have an observation; I haven't said anything in a long time. DR. FADEN: I noticed. DR. MACKLIN: I haven't had anything to say, but it's confusing and it seems to me what emerges from this discussion is a strong dis-analogy between these parts of our charge and the biomedical experiments. The inability to separate out what those atomic vets who were subject to these experiments and all the others is strikingly different from anything that happens in the biomedical experiments. We didn't have any trouble distinguishing -- it may be hard to identify people, it may be hard to find out who the people were and what the harm was and all that stuff, but there's no larger class that also, in all of the biomedical experiments, no larger class of people who are treated similarly and are therefore deserving or may be deserving of some kind of remedy. So I'm now thinking that the attempt to show similarities between the intentional releases and the biomedical categories of experiments may be a mistake conceptually. I mean, we can still say what we want to say about the remedies, because of what happened to people or what the government did or the secrecy or whatever, but I don't think we should try to force analogies where they don't exist. We have talked all along about lots of different kinds of dis-analogies, but it seems to me the biggest dis-analogy is that the people who would be the subjects of experiments, however we would describe them, are indistinguishable from huge numbers of others. Downwinders from Green Run, etcetera. Now it seems to me that has to -- I don't know how exactly it feeds in, I don't think it specifically undercuts what you were saying about what might be owed to these people, but I think we somehow have to say -- I mean, this is a function of the charter and the things we were asked to look at, and to try to cram in the analogies where they don't fit, leaving us with this odd position of not being able to say anything at all the other atomic vets or saying something that goes beyond what we're supposed to be saying is just difficult. So I think to spell out when it comes to these sets of things, they're such a big dis-analogy, because the class of people that we would be authorized to talk about is in all other respects virtually identical with a larger class of people. That's why I found this discussion difficult and hard to draw some conclusions on. PROFESSOR KING: That's why she put it off for months. DR. FADEN: Well, it's also why it was treated as situation five, rather than "let's try to make it" -- what Duncan tried to do is very important, because I think it pushes us to see whether it works or not. But the original thinking behind segregating it was because of the local concerns. DR. MACKLIN: But these now seem to be overriding. I don't disagree with what Duncan tried to do. It's not an argument against that attempt. If we were -- but the argument is only on the fairness or justice grounds or whatever, it's not that this attempt to draw the analogies as far as they go is inappropriate; it's just that it leaves out all the much larger class of people treated similarly but who do not fall under the so-called experimental rubric. DR. FADEN: It leads to awkward, whatever, restrictions or something. Duncan, you wanted to respond? DR. THOMAS: I seem to have lost thread of the argument here. In writing this memo, it became crystal clear to me that these analogies don't work very well. And I thought where I was hearing the discussion going over the last period was to move away from that sort of thing. DR. FADEN: So you're agreeing? DR. THOMAS: So you're expressing the sense of the meeting, are you not, not quarreling with what we've done. DR. FADEN: No. DR. MACKLIN: I'm not quarreling. I'm trying to give an overarching, some general analysis which is going to have to come by way of perhaps a justification for the inability to treat this class of individuals in the way we have treated and thought of for recommendations, the biomedical. DR. THOMAS: That helps me a lot then, because I sense in this agreement that we make a rationale for certain changes in existing statutes on the grounds of fairness and fine tuning and so on. PROFESSOR KING: Fine tuning is not quite the same as fairness. DR. THOMAS: I didn't mean to imply that. PROFESSOR KING: They're vastly different things. DR. FADEN: Just like everything else, there has to be a justification. So whether the justification is fine tuning fairness or both, it will be out there. And then the committee can say yea or nay to each -- and I'm sorry, Duncan, you finish your thought. DR. THOMAS: Well, it was another thought. DR. FADEN: Go ahead. DR. THOMAS: I just wanted to point out that the way that I had drafted this, trying to force this into boxes that didn't quite work, I ended up putting Green Run and the nuclear downwinders under situation 3, and I just don't want this to be noticed now by somebody afterwards who is charged with the problem of coming up with the next draft and not knowing how to deal with it. I think we should give the drafters some guidance as to what the committee thinks here. I like Ruth's suggestion that the appropriate way to deal with Green Run is, they should be treated just like other downwinders, if that's what the outcome of the epidemiologic study should eventually show. And hence it really properly belongs in what's called here situation 2. In other words, all we would do for downwinders is those who developed endpoints which had been shown epidemiologically to have a causal connection would then be eligible for the same kinds of compensation that are foreseen for downwinders in the existing legislation. That's not what's written here, which is a proposal from some sort of expanded medical monitoring program. I tossed this out as a suggestion for debate; it's not one I want to support particularly aggressively. DR. FADEN: I would propose we not pursue it. DR. THOMAS: That's fine. DR. FADEN: Only because -- well, for a complex of reasons. And it's good to get it out there so it's not confusing. This has come up before, so if anybody is listening, we have lots of pieces of paper marked draft everywhere, okay? And people need to understand that when it says draft, it's draft, whether it's offered by a prior committee member, it's offered by a staff member or a combination, it's a draft. And it doesn't mean that this is what the committee is going to conclude. It's accurate, it's inaccurate, it's whatever; it's a piece of paper that says draft. We've had some issues about this one, just taking advantage of this opportunity. Thank you, Duncan, for framing the staff, getting closure on that. In general, if you find something that's from the committee and it says "draft" on the top, that's what it is. It's a draft. It doesn't mean anything other than that, the committee is looking at it and may decide that it's perfect and wonderful and may decide that it's awful and stinks. DR. TUCKSON: But it means draft, though, right? DR. FADEN: But it means draft -- [Laughter] DR. FADEN: It means draft. It doesn't mean anything else. I was just taking advantage of an opportunity to say that. DR. TUCKSON: It means draft. DR. FADEN: It means draft. It means draft. Okay. So we've got something going with the atomic vets. The atomic vets thing, I think enough direction to the staff to know how to type this up. I think we're okay. The intentional releases that were absent the language, everything is in the wording and the language, but the general thrust has been endorsed for development and that's very helpful. Uranium miners, we don't have. We need to do that same sort of specific, in the context of the legislation is there anything we want to add? And mindful of -- you know, if the research -- remember that a lot of these, particularly the experience with uranium miners, we may want to respond as much if not more with respect to the forward-looking stuff. You know, as anything else. And with the Marshallese, similarly we have some -- there the issue seems to be access to documents. MR. GUTTMAN: Participation in the research decision- making process. DR. FADEN: Where the request, the issue has emerged. And we will come up with language, and then that relates to research, so it is part of what we're dealing with. The research enterprise of relationship with the Marshallese, and not the other aspects of the relationship with the Marshallese. Yes? DR. MACKLIN: Seeing as, although they were not biomedical experiments strictly, and the research aspects did not pose an additional risk, nevertheless to the extent that the subjects, the individuals were not told that they were research subjects and in fact in the case of the Marshall Islanders, believed, or at least some believed that they were being treated, it seems to me we do need to say something by way of parallel with what we're saying about the subjects who are not disclosed or not informed that they're being studied. DR. FADEN: They get an apology if research intervention didn't generate a harm. DR. MACKLIN: Well, since we were calling these experiments of opportunity or we have a new word for it, observational studies, they are still subjects of study. DR. FADEN: Yes and it's also not, whether people were harmed from the research intervention, I have no idea. I really don't understand all the things that, all the research interventions that may have been introduced with all the follow- up studies that have been involved with the Marshallese. I don't know. That remains an open question. As Henry points out, there are lots of things that are done to people, medical monitoring or epi studies or anything else, all of which carry some small chance of risk. We've had our endless discussions about nanocuries, but you can go beyond that to biopsies and anything else -- we've never gotten like a protocol. DR. MACKLIN: Well, we do however, for the former uranium miners, because those studies are still going on. DR. FADEN: Well, the Marshallese are still --. DR. MACKLIN: And they are now taking biopsies in the Marshall Islands. DR. FADEN: So in other words, your first comment about its being different, totally different, it's kind of case by case. DR. MACKLIN: Well, it depends on what it is that's totally different. The releases, the environmental releases are totally different. But observational studies of groups where the reason they're in our purview is because these studies were done, becomes low risk studies but ones that the subjects had no idea that they were being studied; and may have falsely believed that they were receiving some kind of medical care. DR. FADEN: That they were receiving -- DR. MACKLIN: Yes. DR. FADEN: Or they were receiving medical care, and in some cases they were. We can't tell the difference. DR. MACKLIN: Right. DR. FADEN: You're right, it just adds to the complexity, which is why I think that all of this leads me to -- it's why we have trouble writing these chapters, they're different. Each one of them is different. With biomedical experiments we finally ended up with two classes. We think that it's going to work to think this through with therapeutic and the nontherapeutic, that it will help with some of the stuff. With this one, each one of them is -- it places different kinds of ethical issues, different kinds of research ethics issues, and that's been part of -- DR. MACKLIN: I think one of the -- from an ethical perspective in a low risk study, one way of -- we've been talking a lot of course about consent, permission. But there was also an element of deception which went beyond failure tese, and not the other aspects of the relationship with the Marshallese. Yes? DR. MACKLIN: Seeing as, although they were not biomedical experiments strictly, and the research aspects did not pose an additional risk, nevertheless to the extent that the subjects, the individuals were not told that they were research subjects and in fact in the case of the Marshall Islanders, believed, or at least some believed that they were being treated, it seems to me we do need to say something by way of parallel with what we're saying about the subjects who are not disclosed or not informed that they're being studied. DR. FADEN