UNITED STATES OF AMERICA - - - - - - ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - - - - PUBLIC MEETING - - - - - - TUESDAY JULY 18, 1995 - - - - - - WASHINGTON, D.C. The public meeting was held in the Executive Chamber of the Madison Hotel, 15th and M Streets, N.W. at 9:00 a.m., Ruth Faden, Chair, presiding. PRESENT: Ruth Faden Jay Katz Eli Glatstein Lois Norris Nancy Oleinick Patricia King Henry Royal Mary Ann Stevenson Philip Russell Susan Lederer Kenneth Feinberg Duncan Thomas Reed Tuckson STAFF PRESENT: Anna Mastroianni Dan Guttman Lanny Keller Jeff Kahn Gail Geller Shobita Parthasarathy Sara Chandros Steve Goodman Jeremy Sugarman Nancy Kass P-R-O -C-E-E-D-I-N-G-S (9:15 a.m.) MS. FADEN: Good morning. Should we start? MR. GLATSTEIN: Guess we better. MS. FADEN: Good idea. I'm sorry. I was caught in traffic, I was a few minutes late. Okay. Good morning. We're going to keep to one part of the agenda as it was, which is at ll:00. After the break, we're going to turn to the RPRP and the SIS, because Nancy, Jeremy and Steve are coming just for that part and had arranged their lives for that part. So, they're coming in from Baltimore for that. So, wherever we are, we'll stop at 11:00 and turn to that as a courtesy to them. I think my own inclination at this point is to proceed into recommendations that are backward looking. We have agreed to do TBI on Wednesday because some of us -- MR. GLATSTEIN: You don't want to finish the findings? MS. FADEN: We've finished the retrospective -- I'm sort of trying to do backward looking findings and then forward looking findings, so we can march all the way through the findings except for the backward looking findings, except for the finding that connects with chapter 4, which we wanted to wait and do together with chapter 4, and except for the finding that goes with the observational chapter. So, I thought if we held those -- did I get that right? Those are the two findings in that first series that looked to the past. Is that all right, if I do those findings with the chapters? MR. GLATSTEIN: That's fine. MS. FADEN: And now just do the recommendations that look to them, which we have been calling remedies for the past, and then pick up with those two chapters. The two residual findings and we turn to them when we do the chapters, if that's agreeable. And the way it looks at this point, it looks like we will do those two chapters, and chapter 4 on Wednesday. Today's Tuesday, right? Yes? Thank you. Henry, you said Tuesday? MR. ROYAL: Yes, it is Ruth. MS. FADEN: Thank you. We have a new motif in addition to it at the end of the day - which we need. So, if can turn to chapter 19. Wait a second, I just realized my recommendation section is out of order, but that's okay. I think I've got it. I've got it. So, basically, both the recommendations and the findings are split into two parts. Findings for the period 1944 and then, recommendations for the period 1944 to 1974. We're on page 1 of the recommendations, which begins now, with apology and financial compensation for subjects of human radiation experiments where government kept information secret to avoid embarrassment or liability. And that's the first recommendation that's up for discussion. Any comments on recommendation 1? If not, I have a comment, as much as I've worked on this, Jeff and Dan -- I'm wandering whether we want to make it specific -- oh, Lois, yes, please. MS. NORRIS: This is a question, because I don't understand the sentence. This is on page 2, line 17, 18 and the first word on line 19. That sentence is simply not clear to me. Or the meaning of, "secrecy was preserved even though at the time justice might not have required -- " MS. FADEN: It's wrong. You're quite right. Two things run together. One thought is the thought that, even though, at the time, even though at the time, had they sued, they might not have gotten anything. It's still the case -- right, you're right -- it doesn't, the two thoughts don't go together at all. They ought to get something now because they were barred from the opportunity of finding out whether they could get anything. MR. NORRIS: I thought that's what you were -- MS. FADEN: Yes. It's a word problem. I mean, a language problem. Jeffrey, are you taking good notes? Good, because my pen just died. MR. THOMAS: Another small point, can we just make it very clear that this is for the biomedical experiments. MS. FADEN: Yes. The heading is biomedical experiments, Duncan. So that there's a separate -- we'll have to come up with a formatting mechanism that makes it clear what the subheading of what -- but, we've basically divided the recommendations now, for the period of 1944 through 1974, first into those that speak to biomedical experiments, and then those -- skipping ahead here, -- MR. KATZ: Ruth, on page 2, on line 7-8, why is it urgent during World War II? I must of missed something. MS. FADEN: Because we don't have any evidence that, in the TBI experiments that occurred after the war, there was this kind of deception. I think what's not clear in the heading, what has to be made -- if this is now going beyond the issue of whether they obtained a consent that would be worthwhile or not, this first recommendation speaks to information being kept secret from people because the thought was, they should not know that they were in experiments at all. MR. GUTTMAN: The Cincinnati experiment is public in that sense. MR. KATZ: Public in the sense of -- MR. GUTTMAN: Not classified if you wanted it to go -- MR. KATZ: Oh, I see, system. MS. FADEN: This first one -- I think, also, we need to make clear, this is what I was going to raise in the bold language of the recommendation itself, that we're talking about keeping the information secret from the subject so they couldn't pursue -- I mean, the people at Cincinnati, at least, knew they were getting treatments. What's in dispute is, whether they were told anything more than that, or told anything relevant about the purpose of the experiment, or the risks, or the risk of death. But in the case of the three that are listed here, it goes beyond that, it goes to an active program of lying to people, making sure -- trying to make sure -- they didn't even know that they were -- MR. KATZ: I didn't read it carefully. Is that clear in the text? MS. FADEN: Well, if it's not, we have to read for that. MR. GUTTMAN: Let me make an important distinction for the record. It might be argued that anytime there's not informed consent, the secrecy in that sense -- MR. KATZ: Yes, yes, yes. MR. GUTTMAN: What we're saying here is, put aside what was going on between the doctor and the patient. The United States Government looked after the experiments and gathered some information, we can disclose it, it's not national security information, but let's keep it secret instead. So, we're focusing on the conduct of the government. What went on between the doctor and the patient, as we know in the plutonium experiments, may or may not be clear. MR. KATZ: I'm not sure, I haven't read it that carefully, but if that's in the text, it can be easily clarified -- MS. FADEN: Yes, if you read lines 8, 9, and 10, of the rationale, the focus is on public officials entrusted in sensitive government positions concealed. MR. GUTTMAN: Yes, 8 lines, 8 to 10 in the bold face recommendations on the government. MS. FADEN: I think we need to make the heading clearer. " -- kept information secret to avoid embarrassment, liability, and in particular, secret from the participants and their families." Yes, Henry. MR. ROYAL: Beginning on page 2, 3 to 4, it says we found three cases that apply above, and I was just going to suggest that, I don't remember, necessarily, that the incriminating documents are reproduced in the report itself. MR. GUTTMAN: Yes. MR. ROYAL: Are they? I was saying, it would be important to provide good examples of exactly what we mean. So, we should pay particular attention to the original document. MS. FADEN: This raises an interesting question of whether we want any original documents to be in the main report, as opposed to, in the companion volume. MR. GUTTMAN: It could remain in the companion volume. MS. FADEN: Well, no, in some cases we could. I mean, the issue that Henry's raising is whether there are any documents so critical to the case we want to make, that they ought to be appended in full to the main report. MR. GUTTMAN: Sarah Flynn is not here. MS. FADEN: I know. I just looked for Sarah. MR. GUTTMAN: I asked her that about, is this in our technical question. I asked her that about examples of Wilson memo, and her -- Sarah's thing is that, the reproductive ability of the document is such that, we're going to type the Wilson memo into the box, rather than -- I think this is a -- MS. FADEN: Well, I think -- why don't we -- I think we should not -- I think you raised an important issue, Henry, and we should at least flag those documents that play that critical role and then make some determination about how to make them available to people. MR. ROYAL: One of the reasons why I bring it up, is that, I don't personally remember the CAL-Z document. MR. GUTTMAN: The CAL-Z was when Shields Warren and Dr. Holland had the exchange, and Dr. Holland said, "I recommend that we not make this report public, because even if you could edit it, you still would have public relations problems," and Shields Warren said, "I couldn't agree with you more." MS. FADEN: So, these are three instances in which the evidentiary base for claiming that the government officials withheld information for these reasons is quite good. It's a small number, in that sense, available for documentation. But, I think that Jay's point, and Lois' too, we just have to work on getting the language a little bit clear. It is a case, though, that these, without reading each line, it's sort of hard to tell what's going on. So, with those changes and leaving open, Henry's question about whether we're going to append in the main report any of the really key documents, or otherwise, maybe, just have a companion volume published of key documents, or something, we could think about how to make those -- those that -- just the ones that are most critical available some way short of having to go to the National Archives to get them. What happen to our fantasy of having this all available on disk? MR. GUTTMAN: Well, some part of it is going to be -- next meeting -- MS. FADEN: On CD, not on disk. On CD. I'm sorry, we're getting of track. Recommendation 2. MR. GLATSTEIN: I'm not sure I understand what's meant by, "In which therapeutic rationale for the experiment was unpersuasive at the time." MS. FADEN: What's meant by that is, at the time, somebody made representations, or claims that there was a plausible prospect of benefit, but at the time, people would have said, that's full of it. In other words, merely saying that -- MR. GLATSTEIN: That's a very dangerous way to word it, because if you word it this way, you're basically trying to codify science in a very orthodox way. The guy who thinks unconventionally, who has everybody out there saying, you know, "The world is flat," occasionally those folks are wrong and the guy is right, moreover, the guy could be right for the wrong reasons. MS. FADEN: Correct. MR. GLATSTEIN: And I don't like the way that is worded at all. I think it very much puts the innovator on the defensive. MS. FADEN: The problem I have, I mean, everything you say about that is true. My concern is that, what's at issue here are the interests of human beings who were serving as subjects. So that, if you've got a person out there who is saying the world is round when everybody's saying the world is flat, as long as he's not putting people at risk of harm in the process, he can be an iconoclast as much as he wants. There's got to be some -- MR. GLATSTEIN: As long as you're talking therapeutic rationale, there will be some harm. There is no way to treat a hundred patients without having a problem. I mean, there's got to be some risks. MS. FADEN: Let me turn it around, let me let Jay get into it, but turn it around and say, merely because I, as a physician, assert that there's some possibility that somebody might benefit. That's enough? MR. GLATSTEIN: Well, who's to say what's unpersuasive? And when is he to say it? MS. FADEN: Okay, Jay? MR. KATZ: I stopped over that phrase too, and I did not know whether Eli had the same thing in mind. It would seem to me that -- it seemed to me that, one could interpret this phrase as suggesting that one can really exonerate completely the Cincinnati experiment or other experiments done with radioresistant tumors. Because, after all, one could make an argument that it wasn't certain yet whether it might not provide therapeutic benefits, particularly with the new equipment and the higher dose rates that they were administering. From my own perspective, and I briefly alluded to this in my review and report to you on the protocol review projects, that I think that investigators are under an obligation to inform patients subjects of the controversy in the field, that if they -- like the Cincinnati people wanted to try something that was considered problematic by the perceived wisdom of the scientific community, they should say, "Look, you ought to know that most investigators in positions at the time do not believe that this is going to help you in any kind of way, but, we aren't really certain, and we want you to know that, and this is the way we plan to proceed." This may be difficult to explicate in here, but I see this -- it has it's own problems, but I see it as a partial way out of the dilemma that Eli identified for us. MS. FADEN: Let me just introduce an additional dilemma for our context. This series of recommendations, remember we agreed, would not be predicated on a finding of the absence of adequate disclosure, or the absence of adequate consent, in any particular case. What we were saying here is, given our finding, that in general, there were not - whatever language we ended up saying yesterday instead of effectuated - there were not policies and practices in place to regulate both disclosure and consent in the way in which that should have been. We're just presuming that because of that, it's likely that both the disclosures and the consents, in many cases, were inadequate. With that backdrop, we're then going to the issue of whether anyone ought to be compensated or receive an apology. So, we're not saying in any particular case, in part because of evidentiary problems, that before a person can get a remedy under either recommendation 1 or recommendation 2, they'd have to prove that in that case, they had received an inadequate disclosure, or had failed to get an adequate consent. MR. GLATSTEIN: The part that I'm having trouble with is focusing on the therapeutic rationale. When he gets a treatment, particularly for something like cancer, if there was an isolated report or two that intravenous chicken soup would work, we would give intravenous chicken soup and worry about the rationale afterwards. MR. KATZ: It has worked. MR. GLATSTEIN: My mother says that too. But, I just don't like the way this is worded. I understand the sentiments. But, I think this is not worded well. MS. FADEN: Let me just get my list. I've got to fill in Mary Ann and -- MS. STEVENSON: Your comments did away with what I was going to say. MS. FADEN: Okay. You were on the same point? Okay. I've got Pat and Duncan. Go ahead. MS. KING: If I recall, there's another part to the history of this recommendation. This was an effort to take account of what we all realized was a problem, and that is, this border between, what I call, non-therapeutic and therapeutic - that it was an attempt to be over-inclusive because it was difficult to define the border. And, if I recall, the committee, at that time, wanted to be over inclusive and it was trying very hard to make room for those experiments that were questionably called by the standards of the time, questionably called "therapeutic." So, I think, if we want to undo this, we're either coming up with better language, because you don't think we -- there's a better way to do the language to accomplish that goal, or we're going back on what we said, that we wanted to accomplish at the time. MS. FADEN: Thank you. That is right. I mean, that's my sense of this, the committee's history on this. MS. KING: We had a long discussion on this. MS. FADEN: Very long discussion on that subject. And now, the language -- so Pat's right, we either have to decide we need better language, or we have to decide that we've changed our mind on how we want to handle this area. MR. GLATSTEIN: I'm for much better language. MS. FADEN: Let me get Duncan in on this, and then let's see if we can come up with better language. MR. THOMAS: I don't know how to fix it. My sentiment is that, we want to keep the thought and fix the language. MR. GLATSTEIN: Yes. MR. THOMAS: And I don't know how to fix the language right now. I had another point, but I think there are other people who want to come in on this. MS. KING: Well, on this point, can we -- we have worried about this language now through three committee meetings, and we're not going very well. Is there a way to leave the language and improve the explanation, which I actually find confusing. See, the explanation here says, it goes back to where we started from - government policies not implemented, etc. - but, the language really doesn't seem to capture for the audience what we were intending to do in terms of being over-inclusive. In some ways, the language doesn't do exactly what we said, it says, "In which there was a therapeutic rationale that was unpersuasive." So the critical word is "unpersuasive." So, if we're going to change anything, it's the word "unpersuasive," because what we're saying is there was a therapeutic rationale which we just don't accept, and they didn't -- and they wouldn't have been accepted then. MS. FADEN: Right. To say we don't accept now would be a little harsh. MS. KING: Right. But it was clearly -- what we were saying, in attempt was, it wasn't accepted then, so I don't know of a better word than unpersuasive. Because that's the word we should be focusing on. But I would do a clearer explanation of what the committee was trying to accomplish. Some of the language is confusing I found. I marked it up. But, I would be very explicit in just saying that. MS. FADEN: In fact, there is no paragraph that speaks to this. What is missing is a paragraph that speaks to the committee struggle on this borderline case. I don't know whether having that paragraph would relieve Eli's concern about how this might be interpreted. But, there is no -- the text that follows speak only to the straight case, the case in which there's no question that it's non-therapeutic, nobody argued that it was. Nobody presented it as such, nobody quarreled with the rationale. MR. GLATSTEIN: I just want to be able to make sure that the iconoclast, the innovator, and he who sees the problem in a totally fresh way, doesn't get squashed by this kind of language. MS. FADEN: You know what, Eli, maybe the way to do it is, in this new paragraph that does not yet exist, we make plain that the missing link is this issue Dan had written me a note about disclosure, that Jay raised, that we don't need to say that, innovative -- MR. GLATSTEIN: Well, but you're going to get problems here because of putting the word in, "unpersuasive." MS. FADEN: Let me finish my thought here, Eli. What I want to say is, that the paragraph can explain that, we don't mean to squelch the person who has an unusual idea. But, what we need is, today we would expect such a person to do what Jay just described - share with the potential human subject, "Look, I'm two standard deviations from standard practice here, and you need know that, and you need to decide that you want to throw in with me, versus throw in with other people." What we are presuming, based on what we know about the history, is that nobody said that to the subjects in these studies, in those days. So, the issue is not that we're saying that you may never do that kind of research, but because we're presuming that it's unlikely, that that kind of honest explanation of how, I, an unusual person on this point, was not made to the potential subjects, that we aren't concerned. But I think Phil wanted to get in. MR. RUSSELL: Then you're shifting it to a consent issue. MS. FADEN: Let me step back, the whole thing is predicated on the fact that it's unlikely that adequate consents and adequate disclosures were made for this whole kettle of fish. Again, that's the edifice on which we are building this. Nancy? MS. OLEINICK: I'm very sympathetic with what Eli is saying. I think we don't want to squelch the innovator. On the other hand, an innovator who has a fresh idea, or fresh approach to some therapy, would be required to provide some background information in animals or cells, or something to backup that the idea at least has some merit before he takes it into a clinical trial. I think we need to go -- in the language there needs to be something about the scientific rationale, as well as the consent issues. MR. GLATSTEIN: We don't like the word "unpersuasive," I'm not sure if that is science. MS. OLEINICK: Oh, I agree with you. I agree with you. I'm not arguing that. MS. FADEN: Well, maybe what you want is something other than -- let me get back on the two issues -- first, I want to mention that everybody is on board on the role that consent plays in this whole structure that we've built. If you look on page 4, lines 5 through 10, that's what we're claiming. Lines 5 through 10 on page 4, basically that -- oh, is it? I'm sorry. I apologize. I've got the wrong version. All right page 4, lines 6 through 11. MS. NORRIS: Starting, "When the government?" MS. FADEN: When the government. I'm sorry. I've got to stop looking at my text. Eli has mine I think. MS. KING: The problem with -- I had marked this -- the problem with this is, that it leaves, what happens to the person who consented, open. I would read -- this is the way it reads -- but I would read the recommendation as covering people who were injured, irrespective of whether they consented or not -- MS. FADEN: That's right. That's right. MS. KING: So, the line here, what we're really saying, we don't want to say, it is possible that a person who was harmed, actually consented. What we want to say is, that whether they consented or not, is irrelevant for the purposes of this recommendation. MS. FADEN: Well, that may be as a practical matter, but I think what I'm trying to get through is the rationale, and I guess, this is just not doing it well. The rationale is, we think that it's likely that these people were not given adequate disclosures, and did not give adequate consents - that's the bad -- MS. KING: Then you need another sentence that says, but if in fact -- MS. FADEN: It's irrelevant. MS. KING: It's irrelevant. MS. FADEN: The point is, the background to the rationale is that we believe, based on our historical investigation and what we know about how the government failed to implement its rules and policies, that it is very likely that people in these studies did not get, what today we would consider an adequate disclosure, and did not get, what today we would consider an adequate consent. With that backdrop, we're going to -- we're not, however, going to, in a particular case, care with that presumption in the background. We are then going forward and saying, everybody in this class, therefore, who was injured, we think should get this apology and compensation. So we need to make clear the role that, whatever we believe was true about disclosure and consent practices plays in our justification for this. Is that -- the language clearly is not doing it. MR. GLATSTEIN: It needs a lot of clarification. MS. KING: It does. MS. FADEN: So then we move from that to the case that is worrying Eli, and all of us, which is, now if you move from the case where the investigator -- in the first clear case, the investigator never claimed that this might benefit the potential subject - that's easy. Now, you get a situation where the investigator claims that the patient subject might receive some medical benefit from his or her participation, but in fact, it's a really, it's a stretch by most other people's assessment of the time. If that's the correct fact situation, and the person was not told that, which is what we're presuming, then we're troubled and think that person ought to get compensation. MR. GLATSTEIN: Well, is this suppose to include Cincinnati? Let me ask that. MS. FADEN: Yes. MR. GLATSTEIN: Fine. Let's take that. Did every patient that gets TBI suffer? MS. FADEN: This is only -- MR. GLATSTEIN: Did anybody get benefit from that treatment? Anybody? MR. GUTTMAN: The Ewings patients, but that's a separate -- MR. GLATSTEIN: I'm not sure they did, but the point is -- MS. FADEN: I don't know. MR. GLATSTEIN: It's a case by case thing. I'm sure we can include it on the basis of a therapeutic rationale which was unpersuasive. MS. FADEN: Eli, I'm trying to connect that with the likelihood -- I'll try to repeat Jay's point again, which I think is central, with the likelihood that these patients were not informed, that there was a lot of evidence to suggest that this was not likely to be helpful, that it was a stretch, that other investigators were not pursuing this line of research anymore. Now, if in fact, that had been said to these patients, and they would have said, I trust you Dr. so and so, I'm throwing in my lot with you, it would have been a different story. We don't know exactly what happened, but given the backdrop of what was practice at the time and the absence of government rigor, and looking or reviewing consent forms, evaluation them, and things of that sort, we are presuming that it's highly, unlikely that, that happened. Pat? MS. KING: Going back to the original rationale about the government's failure to implement regulations, which is the first basic support for this recommendation. That rationale does not extend to therapeutic research by a lot of our -- by a lot of what we've said in the report, because we're trying to pick up the healthy -- basically, going for the healthy -- the volunteers, and it was because we had to exclude what we would accept as therapeutic research that we were troubled. I keep going back to this border -- this border is intended to go to the rationale for thinking that the research, often a benefit, a possible benefit, separate from the question of consent, because this whole thing is dealing with the volunteer situation, not the therapeutic situation. That's what, in part, is creating a problem. I mean, what motivated this, is we just think there are some cases that are of quackery, or we think there are some cases that, what lawyers would call negligent, or off the boundary, work, that we can't think of a conceivable rationale, but would anybody think there is a possible benefit to this? Based on what was available to them, or information at the time, and that is -- there are two things going here -- I mean, the rationale is complicated. There are actually two things going here, there's the consent part, and there's this other part, which is hard to explain, which goes to -- we really think there are some things out there that people want to call, have benefits that was non-therapeutic, and there wouldn't be a reasonable person at the time who would have called it therapeutic in nature, is really what we're trying to say here. MR. GLATSTEIN: Well, that's a different issue, I believe, then the therapeutic rationale . MR. RUSSELL: I think -- actually in addition to that therapeutic rationale, which was questioned at the time, the government -- not instigation, that's the wrong word, but -- MS. KING: Failure to implement. MR. RUSSELL: Encouragement by government funding -- you have three elements there. It had to be an inadequate therapeutic rationale based history of judgment at the time, it had to have evidence that the consent was inadequate, the evidence that the investigators were promoting this because of the government funding. There are three elements in this, and I think we have to have all three of them in there. Some of those three leads us to claim that compensation is appropriate. Not any one -- I fully agree with you, because we don't want to set a precedent for restricting -- there's a lot of research going on today that -- MS. FADEN: But, arguably, the consent context is different, the consent context is arguably different today. But we haven't -- MR. GLATSTEIN: When you get to issues of immunotherapy today, I think it's very complicated. MS. FADEN: Complicated for sure, but -- MR. RUSSELL: Antibiotic therapy for chronic fatigue syndrome, there's a whole list of -- MR. GLATSTEIN: There's a lot of things -- MS. FADEN: Well, wait a minute. MS. KING: Well, Ruth, you wouldn't cure today an inadequately developed design that promise benefit, that a reviewing panel thought was nonsense -- MR. GLATSTEIN: But, nobody promises benefits. MS. KING: I mean, you wouldn't -- one of the things -- it's the separate parts of the things -- the consent is not going to cure against inadequate benefits -- MS. FADEN: -- benefits -- bad sign. MS. KING: But, to say that today, it's making the issue muddier. MS. FADEN: You know, I think we have a choice here, we're clearly all thinking about the TBI experiment, as a case in point, so if Ken were here, he would say, "If that's the one you're thinking about, you could pull this out and have a recommendation that's specific to that if you wanted to, rather than struggling with trying to come up with generalized criteria that we're not sure we can hone down to deal with every reservation, or counter example that people are worried about might be excluded -- " MS. KING: I don't think Ken would say we should have a separate -- MS. FADEN: No. MS. KING: Recommendation on Cincinnati. MS. FADEN: Well, specific -- no, what I'm saying, that's with struggling, that's what we're struggling with here. Okay? And his -- you know, just name it, is the sort of argument, just say the one you're troubled about and why you're troubled about it, rather than try to set up conditions that, then you struggle with later trying to figure out how it's going to fit all subsequent cases. Now, I'm not advocating that we necessarily do that -- MR. GLATSTEIN: In my judgment, Ruth, the Cincinnati folks are to be folded, and not for therapeutic rationale, but for continuing the damn thing for eleven years. I think to try what they tried on a modest number of patients -- MS. FADEN: In the beginning. MR. GLATSTEIN: In the beginning, I think was not unreasonable at all, I think to continue it over eleven years and 88 patients was stretching it. Stretching it beyond reality. But the rationale - I don't want to fault them on the rationale, maybe Dr. Egilman does, but I don't -- MS. KING: Then we do want to take it out. We want to go back to what their original recommendation -- if that is felt by everybody else in the committee, then it is not a question of language, it is -- MS. FADEN: That's what I'm getting to. MS. KING: It's a question of what we intended to do. MR. THOMAS: I'm not entirely persuaded that I want to abandon the rationale even in Cincinnati. These patients weren't told this was coming at the end of a long history of experiments with TBI, all of which were negative. Right? I mean, I agree with you that we don't want to cut off innovative research, but I think there's a heavy burden on the innovative researcher to demonstrate prior plausibility, and that the fact that there's a controversy about the therapeutic benefit has got to be disclosed to the patient. MR. GLATSTEIN: I'm all for that. That's all we're saying. This is why the conclusion, not therapeutic content. MR. THOMAS: It is, it is. It's a question of what you disclose. Obviously, consent is central to this question, but the reason it's central is what we're turning on, is what are the disclosures we need to make to the patient, aside from risk, is benefit. And you can't oversell the benefits - that's what we're saying. MR. GLATSTEIN: I don't have a problem with that. MR. THOMAS: Then what are you arguing about? MR. GLATSTEIN: I don't think that that's implied in therapeutic rationale being unpersuasive. MS. FADEN: Let's do two things -- by your own account, Eli, what I would say happened is, you say the rationale was persuasive in the beginning and lost its persuasiveness twenty patients later. MR. GLATSTEIN: Yes. MS. FADEN: Okay. So, that's a -- that's one -- I'm not saying that's your view -- I mean, I think that's Eli's mind. But Eli's interpretation is that, the rationale was persuasive, perhaps for the first - I don't know what number - ten, five. MR. GLATSTEIN: I don't like the word persuasive, but I would say was adequate. MS. FADEN: Adequate, sufficient, justifiable -- it was justifiable rationale for the first X patients, I don't know when you call it, then at some point, it stopped being adequate rationale, because the database changed, you take more and more negative results and you lose your case. Let me do this, however. In the interest of marching forward, I'm going to say, let us pull this one out, okay? Have -- and when we discuss TBI tomorrow, okay. We will try to figure out what we're dealing with here, and what the committee's sense is of what ought to be recommended, and whether it's specific only to this case and to any other case that might look like that, but we don't know of any other, or how we want to set it up. And have this recommendation, stripped, only be for the non-therapeutic context. MR. GLATSTEIN: Let's understand one point, if you carried this to it's logical conclusion, then after two or three patients who underwent liver transplants, there would be no liver transplantation today, because the first few patients all died quickly. Same for lung transplants. Same for a variety of innovative surgical procedures. MR. ROYAL: In lung transplants, the first forty-four patients died. MS. FADEN: Forty-three? Forty-four? MR. GLATSTEIN: Yes. Therapeutic rationale -- I think -- all of us have to be very broad on therapeutic rationale. Revealing the controversy is fine. I have no problem with that. But, that is not what's being said in therapeutic rationale. MS. FADEN: I think we're all agreeing with you, Eli. That the language, that this isn't going to work the way it is. So, what I'm proposing is, recommendation to, will now be only for, the case of no prospect of direct benefit. Okay? The case in which it is non-therapeutic research from the get-go. We will reserve what to do about this problem, which is grounded in the TBI analysis for our TBI discussion tomorrow. Is that agreeable with everyone? MR. GLATSTEIN: Yes. I would just add one other thing, and that is, I'm sure that after the first forty-four lung transplant patients died, the forty-fifth was not told that the first forty-four all died acutely. MS. FADEN: Oh, I hope so. MR. ROYAL: I know the person that did the forty-fifth transplant, and he says, that he did tell the patient that the first forty-four died, and that the patient answered that, it would be an honor to be the forty-fifth. MR. GLATSTEIN: Good. MS. FADEN: And that's what we hope. That's what we hope has changed. I mean, it's in the high drama, and it's certainly in -- and it's more likely to have changed in the highly dramatic cases than in the more ordinary cases in medical research. Did you want to say something else? MR. ROYAL: I wanted to bring something up about a different facade of this recommendation. MS. FADEN: And so did Duncan, if I remember. So, we're all in agreement that recommendation 2 is only now for the case of non-therapeutic research, which will make it easier to think about it. And now we've got Duncan and Henry on other issues about this recommendation in that narrowed context. Duncan? MR. THOMAS: The phrase "physical injury resulted," to me is not clear as to what we're saying about causation. MS. FADEN: Where are you? MR. THOMAS: Line 20 of the bold text. Recommendation 2, page 3. "Physical injury resulted." MS. FADEN: How would you like it rephrased? MR. THOMAS: I think the language that we used in the supporting text is adequate. It says, "attributable to the experiment." MS. FADEN: Attributable -- and physical injury attributable to the experiment resulted -- MR. THOMAS: Right. MS. FADEN: You've got it. MR. THOMAS: Resulted could mean occurred, which means that anybody, including all the patients -- the patients who eventually died fifty years later of a bicycle accident or -- due compensation. MS. FADEN: Henry? MR. ROYAL: The physical injury question, I think, is well addressed. It appears on page 6, 15 to 23, in terms of causation and all that stuff. The -- I wanted to throw out the potential implication of this recommendation to see if it bothered any committee members. I'm not sure if there's anything you can do about it. I'm thinking about the case of I-131 in thyroid disease, and what I'm thinking about is that, I could imagine a circumstance where some law has been passed that people exposed to I-131 in one of these experiments would be compensated if they had physical injury. And then suddenly, what's going to happen is, people are going to begin getting tests on their thyroids that they wouldn't ordinarily get. For example, if I were to do a thyroid ultrasound on a group of people who were forty or fifty years old, twenty or thirty percent of them would have thyroid nodules. So, one potential downside of this is that it would encourage people to have tests done that they wouldn't ordinarily have done, and they would then be subjected to, in the case of thyroid in particular, most of these thyroid nodules are benign and presumably they're going to end up having unnecessary surgery. Mary Ann, actually, passed around an article that hypothesized that you would cause more deaths by having this screening kind of approach to thyroid disease than if you didn't. So, I'm just sort of bringing that up to see if anyone else is troubled by that concept, and if they have any ideas what to do about it if they are troubled. It's not at all clear that it has a solution. MS. FADEN: I think this is one of those cases we rehearse the argument we had before, about, this would have to be the person's choice. And hopefully, someone would say to this person, look -- we couldn't look at it in the aggregate as a population problem, which would be the way to attack it from a public health point of view, because the issues here are not public health issues, but questions of compensation and justice, say to the individual person, "You're going to run some risks from these diagnostic procedures including, perhaps, the surgery you don't need against the offset, you know, chance that if it comes out that you have this injury attributable to whatever, you're going to get whatever compensation," assuming this recommendation is adopted, "that the government has deemed you would be eligible for." I guess, people would make a trade-off, it might make a big difference how much the compensation actually was, whether they would be willing to run the risk or not. But, I don't know how else to set it up, because otherwise, it would be defeating this sort of moral rationale for the recommendation, to approach it otherwise. MR. KATZ: Henry, I'm not sure the problem you brought before us, that it involves a large group of situations and person. MR. ROYAL: Well, it's unclear to me who this might eventually apply to, because who it applies to very much depends on the value judgment that's addressed on page 6, on line 18, where it says that the policy decision about causation, if it's strict, then -- MS. FADEN: It's going to be a very few people. MR. ROYAL: It's going to be a very few people, but if it were loose, then maybe that's something that the policy decision makers have to include in their calculations about -- MS. FADEN: How they want to set it up? MR. ROYAL: Yes. I just don't know. I was thinking that maybe we should address the issue, but I suspect that whoever had to make that policy decision would be aware of the issue. MR. KATZ: I do not know if what I'm going to say is going to be responsive of your concern, but, when it begins to involve larger entities, then -- and that's the problem of the -- with the regulations enacted in the 40's, 50's and 60's. That the action begins then to draft some new regulations that takes care of these specific kinds of situations, in order to circumscribe the public and say, "Look, for these reasons, this falls outside the more -- the umbrella principles and regulations established, and you have to take care of specific kinds of situations once it involves a large group of patients, or a large group situation, you need to do that because the human situation, the medical situation are too complex. Might that take care of some of the concerns? MR. ROYAL: Yes, I think it will. MS. FADEN: Okay. Are there other comments on the revised recommendation 2? Pat? MS. KING: I wasn't here for the revised recommendation 1, but I want to make a comment about all the recommendations, I think, in general it would be a bad practice to have a heading and then a recommendation. It seems to me that, assuming anybody takes us seriously, and tries to do what we suggest, that we create problems, additional problems of interpretation by having a -- MS. FADEN: Shorter explication? MS. KING: Right. You only want one thing, and even that won't be unambiguous, but you are increasing the problem. MS. FADEN: Fair enough. To go right to the bolded language. MS. KING: It just should be the bolded language -- we should only state a recommendation, in it you state a title, which is what I started to call this, to the recommendation, if it's not outdated exactly -- MS. FADEN: Got it. I see your point. MS. KING: Then you open up problems of -- MS. FADEN: Does anybody disagree? I think Pat's point is well taken. As a format issue, I think that's right. All right, so we will do that all the way through. Okay. I'll deal with that in the break. All right. Can we go to recommendation 3? This was, as you recall, at the last meeting we had considerable discussion about whether a blanket apology was appropriate, and I my sense of it, looking over the minutes, although I didn't call it a formal review, was that a totally blanket apology didn't seem to work. This is an alternative which now we should look at closely and see whether it survives scrutiny. MR. GLATSTEIN: Well, again, we have that same problem with the language, but I presumed that we had taken that clause out? MS. FADEN: Oh, yes. I'm sorry. Of course, the therapeutic rationale would come out. It would be analogous to 2, the revised 2 would now be the revised 3, it's just for the non -- it's to capture the case in which people were used as research subjects without any prospect that they might benefit personally, medically, from their participation. And the problem this is intended to address is that we have reviewed some cases in which that fact description seems to be correct. But, in which it is unlikely, unless the policy maker, assuming they adopt a recommendation, had a very liberal notion of causation that it would ever be the case that it would be shown that they were harmed. So, the question is, what do we do for, if anything, the people who were used as subjects without their, presumably without their consent? And studies that offered no prospect of benefit to them, but they were not harmed as a consequence of their participation. So, this is an issue, do we need to extend an apology to those people for that wrong? And then on page 9, lines 10 through 15, is addressed the problem of the fact that, rather than make a kind of blanket apology out to the world, we make it to those people who we believe fall into that category and recognize that there are others, but we can't reach them, so apologizing to the people to whom we know -- for whom we know this is true, is also a symbolic act for all those others who might also have been so used, but we don't know who they are. Mary Ann. MS. STEVENSON: I wanted to raise the subject that a few of us talked about at lunch yesterday, and I don't really have any experience in this, so I lean to Pat, and Ken, if he was he, to understand what the precedent for doing this kind of thing is in relation -- I mean, we're suggesting it for these radiation experiments, but there are many experiments in the past that at Tuskegee trial -- I mean, has this ever been done? And, is this a reasonable thing to do? Pat talked about an alternative, which she may or may not want to talk about, be something to -- I guess, it's the concept of the apology, I mean, is -- MS. KING: I can answer Mary Ann's first question, I won't talk about what I said, otherwise, but, the Tuskegee -- the people involved in Tuskegee, to my knowledge, have had no apology, although they received financial compensation, some survivors received financial compensation. If I had remembered what Ken said correctly, there is an apology in some of the legislation that has dealt with compensation. Do you know -- MR. GUTTMAN: It goes to the downwinders, as I understood it, downwinders and uranium miners, the atomic vets were put in the 1990 Act, but it was -- as I gather from legislative dealings, they didn't get that -- the politics, so the uranium miners and the -- MS. FADEN: So, in other words, in some relevant pieces of legislation, the legislation begins with an apology. MR. STEVENSON: Okay. All right. That's what I was wondering. So there is a precedent. MR. GUTTMAN: I may stand corrected. MS. FADEN: No, it's true. MS. KING: I don't like to repeat words, but if the committee likes this fine, I'll just put in a footnote that I don't. I've told about a lot of things, it's very hard to organize what you're going to do. I'm not going to say anymore about apology, probably NPR is here today, and I'll hear myself, and it won't be like I said it last time. But, the second thing that I find very troubling about this -- it's hard to be against it, because you say, why not? But I know why not, because it's silly in some ways to act -- to think we're going to do this, but I'm particularly troubled, and I've said this before, there's a lot of human experimentation, not just radiation experimentation, that occurred through this period. We're all aware of the fact that, the record is -- I don't know how to describe the record -- but, on the consent procedures, which is basically what we're talking about here, sometimes it's oral consent, sometimes there was no consent, sometimes it was inadequate documentation. We're making a presumption, and I feel comfortable making a presumption in the cases where people, where I can see a harm that I put in certain kinds of categories -- I just don't see it, except that, you know, I sort of -- I'll say it frankly, I always worry about when you do those things that give people an opportunity to attack the things that really matter. And to me, this is one of those things because of the way I happen to feel about it, and I don't want the credibility of what we do as a totality undermined by people being able to say, gee, these people were -- MS. FADEN: Silly. MS. KING: Silly. And it's one of those things that's very troubling to me. You want to talk about agonizing, I kept saying, why not, why not, who cares? You know, you can send a piece of paper, it's not a big deal. But, in some ways, it really is a big deal if you focus on other things. So, that's the most honest way I can describe my reservations. If I do a footnote, I will be more rational in my footnote, I promise. MS. FADEN: Can I pursue just a minute, the sense of silly that you mean. Silly because people will laugh that it's such a -- that policy means nothing? Or -- MS. KING: No, it's because we know that the background is that, it's not just radiation experiments, but all biomedical experiments at the time were conducted in a less than -- we would want them today. MS. FADEN: Let me just make one comment here, and then Jay is willing to come in -- wanting to come in and read as well. First, on the issue of there hasn't been an apology for Tuskegee as we have already discussed. There are people who are advocating and are trying to get the government to make an apology for Tuskegee. So, the fact that it hasn't been done, doesn't mean it should not have been done in that case. Also, we have in this now new language, this is a, you know, when apologizing to the people about whom we know this to -- this happened to, we're taking this as a symbolic act for all the people for whom we know this happened, but we don't know who they are, and that could extend beyond human radiation experiments. There's no reason why that language could not be included, so that we say here, we have studied this world, and in this world we've found a few cases. From our other historical scholarship, we know that there were probably many other cases, not only in human radiation research, but in all research involving human subjects during this period where people were used, as mere means only, in research without adequate disclosure and adequate consent. And in apologizing to these people, we are expressing our regret to all of those people, even though we obviously don't know who they are now. I'm not entirely sure we should do this. But, I'm just pointing out that those kinds of objections could be so met. Jay? MR. KATZ: I just want to focus on something. I'm sympathetic to what Pat is trying to communicate to us, but I want to remind you that those of us who are interested in an apology being made for Tuskegee - we are not asking for the government to make an apology, what we are arguing for, that the small group of us - we haven't succeeded, that, well first we wanted HEW to apologize because they were involved, or the successor now, HHS, and the Public Health Service to apologize because they were involved. These are the agencies who allowed Tuskegee to happen. It's a much more direct kind of responsibility. And some of us want -- asking that the German Medical Association, the successor to the German Medical Association of Nazi days, that they apologize for what happened in the concentration camps, and they haven't moved either. And the reason for the apology is, that they acknowledge that something wrong was -- has been done. I'm not so sure yet, whether the Public Health Service believes, at this time, that Tuskegee was entirely wrong. So, it's a much more -- an apology coming from the government, as a whole, creates certain kinds of problems. I think that's what, in part, Pat is concerned about, and alluding to. But I can live with that. MS. FADEN: This doesn't say from whom the apology will come. This says that the recommendation goes to the interagency working group to decide for these experiments, and if we or they thought it was more appropriate that the successor agency in the particular case make the apology, then that certainly could be done. That certainly could be done. Again, I mean, I -- I've got Reed and then Mary Ann coming back. MR. TUCKSON: First, I think Pat does us a service by, you know, forcing us to look at this, and I'm glad she was frank about that. That really helped me. I remember reading her comments and trying to understand what she was really get at, so I'm glad I get clear on it. What I'm curious about, Pat, is if -- one of the things I've always been struck by has been the sense of perceived pain and harm, and the effect on people's lives that have testified before us all around the country. One of the purposes of this exercise, that the president engaged us in, was I think, a sense of trying to also bring closure to some of that out in the world. So, that perhaps, in terms of the -- and I think you're right, we don't want to go spreading our shotgun pellets all over the place and having them become irrelevant because we engaged in some things that are not meaningful. But, to a lot of people out there, I wander if you might think that this apology would be the thing that allows people to bring closure to a difficult incident. And in that closure, allowing the country to move on. And I'm sure I'm going to make this even more messy by taking a contemporary example, now, which probably is a crummy example of -- but, the Baptist church example, that we have in contemporary times now, with the apology for the racism and says, "All right, look, let's just move on." We've made the apology and now we have some sense of healing. Whether that's a good example or not, I'm just trying to find a way here of giving closure to people for whom this isn't silly, but perhaps, would be very important. MS. KING: Well, there are two things. One is last in one's discussion, which I discussed the Baptist Convention, and I also talk about the debate and the Japanese Diet, about whether they would do an apology. I think that the broad questions of apologies in my mind do have significance. They do have the ability to bring closure. There's a lot in what you said, and I'm not going to repeat it, because I crossed that barrier last month. This is a different recommendation, this is a recommendation -- we have said we want to apologize to some people for whom, I think, the angst and the problems of closure are particularly acute. This is a recommendation that goes to -- that is based on a presumption that I'm having -- I've always had trouble with, and so the question is how far can I walk with a presumption? The presumption is that during this period of time, lots of things happened for healthy volunteers. Some gave oral consent, some gave no consent, some - we have inadequate documentation of consent. We have -- what we have done is to say, based on what we see, we are making a presumption about what happened to these people. That they were harmed because they did not consent, because this is not the physical harm recommendation. And, when I say, this I find troubling, I find it troubling and I find the comparisons to Tuskegee and Nuremburg and the medical experiments there unpersuasive in this context because, to me, they raise totally different kinds of specters about what I think is a different state of the record, as well as, different statements about the magnitude of what was done. I have no problem with Tuskegee and Nuremburg, I just have a problem with this recommendation, which is built on a presumption. I keep saying, built on a presumption and a call for individualized apology, you know, Reed's argument, seems to me, supports - and this makes it even more difficult - does support a view that says, if you are a healthy volunteer, and is consistent with what the rest of our report says - if you are a healthy volunteer, there's no detectable physical harm - however you want to phrase - that we can see, but you in fact, did not consent, you deserve an apology. Because that really is what Reed's argument supports. MS. FADEN: I want to rephrase that -- it's not a healthy volunteer, it's a person who is used in an experiment without direct benefit -- MS. KING: I understand. Without direct benefit. MS. FADEN: So, you could well have been an ill person. The issue is you were used like an object. MS. KING: Thank you. MS. FADEN: You were used like an object without your consent. As it happened, nothing happened to you. MS. KING: Right. MS. FADEN: Right. You were lucky, or maybe in fact, the investigators were prudent and it was very low risk. It could have been one or the other. But either way you got -- MS. KING: But, I'm not focusing on the harm, Ruth, because I am focusing on, and I'm very careful about this, because the response to the harm issue, before you do something, you don't know whether the person's going to be harmed or not. MS. FADEN: Right. MS. KING: I understand that argument. My argument, and I'm going to be quite specific about this, this is an argument that is based on a presumption. It is not based on harm. It is a presumption that I'm willing to walk with and have walked with, by the way, when we were talking about some of these prior recommendations. When it gets to this end of my spectrum, I'm troubled. What I said before, Reed's argument supports, for me anyway, actual cases, not presumed cases. MS. FADEN: Right. Why don't we -- MR. TUCKSON: The only thing -- and I'll just leave it there, the only thing, I guess, she's really -- it really helped me a lot there, is just, the degree to which we've taken this testimony from people who, either themselves directly or families, were involved in this confused mess, who have suffered, whether -- who believe -- because they don't know, and because they were not harmed directly and they can't get at it, but they know they were somehow caught up in it. And the tears, and the pain, and the angst being so great that, for them, it is so significant. If I had not heard so much unhappiness and inability to get at through the veils and the confusions, whether or not they actually were able to demonstrate the physical harm or not, to them it is a big deal. And that's when I -- I keep finding myself coming back to, having to respect that big dealness in their lives. MS. FADEN: I think at this point we maybe have one of three choices. We can jettison this recommendation, we can retain it with people noting their objections, or we could make it specific to particular cases and still retain the language of - this is in a sense, a symbol of national regret to others. If you look on page 8, lines 1 through 6, you see studies that we did investigate where we could have gone stronger. I'm trying to walk with Pat on her concern about a presumption. What I'm worried about a particular, some concrete examples where we have her testimony and we have investigated, like the children at, the now adults, from Wrentham and Fernald school, as a case in point, where the evidence is, I believe, quite good that they were used as objects without appropriate authorization. And, at least in the case of Fernald school, extremely unlikely that anyone was harmed. And it seems to me that something ought to be done by way of an acknowledgement, and if we want to say, in terms of Jay's language, that it ought to be directed to the successor agency of the agency that sponsored that work. I don't have any trouble with that, Jay. But, I would imagine that would be something the interagency working group would decide, as to who would be the appropriate entity to express this apology. But, we could narrow it and speak to a few specific cases, and then retain the language of this being an important symbolic act for a lot of things about which we think, you know, think there ought to be an expression of generalized regret, but speak to particular cases where we can go beyond the presumption that consent was not obtained, but, can speak to an evidentiary base that says, in these particular instances, we know that these people were used as objects. That would be a third option. MR. RUSSELL: I think that's a very good solution. It does include the evidence of the presumption with informed consent was -- MS. FADEN: Was not there. Now, the risk to that, in terms of reason - I'm going to layer this on, is that there would be people, I suspect, of the type Reed has described, whose particular case won't fall into that category and they will feel aggrieved that their particular case or their family member's particular case was not mentioned. And that would be because we don't have a fact based in their case that supports the -- we just don't know. We'd have to have some sort of footnote that says, this doesn't mean that there aren't other people to whom apologies might be due, but we just -- it's not possible -- it was not possible to investigate all of these cases to the detail, or the evidentiary record was lost, whatever the deal would be. But that would be another approach. Henry? MR. ROYAL: I sort of like the approach that you're describing. If we try to do this all inclusive apology, we're still going to run into this same problem where there are going to be people -- MS. FADEN: Sure. MR. ROYAL: Who don't get an apology who felt that they should. I like the idea that the apology really is symbolic, and we can make it very clear that we've picked out groups of people who are going to receive the policy in the name of everyone -- MS. FADEN: For whom this might also be true. MR. ROYAL: Yes. And that we picked particular groups because it was practical, that we had their names, we thought we knew enough about their cases. I think people would understand that. I like the idea that this apology would be a finite act of some sort, where you wouldn't have to worry about it continuing on for years and years, where people would say, you know, "Gee, maybe you should consider this case for an apology." So, having it be this finite thing, I like that concept. MS. FADEN: Is that an agreeable approach? So we will recraft it. Well, I think we can look -- let's look at lines 1 through 6, and see if we have agreement in these cases, on page 8. The Wrentham and Fernald schools, is that agreeable? It's a little more complicated when we get to research discussed in the -- research with prisoners. MR. ROYAL: You skipped over the pregnant women that -- MS. FADEN: I'm sorry, I skipped that one. MR. ROYAL: Who are also a little more complicated because they may not feel that they fall into this group of no harm. MS. FADEN: Well, I think in each of these things, there would have to be a stipulation, that is, if harmed was occurred, they'd get -- are covered by another recommendation. MR. ROYAL: It is there, but -- MS. FADEN: We would make it clear. MR. ROYAL: But, I'm wondering if they would actually prefer not even to be identified as a group, as a no harm group. MS. FADEN: I think that's true for even Wrentham and Fernald, because there are people there who are arguing otherwise. MR. ROYAL: What an interesting problem. MS. FADEN: So, what I think we can simply say is -- MS. KING: I was actually going to ask about Fernald. Is the record that clear in every case that there was no -- the reason, I think, it's complicated because it's parental consent -- that's the complication. But, if I recall correct, where's the quote that comes from, that says, the letter went to the parent and if the parent didn't object -- MS. FADEN: Did you see the letter? MS. KING: Yes. Is that with respect to Fernald? MS. FADEN: Yes, it is. But I take that letter to be wholly misleading and inappropriate -- MS. KING: I -- we had a different reaction to the letter in its time. But, you've answered my question. MS. FADEN: Yes, you're right. That's right. And the same, I think -- and Wrentham would raise similar issues. So, if you find that evidence to the contrary, then it would go in another pile for you. So, it would be how you would set that up. But, I think the issue that Henry raises is, we'd have to have a real clear qualifier that says, if these people -- if it's shown under whatever recommendation 2 -- just make it plain, pull it up forward, so that no one's offended. You say, this is a subset of that -- we can even make it a subset of the other recommendation if you want, or somehow or other, set it up. But, I think that would not work as well, and say, these people -- while the world is waiting to figure out whether they were harmed or not -- in the meantime, these people can get an apology. And if it turns out that they're harmed, they will then get money as well. We can set it up that way, because we're saying, we're not resolving whether they were harmed or not, and that's for another kind of process. MR. GUTTMAN: The answer, I think, is actually simple, because even if one or two or three of them are harmed, the vast majority probably weren't. MS. FADEN: That's a good point. MR. GUTTMAN: So, that -- right, Henry? Am I wrong? MS. FADEN: That's a good point. MR. ROYAL: One or two or three of -- MS. FADEN: In any particular experiment. Let's assume that it was determined that one person was harmed, the odds are that most of them are still not going to be harmed, so Dan's point is well taken, that given the unlikely that -- these are relatively rare events, so even if in fact, somebody was harmed, it's only likely to be one person in a pool of 50 or something. MR. ROYAL: Well, it's beginning to sound like this is the same letter that you're sending to the group. You're basically saying, "We owe you an apology --" MS. FADEN: No, I think, the difference is this, on the first group, we're loosening the presumption about consent because harm is overwhelming the issue, because they were harmed. In this case, we're tightening the consent thing, it's not a presumption. It's, this committee knew that these people were used without adequate consent. MR. ROYAL: I see, okay. MS. FADEN: So, this is to get around Pat's concern that the apology shouldn't -- MR. ROYAL: Just be based on a presumption. MS. FADEN: Right. Right. Whereas the compensation for harm, we're saying we can base on a presumption because these people suffered an injury and we feel badly about that, and they should get something for it. Here, we're saying the apology is going to be restricted to those cases where the committee or the bulk of the committee concludes, agrees, that the authorization was inappropriate, and we want to say no consent, or whatever, but we want to say that they were used without adequate, valid, whatever language you want. Okay? And we're apologizing. So, it is different, but it would have overlapping cases, and we'd have to just word it in such a way so that people would not take us to be saying, "We've already prejudged and you have no claim to harm," because obviously that would not be in their best interest either, in the context of remedy from the government, or remedy in litigation. So, we don't want to do that. We would have like a big bold whosywhatsit that says, we are not making a judgment about whether harm did or did not occur in any particular case in any of these. But, until, unless it's determined, these people deserve an apology for the wrong that was done to them, quite apart from whether or not they've been harmed. Is that okay? So, now we've got to march through the -- real quickly through the cases. Fernald and Wrentham schools - would that be agreeable to include in this group for an apology? MR. ROYAL: You have to -- now I'm going back to, we have this strict criteria whether they did or did not give consent. And I thought, matter-of-fact, I thought I heard you say that at Wrentham we didn't have any documentation -- MS. FADEN: That's true. So, you're right. So, if you wanted to hold out on that one, you'd have to say -- MR. ROYAL: Well, I don't know. Do we have any documentation on the thing about -- in the prisons, it's exactly the opposite. MS. FADEN: I know, the prisoners are a problem. MR. ROYAL: Do you have documentation that they did give consent of some sort? MS. FADEN: It's hard. That's why it was set up this way in the first place. MS. LEDERER: Well, is it just the issue of consent, or is it adequate -- MR. GUTTMAN: Well, it's also the government implementation for it. That's the structure. That's the problem. MS. FADEN: No, I think the government is part of this -- I think we could soften it to "adequate consent," but then you get into all these definitional issues. That's why this was set up the way it was set up in the first place, because once you get into a case by case determination, then you either have a poor evidentiary record, as in Wrentham, couldn't figure out what happened. Or you have something like the prisoners, where you have some sort of authorization, but people are not happy with what the authorization involved. So, there are no neat solutions here, folks. MR. ROYAL: In it's original conception, as you answered once before we changed it, it's not clear to me, how many people we're talking about. MS. FADEN: It's in these paragraphs. It's in this paragraph. It was to be just these few. MR. ROYAL: Just those people? MS. FADEN: Right. MR. GUTTMAN: Or even less because in most cases we don't even know who they are. MS. FADEN: In many cases, we don't know who they are. MR. ROYAL: But, how did this list get here? MR. GUTTMAN: This list got here when Ruth said do a list, and I thought about the things that we've written about in the various -- if you think about, is there's something in the chapter that should be in here we didn't list. Each list is basically the thing we wrote about. MS. FADEN: Basically, this is a list of experiments. The ones that we studied in some detail. Not all equally in the same detail, where the non-therapeutic stuff fits. There's no issue in any of these about prospective benefit. MR. ROYAL: And there was no attempt to weigh any sort of evidence about whatever reasons we had about concerns of -- MS. FADEN: No, this is working with the presumption notion. So, it's going through the cases that we, are written in part 2 of our book. Saying, let's look at those cases that are in part 2 of our book, that involve no prospect of medical benefit to the subjects, which is most of them, as a matter-of-fact. Okay? Which is most of them. And then the issue that came up was, gee, these people will get nothing unless they were harmed. They won't get nothing. They won't get any expression of anything. There is no remedy of any sort for the people who are in these chapters unless they were harmed. So this was set up to address that. It's still a finite number, and it could end there. It can still have the same symbolic stuff, but we're back to the presumption approach, rather than the, let's say, asserting that in each case, it was inadequate or no consent, whatever we want to walk through. MR. RUSSELL: Which prisoner experiments are -- MR. GUTTMAN: Washington, Oregon -- MS. FADEN: But there were others. MR. GUTTMAN: There were others, yes. Five, or six, or seven, or eight. MR. RUSSELL: Well, which ones were from the atomic vets? MR. GUTTMAN: Well, this is where it gets kind of complex -- MS. FADEN: Right. We were talking about that this morning -- MR. GUTTMAN: This is where Phil is going to say, if we have the presumption that the government didn't implement the Nuremburg code, I think, that's probably fair for virtually all -- it's clearly all -- MS. FADEN: All of what? The question is which of the experiments? MR. GUTTMAN: All the experiments -- there are a copy cases where we know that, for example, in the flash blindness, it looks like Colonel Pickering and the School of Aviation Medicine went ahead and did whatever consent that they normally do, but it seems to have been independent of -- please the government. In that sense, it was a government activity. But, it was without -- if you put the chain of command saying do this kind of experiment -- MR. RUSSELL: The evidence -- the only evidence we have is the consent was adequate for flash blindness. MR. GUTTMAN: And of course, in the case of -- MR. RUSSELL: Now which -- what other one did you want to put in? MS. FADEN: Phil wants to know what are the experiments? MR. RUSSELL: Which experiments? MR. GUTTMAN: The HumRRO physiological and psychological testing, the cloud fly throughs the guys who put their hands on, the decontamination experiments. Then the ones which Phil and I were discussing over the E-mail, whether they were experiments or training, or operational with people who crawled on the ground and rode the tanks and tested the gas masks, whether they're experiments or not, I leave with the chapter. But, I think those were -- and there were people, folks who were in, as Dennis Nelson mentioned yesterday, in the civil defense test that put them in a shelter at ground zero. MR. RUSSELL: There is a -- MS. FADEN: Big problem. MR. RUSSELL: Probability that you may be apologizing to folks who are very proud of having volunteered to do something that was dangerous and thought to be very appropriate at the time. A very strong probability of that, and I think with the -- MS. FADEN: You know what -- you know -- yes. My problem with it - MR. KATZ: You can include a return envelope for them to check apologies not accepted. MS. FADEN: You know, the problem that I have that makes me feel silly with respect to the atomic vets and apologizing for that, is the issue of the, you know, we're going to apologize to them for not consenting to fill out a paper and pencil test in HumRRO, but we're not going to apologize for the fact that they're there that's the part I find silly about, with the atomic vets. It's just ludicrous. So, as a practical matter, I think this should be restricted to human radiation experiments and the population exposures, including the atomic vets, have to be treated separately. I think either this works, if it works, it works for all human radiation experiments. If something is, or is not, owed the atomic vets, it ought to be in another -- in the human radiation experiments, outside of the context of population exposures. It would be the only way that you'd have to -- I just think it's -- I mean, can you see apologizing to somebody, "We didn't get your consent to fill out this paper and pencil test, but we ordered you to march around on a nuclear battle field?" I have a lot of trouble with that. MS. KING: But this is the problem. There's a lot of problems with this discussion from my point of view. What we talked about is a much broader issue than this recommendation, and trying to capture a recommendation language is troublesome. It reminds of trying to figure out how to think about the Declaration of Independence. What Reed focused on was, the sense among those who perceive themselves as wrong -- and he's quite eloquent about that. What he also did not focus on though, is that the real sort of tragedy in looking at what we have looked at, is what we have done to all of us, as well as to the individuals that we're worrying so hard to identify. It seems to me that, what we have tried to capture, and maybe lose sight of in all these details, is that the country went through a period that we would not like to revisit under any circumstances for a variety of reasons in which, damage was done to individuals, damage is done to the polity. And now, what we want is an acknowledgement of the damage to both, number one, which takes care of, by the way, in part, Ruth, your problem of, isn't it absurd to apologize to people who are in research, but not apologize to people who marched in. In some ways, what Reed is trying to get to, is the broader issue of how we all sort of feel about a period in our history. I don't know how to describe it - with regret, sorrow, a sense of tragedy. I don't think it's communicated by this effort. So, I have been trying to figure out how you communicate that, and say to a President, when you talk about this, would you talk about this? And, would you express some of this to the nation? I don't think that's the recommendation. The best way I can think of how to communicate that is in the transmittal letter from the Chair to the President -- MS. FADEN: That's a nice thought. MS. KING: I think we're making -- we're belittling, in some ways, by -- this is my trouble with this conversation -- the very goal that we're -- that we really truly want to see, and it's consistent with our report because in the chapter on atomic vets, when I kept saying that the problem was we exposed people to risk, these labels are in the way. You know, there's a bigger issue here that we don't seem to emphasize by being caught up in biomedical experimentation. That's sort of what we are trying to accomplish with that recommendation last month that we talked about, and this month. And it's not working right because it's not quite the right things to focus on, and not quite the right thing -- it's got some of it that we, sort of, all feel some angst about. MS. FADEN: I think what you're saying is incredibly important, and let me propose -- but I don't think it's the same thing, for the following reasons - I would like to propose, to support Pat's suggestion that kind of a large message, presented in the transmittal letter, that goes with our report to the interagency working group, and let that be a very important statement of the overall distillation of this committee's concerns about this period of history, and have it replace recommendation 5, which I thought was stupid, but we kept in there because it was a residual from the last discussion, and an acknowledgement to the American people as a recommendation -- get rid of -- and then I want to return to this one about apologies. Get rid of recommendation 5, which is in here, which is a hangover from -- we put it in to just capture all the views that had come out in the last discussion. Get rid of acknowledgement to the American people, it's on page 13, as a recommendation, and put it in more rich language, and a broader sense of the history that we have come to feel badly about in the transmittal letter. So, let me just, get resolution if people are comfortable with Pat's suggestion, and the elimination of recommendation 5 -- and then return to -- is that agreeable? Jay? MR. KATZ: Just very briefly. I do not know whether Pat has that in mind or not. I've alluded to it in some of my comments to the committee, both verbally and in written form throughout our chapters, by and large. I noticed the absence of any sense of pathos, of any sense of outrage about certain kinds of things. The language was all the time much too subdued, and I doubt whether you want to employ the language of outrage that I used in my concurring dissenting opinion to the Tuskegee syphilis study. But, I -- that probably wouldn't sit well with this committee, but I think that some sense of pathos should become part of various chapters or sections of chapters and it's missing from the report. Pat, did you have something like that in mind too, or not? MS. KING: It's very interesting. I deliberately picked the Declaration of Independence because it was a declaration, and not the Constitution of the United States, which serves a very different purpose and role. I think there are places for expressing the sentiment -- and quite frankly I keep thinking, this is sort of the unknown soldier recognition, that -- you all are laughing at me, but it's very much -- MS. FADEN: That was very nice. It's very nice. MS. KING: It's what we're trying to do, but, you know, the point that I made originally, I still extend to this recommendation, because I do recognize differences between declarations and constitutions in terms of the different levels to which you appeal. But, I am sympathetic with the effort of trying to recognize the unknown solider, but I really think that for me, when I was sitting here agonizing, trying to figure out what this debate was doing to me, what I really want to have happen is the President of the United States get up and talk about this period to the American people, as corny as it sounds, and say, "There are lots of unknown people out there for whom this is for." That kind of doesn't fit in the recommendations, that's what I keep telling -- I mean, it's sort of like saying, "Mr. President, we think is the thing that should be done." It's not our recommendation that can bring the kind of healing that Reed is talking about. The only kind of healing about that is, having created this committee, having responded to this, sort of, higher goals of the committee and sort of putting these issues on a national stage -- that's where I want to go. I mean, I don't disagree with Reed. I've been having a lot of trouble with -- MS. FADEN: All right. MS. KING: Our appropriate end point for the narrow focus of our charter, for there are broader issues here. Now, we can argue about placement and all that kind of stuff and talk about it, but, when I formulated, sitting here, and thinking about the symbolic value and stuff like that, I didn't like it here, and so, I've got to tell you that was the way I was going. MS. FADEN: I've got Sue and Reed. Sue? MS. LEDERER: I was going to say, during this conversation I was thinking, well, what would happen if we dropped this recommendation entirely? MS. FADEN: We're back onto the apology recommendation. Yes. MS. LEDERER: Yes. I think that I feel, if we can't say anything to the children, or now adults of Fernald, I would be unhappy. So, it's not just unknowns, though I agree with you in most parts. But there are some known people who I think were treated very badly, and this is an appropriate expression of outrage in this instance that I would like to see in. MS. FADEN: I think we are confusing sentiments. I was going to respond the same as that. So I think Pat is exactly right on the issues that she said. But I still am troubled by real people, or their family members who we saw, who we know who they are. And we know that something wrong was done to them, and we're not sure whether precisely it was inadequate consent or total non-consent, or whatever it was, but we know, this was not as it should have been. And quite apart from whether we want to blame anybody for it or not, which is another discussion we're going to have later, tomorrow, or whatever, we want to say we're sorry. You know, there ought to be an expression of regret to them for what happened to them, which is, I have that same sense that I'll feel really -- but how I feel - the issue is whether how you and I feel, it's really -- I don't know what to do with that -- it's really what is fitting. I think what Pat is pushing us to consider is, is this of fitting response? Is it a seemly, fitting, appropriate vehicle for dealing with these sentiments? And I'm struggling myself to -- to figure that out. MS. KING: I think that Susan picked up what is -- one of the things that I always think about, among others, when I think about Tuskegee, because the names are known, the people are known, -- there's not a whole lot of confusion about Tuskegee. What got to me in the discussion was us going through -- because I'm not sure that we really know what we think we know. I mean, I understand the sentiment about, if we know, this is what we should do. I think that what has gotten to me here is, how much do we really know? And, when we start getting into - what do we know about Wrentham? What do we know about Fernald? That seems to be belittling, in some ways, or undermine, Sue, the very thought that you expressed, and that's when my comfort reached -- discomfort reached, when I was listening to the discussion, great stages, because I said to myself - I think we think we know some of these things, but every time we start getting down to these discussions, or these incidents, then it gets to be a lot more complicated than that first broad statement of "we think we know." And, that part of the discussion made me most uncomfortable. If I had -- I would not disagree with you if I had a comfort level about what we know. That would be my sentiment. MS. FADEN: I have Reed, and then maybe we can bring some sort of closure. MR. TUCKSON: In fact, in the interest of time, the general notion of -- I want to sign on to the consensus that I think I see growing on this point of where we are able to be precise, and we're able to have emotion -- you know, we state what we need to say, I'm joining that consensus. The only thing -- I don't think we need to discuss it now, but I think that Pat has opened up a very useful technical strategy for this commission. MS. FADEN: I agree. MR. TUCKSON: I think that the -- there's no question that, in the way in which the modern world works, the recommendations have one life, but the presentation of them at that moment, and when the President stands and does whatever he does, is a particular -- requires particular attention, not now, but at some point. MS. FADEN: Assuming he does. MR. TUCKSON: Well, if he does. I don't have any idea. But just knowing the way things are released, attention to that kind of detail -- and I would think that, hopefully, in the letter of transmittal that we write, that we would try to take Pat's notion that we say, you know, Mr. President, we hope and pray that you will be able to communicate to the American people this feeling, this sense. And that doesn't get bound up, perhaps, in all of the -- as she said, the technical business. But allows a little more room for how we, as human beings, feel. And Mr. President, we hope you are able to do something -- we entrust that you will say these things. Then he can go do whatever he wants to do. But anyway, later we get to that business. MS. FADEN: Right. Right. Can I -- it occurs to me that also, in addition to the recommendation -- to the transmittal letter, some of this can be expressed in the preface to part, to this part of the recommendations and findings to part 4, which is now -- it exists in draft form, but it's certainly their place to sort of address to these concerns to say, "Look, a lot of what you've said before, is reported in -- report style, you know, we've laid it out there, and we expressed certain things. Perhaps, what you have just read in parts 1 through 3. Reader doesn't convey all of the themes that -- the stuff that we were just talking about, and the recommendations and findings similarly will have that dry, detached, you know, recommendation quality. And we want to make sure the reader understands, in the same sort of language that Pat has described at the beginning -- MR. TUCKSON: Ruth, would you allow for the precision that we need in the actual body of the document, without taking risks, or chances beyond what the facts as we know them to be, lead to the logical conclusion? MS. FADEN: It's a wonderful suggestion. Can I go back to recommendation 3, I mean, we hearing Pat's reservation, I need a sense from the rest of the group on this presumption issue because this is very difficult. We have now, three choices on this. This is the apology -- back to the apology. We can jettison the apology entirely, okay? We can have recommendation 3 essentially the way we have it, maybe making it specific to the cases that we studied that, wherein case there's no harm at -- the cases we studied where it's clear there's no prospect of medical benefit, and in case these people end up not having been harmed. Which, hopefully, will not happen for most of them, because we don't want people to be harmed, but, still make a presumption about the consent. Not say that in each of these cases we are attesting for sure that we have evidence that adequate consent was not obtained in every single instance. Or, we can do this apology only for the cases that as a group, we believe, meet some threshold of evidentiary base on the consent question, which will be very difficult to do. Okay. I'm assuming that if we adopt either two or three, the atomic vets are out of this. And this is for human radiation experiments not conducted in conjunction with population exposures because of the problems we have already discussed in it. We have other recommendations directed for the atomic vet experience. So, do we want -- do we need -- which of the three options would other committee members prefer. I'm assuming, Pat, that you would prefer that it go away - the recommendation. MS. KING: Right. MS. FADEN: Okay. So, we have one person who's saying, let's get rid of it. So, there's option A, get rid of it. Option B - keep it with this -- specific to the cases that we've reviewed, say that's why we're doing it, because we reviewed them. But, in all cases we don't have the accurate evidence to be sure that consent wasn't obtain, but we thinking it's likely that in, at least some of those subjects did not give the kind of consent, whatever. And the third is restricted to maybe Fernald and perhaps, Alaskan natives. We would have to sit there not in committee time trying to figure out whether one or two, where we've all agreed that the consent situation is abysmal enough, and the evidence is there enough that we can let it go. MR. TUCKSON: Ruth, would you just clarify -- I think I got lost -- MS. FADEN: I'm sorry. MR. TUCKSON: The last -- for some reason, number two and number three, in my mind, keep being the same. MS. FADEN: The difference between two and three is as follows: in recommendation two, the apology -- we would recommend that an apology be extended to the subjects and family members of those research projects which we discuss in part 2, which offered no prospect of therapeutic benefit in the evidence that none of those -- that the person was not harmed. It is basically as it is, but we would make it clear that we're speaking about the universe we looked at, and that's why we picked them. And we would also make it clear that we don't have an evidentiary base, or a clear enough evidentiary record for every single one of those subjects that adequate consent was not obtained. But, in the general picture of things, we think that would be true for enough of them that we are saying this apology should be extended to all of these people. The third option reads, is to restrict the apology to those particular experiments where the evidentiary base is the strongest - that there was inadequate consent. So that would be a subset of the ones that we looked at, and would probably be a relatively small subset because the evidentiary record is poor in so many cases or conflicted. Okay. Nancy. MS. OLEINICK: I've been listening to all the discussion here, and obviously, this is something I have no experience with and know absolutely nothing about. But having listened to all my learned colleagues, I'm becoming more uneasy all the time with this recommendation because I see that if it actually is implemented, that there's going to be tremendous attention drawn to this in a negative way, which I think is going to detract from all the good recommendations that we have to make. For example, I can see, if this is already been brought up. I can see people that were involved in other kinds of experiments that are not named, whether we think it's inclusive or not inclusive, however it is, there's going to be somebody who is going to be outside the range. MS. FADEN: Well, there's no question. MS. OLEINICK: And particularly, there is certainly going to be people who have testified before us who think they were involved in experiments for which there is no hard evidence -- MS. FADEN: That there was even an experiment. MS. OLEINICK: That there was even an experiment. And I can see this as being played up in the press as something that's going to be very negative. I'm just listening to it and I'm having a very hard time with it. I'm certainly in sympathy with the idea that the kids at Fernald deserve something, there's no question. I mean, I am in sympathy with the idea. I just think we're going to have a lot of problems with this, and I think I'm persuaded the more I've listened to what Pat's trying to get across. MS. FADEN: Duncan. MR. THOMAS: I guess I'm moved by Susan's eloquent comment about how, at least in some instances, we would be remiss not to offer an apology. And, I, frankly, don't see how we can make these fine distinctions about where we think we have enough evidence and where we don't think we have enough evidence. So, my preference is clearly for option 2. I have no problem with enumerating a few "for examples," and we have the beginnings of a list "for examples." I think there are a few additional ones that need to be added to the list. Somehow the Ewings and injection patients got omitted. I think that's an oversight. And I'm a little bit unclear what we're saying about the other isotope experiments in children. But, I think, with the language in here about how these specific examples that we've chosen, are because that's the ones whose stories we have told, but they are symbolic of a larger universe. That, to me, deals with Nancy's concern about all the people that will think that they're left out. MS. FADEN: I would like to hear from other people and then we should take a break. And based on how many people -- we'll either craft another one or not. Phil. MR. RUSSELL: Nancy's argument is very persuasive. The issue of trying to sort out these details is so overwhelming and leaves it open to so much potential criticism that I think we better deal with the issue in the upfront generic manner, rather than trying to be specific on this. MS. FADEN: So you would take the recommendation out. So right now, I'm hearing three voices. You know, I'm just trying to get a sense to see where we're going on this. This is important. This is rough. You know, this is really difficult. This is, like, among the really hard things the committee has to do. Henry. MR. ROYAL: I'd like to hear more from Sue about what criteria she's using to single out Fernald children for an apology, why she feels so strongly about that particular group so I can better understand whether or not we should have a select group of people that we send an apology to, or a more general apology. MS. LEDERER: I guess, before I answer Henry, I just want to say that I agree with Duncan. So, if the group were to have a vote right now, I would go -- MS. FADEN: You would go with the B option. MS. LEDERER: -- with number 2, rather than try to go through the exercise of narrowing the list and fine tuning it. I'm not sure this is the time to go into what offends me most about Fernald, but, it has less to do with experimentation than with just the, what I take to be an anti-American idea that somehow, children of the poor or children who are socially disadvantaged are less valued members of society and that people are freer to do with them what they will. And to me, it's the clearest case. So, it's not about -- that's really my objection to recommendation 5, which I gather we have -- MS. FADEN: We have jettisoned. MS. LEDERER: We have jettisoned, because it goes to a concern that Pat has expressed early about, what we really want is for our nation to come to terms with this turbulent and disturbing period of American history in which so much changed and so many of our sensibilities changed. And getting consent from experimental subjects is only a very small part of it. MS. FADEN: I can't wait to have the transcript of this meeting. It's really going to be a lot of help to have the transcript of this meeting. I not kidding. I'm quite serious. There's language here I can't wait to clip, cut and paste, and use. So, Henry, I don't know if that helped you, but it -- MR. KATZ: I would leave it in, in some form. But maybe we can even find words to say something about the problematics of apologies, but at the same time, say an apology needs to be made, ought to be made, just as a footnote to Henry's question to Susan. One thing that troubled me about the Fernald study was the incident of two people refusing -- two children didn't want to participate in the experiment, and they were ostracized, they were condemned by the officials - what kind of science club members are you for -- MS. FADEN: Not wanting to participate. MR. KATZ: Your unwillingness to participate in this wonderful oatmeal study. I came close to tears, but things like that happen elsewhere too. It's a minor point, but a major incident and poignant example of what went on during the 50's, 60's and 70's. MS. FADEN: Eli. MR. GLATSTEIN: Well, I have a lot of sympathy for all that, but at the same time, I'm not sure what the apology honestly accomplishes. I think, the apology from the government -- MS. FADEN: That's what we're talking about. MR. GLATSTEIN: -- in that era. I do believe apologies are in order, but I don't think they're governmental. I think in this instance, it's a bunch of individuals who did something -- they weren't overseen - I agree with that, but I think the apology really should be coming from individuals who did this rather than the government. In terms of voting on this, I would agree with Nancy and Pat - I would delete. MS. FADEN: Okay. This is what we need to hear. I'm just going to look at people. Lois? MS. NORRIS: I'm sorry to say that I agree with Sue and I agree with Nancy and Pat. MS. KING: That's the best statement, actually, because Sue and I are on the same wavelength, we understand that. MS. NORRIS: So if you can put me one-half on each side. I'm going to have to go with Nancy and Pat, but I'm most sympathetic to Sue's. MS. FADEN: Reed? MR. TUCKSON: I love this. I'm actually -I'm firmly on both sides. The difficulty I'm having is, I actually want to be with number 3 because I want the most -- I've got the preamble in my mind in the general statement that we've kind of agreed to in terms of how we'd get at this issue. And now I want hone down in terms of the recommendation as being the most rigid -- putting out those cases that we actually have the most laser like precision to be able to make the point with, and restrict it to those laser like cases. So, I'm actually for your third option, which is why I feel crummy. MS. FADEN: Henry. MR. ROYAL: Well, I was thinking that one of the ways that Lois and I could be 50-50, is for me to vote for whichever way she did not vote. MS. FADEN: Cute. Very cute. I like that. I'm voting against her just to even things out. MR. ROYAL: Well, I don't know if it's going to make it more complicated if I vote for Reed. MS. FADEN: We'll have to just say something, then we've got to hear from Mary Ann. All right, Mary Ann? MS. STEVENSON: I will go with Pat and Nancy. But again, the same kind of reservations other people have expressed, and really, a strong endorsement for the idea for the transmittal letter. MS. FADEN: Well, I mean, obviously we can all -- oh, Jay. Jay already expressed his B, he was a B person. MS. KING: Phil expressed his too. MS. FADEN: Phil was an A person. Right? I mean, I think we've got it. I think we should -- if we were to go by strict numbers, okay? Then the apology would go. So, what we -- MS. OLEINICK: We have two members who haven't voted. MS. FADEN: Oh, that's true, we don't have Ruth's and we don't have Ken's. So we have to put the issue to them. One possibility, again, in the preface, if we decide not to have the apology because the majority of the committee did not want it, is to express the difficulty the committee had around this issue in the preface to the recommendations. We also might consider, rather than singling out the cases in a separate apology, that in the chapter where those particular cases are discussed, saying that that's in order, rather than a recommendation that's visible that says, we think these two experiments - the people in these two experiments should get an apology, by implication nobody else should. That in the chapter where Fernald is discussed, for example, that the committee make it very plain how outraged it is about this and how strongly we feel that something is, as a human matter, that not only the government, but as Eli says, the people who were involved in this, really ought to extend some kind of expression of regret for what occurred. These are different ways to work it. MR. GUTTMAN: Also, it's not that we're not recommending the apology, we're recommending an apology for these other cases too. MS. FADEN: Well, those are a given. But those are harmed cases. We're just struggling with what to do for the people for whom there was not harm. Yes. Yes, apologies to people who are harmed have already been thrown in and the cover up -- but we have -- we are -- we are now, so, we'll have to put this to Ruth and Ken because this is important. But, I'm taking it that more people are in favor of removing the recommendation as it stands than in the other two categories, that we will try both in the preface to express this difficulty that the committee struggled with, how to -- is that -- you know, this ought to be -- MS. KING: That's Lois' dilemma. The dilemma is not about whether people that you know, so that you overcome the divisiveness. I mean, Nancy's plea to the divisiveness is, you can never take an action in isolation. When you think you're doing good here, believe me, there's always somebody who doesn't agree with you. But, you have the strongest case where you know what happened, you know who the people are and you can single them out. But, singling people out does cause division, and that's -- I think there's agreement on the point that, at a level, not of application, there is broad consensus on the committee, that we would do it for individuals for whom we had comfort about the fact that they were known. I mean, where the comfort level is different for everybody, but, at the principle level, I think that's probably right. MS. FADEN: Well, the problem -- the issue I want to describe for one second, then we are due a break, and our contemporary people are here, so we need to move onto that issue, we're about fifteen minutes or so behind schedule. Can I have a general sense of whether people would feel comfortable, in the chapters where the cases about which we feel both strongest and the evidentiary base is the clearest, if we went further than the chapters currently go in terms of indicating the committee's sentiment on those cases, and a way to capture some of what is unsatisfying about not having -- by not making these -- not having specific recommendations as in this case, these people should get an apology as a way of dealing with it. And that signals where the committee has the strongest base for saying that, without having a recommendation that says, you guys made it and you guys, by implication, didn't. And we may even go so far as to say these people are owed an apology by somebody for what happened to them in the cases where the committee feels clear that that's the case, but not make it a recommendation. Okay. That was very difficult, but we did it, and I think the outcome is certainly a good - a defensible one. There probably were other outcomes that were also defensible, but this is a good outcome, I think about which we can feel okay. We're going to take a -- Lois, I'm sorry. MS. NORRIS: We're still planning to beef up a preface to -- MS. FADEN: Oh, yes. Absolutely. MS. NORRIS: -- to explain our problem. MS. FADEN: Yes. The preface will explain the difficulty we feel about this apology issue, generally, and why -- you know, how -- we're now going to take a ten minute break and convene at 11:20. (Whereupon, the proceedings went off the record from 11:10 a.m. until 11:20 a.m.) MS. FADEN: Jay, if you want to start, we should start. Okay, let's go. Here's the dynamics. Would the RPR staff please come to the table? Here's the deal. Okay? We need to do -- if you have not had a piece of danish, please eat it, because we're going to have a late lunch. Okay? We're going to try -- because of the complications of people's different schedules, we are going to do RPR and SIS before lunch. So, instead of having lunch at 12:30, we'll probably have lunch at 1:00 or 1:15, and the reasons are overdetermined, but trust us, there's really no other way to do it. We're going to do RPR first, and we really need to bring closure to the RPR discussion by a few minutes after 12:00. Then, we're going to go to SIS, then we're going to end at quarter to one or one o'clock, and then we eat. So, if you haven't yet had a danish, have one, because we're not having an early lunch today, we're going to have a late lunch. Oh, and the other thing I, unfortunately, have to communicate is that Ruth is still not feeling well and will likely not be able to join us. So what we're trying -- she would very much like to at least hear what's going, so we're going to try to set up a speaker phone for her so she can listen and maybe identify the two or three areas where she would like to be part of the discussion. The problem is, it's hard to acknowledge somebody each time they speak, and I don't want it to be too disruptive from our point of view. So, we're trying to figure out some way where at least Ruth can hear what's going on, and maybe somebody can be -- what we can do is identify the two chapters or so where she really wants to make sure she can say something and turn to her first for her comments -- some mechanism that allows her to participate. So, we're working on that. We're working on it as we speak. Could we have the RPR people come up? Gail, and Sara, and Shobita. And then we're going to do this until a little after -- five after noon, or so, and then switch to SIS. Okay, so we are now doing chapter 15. I don't think we need to have a summary at this point in the interest of time. The chapter -- many of you have sent in comments on chapter 15, and I'm happy to report that almost all of the comments that have been received, had been laudatory. Laudatory over does it - you liked -- you said it was okay. In some cases you said it was okay, and in some cases you had higher praise. But, we didn't get any comments back from those of you who did respond and said there are big problems with this chapter, so maybe we can do it in less than forty-five minutes, but it's now out there for discussion. Mary Ann? MS. STEVENSON: I just have one question. Do you think Jay's comments need some sort of an introduction, I mean, why -- I mean, Jay would be the one to answer. We all know, you know, Jay's efforts and his background and interest, but do you think the general reader will wonder why -- MS. FADEN: This particular committee member? MS. STEVENSON: Did a separate study. Jay would be the best to answer that. Do you want some sort of -- MR. KATZ: No, you answer it. What do you think it needs? MS. STEVENSON: Yes, I think the lay reader will wonder why is this here? I'm happy that it's there, but maybe a sentence or two would explain why. MS. FADEN: So, the suggestion is, -- MR. KATZ: Go to page 31. MS. FADEN: Page 31. Thank you. Page 31 where we start Independent Review of Proposals with a line to be added as to Professor Katz' life-long interest in these issues that propelled him to -- MS. STEVENSON: Interest in -- MS. FADEN: Right, and expertise in this issue. Is that all right, Jay? We'll come up with something short of -- MR. KATZ: And perverse masochism. MS. FADEN: Sick sense of duty caused him to spend -- we can certainly do that. All right. So, I'm adding -- okay. Floor's open. Yes, Nancy. MS. OLEINICK: Well, I have -- I still have several small points on here. I've sent in all kinds of comments. MS. FADEN: Please speak into the microphone. We got feedback during the break that our profound thoughts are not being recorded. MS. OLEINICK: Well, this one maybe is, maybe it hasn't reached the level of profound, but -- I guess, the one comment I wanted to make at this time is the idea that -- should we be making some kind of statement about -- I wrote myself a note here -- that, in terms of assessing scientific merit, there was the issue that came up here about, should IRB's, you know, be -- MS. FADEN: What page are you on? MS. OLEINICK: What page am I on? 28. MS. FADEN: It helps to look at the text. MS. OLEINICK: I'm sorry about that. Okay. The evaluation -- should IRB's be evaluating the scientific merit, and there's the issue of, are the IRB's qualified and so forth. I think it's really very problematic when the only review that is going to be given to any proposal is that given by the IRB. And -- MS. FADEN: So, something -- MS. OLEINICK: So, something ought to be said about that. Yes. There are cases that are not going to go to NIH for a second review. And the IRB's maybe have to deal with it. MR. GLATSTEIN: Well, I agree with that. It also requires -- MR. RUSSELL: Especially if it's industrially supported research. MR. GLATSTEIN: It also requires some commentary on the variance among the different IRB's. There's quite a range of performance. MS. FADEN: Right. MR. GLATSTEIN: They're not standard, and I think one of the points that most of us, I think, have concluded -- I think there needs to be some kind of reference source to which the IRB's can turn to for guidance and advice, at the very least. I mean, at this point, they're the final arbitrators, and I think there's a need for something in the higher level. MS. FADEN: Eli, can I ask you to hold that to when we get to recommendations that flow from the study -- I think that's with that issue. But, I can also point to another -- remember to bring it up. MR. GLATSTEIN: It's not in the findings either. MS. FADEN: Right. Remember to bring it up. When we do the findings and recommendations for the contemporary period. On page 45, to follow up on Nancy's point, though, we can also put it in there where there's the implications of this. That this is particularly a problem when the IRB is the only merit review -- location for merit review for proposal. But the issue of what should be done about it will go into recommendations and findings as Eli -- when Eli will remind us of what he has in his notes. Jay? MR. KATZ: While Eli's and Nancy's points are very well taken, as all of you know, there's a great deal of variability among IRB's whether they review protocols for scientific merit. And, it is an issue, and we'll get to it later, where some kind of overarching body would really have to consider if it can give instructions to IRB because it would be in this state. If all the search proposals were subjected to scientific merit and analysis, it would just overpower and overwhelm IRB's. But, to go back to a point Philip made yesterday, when I served on Yale's IRB for seven years at its very beginning and we debated at the time, I do not know what Yale's practices are now, whether we should review for scientific merit or not. The decision was ultimately made to not review it, in part also, because, you know me by now, my challenge that I raised with the committee, that if it be reviewed for scientific merit, I would reject 97 percent of psychiatric research proposals, which is the point you made yesterday -- and I agree with you. And so, on the basis of that -- but, whether it should or shouldn't be, is another question. MS. FADEN: This may be the quickest in history. Jay. MR. KATZ: Yes, let me just make one brief comment. I said in my remarks to you, I just want to alert you to this, in -- I thought that the chapter was well done, particularly there is a -- more than significant improvement in the conclusions. But I just want -- and I think, with respect to the conclusions, in the light of the official review, this is as far as we could go as a committee in what we have written in the conclusions. Of course, it ought to be clear to you, but that will come later and I may have to say something about it separately, that, in the light of my findings, my conclusions would be much more devastating than they were. But, I don't think that the present group conclusion should be altered because I think we have to pay greater deference to the committee review than to my review and what I've written in the section that is now included in the report. It's only the findings of one person. MS. FADEN: Eli. MR. GLATSTEIN: Relating to the business of findings and recommendations, and not having a basis in the chapter, I think another thing that -- I, at least, have come to the conclusion with -- we need to ultimately make a recommendation, I think, that medical schools and residency training programs beef up their orientation towards basic ethics as part of their teaching programs. I honestly did not think that was going to be a conclusion that I would make from this protocol review, but it is. And I think we have to -- we have nothing in the chapter that addresses that, and I believe that needs to be explicitly covered. MS. FADEN: You want it in the chapter, or in the -- because we do have it in the, in chapter 19, the recommendations. But, you want -- I'm unclear about it. MR. GLATSTEIN: I didn't see it in the chapter and I didn't see it in the findings, so therefore, the basis for it as a recommendation doesn't really come out. MS. FADEN: Well, the problem is, when is the finding? I mean, we didn't find that medical schools had inadequate ethics education because we didn't study that. MR. GLATSTEIN: Well, what we found was that there are basic ethical questions in some of the protocols - much more commonly seen than what I had anticipated. And I believe that the only way that can be dealt with is to educate. Educate doctors. MS. FADEN: That's the structure that we've got now, Eli. The finding we report are the deficiencies we've identified. And the recommendations that we make in response to these deficiencies include a recommendation about education. But, my awkwardness is that we didn't find -- we don't have a finding that says, medical schools don't do enough, because we didn't do a survey of medical schools, we didn't evaluate -- our findings are, the outcome isn't good, and we think that addressing medical education is one means towards improving the outcome. So that's the kind of reasoning, and the findings are restricted to our results of things we had investigated. So, if that's all right, that would be restricted, but if you can think of ways to weave it in, that would be -- that would be fine. But, that's the rationale for why there isn't a finding on that point, because we didn't evaluate the current status of medical research ethics education in medical training or anybody else's training, for that matter. MR. GLATSTEIN: Which recommendation was that? MS. FADEN: It's recommendation -- well, we'll get to recommendations eventually, but it's recommendation -- see, I have the wrong draft in front of me. MR. GLATSTEIN: I think I do too. MS. FADEN: So, then you and I have got the same one; Professional and Public Education is Recommendation 10. MS. KING: What's the date? MS. FADEN: I think it's recommendation 10 no matter which one you have. Eli, mine's dated July 14th. Is that the one you have? MR. GLATSTEIN: No. I have July 13th. MS. FADEN: If it's all right, I would like to hold off on recommendations till we do recommendations. I would like to get -- MR. GLATSTEIN: I guess, I just forgot. MS. FADEN: I would like to get -- it may be not as strong or articulated as explicitly as you would like. But if we could hold off on the recommendations, we will get to recommendations. Phil. MR. RUSSELL: I'd like to pursue the evaluation of scientific merit a little further with regard to the perceived responsibilities of the IRB. It would seem to me that the IRB has a responsibility to determine that an adequate review had been done, or do it themselves. Now, is this -- they could do one or the other. But they -- but it would seem to me, that they cannot address the issue. I'm not convinced that all our IRB's even address the issue. That they don't -- that they don't make a clear cut determination that, yes, a scientific -- and adequate review has been done by somebody, whether it's an NIH committee study section, or a department appointed review committee or -- they don't explicitly make that determination and check off a box that an adequate scientific review was part of the record. MR. KATZ: Phil, the chairman usually, at least at Yale, the chairman of the department signs off on the research protocol before it is submitted to the IRB. MS. FADEN: Yes, but we don't know what the chairman -- MR. KATZ: But, the chairman just signs it. MR. RUSSELL: That's different than a positive determination that an adequate scientific review has been done. MR. KATZ: I know. I know. But, it's used as an excuse for not reviewing it, because after all, the chairman would -- MS. FADEN: Again, let me do this -- MR. RUSSELL: What I would hope is that there's some language in the -- MS. FADEN: Let me do this, Phil, again, I think this speaks to recommendations. I mean, here we're describing what we found, and we have a section on recommendations about what needs to change, and in there, there's discussion about IRB's and scientific merit. If we would hold these thoughts and see whether the recommendations we are making about IRB's and scientific merit are the -- the way it's phrased is what we want to say. I mean, it's clear that this committee wants to comment on this problem in terms of what ought to be done in the future. But, I think that the way we phrase it, we can stick it in the recommendation section. I'm just -- the implication section here is quite narrowly crafted to leave something to say in the recommendations. Nancy. MS. OLEINICK: I'm not sure that I have the latest version of this because there have been so many going back and forth. MS. FADEN: What's your date on it. MS. OLEINICK: What I'm looking at is revised July 6th. MS. FADEN: That's the one we're all working on. That's fine. MS. OLEINICK: Anyway, there's been some back and forth between me and Shobita, and Sara, so I'm not sure if some of what I'm going to say has been incorporated or not, and there's also some comments from Ruth, and I'm not quite sure where we are with that. But there is -- there are just two issues that I also wanted to bring before the committee. One is, somewhere in digging about, in all the paper that had to do with this, and trying to organize my office, I found a memo dated April 11, 1995, about some sub-project having to do with therapeutic X-radiation. I asked in something I sent back -- what's happening with that? MS. FADEN: Jeff -- I think -- Jeff, can you respond to that? DR. KAHN: It's now actually discussed very briefly in part 3, which is the only place it's discussed. The numbers were so small, and the response so limited that I don't think we can make any kind of broad based conclusions from it. So -- it fizzled, in effect. So, see what you think about where it is now, read what's in part 3 and we can change it, take it out, beef it up, whatever you want to do. MS. OLEINICK: Okay. Since we hadn't heard anything about it, I assumed it fizzled in some form. Okay. The second is in the section on limitations, we need to say something about the fact that our overview was limited to protocols that were supported by the U.S. Government, and not all the other kinds of support. And just to indicate these conclusions may or may not apply elsewhere -- MS. FADEN: To the limitation section we will add that this only speaks to federally funded research, and who knows what the world is like for the nonfederal -- MS. OLEINICK: Exactly. Okay. MS. FADEN: That's an important oversight. Easily repaired, but an important oversight. Yes, Duncan. MR. THOMAS: I seem to recall the earlier edition of this chapter had a bit more descriptive data in terms of summaries of our overall ratings of not just by radiation versus nonradiation, and minimal versus low-risk, but also by things like biomedical category by agency, by whether intro or extramural. If I'm not mistaken, that's information which, even if there were no such differences, would be of interest for people to know about. And if there isn't, well, it seems to ought to be in there. MS. STEVENSON: We're going to be including that in the supplemental filing. MS. FADEN: In what? MR. THOMAS: Well, in the supplemental filing. I think it's important enough to have in here. It could be dealt with very briefly if you didn't find anything -- MS. FADEN: We didn't. So you should put a line in that basically says we didn't find anything, and then the tables and stuff could be somewhere else. MS. OLEINICK: Sure. MR. THOMAS: We want to diffuse the impression that all military research is bad if nothing else. MS. FADEN: Right. You're right. It's important to note that we didn't -- if we had found differences we could stick all the stuff in to show. But, since we can basically say we looked for it, we didn't find any differences, here are the kinds of differences we looked for, and then a footnote saying if you want to see the data, they're presented in the supplement. Would that be agreeable? MR. THOMAS: Yes. MS. FADEN: So that's going to go in around page 5 somewhere. No, no, I'm sorry, it's later. It's way later. MR. ROYAL: I have page 11, I think where it's -- MS. FADEN: I'm sorry, I'm off. Yes, where we talk about the ratings. Okay. So we'll add the differences and the nondifferences by agency, by type of research and by intramural, extramural. That's a good point. We put that -- it was cut out to see if anybody noticed, Duncan. You noticed. You get the door prize. What type of research? Agency type research and intramural, extramural. Okay. Yes, Jay. MR. KATZ: Ruth, could we ask either Shobita or Sara to tell us -- you know, I threw in some comments and Nancy threw in some comments, what changes you have made in the draft now before you touched the major ones -- that the statistics on the greater than minimal list study should not be merely in the footnotes, but should be moved also into the text because they tell a slightly different story. Which of any of the suggestions various committee members, major ones not just stylistic ones, have been incorporated in the draft now before you that was not before us? MS. PARTHASARATHY: Well, obviously at this point, we haven't had a chance to incorporate all of the committee comments, we've just been collecting them. The only major change is the discussion that we've been having with Nancy and Duncan about the formatting of the graphs. We had changed them a little bit to reflect some of the changes that had been suggested by Nancy and Duncan. The only major change was that in graph 2 and graph 3, instead of showing the number of proposals for each overall rating, we changed it to the percentage of proposals for each overall meeting. That's the only major change that we've actually made in the chapter. MS. FADEN: Let me say this about this so that everybody's clear - the chapter will change, I mean, Jay has small comments, big comments, I have some, other committee members have sent in some. What needs to come before the whole group are those that you think that others of your colleagues might not agree with. We will send you the revised one showing the changes so that you can see and we all will get answers back about what happened to our suggestion that a footnote be added, or a footnote be moved up, or one deleted, or what have you. But, what's really important now is, if there are, you know, sort of the substantive kinds of things that you think your colleagues might not agree with you about a change and you want to get an airing of it, or you think it's worthy for discussion, so that the committee can flush out its view on a topic. I looked and it's pretty much -- comments have come in since this. This is one of the earlier ones, relatively speaking, of the material that we're discussing at this committee meeting, July 6th indicates its date. It's one of the earlier ones to have been sent out to committee members relative to the date of this meeting. So there have been comments back from several people that have not yet been incorporated, but most of them have been the kind that should be, you know, no issue to incorporate, and I can't imagine anybody will say anything other than, you know, "Good editing job," or "You're right, that idea really needs to be pulled in," or something of that sort at least in the comments I've looked at which was a great relief. But there may still be others. So, we should all know that nothing is final. This is not the final draft. Jay? MR. KATZ: I just want to raise one question with all of you, and because it has major implications with respect to findings and recommendations. The question is, and feel perfectly comfortable about it in terms of me, why do you want to have my independent review included in this chapter. As I told you at the last meeting, I have no objections if you were to exclude it. After all, I did this work also for the committee. I, of course, have no problems with you including it. But, in including it, and you may be able to isolate my findings and my discussion from the review by the committee as a whole, what is included there now, to my mind, raises fundamental questions about whether the present system is not flawed. You may not -- in it's -- in major kind of ways, and of course this is my own personal conclusion, and who knows how far we will go when we get to this, but I just want to alert you to the fact that, including my material has all kinds of implications that the committee may not wish to address that I will address. Keep that in mind in endorsing this chapter in its present form. MS. FADEN: Some people look puzzled. Duncan. MR. THOMAS: I guess the puzzlement is the way Jay's text has been edited for insertion in here. Repeatedly it says, "Katz found," "Katz thinks," so on. Occasionally with additional statements like, "Katz, like the rest of the committee -- MS. FADEN: Like the findings of the rest of the committee. MR. THOMAS: Findings, that's right. So it isn't entirely clear whether this is here because the rest of us signed on to it. Speaking for myself, I actually find myself in broad agreement with the points that are made in this section. And I would be sort of happy to adopt it, but it's not clear to me whether the entire committee does, in fact, adopt this section. I think that's what Jay is asking. MR. KATZ: You said it more succinctly and better. MS. FADEN: Well, I think there are two different issues. One is, I though you went further than the issue of adopting, Jay. I mean, what we've put in here are not your conclusions or your interpretation, but your description of what you found. Okay. The issue you're raising is that you draw from what you found and what we found collectively. MR. KATZ: But we may have to find in the light of your adopting -- MS. FADEN: Well, but, you see there's an issue of, you can look at the same facts and interpret them differently. So, I think it does follow that because we endorse your description of what you found, that the committee as a whole will agree about what you believe follows from that, which is intentionally why your implications and recommendations section are not in the committee's joint report. So, I think that's important. I mean, what we are doing, I think, is saying - what you have learned from your review is very important and we want -- and you did that as part of the work of the committee, and that's part of the data we used to make our conclusions, because we listened to -- you told us, and we were affected by what you said to us about your own review. And so, what you learned in your review and what we learned together in our collective review, formed the basis for the judgments that we are making as a committee about the state of affairs today. And that's what's acknowledged here. If you or any other member of the committee wants to say, "Personally I think the judgments are more harsh," or "The committee is too critical," that could happen just from the committee's review itself or from yours alone. So I think that's really the issue here, and I think that when we discussed it, it was intentionally that your implications and discussion sections isn't incorporated in the committee's collective. If you remember from Jay's memo, which we all have, that text at the end is not included and that is available for us all to decide how much of it we would want to endorse. MS. KING: I won't speak for Mary Ann, but I -- so if I'm wrong, she will correct me, I'm sure. But I took it to mean that when she said this needed some explanation, that this is a bit at what she was getting at. Exactly what the committee did when it incorporated the additional findings -- MS. STEVENSON: I think we've identified who Jay is -- MS. FADEN: But you wanted -- I didn't understand -- MS. KING: I thought she had said that the reader wouldn't be able to follow what was going on here, and that we needed an explanation of what we've done. We knew what had happened, but others would not. And so, I do -- MS. FADEN: Do, do you want -- MS. KING: I do -- yes. I think that -- I thought she was right. That others would not understand how this all came about unless we explained it some place, and that required -- MS. FADEN: So, where we introduce that on page 31, I don't -- I'm sorry, because I -- I'm glad this is coming up because I thought that, Mary Ann, that your suggestion went only to explain to the reader why Professor Katz had taken this on, and so the reader can understand that he's an expert in this area. But, you also now, what I'm hearing, want another sentence or two explaining the relationship of this review to the committee's whole work. MS. KING: That's the only way I can understand it. MS. FADEN: That's fine. That's right. And it would mean essentially what I've just said about the relationship between the two. Again, the transcript - I will take it from the transcript that is the relationship between Jay's review and our collective experience. MS. KING: I thought that your description comported with my understanding -- MS. FADEN: That is it. MS. KING: -- of what was going on when I listened to you. So, that was what I was saying I thought we were doing. So, apparently it had not been clear before. MS. FADEN: We will do that. We will add several sentences to make clear what the relationship is between Jay's project and the committee's work as a whole. If that's all right with you, Jay, that we do that. MR. KATZ: That's fine, that's fine. MS. FADEN: So we understand what the difference is. Yes, Duncan. MR. THOMAS: I've not done the hard work of going through this line by line at each point, seeing whether as statement is being offered as Jay's views or the committee's views, but I think that someone ought to undertake that responsibility. MS. FADEN: Well, I've done that, and somebody should back me up - but I don't want to say Jay's views versus our views. These are findings. These are data. So what it is, is where Jay found something that sounded just like something we've just reported for the collective review - that's when I use that language. Okay? So, if Jay found that, you know, X people - this happened, and X consent forms - this happened to, and we found the same sort of thing. Jay looked for some things that we didn't look for, and we looked for some things that he didn't look for. But where the results would be like, just like in Y study, we also found. But somebody should back me up on this. MR. THOMAS: I'm referring more to the section on specific problems -- MS. FADEN: Thank you, Mary Ann. MR. THOMAS: -- with informed consent process where he goes through his category of 5 -- categorization of 5 general areas, and that's a more philosophical section, and it is a reflection -- MS. FADEN: Could you tell me what page we're one? MR. GLATSTEIN: Page 35. MR. THOMAS: Starts on page -- well, top of page 36, the 5 points are outlined at the bottom of page 35. And this after we're finished with data at this point. MS. FADEN: Right. MR. THOMAS: This is Jay's general reflections, but not quite conclusions, as you pointed out, that part has been removed. I found that many places where it says, "Jay concluded this," or "Jay was struck by that," were things which also struck, or at least upon reflection after Jay pointed it out, where I was sort of in agreement with. In some ways it kinds of detracts from the force of it because it reads as if this is just one member's opinions. MS. FADEN: I did not introduce that in -- at that point I stopped making connections. MR. THOMAS: Right. I think that's what needs to be done. It's this section that needs to be looked at carefully. MS. FADEN: That would require -- I mean, that's where I stopped because then we started moving into interpretation and I let Jay's voice speak for Jay and did not make that connection. It was when Jay was reporting his results that I noted, this was with Sara and Shobita, that we noted where there were commonalities reported. So this would be another undertaking. MR. THOMAS: Well, I think it's an important undertaking. In many places, I mean, it's been basically done almost by wordprocessor global change, "I found" to "Katz found," but in many cases, simply the omission of that introduction, just say what was found. MS. KING: That's a different process -- you're saying -- MR. THOMAS: That's exactly -- I mean, that's the process I'm asking for. In each case where it says -- MS. KING: For you or for the committee? That's what I'm trying to be clear about. MR. THOMAS: Well, it's not something the whole committee can actually do. I would take us hours to go through this with the committee deciding sentence by sentence -- MS. FADEN: That's right. MR. THOMAS: I think we have to delegate Ruth or someone. MS. FADEN: No, you can't. You can't do that, Duncan, because that's a matter -- that really goes to their discussion -- I can't -- the other one I could do, I mean, because it was a matter of lining up findings, sort of data, results. Now we're going to interpretation. I think we would need to -- I mean, we can't do it now, but I would need to hear discussion of how many people agree with -- MS. KING: What you could do -- MS. FADEN: I'm troubled. I can't take on that responsibility for the whole committee. MS. KING: A proposal. MS. FADEN: Okay. MS. KING: When people read this -- this is simple to do. Each individual committee member, because it's clearly identified, at least the parts I've looked at, it says, "Katz' views are." If a committee member wants to sign on to Katz' view, it ought to say, "Katz and Thomas." And if Thomas wants to do that, I'm happy. I mean, I don't want to have to go, as a committee, to see if the committee says, "Katz and committee's views are." MS. FADEN: Let me point out one difficulty, which is, that I had, I read a lot of these - and I've obviously read this many times and resonate with much of this, but I haven't read these proposals. So the difficulty that I have is saying that this proposal said this and such. I'm very happy to trust Jay that that's what it said, but it's a different manner from my saying, "I agree with Jay that it said that," because I didn't read it. So, that's the difficulty I have, Duncan, with, you know, these are not - Jays says the world is coming to an end, or the world is a problem and I agree with him about that - this is, in this project there was insufficiently informed about the combination of radiation treatments and something else, and I didn't read that proposal, so I can't say that I agree with you in that particular case. There was insufficient -- that's my problem with it. And that's why I made the decision to do it this way. But maybe there are statements in there that aren't of that type that you think you would want to endorse. MS. KING: But I want to say something in addition. I have no problem with Duncan adding his name to Jay's. That's a decision he has to make. MS. FADEN: That's fine -- MS. KING: I mean, not every committee member read every proposal, so if his -- MS. FADEN: But, that was a different -- we had a process there. MS. KING: I understand. MS. FADEN: And this is different. This is one person's project, a very important one. But in our collective one, we had a project, a process, we had teams, we had double checks and all that kind of stuff. MS. KING: I'm not disagreeing, Ruth. I saying that, if Duncan wants to associate himself with some of Jay's views here, I don't see why we should stop it. MS. FADEN: I have no intention. MS. KING: Well, that's really what I'm saying. Or any other committee member. I don't -- MR. THOMAS: I think that's a bad idea and my reason for saying it's a bad idea is, if I selectively sign on to a few points, it weakens the other points and it gives indication of divisiveness, because why did Duncan sign on to it and not Nancy? So, I propose not to do this. There are a few instances in here where there's a statement that Katz and one other committee member, in some cases identified by name, in some cases not identified by name, and I'd like to, actually I would propose to eliminate those. Either we go -- I suggest we go one of two routes. Either this be a pure expression of Jay's views - and I'm not sure that, with a sufficient introduction which says that this is Jay's views, we need to keep saying, Katz found, Katz found, Katz found. Just as a stylistic matter I found it redundant after a while and sort of detracted from the force of it. But, without necessarily implying that the entire committee has signed on to everything that is written in this section here. MS. FADEN: I don't know how else -- MR. KATZ: I had nothing to do with that, but just who can be clarified whenever -- whosoever did this, it went to the same protocol. It came from people who reviewed -- happened to review the same protocol that I identified and was reviewed in my report and there was this incongruence. It was not agreement coming out of the committee meeting. I do not know whether that makes a difference, but that could be clarified. MR. THOMAS: But it probably takes more words to clarify than it's worth. I think we should take a look at each one of those statements where that happens. MS. FADEN: Can I ask for an example, because I'm lost. MS. GELLER: About three-quarters of the way down on page 36. MS. FADEN: Thank you. MR. THOMAS: Line 14. There's another one at the top of page 39, line 1 and 2. I'm sorry, no. That's Katz' likely advisory committee. MS. FADEN: That's comparing findings. This was from Jays's. I can see, Duncan, what you're coming from now. Can I just put in a little light note here? Nancy said it should be Professor Katz. I said we should ask Professor Katz what he wanted and Professor Katz wanted Katz. But if you would like Professor Katz, we can do -- I know, we asked you -- I wanted to tell Nancy that was your preference. Right? MR. KATZ: Yes. Shobita or Sara quoted me as Professor Katz throughout, and titles always embarrass me. I guess, in law school writings people are referred to usually by their -- the first time maybe by Professor Katz, but then, you know, by Katz, but twenty times referred to as Professor Katz makes me blush. MS. FADEN: All right, Duncan. I see your problem now. That one sort of stands out, but that was in Jay's memo to us. But we could, if it's all right with Jay, the path of least resistance would be to eliminate it. MR. THOMAS: It was quite natural when Jay was writing his memo to us to write it in the first person - I was struck by blah, blah, blah. It doesn't necessarily follow that a wordprocessor changing all the I's to Katz's necessarily -- it's just good writing. MS. FADEN: If it's all right with Jay, then we can eliminate -- we can see where this happens, and in the interest of not confusing things or suggesting that other committee members did or did not agree, we could eliminate those references -- acknowledging that this is now a different purpose. MS. PARTHASARATHY: Would you want to review lines 18 and 19 with respect to the informed consent form -- MS. FADEN: 32, where Shobita? 32, where? MS. PARTHASARATHY: 32, line 18 and 19. MS. FADEN: Oh, Henry's -- MR. THOMAS: That's one I was looking at. MS. FADEN: If that's all right with you, Jay, in the interest of not introducing confusion about why Henry's name and nobody else's name -- we would just eliminate -- MR. KATZ: Oh, no, that's -- no, that is different. I hope this can stay in, and if Henry agrees to this - that has nothing to do with review. MS. FADEN: But, how about if we put it in the discussion of the whole chapter so that it isn't in your part, as such, but it's in the committee's part where we discuss the committee's -- MS. GELLER: Is this the case of where Henry reviewed the same proposal as part of the -- MR. KATZ: No, it has nothing to do with -- it was a comment that he made at a meeting. I think it's such a cogent point. I don't care where it goes -- MS. FADEN: Okay, we will move it to the discussion, if that's all right. MR. KATZ: But, it -- but I would -- MS. FADEN: That's easy. If you don't mind, Jay? MR. KATZ: Unless -- no, I don't mind -- unless overruled, it should appear somewhere, it's one of the greatest remarks made by Henry Royal in the last fifteen months. MS. FADEN: Now Henry will blush. MR. ROYAL: Where is the press when I need them? MS. FADEN: All right. So we will move that, and as a matter of style, Henry, do you mind if we don't attribute it to you and just use the language line so that it isn't as if -- MR. ROYAL: No, that's fine. MS. FADEN: -- otherwise, I would feel like we have to go through the whole report and make sure we have credible quotes from every member of the committee which would be a difficult thing to do. So if you don't mind, we will collectively steal your line and put it in the discussion section. So, your great quote will now go down as anonymous as opposed to Royal. MR. GLATSTEIN: Story of your life, Henry. MS. FADEN: All right, are we done with this? Obviously, there are, as I pointed out, changes that still need to be incorporated and they are all important changes and we will try to make them all, but if we could move one to SIS. Thank you, guys, very much. Now we move to SIS and chapter 16. I just want to announce, but don't expect a response, we think that Ruth is on the other end of the telephone over there - that little box. We don't know if that's Ruth or not, but we think that it is Ruth. If she is, we really miss you, so if you're not there you can't answer us. She's there somewhere. If you talk into the mic, she's going to be more likely to hear you because it's wired in in some high tech fashion which I don't understand - she's hearing better. Oh, I see. For what it's worth, Ruth, Susan has just put your name card in front of the telephone. So, you are here. It might seem like a Twilight Zone episode where some of these, you know, the brain is present and pulsing but we can't get the (laughter). Funny images. All right, so we will try to hook it up so that Ruth can participate in the discussion, but that's going to be a little more high tech. We haven't got that far yet, is my understanding of where we are in the technology. So, if she doesn't like something, she's probably just seething on the other end. What a terrible feeling -- like, my gosh, they're getting it all wrong. Okay. Part III, chapter 16. We've got Steve, and Jeremy, and Nancy and the floor's open for discussion again. If you don't mind, in the interest of time, and this chapter has been around for whatever iterations, although it is much changed in this current form. The floor is open for discussion and comment. We've also have gotten summary actions to this chapter as well as some line by line editing kinds of comments and things of that sort in some more substantive discussions, but nothing in the way of indicating a huge -- we haven't gotten too many comments back yet, so, anything can happen. Nobody? Eli. MR. GLATSTEIN: Well, in light of the newspaper articles that came out, I think we need a diagram, a picture, something that is very clear about the issue of "unwitting patients." So many mistakes were made in what was published by the press, that I think we need something beyond just words and even tables, but pictures. Some way of portraying this issue of people who were confused about their status. MR. SUGARMAN: We have provided now table 4, which is part of this draft along with much more -- MR. GLATSTEIN: Mine says table 4 goes near here. MS. FADEN: It should be at the very -- appended to the end. They didn't put it in the text. MR. SUGARMAN: It's 52 of that chapter, along with more explanatory text to be able to place that into context. MR. GLATSTEIN: Well, to get the percentage of people who were incorrect about their status, you might have to show it to the reporters. I don't trust them to add the numbers up right. MR. SUGARMAN. Yes. Neither do I. MR. GOODMAN: Of course, it depends on which denominator you use. MR. GLATSTEIN: Well, that's the part where I think we need to have the numbers added for them so they can do it correctly. MR. SUGARMAN: We do that in the language in the chapter. The problem with providing a figure is then you're not able to find out how we sort of got them. We are planning to put in a figure into the supplemental volume which goes into excruciating detail about where each of these data elements come from and we've tried to remove from the chapter the pieces of information that seem to be extraneous to getting to the point. I would say in light of that, if there are ways to read the chapter now that can be misconstrued, we would need your guidance. We have been very careful in this draft, and thanks to a lot of hard work on the part of Ruth to go through this to try to make it closer to impossible for someone to misconstrue these data so incredibly. MR. GLATSTEIN: The word -- we used to say idiot proof, but now we mean reporter proof. MS. FADEN: I think the idea of some other visual way of doing it would be nice. But I'm at a loss for how to do it. We might think about it. It's very, you know, there's always the pie chart analog to the table -- MR. GLATSTEIN: I was thinking more about some sort of flow diagram - we started with this many people -- MS. FADEN: Well, here's the issue. This is what Jeremy was pointing out. We now have this flow diagram that only a masochist would want to deal with because it shows like every conceivable -- I don't know how many hours collectively it took to do this flow chart, but it will be in the supplemental volume. So the strategy is that everything that is done here should be out and available so that, for people who want to understand in the, you know, most careful detail how every person is accounted for, or was ruled in, or was ruled out. This flow diagram will provide it. But, our anticipation is that only a small number of people working in the field really are going to care. To truncate the flow diagram, however, would be -- could introduce some misrepresentations. Is that the intention, basically? MR. SUGARMAN: It sort of looks like a schematic from a, you know, a 98 channel VCR or something. And, you know, for people who want to get there, it's important, but I think to an average reader without a background, I don't think it would clarify. We play -- we're trying to simplify it when you do that, we found that the easiest way really wasn't a table for it, and the text that adds them and adds percentages in text. MR. GOODMAN: One of the reasons for that, in the "couldn't tell" category, those are people who fell out at multiple times -- MS. FADEN: For different reasons. MR. GOODMAN: For different reasons. So, we just put them all in one box. I really think that this -- for the purposes of this report, is about as compressed and -- MS. FADEN: Accurate. MR. GOODMAN: -- and we could put in the percentages in the table. I think that might help. MS. FADEN: So the relevant one is the 69/1223. Nancy. MS. OLEINICK: I have to apologize for not having read this draft. It was just -- it didn't make the cut with the amount of time, but, just looking at table 4 and making a suggestion just to avoid what happened before, because many people -- first of all, many people will never get this far, but those who do get this far, may never get to the supplemental volume with the excruciating detail. And, in order to just point this out, it might not be a bad idea to have a very short legend under the table which point -- or just point to the number -- the relevant number here, the one we're going to get into any kind of trouble for is the 69/1223. MS. FADEN: Right. MS. OLEINICK: And, maybe just asterisk that and say that is X percent of the total, and although we cannot be sure of what the reason is, the several plausible reasons are given in the text, or something. MS. FADEN: Well, this will appear in the text, and when it shows up, it's going to be in the -- MS. OLEINICK: You have people sometimes who -- MS. FADEN: Just look at tables? MS. OLEINICK: -- just look at tables and skim through, I mean, just to avoid that. Yes, you have it in the text, but we're trying to avoid a problem arising again as arose before. MR. SUGARMAN: If I could try -- then if we were to actually to provide the balance that I think is important, it's not just the one number that we now know somebody misconstrued, it's that, you know, all these numbers taken out of context would be troublesome, and so the thing is to put them into context. Now, we have table 4 put in right between 17 -- page 17 and 18. Would you want us to try to capture in sort of one line summary statements in a legend what goes on in the paragraph on 17 and the paragraph on 18? MS. OLEINICK: You might try it. You want it to be very short. But, I guess, the goal is that anybody looking just at that table and not taking the time to read all of the text would not walk away with the same misconception that reporters have been know to walk away with from listening to a few lines of discussion. Okay? That's the goal. And, I don't know, maybe it will work, maybe it won't. You can just try it. MS. FADEN: I mean, the worst that would happen is it looks redundant. I mean -- MS. OLEINICK: Yes, that would be -- it would be redundant. MS. FADEN: It would be redundant. Actually, the worst that would happen is that you can't say it in one or two lines, and then you'd have problems. I mean, if you couldn't say what needed to be said in two lines on the bottom of the table, we might have a problem, but we can try it. MS. KASS: Is it appropriate to asterisk both the 69 and the 36 in the previous column which refers to a different type of discrepancy and say something like, "Significant discussion of these discrepancies occur in the text." MS. FADEN: Yes. Right. MS. OLEINICK: That's fine. MR. SUGARMAN: That we can do. That's not -- MS. OLEINICK: I don't think we need to say very much, but I think you need to just point out that - just don't look at these numbers and run away with them and not do anything else. MS. FADEN: For the people -- the 36 are the people who thought they were in research when it looks like they probably weren't. So, that's 36/570. MR. THOMAS: I wonder whether we need stronger language in the discussion. The results section seems to me to be excellent, especially this paragraph on page 19 where it summarizes -- takes us through the 69 in all of their subcategories and tells us what we do and don't know about them. But it's a very dry account of that most people would not be particularly interested in. MS. FADEN: Right. MR. THOMAS: We revisited this question on the discussion on page 43 since that whole page is devoted trying to interpret this. And again, the casual reader, although it's a good discussion, will not come away with the impression that we believe -- we do not believe that a quarter of all research subjects are unwitting subjects and there are other kinds of languages that we've seen in certain editorials. I think we need to diffuse those -- that language. MS. FADEN: Well, for one thing, we know that percentage is wrong. I mean, that's -- the number was wrong. The easiest way to refuse, you simply got the numbers wrong. But then, beyond that, I'm not sure, I mean, -- MS. STEVENSON: In the text did we ever actually give the number -- we said that the absolute number of a percentage? I didn't see that. MS. FADEN: The problem is the percentage -- of how you cut the percentage. It goes two ways. Of the people who did not think they were in research, how many were wrong? And then it's, of the people who were in research, how many people said that they weren't? So there are two different percentages. MS. STEVENSON: Right. But in either case I don't see the percentage. I mean, you can get that off the table and somebody else is going to do it if we don't, so we might just as well do it. MS. FADEN: You can do that. MR. GOODMAN: It depends on how you handle that "couldn't tell," of which there are quite a number in the -- MS. FADEN: We don't know what they are. I mean, it could go either way. MR. SUGARMAN: Dr. Thomas, you are willing to go -- to take on that language head on? To keep the discussion, and just say, -- MR. THOMAS: I should have kept my big mouth shut. MS. FADEN: You know what I'm thinking about? We certainly don't want to take the line on -- Who was it that we quote who said nobody reads yesterday's newspapers? We fervently hope in some cases that's true. And we certainly don't want to remind people that there was a flurry of news reports that got it wrong. So, I mean, our job is not to, you know, set the chapter up to refute something that most people who read the report would never have known about, hopefully. But, rather that we write the report -- we write the chapter the way it is, and get it out as clearly as we can. So if the message isn't clear, then -- it needs to be unambiguous, or if we can make stronger statements, we ought to make them. But not because it was -- I mean, obviously informed by the fact that we know that this could be misinterpreted, but directed towards getting our conclusions and our findings out in a straight a language as possible. MR. THOMAS: I guess I'm disturbed because someone can take the data in table 4 and compute the raw percentage for 69, and although it's not exactly 25 percent, it isn't all that different from 25 percent. Sorry? Did I miss something? MS. FADEN: Which percent are we doing here? MR. THOMAS: I'm talking about the raw percentage, and they're going to get number like what was quoted in this story. That's -- and the difficulty is, although it's further compounded by the "couldn't tells," the difficulty is, not all 69 really don't know that they're in research and that's what we have to attack. MR. GOODMAN: I guess part of the answer is in, what is, the limitations, which is right at the beginning of the discussion. Maybe what you're saying is that we should revisit some of those limitations here in the latter part of the discussion. I think it's pretty clearly laid out why, you know, the problem of with asking only one question, then not returning to the subject, I think that's all laid out very clearly several pages before. So maybe when we specifically discuss this discordance, that should be alluded to again. MR. THOMAS: I think that would help. MS. FADEN: I'm sorry, I missed that last part. I was sitting here doing percentages. MR. SUGARMAN: The idea was to revisit the limitations section again to add some lines from the limitations section, or reiterate what goes on in the limitation section earlier in the discussion section in that paragraph that describes the discordance. MS. FADEN: That's fine. MR. SUGARMAN: Which is not a bad idea. MS. FADEN: I want to go back -- because I am worried about this being misconstrued. When you say the percentages are not all that different, how do you find that to be the case? MR. THOMAS: 69 divided by the total, 371. MS. FADEN: 371 wouldn't be the relevant total. MR. THOMAS: No. It is. MS. FADEN: Why would it? MR. THOMAS: It's saying, of those subjects that we think are truly in research, how many of them know it? That's the percentage that's being bandied out. MS. FADEN: The reason that -- the problem with that is the presumption is made that of the 203 we think probably are research subjects, in this case, and the reason -- that's why Steve was saying it's so important to look at the "couldn't tell," and the "couldn't tell" is different in the two cases. The reason is that it's hard to prove, you know, these people say they were research subjects, we can only look at the records that were available. They could have been a research subject at another institution, at another -- I mean, -- MR. THOMAS: I mean, I appreciate this. I'm just pointing out that the naive reader, who will take this table and try to compute a percentage out of it is going to arrive at a number that isn't all that different. MS. FADEN: Well, then I think your point echoes Mary Ann's point that we probably should draw the percentages ourselves and discuss it so that people can see what we think is the relevant denominator and the reasons why we think it's the relevant denominator. I think you've just proven Mary Ann's point, and it's well taken. MR. SUGARMAN: So, what we could do then, is take the percentages that we use in the text and add a column of the relevant percentages in the table. MS. FADEN: But even in -- but in the text as well -- MR. SUGARMAN: It's hard to figure out what are the relevant percentages. MS. FADEN: The point is, we need to explain why we think it is defensible to look at the data this way. Okay? And we can say there are different ways to look at it. And here are the ways that we think are reasonable to look at it, from which one draws the following impressions. MR. GOODMAN: I still think the issue of the limitations is the most important because we can write anything we want and somebody can still take those numbers and do exactly the calculation that Duncan said. We can't control how someone chooses to do something. MS. STEVENSON: At least you can try to do some damage control. MS. FADEN: Well, it also allows you to refute and say, "Look, we presented it one way and you presented it a different way. What's your rationale for doing it?" But I think your point about what's most important, Steve, who knows? I mean, somebody may not read the limitations either, so, I think we want to do it as honestly as we can do it. Okay? And as clearly as we can do it. And then we can't go anything further than that, but, you know, and hope that people who are reading this will try to read it as responsibly as we have tried to report it. That's really all we can do. So, everything we can do -- make the limitation section clearer, get the percentages in there in a straight way and explain why we used those percentages. We will do all of those things to try to address this potentially very confusing issue. We don't want to say that it's -- you know, we don't want to exit it away, or whatever. It's there and we're dealing with it, and it's of concern. But we want to make sure that it's handled -- we want to do what we can. So, all of these changes, I wouldn't even try to figure out which is better. I'd do all of them. You know, anything. Anything that can get a straighter story out, we should do. How about the rest of the chapter? There's a lot of stuff in here. But, admittedly, we're focused on where we have had concerns. But, I've had concerns in terms of getting the clarity of our conclusions, our findings out, getting them out right. But by in large, otherwise, we're do have changes from people that we need to make, but we're looking for big things now. Are we okay? We may eat earlier than I thought, which wouldn't be bad. Okay. Are we ready to close on the chapter? MR. ROYAL: Yes we are, Ruth. MS. FADEN: Thank you, Henry. Again, this does not mean -- nothing is final, just so it's out there. We will continue to work with it, but we have made real progress between the two drafts. Okay, thank you all very much. We're going to break for lunch earlier than we thought, and close to when we said we were going to break for lunch. But we didn't get as far -- don't be -- we shouldn't be too excited because we didn't get nearly as far into the recommendations as we were supposed to have gotten. So, we will come back -- let us try -- it think it will be a little better today at lunch. Can we try to come back by 1:30, if we possibly can? We'll try. I know it's outside of our control. (Whereupon, the proceedings went off the record from 12:24 p.m. until 1:49 p.m.) A F T E R N O O N S E S S I O N 1:49 p.m. MS. FADEN: If the Committee could get started. I'm trying to establish whether Ruth can interact with us. We're going to find that out. And if she can, she's going to do it by ringing a bell and letting us know that she wants -- MR. GLATSTEIN: Ringing a bell? MS. FADEN: Ringing a bell so we can know that she wants to contribute to the discussion on this point. But we don't know whether this is going to work or not yet. For right now we'll presume. I don't know if Ruth's on the phone or not. Okay, we need Jeff, I guess, to go into Chapter 17. Here's what I'd like to propose. We're into the contemporary period. I would propose that we stick with the agenda for right now and march through the Chapter 17 and then on to the findings and recommendations on the contemporary period. Tomorrow, I would suggest that we pick up with the discussion of TBI and Chapter 4 and the residual findings for the '44 to '74 period that we have not yet discussed or that we tabled. One of which is finding 2, on harm and in your blue folders is the revised version of it that Duncan had put together. So, we should look at that. The other two findings that we're going to go back to tomorrow from the historical period are the findings 11C which talks about, essentially, our retrospective moral judgement finding, and then the finding for that correlates the observational chapter which we'll also revisit tomorrow. Now, if we can get through the contemporary period faster, we'll pick up with some of these today. MR. THOMAS: Number 16? MS. FADEN: I don't remember which number it is, Duncan. But now we're going to do Chapter 17. MR. THOMAS: No, no, no. Which finding? MS. FADEN: Which findings are we picking up with tomorrow? MR. THOMAS: Yes. You said the findings from the observational study. MS. FADEN: There is a finding, the finding we just started to discuss yesterday on uranium miners and Marshallese which we said let's table until we talk about the whole chapter. The finding on retrospective moral judgement which we said let's table until we do Chapter 4, we'll do it together. MR. THOMAS: So does that mean you're planning a discussion of the rest of the chapter as well? MS. FADEN: Yes, yes. Sort of in conjunction; do it as a piece. Now, if it turns out that we get through the contemporary stuff faster, we'll pick up with one of the those chapters this afternoon. It's a matter of how fast we go through this. Which I don't know how that will go. But, if it's all right with everyone, we'll start with Chapter 17. We're missing Jeff who I guess will join us in a minute. Chapter 17 is the chapter that emerged out of the last committee meeting. The idea that we ought to have a chapter that attempts to synthesize kind of our overall impressions based on the three chapters that precede it on findings about the modern world. The reason this was not marked in your final, is that it was a first draft, basically. Since this is a brand new chapter, just envisioned, it was a first draft, so it was never meant to be treated like the other chapters as having gone through multiple revisions. Also, Jeff's not here but -- here's Jeff. Do you want to describe what's not in this chapter that would be in it? And then, what's at issue here is whether should be involved and do we need this chapter or not is really the question? DR. KAHN: One thing that we would add would be a literature review and some empirical results from work that's come before along the lines of the SIS and the RPRP. So related to perception of subjects, how IRBs function well and not so well. That sort of thing. Buttress what has already been done before as evidence as why our results are interesting and important and conclusions can be drawn. MS. FADEN: One of the problems right now, is, I think rightly, people who have done work in this field might say wait a second; you haven't taken account of our work which also bears on these issues. Perhaps, didn't do exactly what you did, but it's in the same family and you want to acknowledge the work that's preceded you on IRBs and subject perceptions and their participation and patient reactions and all that kind of stuff. So, this seems like a convenient vehicle for situating our findings in the light of what other people have reported in the literature up until now. I think our options are -- we don't have to decide right now, we can discuss the chapter, but we basically have two choices: We can disband this chapter and we can try to stick into the other chapters that which we think we need to stick in, or we can try to work with this chapter. Sticking in into the two chapters that we already have is not an easy matter, because they kind of, as was just realize from the earlier discussion, they're actually working okay. People are reasonably comfortable with them. So, there's always an awkwardness to go back and tinker with something that's working reasonably well. On the other hand, this is a very primitive effort, late in the life of the Committee, so the concern is, can we pull it off in the time frame? And with that, let me just start taking my list. Mary Ann? MS. STEVENSON: Well, when I first started, I sort of wondered why this -- why can't this be included in the other two chapters, but I think you've answered that. And I would be much more positive, or it would be positive about it with that additional material. I think then it really shores it up and strengthens it. I think that's a great idea. MR. GLATSTEIN: I agree. MS. STEVENSON: I mean, otherwise, you wonder why is it here. But if you add that historical data, I think it has a real grounding. MS. FADEN: I suppose we could try another draft if we really hate it. We don't exactly have a lot of time. DR. KAHN: This weekend's work. This week's. MS. FADEN: Saturday's work. DR. KAHN: Yes. MS. KING: What happens if we drop everything that's in this chapter and not try to put it in any preceding chapter. MS. FADEN: Just get rid of it. MS. KING: But get rid of it. I'm actually not pushing this, but I'd like to think I'm practical. It's hard to make a good -- I, for example, think this is the chapter to try to make the connections between selection of subjects and consent, for example that was what was in my notation. I think that there's a way to move the level of discussion about the protection of human subjects ahead a notch or two. But I am impressed with the fact that there is still so much work to remain on the whole report. Because I think that's important, because I think the effort is important, I don't want to botch. And at this point -- MS. FADEN: That's my concern, exactly. MS. KING: So what would happen if we didn't try to do it at all, in your judgement? MR. THOMAS: I'm kind of sympathetic to that view. MS. KING: Yes, because you have the best overview of everything. MS. FADEN: Well, I think the area where I think we would be open to criticism would be in not acknowledging the relevant work that has preceded this Committee. We'd have to figure out some way to put that in. Now, you might be able to put it in the intro to the chapter, but it's not going to flow as well. Somewhere, we've got to reference it. I think some of the stuff that's in this drafted Chapter 17 could be put in the discussion section of the RPRP chapter where there might be room for it. But the big problem is that somewhere we have to signal to the world that we realize that we are not the first group of people to ever think about these issues. And we'd have to figure out some way to do that. I don't think we can get away with not doing anything on that subject, and maintain, you know, a certain minimal level of credibility. It's an oversight. Let's put it this way, it's an oversight in this part of the report, as it stands right now, not to situate us in the history of this work. Duncan. MR. THOMAS: You do have a preface to this whole part which could quite naturally be expanded to include that literature review if you didn't think it fit more naturally in the subject interview chapter. I don't know what the nature of this previous literature is and whether it's all of it that would tie in very naturally with subject interview study or whether the more general discussion. MS. FADEN: For both, it would be for both. MR. THOMAS: So I would be inclined to think the preface is the natural place to put it. My own reaction to this chapter is that I didn't see a lot in it, on a relatively casual reading, which hadn't already been said someplace else. And my feeling was that the data speaks louder than our conclusions. And that we have enough in the two chapters on which to base the various findings and recommendations without the need for this. So, I'm sort of agreeing with Pat, that given the limited time and resources remaining, that time is better spent doing other things. MS. FADEN: But -- MR. THOMAS: It would be very nice to have a synthesis, but I think to do a good synthesis is going to be tough. MS. KING: The one point I think you should bear in mind is, there are many people, myself included, and I make this point over again, who will not bother to read a study. This is a foreign framework to, -- not to those of us here, particularly, but it is a foreign framework for a lot of people. So, when you say the data speaks for itself, it does, and it speaks to those people who will deal with the data. So, that is the point that is really had me in the direction of what can we do is the practical point. And I'm at the point where maybe what we want, the little bit we want people to read, maybe it should go in the preface. MR. THOMAS: I'm hoping those people that don't read data will be as likely to read the conclusions of the two chapters as they would a separate chapter. MS. KING: I agree with that, Duncan. MS. FADEN: The problem with putting the review of the literature in the preface is that you cannot connect your own findings because you haven't reported your findings yet. So, it's a little -- just think about the way you write a paper. Other work was done, but then you go back at the end and you say therefore we found in line with the blah, blah, -- we can't do that part until you report your results first. MR. THOMAS: That speaks to your having to write that preface first and see what are the points of connection. Which then could be made in revised conclusions for the two chapters. You can still do it in your conclusions sections. MS. KING: There's going to be a loss here and we may wish to identify it. The loss is that the two studies are complementary -- MS. FADEN: And you got to pull them together. MS. KING: And there needs to be someplace to pull them together. MS. FADEN: And this is the place. MS. KING: Because they go at a question in two different ways. And that's how we got ourselves in a bind before of maybe having an additional chapter. So, now the issue really becomes, in effect can you write a conclusion to the two studies? Now, one way to do that is not to have a separate chapter. MS. FADEN: That's what I'm struggling with. MS. KING: It's to combine, it's to somehow make the two studies, A and B, and then have one overall conclusion that's much shorter and doesn't attempt to do as much. Based on what we draw just from our own studies and be explicit about that and acknowledge the debt that is owed other areas. Say what our problem is, I mean, don't try to cover it up. We just didn't pick it up. But I think we minimally need to put together our own two studies and maybe we don't have to have a separate chapter to do that. MS. FADEN: The bottom line issue is, is this a problem -- a bottom line issue -- Is this a problem of we don't have enough time. Or is this a problem of it doesn't need to be done. If the issue is, we don't have enough time, then frankly, from my perspective, but I'd like to hear Jeff's, because he's been doing it, all of these other alternatives are just as much work. Figuring out how to stick it back into preface, figuring out how to put it into Chapter 15, or how to put it -- is just as much work, in fact more work. DR. KAHN: The most efficient way is to rewrite 17. MS. FADEN: It's just easier than tinkering with what you've got. MS. KING: That wasn't my original question. MS. FADEN: But, if you decide we don't need to do it at all, okay, that's -- so we have three choices: Don't comment on this at all, don't try a synthesis and don't try to reference the literature except maybe in a footnote that would then have a hundred citations in it, at the beginning of each of the two chapters, empirical chapters for their relevant literatures. Make a note, try to get Chapter 17. And maybe there's a way to signal that's it's going to be shorter. I mean that it's not going to be a very long chapter. MR. THOMAS: Then let me clarify my position. I'm clearly concerned about the question of time. I believe, like everybody else that I've heard that it's a good idea to do. MS. FADEN: Okay. MR. THOMAS: I believe it could be done by putting the literature at the beginning and commenting on it at the end of each chapter. But if in your opinion and staff's opinion that it's easier to do by tinkering with the chapter that we already have, I'm quite happy to say go ahead with it. MS. FADEN: Jay? MR. KATZ: I agree with Duncan, this is an important chapter that requires a lot of work. I do not know -- MS. KING: Talk into the mike, Jay. MR. KATZ: I do not know whether we can, whether we really have the time to do it in a satisfactory fashion. In its present form, I think there's a certain amount of redundancy in there that could be eliminated. But what is also missing, is that the chapter on the common rule -- MS. FADEN: Has to be pulled. MR. KATZ: What? MS. FADEN: Has to be pulled in too, do you think? MR. KATZ: Well, you know the chapter on the common rule, after I read it, I said, we don't really need it. And, if it's kept in its present form, because we can just reproduce in one of the appendices, the regulations of 1994, whenever they were promulgated, because there's no critical analysis in that chapter. And in a certain sense, it just repeats what the regulations are all about. There is a need for critical evaluation of the regulations because that has implications particularly for our recommendations. But whether that can be done is another matter. And in a fashion all of us can subscribe to. In some of my writings in the last couple of years I have written about my critique of the current regulations. I might want to take a look at it. So, it would be nice if we can do something more, but again there's time. With respect to this present version, I only want to make one substantive comment. That is, on page 11, line 12, I think it's a crucial issue where it says, "Now, the tension in biomedical research sometimes arises when we attempt to satisfy the goals of medical research while serving and protecting the rights and interests of participants." I think that "sometimes" is wrong. They always arise and that's what has to be -- Tensions always have to arise because these are objectives, important objectives that ultimately come -- these tensions cannot be completely reconciled. We can make an attempt at reconciliation, but to say that they only sometimes arise, I think is not stating accurately the problematic of human research. MS. FADEN: Can I just do two things here? I think Ruth has joined us, that's the sound that we hear and, Ruth, are you there? She's not there? That's when these things don't work. I don't want this to serve as too much of a distraction, so somebody better figure out if Ruth is on the line or not. But, what we do know, is that if she is there, she can't hear us unless we talk into the mic. So now there is yet another reason for talking into the mic in addition to the important purpose of getting a transcript. But, we don't know if she is there or not, so, since we don't hear a bell ringing, she probably can't communicate back out, so we're sort of stuck. Jay, on your comment with respect to the Common Rule, if I could just interject. That chapter was there, not to critique the Common Rule but to -- the purpose of the project was to report on our evaluation of oversight and implementation at the agencies. So most of that chapter discusses how the various agencies conduct their oversight of research involving human subjects. We have not taken on as committee project to critique the Common Rule, collectively. We could have done that, but I don't think we took that on as a charge and I really hesitate to suggest that we take it on now. I just don't see how we could have. It would have been a very legitimate thing for use to have done, but we did not do that and I don't think we can, at this juncture , even entertain it. So that we can comment that we didn't do that, which would probably be the fairest thing to say, rather than our not discussing it being misconstrued as endorsing the Common Rule as perfect or good or anything. We can simply say, we did not undertake, as a committee to evaluate or critique the Common Rule, but we did take it on as a committee to look at oversight issues, and here is our comment on that. I had Phil waiting to comment, was it on chapters? No? So we're sort of stuck with what to do with Chapter 17. I would be inclined to try another revision, see how it goes. Or leave it to Jeff to see which is the easier way to deal with it, since the primary drafting responsibility is going to go to him as to whether there is a revision to Chapter 15 and 16 and 17. But, if we do go with the 17, what we've heard were, we've heard the suggestion from Pat that we use this a vehicle to talk about the relationship between selection of subject and justice issues and consent questions. The validity of authorization issues and how they come together for us as a report. And that we include the literature. My own preference, if that's all right, my own preference is that this be a short chapter. We shouldn't hold to the view that it should be a forty page chapter, and the more we write, the more in trouble we're going to get in terms of reaching consensus about how to say these things. So if we could get the core issues we want to get out and get this out in 15 - 20 pages, that would be sufficient. Just to make the connections between -- I would like to see -- I thought Jay was going to another point -- I would like to see the first project pulled in a little bit too. What we did say, what we learned about oversight and how it might be connected to the IRB issue. The current oversight approaches would never pick up what we picked up in the RPRP. That's the point we want to make to support the recommendation. The way that the current system currently evaluates itself would not likely produce the kind of results that the RPRP produced. That's the kind of connection we need to make to build a recommendation that we want to make later. So, are we okay with that? Okay, so that's what's going to happen with Chapter 17. That means that that chapter is going to come to you, I'm not sure exactly when, but needs to be read, obviously not like the eighteenth version of a chapter, but just what it'll be; the second draft of a chapter. I guess the plea there is to put it up to the top of your list as you get stuff coming back to you because it will be new material in substantial part. Pat? MS. KING: At this point, I have to confess, I hope I'm not being redundant, but I'm trying to read my notes and I think I had down for perhaps additional areas to cover in this chapter is that there needs to be some recognition that important areas of research occur outside the federal umbrella altogether. And I have in mind, not only for example, one I know best, a lot of the reproductive research, which I think we need to mention because abuses keep surfacing. And we want to say that we understand that. But the other is, I think it would be important here to do some tie back, which goes a little bit beyond the preceding two chapters, but ties into our whole report, about occupational and military research. Part of it is the Common Rule does, in fact, cover biomedical research, but I think it is worth making the point over and over again about how we would feel about some of these other areas where you expose people to risks and recognize a gain, the edges of what we label research and where we have similar concerns. Does that make sense? MS. FADEN: It makes a lot of sense. MS. KING: Because the stuff about consent and risk and a lot of discussion we had here, also seemed to be pertinent there, too. MS. FADEN: And also, I think here would be the chance, although it has not appeared elsewhere, to point out that while we focused on our empirical projects clinical research, the tension between the roles, where Jay says there inevitably there are tensions between these two enterprises. You have the parallel tensions that we have discussed in a military and occupational setting. And we should say that each of these contexts, when research is introduced, also brings with it, inherent tensions and conflicts that compromise the ability to -- And this would be another vehicle to point out that we don't mean to say that it is only in this arena that people have to worry about conflicting role duties or conflicting goals. Hopefully, we can say this briefly, -- MS. KING: Right. MS. FADEN: But, we can highlight the message. Okay, if it's all right. And again, if you have any thoughts, if you go back and take a look that this is obviously going to be whatever, so communicate to Jeff quickly, very quickly. Right. I know. If we could move on the contemporary -- I guess we do findings first. And that would be beginning on -- do I have the right or the wrong chapter on findings? It's finding 20. I have it on page, but I am now lost as to MR. THOMAS: Page 22. MS. FADEN: Page 22. Excuse me. So I am in the right place. Finding 20, page 22. This goes beyond -- I would like to do all of them, if we can, even though some of these are not with human radiation experiments. But let's see how far we can get. There are only a few findings and then we go on to recommendations. But they're important findings. Can we look at finding 20 first? This one has not changed much from the last iteration. PAUSE Is 20 okay? Or, not hearing any major whatever, I'll go on to 21? PAUSE MR. KATZ: Where are we, 20? MS. FADEN: We just did 20, unless you want to raise something about 20. MR. KATZ: No, no. MS. FADEN: Now we're on to 21. Eli, are you wanting to comment on 20 or 21? MR. GLATSTEIN: Twenty-one. I'd like to add something in the description -- I don't want to change the finding, but I would like to add the following underneath it because it sets up some recommendations, if people would agree. WE also found evidence of considerable variation among IRBs and concluded there's a definite need for some source to which IRBs can go to for advice and guidance on the wide range of ethical issues. MS. FADEN: Can we put that in 22? MR. GLATSTEIN: I've got some things for 22 which are quite extensive. MS. FADEN: Because I think it's not a human radiation, a non-human radiation issue. MR. GLATSTEIN: All right. MS. FADEN: It's a -- 21 speaks -- it's a generic issue. I have no objection to that being added, in fact I think it's an important addition. But I think that 21 is specific to what did we find when we compared human radiation research to other research involving human subjects. Yes, Jay? MR. KATZ: I have something with respect to the bold face. MS. FADEN: In 21? MR. KATZ: In 21, yes. We found earlier that we thought radiation research is handled better than non-radiation research. And assuming that is the feeling of the Committee then it should it should be stated in that fashion. But to say that, to be at least as likely as other areas of research to address appropriate issues concerning the ethical involvement of human subject, I think that when you bring in other areas of research I would want to add, 'address appropriately and inappropriately issues'. Because the implication here is that in other areas of research it is handled appropriately. And there is some problem with the wording that could be misunderstood. MS. FADEN: You want to say, 'it's no better and no worse than'? Here's what we had. What we had were -- I've forgotten which project. I think it was in the RPRP project -- an indication that there were fewer human radiation studies in the 4-5 category, and that's a finding that we report. That's the basis of 'at least as likely', there may even be more. When you go to the SIS it kind of goes the other way. There's a little bit of data that suggests that people in radiation research were -- there is a slight indication in the other direction. It's not a profound finding, but I don't know how to phrase it. Nancy? MR. KATZ: I would say 'more appropriately, somewhat more appropriately'. That's the way I would put it, than in other areas of research. MS. STEVENSON: Except for in the RPRP, in the end, the numbers were very small. MS. OLEINICK: I think the numbers are too small to draw any kind of a group conclusion about that. MS. STEVENSON: I think the best we could say is that it is no worse. MS. OLEINICK: Yes, yes. That's safe. MS. FADEN: You want to get rid of 'at least as likely', and say 'the same as'? MR. THOMAS: Yes. MS. FADEN: We have no basis for concluding any differences. Then you avoid the word appropriate. MS. LEDERER: Although, in Chapter 15, on page 44, we do say, "Our results suggest that human subject protections may be more effective -- MS. FADEN: That's why the 'at least as likely' is there. MR. THOMAS: That's why that needs to be changed as well. MS. FADEN: Okay, we can back down on there too and simply say we saw this but the numbers weren't great enough to get all excited about. We can do that. MR. THOMAS: Ruth, can you remind us as to what the contrary evidence from the SIS? MS. FADEN: I think I want to dismiss it, because it was in some of the regressions, I don't think it matters. Let's just forget that. MR. THOMAS: It's not in the conclusions at all. MS. FADEN: That's because it was not -- MR. THOMAS: I've looked through there, and I think if we're going to make a statement like the committees two empirical projects, it's not a finding at all. MS. FADEN: We found no meaningful differences. MR. THOMAS: That may be an important result, which belongs in the chapter then. MS. FADEN: Okay. So we'll say that in the SIS chapter. Can we make a note that there were no meaningful differences, assuming I'll check with the SIS people and make sure we can say that. But let's not do that now. The key thing is we're changing this to, 'there were no differences, found no differences between human radiation research and other research with respect to ethics and so on. Susan? MS. LEDERER: I guess my problem with the wording of this finding, it says 'to address appropriately, issues concerning the ethical involvement', and that seems to contradict the sense of the next point. MS. FADEN: Good. That's Jay's concern, I believe. MS. LEDERER: You need to change that word -- MS. FADEN: So we're simply going to say 'no differences between', which doesn't say 'appropriate', period. It just says we found no evidence of differences between human radiation research and other areas of research in our review with respect to human subjects. I think we can certainly keep the lines 15, 16 and 17 because we did find there is more regulatory oversight. MR. RUSSELL: Right. MS. FADEN: So we can say that. That it is a fact, because we have this other level of structure for at least some radiation research. Now, here we go to finding -- Is that agreeable to everyone, about how finding 21 will change? And we will go back and make sure the two empirical projects, if it's accurate, can say that. That there were no meaningful differences, or no significant differences. MR. RUSSELL: Isn't the more important finding that the research involving radioisotopes is subjected to more safeguards and levels of review? MS. FADEN: You want to make that finding? MR. RUSSELL: That's an important finding. MS. FADEN: Let's put it in the finding. MR. RUSSELL: The finding that's stated is less important. You could reverse the two, as a matter of fact. MS. FADEN: Okay, we will pull -- The suggestion from Phil, is that the line -- MR. RUSSELL: One is a finding and the other is a non- finding. (LAUGHTER) MS. FADEN: yes, we found both, that's true. The point is the first, you didn't even have an advisory committee to discover that fact whereas with the other one you did. But nevertheless, we can certainly put them both in the finding. Okay. Is that agreeable with everyone? These finding will say two things: It will say there's more regulation and we didn't find any -- MR. RUSSELL: No difference in outcomes. MS. FADEN: -- differences in outcomes. Okay? From which some people might infer then get rid of the extra. We won't get into that right now. All right, finding 22. We've already had one amendment, Eli's, that that finding included discussion of variation in IRBs. Did you want to start with the other ones that you would like to change? MR. GLATSTEIN: I didn't actually finish that one. MS. FADEN: Yes, please, go ahead. MR. GLATSTEIN: I had a second sentence to follow it, which said 'From this, we also conclude that medical schools and resident teaching programs need to increase the emphasis of basis ethics as part of their efforts.' MS. FADEN: It's a recommendation, I think is what we're hearing. That's a recommendation. MR. GLATSTEIN: It is a recommendation, but somehow, we've got to get the thought in the findings to justify it. MS. FADEN: No, I'd rather you pull the finding into the recommendation, would be the -- MR. GLATSTEIN: All right, then I also wanted to add something we talked about last time but didn't get included. At the end of all the discussion, 'We also learned from testimony from individual witnesses, there's a considerable confusion in the minds of many members of the public at large concerning what is research or experimentation and what is simply an application of a new technology or approach to a specific patient problem. 'Following published reports of new research, other physicians may attempt to apply such innovations in their practices. Technically, that is not research, but the public must still be educated to the fact that innovation in diagnosis and therapy, when employed by other physicians who did not develop these techniques initially, are associated with a definite learning curve. Such innovations, when initially used by practitioners who did not carry out the original research, may still be associated with major morbidities and complications until these innovative techniques are mastered. 'In addition, if a drug or procedure has only existed for a few years in terms of human usage, it does not preclude the possibility of some other unforseen late effect appearing with greater length of follow-up.' MS. FADEN: Nancy, did you want to respond? MS. OLEINICK: I think it's extremely important, but I don't think this is the place for it. I think it maybe goes to someplace where we're talking about risk of research or something, in some of the introductory material. It's not a finding from our research. MS. FADEN: I think there are two things. The first part is finding based on testimony. We found that people are confused about the difference between practice and research. That's a finding. The commentary about innovative practice and the boundary question may belong in Chapter 17, when we're talking about this problem that we're dealing with here and the contours and the tensions. MR. GLATSTEIN: I don't have any problem with that, but I want to see it in here somewhere. MS. FADEN: Okay. So one argument would be the commentary part belongs in the discussion in 17 where we're talking about what does all this mean. And how this is such a confusing problem. Just like the boundaries between training and research or occupational monitoring and research. You've got this problem of research and innovative practice and risk is not only to be found in a research protocol but elsewhere in medical -- all that stuff. So, if it's all right with you, Eli, I would separate the two and the issue is what to do with your comment about what we learned from the testimony of people about how they were -- some of the people who spoke to us, seemed to thing that anything that they got that was new, was, by definition, research or an experiment -- MS. KING: The issue though, is not these gentle exhortations to educate the public, while terrific, all end up with everybody calling for public education. I think that this discussion belongs in the context of what it is we expect to have communicated to patient and subjects. I mean that is the way Eli started with his recommendation. I think it is more something that you keep within the framework of research than a public education issue, because it will get lost there. MS. FADEN: I think that's fine and I think there might be a recommendation that comes -- I'm thinking about where the commentary could go would be when we're talking about how elusive the differences are between research and practice and new stuff and risk. MS. FADEN: The Belmont Report, by the way, might be referenced, because this discussion actually began twenty years ago by ethics commissions. Same discussion. MS. FADEN: That's the sort of thing I don't want us to be accused of, did you remember that there were all these other people who cam before you who have also thought about these issues. It's kind of embarrassing. MS. KING: But there is a certain strength to the fact that we've still got the problem twenty years later. It's even bigger than it was twenty years ago. MS. FADEN: I think that's the point. But can we go to the other point that Eli has written that is kind of like a finding. That we -- is it all right to add a finding? One of our findings based on testimony is that it appears that people are not, are sometimes or frequently confused between a new use of a medical treatment and it's being a research use of -- That's a finding we have from the testimony we got. MR. THOMAS: We could probably draw on the subject interview study as well. MS. FADEN: That's right. And we suspected that's what's going on in some of the SIS stuff. Where people think they're in research but they're not. They're probably just getting a new application. MS. KING: I would actually would do it the opposite. I would reference the SIS subject first and say that the testimony bolstered some of the findings. MS. FADEN: Fine. Excellent. I am getting anxious because I am not writing and when I don't write I get really nervous. So I have to make sure that Jeff is writing. So that's what's going on. I keep looking. MR. KATZ: Do we want to -- in the light of Eli's recommendation, do we want to find some words that will also express what came out so clearly in the subject interview study, mainly that patients trust physicians that they will only do things that are in their best therapeutic interest. Without the addition, and therefore, because of what Eli said earlier, and therefore, they confuse research and treatment. Find the right words, these are not -- MS. FADEN: Link it up to the belief that no one would do MR. KATZ: Link this up, most definitely. I think it is one of the important findings from the subject interview studies. MS. FADEN: Henry? MR. ROYAL: When Jay was talking about trust, I was wondering where he was going with it. And I was thinking about linking it with that somehow increasing the obligation of the physician to satisfy that trust or not betray that trust. MR. GLATSTEIN: And not abuse it, right. MS. FADEN: Is that a finding? MR. KATZ: No, that would go -- MR. ROYAL: I'm not sure about the - MS. FADEN: Exhortation. MR. ROYAL: Exhortation to -- MS. FADEN: That could be a recommendation. I don't know what you do with it. It's an odd recommendation. We recommend that physicians live up to the trust which is placed in them, but you know it's funny. MR. KATZ: The recommendation would be, you know, that as Eric Ericson has said so eloquently that in order to go through life, you not only have to have a basic sense of trust but also a basic sense of mistrust. MS. FADEN: That also would make a great recommendation. (LAUGHTER) Eli, can we get you language. I mean not this second. Just don't leave without it. MR. GLATSTEIN: Sure. MS. FADEN: Just make sure we -- this sort of thing makes me so nervous. Okay. I don't know what to do about the exhortation. I mean, it's the sort of thing you can say, but it doesn't make for a recommendation and it's sort of not a finding, either. Go forth and be faithful. How about the other aspects of 22? This was a great struggle. The bolded part in particular. We're all right with that? I hate to revisit it if nobody's going to object to it because it's there. And we now have Eli's amendments with respect to both noting the variation in IRBs and noting the finding about confusing innovative practice with research. And not merely research. It's a fine point confusing research and treatment is the innovative practice problem which is right on the boundary. Okay. Then we can go forward. That's great. Now, let's go to the recommendations that also speak to this period. And here's where I need the other draft because I have the wrong one. We're now going to recommendations. MR. GLATSTEIN: Which recommendation? MS. FADEN: This is now contemporary recommendations. They would begin with recommendation 10, but it's -- Eli, you and I may be -- MS. LEDERER: July 14. MS. FADEN: You have July 14 for that one? Okay, then I'm okay with that one. The revised July 14th. Is that what everybody has? MR. GLATSTEIN: Yes. MS. FADEN: All right. Then we're okay. The bottom says the 13th and the top says the 14th. Recommendations looking backward and recommendations looking forward were not done at the same time. Okay. So looking forward is 14 and then we're all right. Do I have it? So we're all right there. We're going to go back to those tomorrow when we pick up the relevant -- We'll go back there today if we want. My notion was we're on a roll with respect to the modern period. If we could lock it up or get close to it since we have residual chapters from Part II as well, we can go back to both either this afternoon if we get there in time or tomorrow if it comes to it. Okay. MR. KATZ: Where do you want to start? MS. FADEN: Chapter 10. MR. KATZ: On recommendation ten? MS. FADEN: That's the first recommendation under the forward. If we could just get through the recommendations for the protection of the rights and interests of human subjects. They're broken up into three big categories, ten, eleven and twelve. Ten speaks to education, eleven speaks to the current federal system and twelve speaks to compensation which is now not part of the current federal system. So let's start with ten first. And this is where Eli, the point you kept raising about the education of medical students. Does this work for you or do you want more or different? MR. GLATSTEIN: Not just medical schools. The residency training programs as well. MS. FADEN: All right. On page 30, lines 15, 16 and 17 is trying to list everybody. I mean this is the issue about what do you do? Last time we had a whole bunch of specific ones that people didn't like because it was too specific and some people didn't like this thing and some people didn't like that thing. So the idea is just have a general out there that says go forth and educate. So this is the go forth and educate recommendation. But when you see that, you may want to go back to the let's recommend some specific stuff. So, that's what's out there. They're in here as examples. But the general strategy is that somebody's got to go do this, go do it. Here are some things that need to be done. Whereas, the last one said go do a, b, c and d. Does the -- Nancy, you look unhappy. MS. OLEINICK: No, no, I'm not unhappy. I just think this is just, I don't know. I don't know it is really better to take it all apart or put it all together, because it really becomes like everything together and it's motherhood and apple pie. I mean I can't argue with any of this. I think it would be wonderful. I'm particularly interested in awareness among the public of the importance and nature of such research and the rights of human subjects. We have a public we keep hearing from all sides that the public understands so little of science and scientific method and why these kinds of experiments would be needed. You're talking about a major public education process. I'm all for it, don't get me wrong. It's absolutely wonderful. It's not terribly specific. MS. FADEN: No, it isn't, it isn't. This is like our carrot/stick problem. We went back last time. We can either try another hand at going back and coming up with some very specific ones or we can go this route which says basically something has got to be done about it. Give it to another group to figure out what to do, is basically what this is. MR. RUSSELL: What's the likelihood of any action coming from this? MS. FADEN: You, know, I think there might be, but who knows. It depends on how this is received. This is actually an area that's easier to do something about than some of the other things we're asking to do something about. MS. KING: Well, actually this is a two-part problem. The general public education is very unlikely. The part of this recommendation that deals with professional education, there are possibilities. So, what we have here is a decision, I think, about the split between public and professional: Do you drop public altogether and just focus on professional? That's my preference. I mean I don't like god and apple pie and motherhood and all that kind of stuff as we all know. I like, you know -- MS. FADEN: We should just like those things! (LAUGHTER) MR. GLATSTEIN: If you put enough ice cream on it, it's okay. MS. KING: But the recommendations addressed to accrediting agencies and that sort of thing actually has a specific landing place and some of these agencies have histories, as you pointed out last time, or try to do something about research fraud and those kinds of issues. If they can tackle those kind of issues, they can tackle this kind of issue. So, that would be the way I would lean, but I have to tell you, I won't make a big deal out of it. Either way. MS. FADEN: We have the option of segregating this and making it two parts. Having one part speak to professional education where we can be more particular and the other part speak to public education. We can also drop the public education recommendation et al. MR. RUSSELL: I think the public education one is a throw away and I think it dilutes the professional education one which is likely to be executed and likely to have an impact. MS. FADEN: Okay. So, now, are you saying, with Pat, that we shouldn't have any recommendation addressed to public education? It's okay. I'm trying to get out where people are. I'm sorry, Lois, go ahead. MS. NORRIS: I'm rather inclined to agree with Phil and Pat because if you come out with a strong, specific recommendation with respect to accreditation and colleges and to researcher ethic training and then a very weak, wishy-washy, non-specific recommendation with respect to public education -- MS. FADEN: It doesn't sound too good. MR. GLATSTEIN: Well, on the bold print I certainly want to see the medical training aspect emphasized. Maybe in the discussion, some allusion can be made to -- MR. RUSSELL: General. MR. GLATSTEIN: General public education without making it a formal recommendation. I agree it has the effect of diluting impact of what's probably going to be more beneficial in the long run. But, there is a need to try to improve the public state of knowledge. MR. TUCKSON: I would, if we're going to do this, and I'll sign on to this consensus. But I would think, again, in the introductory part ft the document, either the preamble part and certainly in the letter that -- maybe in the body of the letter that gets transmitted to the President, is a sense that it's important that the American people have the opportunities to be educated about these issues. If they're going to be empowered to protect their own health, to participate and make informed judgements. And while we may not speak to it specifically, I think again, a whole hunk of why we got created had to do with the notion of the public and its concern. And I think we learned a lot through hearing from so many people about the degree to which people do need to be educated. Maybe we can do the same thing we did earlier today. MS. FADEN: Here's one strategy. And maybe this is not sufficiently satisfying, but, you could have a more or less detailed recommendation on education of health professionals or biomedical scientists. Which is like this, cutting out the other stuff and still gives people options because we don't want to say do one thing or another. And then we could also say that we recognize, I don't know whether this is a recommendation or not, that it's important to do the kinds of things that Reed just said. We're not the right group. We don't have the expertise, we don't know very much about the education of the public. Whereas, we have all this specific thought -- I mean, the reason we have all these specific thoughts about professional education is because we know something about it. We live in, some of us anyway or most of us, live in this world so we can all think quickly of things that it might be useful to do. Most of us, or I guess, none of us is public educators or generally are familiar with how it is one deals with those sorts of issues. So we may be able to get around it by saying we know this is an important issue, but we don't have any great insights about how to accomplish this or any way to even beginning to think about it. Now, whether that's a recommendation or it sort of goes in the introduction to Part IV where we talk about areas. For example we don't have a recommendation about this for the following reason. We don't have a recommendation about that for this or that reason. Not because we don't think it's important but because we have neither investigated it nor do we have any expertise that bears on it. Now, the response to that could be, have a recommendation that says somebody needs to think about this. It isn't us. That's not too different from what we've got here, however, for professional education. For professional education we say somebody else has got to figure out the details of how to do this, but we at least give some ideas. So, in a way, there's not a whole lot of difference between these two strategies. But, I lay it out. MR. TUCKSON: I don't think it's worth agonizing a lot about. MS. FADEN: Okay. MR. TUCKSON: I would think that I would be willing to maybe look at, outside of the meeting at the areas -- I think again, I keep finding myself being more and more interested now in the introductory parts of the document that lay out why it is we did what we did. Why it is we came together. (LAUGHTER) The larger purposes of all this. And I think that we're going to have to be -- obviously, we have to be so attentive to the larger purposes. One of those larger purposes, I mean the fundamental reasons are, the education of the American people, such that this chapter is clear in their mind, in Americans' minds. But also, such that the American people are better able to conduct their own lives and to interact with their government in the future in a much more intelligent way, based on the lessons of the past. I mean, that's what this thing ultimately is all about. MS. FADEN: Transcript time again. That's right, that's absolutely right. And that's different from this, but it's related. MR. TUCKSON: So, we can deal with that. MS. FADEN: Okay, we'll work on it. I think what we're saying is we want a recommendation that is specific to professional education, that's clear, and then how we're going to handle the public education we're not quite clear yet, if that's all right. We'll try different strategies, either it will be a recommendation or it will sort of be diffused throughout the report that that's what we're about. MS. STEVENSON: Or could it show up in Chapter 17. I know that everything is getting dumped into it. MS. FADEN: Into Chapter 17? MS. STEVENSON: But actually, it could appropriately appear in Chapter 17, because -- MS. FADEN: One of the things we found is that people MS. STEVENSON: Exactly. MS. FADEN: -- don't seem to know what's going on. MS. KING: Let's not mix apples and oranges. MS. FADEN: Right. MS. KING: Chapter 17, the problems that we found about distrust can be handled within the context of what we professionals do in a research enterprise. That's very different than talking about public education. So, there is something that can be done when your involved in a relationship with a patient or a subject that we can talk about meaningfully, I think. Public education's really tricky. What Reed I don't think -- here I go putting words in his mouth, but I'm sure he'll speak up. I think that what Reed's trying to get at is not what we call public education. I'm very uncomfortable talking about this. You know we're talking about literacy rates in the country. We're talking about a lot of stuff that none of us knows anything about. And I would say that if I had a subject of priorities, let's learn how to read and write and compute, and the rest of it will take care of itself. But I think I understand a little bit of what Reed is trying to say. He's appealing to the overall ideal of a country with an involved citizenry, and a citizenry that not only looks to its government, trust its government, but also takes some responsibility for itself. That's not public education in the sense that we understand the public education system. It goes back to our theory of understanding how we see our government and the relationship of citizens to government. So, when we recast the introduction of the report, I think that's what Reed wants emphasized. It's not education so much, it's Poli. Sci. 101, in some ways, but very important. MS. FADEN: But it's also tied to the mission of this whole Committee. MS. KING: And it's tied to our mission, right. MS. FADEN: That's why we were set up, in part, to accomplish in this particular arena, that end. MR. TUCKSON: And let me just say I wish I could have said it as well as Pat did. The only addendum would be is that I have a sense of trust in the market place of ideas out there in the world. That once we say this and it becomes front and central to what we do, America On-Line and Compuserve, the next thing you know they will have an interactive forum of people who will begin this conversation. It happens in a variety -- which is beyond our control to be specific about. MR. RUSSELL: Make that a specific recommendation, this Web site? (LAUGHTER) MR. GLATSTEIN: Let me just emphasize what Phil said earlier however, and I think it's true, I wish it weren't. But, to use that as a recommendation, put that in the bold type is so general it undercuts the impact. MS. FADEN: It won't be, it won't be. MR. GLATSTEIN: Fine. MS. FADEN: Can we -- So, we will talk about this. Recommendation 10 is only now professional education. Can I ask the Committee's view on page 31, lines 4-10, there's an intermediary step. I want everybody to sign in on this. Right now, what it says is, 'The Advisory Committee is advising the Interagency Working Group to set up a panel or a study to figure out how to do this.' And then we have a list of things that that review should consider. And the issue is, is that how we want to approach it? Or do we want to go right to, these are the sorts of things that the Interagency Working Group, in fact the relevant cabinet secretary should consider? MR. GLATSTEIN: That's fine. MS. FADEN: Going through an intermediate panel or commission is what we want to do? I just want to make sure that people realize that that's how it's set up. MS. OLEINICK: Well, we can't address how it should be done. MS. FADEN: The balance? MS. OLEINICK: Yes. So, it depends on another group to do that. MS. FADEN: The point I'm saying here is the group could be members -- people within the government itself. This, says set up a panel or study. MS. OLEINICK: Yes. MS. FADEN: That's what I'm saying. Okay? In other words, we could just simply say, somebody's got to fix it. Here's the kind of things that need to be considered. MR. TUCKSON: I think the Interagency Government Group ought to cause to occur, the following things, and how they cause it to occur. I do think it's too specific. I mean I don't think we need to be. They should cause these things to occur. MS. FADEN: And if they want to do it via convening such a group, they can. What we want them to cause to occur is this large outcome. The kinds of things they need to consider in figuring out how to achieve it is the following. And then we can say this a useful route to this might be to convene a group. MR. TUCKSON: I'll agree with that. MS. FADEN: Is there a that a better way to do it? MR. TUCKSON: I think so. MS. FADEN: What we want them to cause to occur is making ethics central to the conduct to researchers, whose work involves human subjects. Here's the kind of means that could be -- some combination of need to be explored. And in figuring out the best strategy for achieving this, you may wish to consider convening advisory panels or studies. Is that okay? Got that Anna? MS. MASTROIANNI: Yes. MS. FADEN: Good. MR. GLATSTEIN: Way to go. MS. FADEN: We're on to recommendation 11, which has four parts to it, one part of which is missing, but you'll get tomorrow. That is the part on page 42, 11D, Oversight Accountability and Sanctions has not yet been final, put together in a form that you can review. The plan is that you'll get it at lunch and be able to read it real quickly at lunch and we'll have a discussion. Eleven A speaks to things we would like to see change with respect to the IRB system. Eleven D to the issue of interpretation rules and principles. And Eleven C to research conducted n the context of the military. And what's happened here, is we used to have the military as a sort of stand-alone, separate recommendation. The idea here is if this recommendation is directed at the government's changing its current system for the protection and rights of human subjects, that includes research involving subjects who happen to be military personnel. So it was put in under that. Part of the other thing is that we are going to address all of our recommendations to the Interagency Working Group who will be dividing it up. So that's the structure, the whole structure and the content is up for consideration. MR. THOMAS: I find them all so disparate that they don't fit well together under one recommendation with subheadings. MS. FADEN: You want to make them separate recommendations? MR. THOMAS: I would still like to see them as four separate recommendations. MS. FADEN: That's do-able. We'd have to do something with the stuff in the beginning, but that's fine. MR. THOMAS: Well, I don't think the stuff in the beginning adds, that's part of my problem. MS. FADEN: So you would see them as four separate recommendations? MR. KATZ: You have one, two, three, four there on page 33. MS. FADEN: I'm sorry, Jay, I can't hear you. MR. KATZ: You have one, two, three, four there on page 33. There should be a fifth one, namely Research and Review of the Federal Regulations as a Whole. MS. FADEN: All right. So, Jay is proposing an additional one which is that there be a review of the federal regulations, the Common Rule as it stands right now. Okay, so we have that proposal on. By that, you mean that the government be charged with taking a hard look at the whole, the regulations themselves. MR. KATZ: Yes. In a sense the Common Rule is merely an amplification of the 1974 federal regulations. There has not been any review of federal regulations since 1974. As I understand it, am I right or wrong, that the Common Rule really sort of brings the various governmental agencies under the-- MS. FADEN: Same umbrella. MR. KATZ: -- rubric of the regulations that had been enacted in 1974. Am I correct in that? MS. FADEN: With changes in 1981. MR. KATZ: What? Yes, there were some minor, but they were not major changes. MS. FADEN: I'm looking for reactions. MR. THOMAS: Well, other than the changes in process which come under our first recommendation here, this seems sort of nebulous unless we give them some guidance in terms of the specific directions we'd like those regulations changed. There has to be some motivating text that says why we thing the regulations need to be changed. AS opposed to just simply changing these areas of process. Accountability, IRB system and so on. MR. KATZ: Well, you need to do the same thing for the IRB system, right? MR. THOMAS: Well, except we have laid out some specifics about what are the problems with the IRBs that we would like to see them change. So, what besides the things that are already in recommendations 1 through 4, in the regulations themselves, not the process, but what protections are offered to human subjects do you want to see changed? MS. KING: I'm having one problem, Duncan, and that is that we did two studies, I think everybody here has IRB experience of some sort. But you know, we really didn't do this stuff as group. I'm not speaking against recommendations. I'm speaking against being very specific. One of the things that really caught my attention is that one of the things that I think that we do, for example, that's very important, is to call attention to the financial aspects of informed consent. I think that's really important. And what we're saying is, this is so important, that we really want somebody to do it. I have a hard time actually putting into the recommendation all the directions. Because you know what, we discussed it, but we didn't discuss it like I know the way the National Commission discussed the specifics of what it thought the direction that the regulations should go in. But I think then we've done something very important when we say financial aspects and economic aspects is an overlooked part, we've got some data to support that. What I really want to tell them is, this needs to be looked at. MS. FADEN: That's what Reed's saying. MS. KING: But we actually have specifics. MS. FADEN: Oh, I like the specifics. When you like one specific, somebody else likes another specific, and that's going to be part of the issue here, Pat. I mean you're -- MS. KING: No, no, I'm talking the subspecifics under financial. There is a level of specificity, and I'm not being clear about it. It's the financial subpart that deals with the recommendation, points to financial costs, and then the bolder part goes on to talk about third-party payers, it talks about whether research is free or paid for. We want them to go into third-party payment. That's the part I actually get most trouble about. I want to be specific to the part of what surfaced our attention and where we think the problem area is. I'm having a difficult time saying that, as a group, we -- this is an emerging consensus in this area, although if we discussed it long enough there might be. MS. FADEN: Give me an example. MS. KING: I'm reading from page 35, that's the one that triggered it. MS. FADEN: Okay. That's where I am. I'm having trouble because I don't know what you're talking about. MS. KING: I was looking at page 35, about -- MS. FADEN: Okay, what part do you like and what part do you not like? MS. KING: I like -- I want to hammer people over the head with the fact that we haven't been looking at the financial cost. I want to say that this has to be looked at. MS. FADEN: Okay. And what part don't you -- MS. KING: And what I really would like in a discussion to say that this came to our attention through our studies. These are the things we think are troublesome areas and leave it out of the recommendation. The question was how specific are -- MS. FADEN: Leave what part out of the recommendation? MS. KING: The part that says -- MS. FADEN: Just tell me what part and I'll know what you're talking about. What line, so and so. Where do you want, what do you want taken out? MS. KING: It would be something like mechanisms for assuring that the information provided to potential subjects clearly identifies the financial implications is what I would be saying. The financial implications in participation in research. MS. FADEN: And stop it there. MS. KING: And stop it there. MS. FADEN: Fine. MS. KING: And then I would have, because -- MS. FADEN: That's fine. MS. KING: Okay. MS. FADEN: And then take the other stuff and put it in the supplementary text. MS. KING: Right. MS. FADEN: No problem. I mean, unless anybody else objects. I was just having trouble figuring out. MS. KING: I'm sorry Ruth, I apologize. MS. FADEN: No, that's fine. That's very helpful. MS. KING: In my goal -- The way I got started on this was, and that was an example about what I understood to be the conversation preceding me about level of specificity. I was indicating some trouble where we really hadn't deliberated at the level of specificity that was being spoken of in the recommendation itself. MS. FADEN: But if you could find me other examples, that would be helpful. MS. KING: I have to go back and read them. MS. FADEN: This one is not, to me, a matter of level of specificity. It's a matter of striking the right balance between the recommendation statement and the expository text. MS. KING: Okay. MS. FADEN: Okay? And every single one of these recommendations, I think this was Duncan's point to Jay, every one -- again, everybody's putting words into everybody else's mouth. But all these other recommendations are grounded in findings that we have discussed and approved as findings of this Committee. Whether we put too much detail or too little detail in the bolded part versus the expository part, is a separate issue. But these are all relating to stuff we found and debated. MS. KING: Okay. MS. FADEN: So, what Jay is proposing for response, I think, and I'm sympathetic to the observation I made earlier which is, we did not take on the charge of analyzing the Common Rule. MR. TUCKSON: Right. MS. FADEN: We did not take that charge on. I hear Jay saying we should make a recommendation that somebody else do that. That it's been twenty years or ten years, or depending on how you phrase it, since a hard look has been given to the Common Rule itself. We didn't do it, we think somebody should. Is that basically what you're saying, Jay? MR. KATZ: It's not basically what I'm saying, but I'll be satisfied if you say that. MS. FADEN: But that's the recommendation you're putting for the whole Committee to consider? MR. KATZ: They can take off on that. MS. FADEN: Okay. So that's a new recommendation that's not here. Which is different from the other recommendations which are drawing from our work. MS. KING: Okay, can I ask Jay -- MR. KATZ: Ladies and gentlemen, if our research protocol review study tells us anything it is that the federal regulations are in need of re-examination. We have the facts, even on the basis of the findings of the Committee as a whole, 33 per cent in 1995 in the age of moral progress, we find 33 per cent serious deficiencies in research protocols. Three must be something about the federal regulations that ain't working. To me that's almost self-evident. MS. FADEN: I think the reality is that the response would be that it might not be in the regulations. It might be in the implementation of the regulations. It doesn't follow. MR. RUSSELL: I wouldn't agree with that. MR. KATZ: Well, it's because -- these are interesting distinctions. My view is, if the regulations -- There's always a tension between regulations and implementation of regulations, but, believe or don't believe me, the regulations are so badly worded in so many ways that they cannot really be appropriately implemented. MR. RUSSELL: I'm not sure that's true. We have good evidence, many superb protocols were reviewed. They were adequately implemented in many instances. And that's where the tension comes. We have in some instances, very excellent execution of very good research and good informed consent. And other cases, with the same regulations, failure to perform. MR. GLATSTEIN: Well, but if somebody reviews the rules, that may be what they find. MS. FADEN: Duncan, did you want to respond? MR. THOMAS: Yes. It really seems to me that the problems that I see in the RPRP are not problems with the regulations, per se, they're problems with violations of the regulations. Hence, it speaks more to implementation than to a need for redoing the regulations, per se. My appeal for greater specificity was not necessarily that we want to load up the recommendation with lots of details as to what should be changed. But that I still need to be persuaded, myself, that there is need for us to recommend yet another commission to follow in our footsteps. MS. FADEN: We're not recommending that. MS. KING: We're not recommending that. Not here. MR. THOMAS: Then to make -- I'm not quite sure how one would go about implementing this. MS. FADEN: Implementing which, Jay? I'm sorry. MR. KATZ: Just let the foxes review it. MR. THOMAS: Let what review? MR. KATZ: Let the foxes review. MS. FADEN: I want get clear. MR. THOMAS: I want to be persuaded there's a need for change in the regulations, per se. MS. FADEN: No. Wait. MR. THOMAS: That isn't already subsumed in the other specific recommendations that we're making here. MS. FADEN: Here's one way to look at this. First of all, if you'll notice, these recommendations that are here, I'm going to put a hold for a minute on what Jay is proposing that be added, do not recommend that a new commission or committee be set up. It leaves it to the Interagency Working Group to decide how they would want to address making these changes, if they want to take our advice at all. And if, in their wisdom, want to set up another committee or commission, they can do that. If they want to do it themselves, they can do that. We're not commenting on that in the way this is set up. The way this is set up now. We're saying here are the problems, figure out a way to fix it. If you think that the way to fix it involves setting up another commission, that's -- MR. THOMAS: I don't see how else they could do it. MS. FADEN: We can put that aside. Okay? I think there are lots of -- some of these things could be done internally and they are being addressed. We can each have views, but because we had no agreement about that issue, we decided we would not stipulate the means, we would identify the end. MR. THOMAS: Well, they could do fix-ups. I agree. That's not the comprehensive review that Jay was calling for. MS. FADEN: No, I'm not speaking about Jay's. Okay. I was speaking about the recommendations that are here. MR. THOMAS: Oh, yes. MS. FADEN: Okay? Now we get to Jay's recommendation. And the issue is how many people are in sympathy of what Jay has proposed and do we want to go forward? What is the case is, we found problems. What we don't know, okay, is the extent to which the problems are a function of failure of implementation of the regs or problems with the regs. We did not conduct that analysis. I mean, we didn't do the work to try to establish how much of the problem are problems with the regs, how much of the problems were problems with implementation. It could be that it's all one way or all the other way or some combination. We didn't do the work. We didn't do that work. So it is not unreasonable for us to point that out and to recommend that when the government looks at these problems, it addresses whether the problems we found, and to what extent, are a function of problems with the regs versus a function of problems with implementation. This is certainly something that we can do that get us to the point that Jay wants, is take a look, is there any reason to think that there's something in the regs that's causing some of these problems. We didn't do that. So it seems to me quite reasonable to point that out and to say that we found the bad stuff but don't know -- you know, we found good stuff and bad stuff and we don't know what's accounting for the bad stuff. MR. THOMAS: I agree with you. But that's not a recommendation per se. That's more your introductory text where you describe the limitations of our study and you say that amongst the other things that we didn't do was this, that and you've already enumerated several things earlier today. MS. FADEN: Well, I was -- MR. THOMAS: That we proposed to put in the introduction. And that's why we don't have a recommendation for example, for public education. MS. FADEN: No, I would think that's different, Duncan. I would say that we recommend to the government to figure out why these problems are here and that would include looking at whether or to what extent the regulatory structure is contributing to the problem versus the extent to which implementation is the problem. We just looked at the end point, okay. MR. GLATSTEIN: Good way to word it, too. MS. FADEN: Right. MR. GLATSTEIN: If you imply that the regulations are the problem, it might be heard. MS. FADEN: You've got a point there. MS. KING: Could I ask a point of clarification? MS. FADEN: Sure. Then I've got Susan waiting. MS. KING: You know it is, I would suspect, the exception rather than the rule that federal regulations of all sorts involving risk, are modified through the actions of a public committee as opposed to being put out for public comment. Therefore, I have a question of fact and maybe somebody knows it or not. The answer to it. And that is, at the time the Common Rule was adopted, do we know that within the existing bureaucratic structure, that these considerations did not take place. MS. FADEN: Which considerations? MS. KING: The considerations of whether there was a need or a perceived need to redo the regulations at that point. You know, we've been talking as though there wasn't. What I think we know is, there was no public committee appointed to undertake that kind of consideration, but do we know that the kind of consideration we're talking about that might not have been done by a public committee, in fact, was not done? MS. FADEN: No, I don't know that. MS. KING: I don't know it either. That's why I was asking. MS. FADEN: I don't know that that bears on what I've just proposed. MS. KING: No, it supports what you proposed, because in the absence of having an answer to that and under the assumption that most federal regulations, when they're changed, don't go through the process that these regulations went through -- MS. FADEN: When they were promulgated. MS. KING: -- when they were promulgated, leads me to support what you proposed, because I think we are on our soundest, factual ground. It's basically what I'm saying. MS. FADEN: What I'm suggesting by way of amendment is our acknowledging what we don't know and we're saying please look at the two -- there are multiple possibilities, but the two big possibilities are some combination of the problem is the fault of the regs and some combination, some part of the problem has to do with the implementation side. So, please go look at both. Because our committee's job was not to figure out the why, it was just to see what the status was. How are things looking. Is that agreeable, generally? This is related to Duncan's point about whether this is four different recommendations or one recommendation. I mean there could be -- If it's four different parts, you've got the same, the issue is if it's four different -- I am losing it now in terms of speech. But this exhortation to the government to take a look at the two possible sources for the problems that we've identified, can either be part of 11 or it can be a preamble to -- be part of 11A or it can be the preamble to 11A, B, C and D. I'm not sure how we want to set that up. Maybe we should speak a little bit to Duncan. We'll agree that we want to say this. Okay? This, being government please check to see what's causing what. And what role the regulations versus implementation play. Can we go back to Duncan's original suggestion that 11A, B. C. and D be stand alone, separate recommendations? Then we can figure out what to do with this other one in that context. Is there a preference as to whether they should be pulled together under this heading, or separated? And made separate recommendations. PAUSE I mean, people do not have strong feelings? I'm mindful of what you said, Pat, about the importance of not having cryptic headings. MS. KING: If we eliminate all the headings, what we'll just have is recommendation, recommendation, recommendation, then that's the force of what the paper's going to look like when we're finished. MS. FADEN: That would argue for Duncan's approach of separating. MS. KING: For Duncan's approach, yes. MS. FADEN: Of having four ones that just reads -- The problem is then where to stick in the language? MR. THOMAS: Under that scenario, does this qualify as a separate recommendation or a preamble to a bunch of recommendations? MS. FADEN: I think it's a preamble. MR. THOMAS: I think it's a preamble. MS. FADEN: But then you get to the issue of the structure. That's why -- it works as a preamble if these are A, B, C, and D. It's hard to make it work as a preamble if they're stand alone. That's my tension. That if you take 11 and say make that your main recommendation and included in that you've got to take a look at the two -- they're really two pieces. There is implementation, and there's the culture of the community that receives it. And the education one is directed to the culture of the community that receives the recommendation. This is what's in the government's control. So it just is a little bit more awkward, structurally. MR. THOMAS: Well, it's arguable that we don't really have a total of three recommendations of which one of them had four parts in this entire contemporary section. Really, we have six recommendations, and this fifth that we've been talking about could be a preamble to the whole thing. The review, then, could incorporate these broader issues of education and compensation for research injuries. MS. FADEN: All right, should we -- MR. THOMAS: And there could be an introduction to the entire section, contemporary section. MS. FADEN: When what am I hearing now? I have a feeling, that as a group, we're not very interested in resolving this issue of whether it should be four recommendations or one. MR. THOMAS: No, I don't think it's a fundamental question. MS. FADEN: All right, we'll work on how it flows best, and come up with something. MR. THOMAS: Maybe just reordering the whole section. MS. FADEN: It's not worth taking committee time. What about the substance of A, B, C and D? MR. ROYAL: I just had a meeting with my own IRB last week. And one of the things that they were talking about in terms of -- which now 11A-1, MS. FADEN: What page was that on? MR. ROYAL: On page 33. MS. FADEN: Okay. MR. ROYAL: Is to allocate their time better. One of the things -- Let me first of all, put this into perspective. The number of applications that they review has increased by a factor of three in the last three years at a time that their funding is not likely to increase by a factor of three. They really, seriously have a problem. And one of the things they have to do, is they have to review protocols that are being submitted as part of grant applications. And yet only, if you were lucky, 15 per cent of those protocols are going to be funded. So, I wonder if there's some way we could have some type of expedited review of those things that are being put in for grant funding? MS. FADEN: Birds in the hand versus birds in the bush kind of thing? MR. ROYAL: Yes. MS. STEVENSON: That's going to be a requirement for those people to be able to send their grants. MR. ROYAL: I understand. But that's what I'm saying we should get the federal government to recognize that this is a -- MS. FADEN: We certainly could put in the text that one of the things that has to be explored is what we really want is carefully scrutiny of the work that gets done. MR.ROYAL: That's right. MS. FADEN: And, in the interests of that we have to think through maybe, especially given the changing times, it used to be a 70 per cent hit rate. MR. ROYAL: Yes. MS. FADEN: A grant went in and had a 70 to 80 per cent chance to get funded. There wasn't nearly as much wasted work. Now you're down to a payout of a lot less than that. I don't think we can think through whether you want to jettison -- I mean just flag it as an issue and point out that this one bears thinking about how to help make sure the studies that really are slated to be implemented with people have the most careful scrutiny. Mary Ann? MS. STEVENSON: I guess it, to some degree, depends on if that's a redundant function or it that's an essential function. See what I mean? If that kind of scrutiny is going to occur at a higher level then maybe it's just a redundant function regardless of whether the grant would get funded. But if in the NIH review process that's actually very essential, then to jettison it is not such a great idea. MS. FADEN: It's a problem, because at the other end the study section will say I don't want -- unless somebody else has much -- MS. STEVENSON: Unless study section wants to take on the responsibility, then you really -- MS. FADEN: It's a very serious problem, because the study section doesn't want to waste its time funding a project that's ethically unacceptable and doesn't want to take on -- MS. STEVENSON: The responsibility of determining it. MS. FADEN: -- the same level of responsibility. And there's a whole debate about what role study sections have. So this is a complicated issue. We can simply flag it and say -- It's an easy one in the sense that we don't have to resolve it in the next ten minutes, when we can point out that this is a tension that's taken on new proportions given that the payout's now way less. And we realize that people -- we see that IRBs are struggling to find the time to do right by the work that actually is going to be done on human beings. So, just put that into the hopper when you think through how to handle this time problem. So we can add that in the text as examples of an issue that bears rethinking now. Part of the reason why people are sending more grant proposals is because the payout is less. It's all a vicious cycle. So people are writing more grants because the payout is less. The more grants people write, the lower the payout. And the more work for IRBs for the same number of projects that actually get done with human beings. So it's a real time problem which we can flag as getting worse and is not the way it was in 1970 when this stuff was set up. And the payout was I think way higher in 1970. Any other comments. We're sort of on 11A, B, or C. If not, you will feel free, obviously, to send in other comments, but I'm assuming that -- Much of this you've seen before so I'm not surprised if there isn't a lot of commentary and D, the 'Oversight, Accountability and Sanctions' is new and you'll get it tomorrow. We threw out what we had before. Susan? MS. LEDERER: I had a question about I guess, 11C-4, which is the maintenance of the registry. MS. FADEN: 11C -- MS. LEDERER: On page 41. MS. FADEN: For the military? MS. LEDERER: It seems to me, in some ways, that's an open recommendation, isn't it? To me it doesn't seem to belong with the other three Improving Protections for Military Personnel that go to the regulations about recruiting and -- MS. FADEN: I see what you're saying. MS. LEDERER: Doesn't that go along with the recommendations that improving public access to information about their own participation? MS. FADEN: That's an interesting question, because I can see why you say that. MS. LEDERER: It's an organizational question. MS. FADEN: I can see why you say that. Should we hold it and wait? MS. LEDERER: Depending on how we reorganize the other material, because it seems to me that the other ones goes to regulations about the conduct of military research -- MS. FADEN: Whereas this goes to maintaining records. MR. THOMAS: Well, Sue, the stated purpose on the top of page 42 though, as a tool of long term monitoring and follow-up which turns more to questions of subject protection. MS. LEDERER: Okay, I guess looking at the phraseology of this. I was thinking of it in terms of access of individual to know or to be able to prove or verify that they were -- MS. FADEN: Right. MS. LEDERER: -- at certain places when there were exposures or other things occurred. MS. FADEN: I think you could arguably put in both places because it's serving multiple functions. Why don't we leave it as an open question. If we're agreed that the recommendation should be there, then it does become a kind of placement issue and we can look to see where -- we can flag it when we get to openness whether we think it fits better there. If that's agreeable. The recommendations for -- MR. THOMAS: It's not obvious to me why we have a recommendation for research done by the military and not for other federally funded research at the same time. MS. FADEN: The reality is that this plays off of what is the actual policy of the Army at the moment for its R&D related research. If you read the regs, the Army has such a policy and what we're saying is the other services ought to have it. And it is right now for not clinical research, but for R&D research. MR. THOMAS: Okay. MS. FADEN: And there's a thing in there that says maybe you should think about clinical research. And the clinical research would have more of an analog to regular research, generally. If I've got this right. The current Army policy is that this registry is maintained for people who are involved as volunteers in non- clinical, non-medical studies. Akin to what, historically, if this had existed -- MR. THOMAS: I see the point of consistency, but, consistency for something that isn't useful is a silly virtue. So that assumes then we've decided that such a registry is useful, and if it is useful, it may be more widely useful outside. MS. FADEN: It actually, and I think this goes to the why the openness issue, it speaks to the recommendation about the military needs to keep good records, generally, of exposures. MR. THOMAS: I'm not disputing that. MS. FADEN: This is a subcase of this. MR. THOMAS: I agree. And I actually am persuaded of the usefulness of it here. MS. FADEN: All right. MR. THOMAS: The purpose of my question is to ask whether it is not useful, more broadly. MR. RUSSELL: Since most of the -- MR. THOMAS: Other agencies. MR. RUSSELL: Yes, clinical research on the subject matter and the means of execution are totally indistinguishable from what's going on in any civilian medical center. MS. FADEN: All right, that's why it's not in here. It's only in here as a consideration.. Because if you do that -- If you want, we have three choices, like everything else. Or four or five. Ten. But one is we take the line beginning on page -- the sentence beginning at the end of line 15 and get rid of it. Because then that does raise the issue that we think the Defense Department should consider having a registry like this for clinical research, then we should go back to the registry recommendation for all research which we jettisoned because it was an overwhelming prospect with very little enthusiasm for it. In which case this would be more coherent because it dovetails with our recommendation with respect to keeping exposure records for military personnel, generally. And the atomic vets stuff. So, if it's agreeable, we can stop it after follow-up. And the issue is the Navy and the Air Force should do what the Army have already doing. Is that agreeable? Okay. Which is how it was before, by the way. Just for what it's worth. Mary Ann? MS. STEVENSON: I just, Phil can correct this, but on three, I thought that last time we had added a proviso in instances when it is not militarily required for the non-commissioned officers and unit officers not to be there. I thought we had put a proviso that -- MS. FADEN: In all but clearly defined excepted cases. MR. THOMAS: Yes, but those clearly defined excepted cases are not clearly defined. MS. FADEN: No, not by us. Somebody else will have to figure it out. If you want to do it, fine. If we want to come up with -- MR. THOMAS: I thought we had words last time. MS. STEVENSON: We do. We said when it is not -- MR. THOMAS: The two exceptions that I recall were, first of all, when the officer himself is being asked to volunteer and the second where entire units have to volunteer. MS. FADEN: But even with -- MR. THOMAS: The details of how the implementation of those two, of course, are beyond us to specify. But I get nervous about unspecified exceptions. MR. RUSSELL: I do too. MS. FADEN: Okay. MR. RUSSELL: I'm nervous about two things. One, the unspecified exceptions and two, the restriction on non-commissioned officers. Non-commissioned officers make up such a huge percentage of many military units -- MS. FADEN: Okay. MR. RUSSELL: That you wind up not having any volunteers if you excluded the non-coms. MS. FADEN: The issue here is not that they can't be asked to volunteer. MR. RUSSELL: There aren't very many privates left in many organizations. MS. FADEN: But just to clarify this, because maybe this wasn't clear. We weren't saying that officers or non-commissioned officers couldn't be asked to volunteer, we were asking that people who were below them in power be allowed to consider this in the absence of the presence of the people who were above them in authority. Not that you couldn't ask an NCO. MR. RUSSELL: But that isn't what this says. It says no unit officers or non-commissioned officers, it doesn't -- MS. FADEN: Be present. MR. RUSSELL: It doesn't specify it being the chain of command. MS. FADEN: Okay. So we have to change that. We can make that -- and then you want an exception case even to that. What we're saying is that Mary Ann and Duncan are reminding us that even there, where they are in a chain of command, we want to allow for conditions under which we could let the officer or non- commissioned officer be there. MS. STEVENSON: Be present. MR. RUSSELL: Or you could change it to the unit officers and non-commissioned officers in the chain of command be excluded from subject recruitment sessions. MS. FADEN: Right. They could be recruited separately. If they're to be participants, they could be recruited -- you can have a separate recruitment session for the NCOs or for the officers so that there isn't a subtle pressure. MR. RUSSELL: I agree with the intent, I'm just trying to that there's not a lot of collateral damage. MS. FADEN: No, we don't -- MR. KATZ: Phil, here I would agree with something that you haven't said. (LAUGHTER) But I'll say it for you. Isn't all this going into much too excessive detail. Could we not make a general recommendation that the military ought to pay attention to this? And then in the commentary just flag some of the issues that they might want to consider. Is this really for us, in this particular instance, and go in bold face in this amount of detail. I raise it as a question for you and defer to your judgement, myself. But I wondered, in light of comments you made on other occasions that you might have some of the same here. MR. RUSSELL: The issue of command influence on recruitment is one that comes up every time there's a discussion of military medical volunteers. The one specific way it has been dealt with in the past is by excluding officer and senior non-coms in the chain of command from the recruitment session. Well, if this is carefully worded so it doesn't have a lot of excessive or potential for collateral damage and too restrictive, I really do think it's all right. Because the issue of the ability of the military to volunteer is always an issue in these and that's why it's here. MR. KATZ: You think it's all right? MR. RUSSELL: I do. I think it is. I think we can make it right. I don't think it's correct right now. MS. FADEN: We will work on the language with Phil, Mary Ann and Duncan to get it right. And also, as I understand, Phil, it plays off a practice that's commonly engaged in. So, it's basically saying let's up the frequency with which this practice is engaged in because it has proven to be useful to the people we've talked to. And this idea came from Phil. And then talking with other military investigators who have used this practice and believes that indeed, improves the likelihood that what they're getting are 'genuine' volunteers. It has a track record. Okay. Other comments on the 11A, B or C. We're leaving for a moment, how it's going to be set up. If not, we can go on to D, I mean recommendation 12, which we also discussed last time and we were sent the sections from the President's commission. PAUSE MR. RUSSELL: Let me make one comment on B. The Public Health Service recently completed a huge trial of pertussis vaccine in Sweden, and I don't believe there were any untoward effects from that trial. But there may well have been something that might have been attributed to the trial. These are long ranging, long term issues, and do you really want to basically indemnify every possible federally funded trial no matter how extensive? MS. FADEN: But what -- MR. RUSSELL: Sometimes, you're even getting into phase four kinds of trials. MS. FADEN: This recommendation says merely this is an enduring public policy issue and it needs to be resolved. It also doesn't say how to resolve it. It just say, look, this has been lingering. We faced it, other people have faced it, we add our voice to a long chain of voices that say that somebody's got to figure out how to resolve this problem. It goes further than that and says that the President's Commission in the early Eighties came up with a solution that some subset of us think is worth pursuing. But we're not endorsing it whole cloth as a committee handoff. So there's sort of two parts. The first part is the recommendation can simply stop with this is a long standing problem that remains unresolved and we are saying to the government, figure out what to do here. In not doing anything, the problem does not go away. So, in failing to have a policy that says -- if the policy is that we'll never do it, then that becomes a conscious decision that 20 or 30 years from now somebody else is going to be sitting there trying to figure out who's supposed to get compensation, who's not supposed to get compensation under what considerations. Because, it's not going to make it go away. The next point of the thing goes on to the President's commission and says -- maybe it's not appropriate to do them, maybe it should be in a footnote, the part about the President's Commission so as not to dilute that some members feel one way and some members another. We haven't debated the merits of the President's Commission's recommendations. So, maybe I could start with the first part first and see how many people are comfortable with the recommendation as it stands. Is that agreeable? MS. KING: It sounds agreeable. I should say that the President's commission's recommendation is actually much narrower than what we have been talking about. Its recommendation was for an experiment to see if in fact, the feared infeasibility is in fact, real. That there are real world obstacles to do what they thought was ethically required is basically the position that they took. And they said we can't answer that question and as far as they could figure out, from reading the report again, nobody else could answer the question either. So, really what they were saying is, lets test. The reason I support this is because I don't think the issue is the ethical issue. I think the issue has been for a very, very long time the feasibility issue and you can't put feasibility issues which is again, in some ways, what Phil raised, you can't sort of put the feasibility issues to rest by continuing to have these discussions. So, what is needed, I think, is actually what the President's Commission called for. Let's put this argument to rest by seeing if it is feasible, if it's doable. It may be, it may not be. So, I think that this is actually narrowing what we're saying and could have been stronger. It could have been saying that there is broad acceptance of the ethical -- MS. FADEN: We didn't say that. MS. KING: We didn't say that. So I like this. MS. FADEN: Well, let's -- MS. KING: We just said resolve the issue and the President's Commission, that was their solution. MS. FADEN: Well, it's not a solution, it's a means. MS. KING: It's a means. MS. FADEN: And somebody else might say we don't need to do that, we'll do some other means or we'll let a state do it, or whatever the deal is. First, what we want to do is just flag -- we struggled for how many committee meeting hours, or continue to struggle with what's fair, what's practical, what's right and what's doable in respect to compensating people. So, we know this is a big problem from our own experience. That's what gives us the authority to comment on this. And what we're saying is it's not going to go away because we went away. Somebody else is going to have this problem. So, figure out what to do about it. We can sign off on that part then we can go on to say whether we want, as a group, to say anything about the wisdom to pursuing the strategy suggested by the President's Commission. We could have a line that simply says this Committee recommends the administration consider the wisdom of pursuing the strategy outlined by the President's Commission and that would take care of it. That's not even an endorsement, it's just take a look at it again. Remind them, as I'm sure they know, that there's this other report out there that's entirely on this subject, whereas we have only a few lines on it and that it would be worth taking a look at it again. MS. KING: Believing as I do that the requirements for protecting humans will continue to evolve, it's conceivable to me that 25 years from now, somebody will look back and say, you know what we did in the Nineties, we now find ethically unacceptable. And they'll be faced with precisely the same issue, only it will be immeasurably harder than our was because we're not operating in the face of people calling attention to these questions and nobody doing anything about them. I can see 25 or 30 years from now being -- actually, I can see on the financial issues and informed consent as an easy way to see it. So, I think it's a nice, soft recommendation myself. I don't think it's too hard. MS. FADEN: Are we okay with it? All right. And we will change it to the -- instead of having a number of us endorse, we'll simply say that the Committee recommends that the Interagency Working Group look again at the President's Commission's strategies. It may have merit, as a way to attack, as Susie puts it. All right. Now we have an interesting branch point. Our break doesn't come until four, but we have done all the recommendations for the human subjects area. You know, I think what we could do at this point. What I really wish we could do is take a break, but the stuff isn't here. How about if we just take a five minute break and when the food comes, people will help themselves. Just come back and bring the food. Is that all right. We are taking a break for five or ten minutes. When the food comes, just help yourself and bring it back to the table. (Whereupon, the meeting was recessed from 3:34 p.m. to 3:59 p.m.) MS. FADEN: I'm very grateful to the Madison for bringing the food at just the right time. That was perfect. MS. KING: It may work for you, Ruth, but the jury's out on what it did for the rest of us. MS. FADEN: You're right. If it's put you to sleep or revived you is the empirical question. But at least you came at the right time. It would have been a distraction if we had just sat down to come back and the food came. If the Committee could come to the table, let me propose how to proceed at this point. We are ahead of schedule in some respects and behind schedule in other respects and let's see if we can come up with a strategy for adjusting the agenda accordingly. If you look at our agenda, it was anticipated that we would be on the Protection for the Rights and Interests of Human Subjects through the end of the day and fortunately we are not. However, we have several large pieces of unfinished business about the historical period from 1944 to 1974. What I would propose, is if you can bear with us and switch gears, if you look at the agenda item that is scheduled from 9:30 to 10:45 tomorrow morning, this would be continuing Findings and Recommendations for Intentional -- we've actually done the finding for intentional releases. If you pick up with Recommendations from Balancing National Security Interests and the Rights of the Public, we could just stay right in the recommendations chapter and keep on plowing through. We could free up the time we need tomorrow for the period from 1944 to 1974 if we plow right through the chapter that we're dealing in. So, if that's agreeable, we'll just do that. You don't have to change your pages or anything. Flip over to page 44. We're in a new heading. This is on Classified Research and then we also go on to Intentional Releases. The Classified Research one, just in case we should have done a red lined one here, is changed almost not at all from the last one except that the group decided last month that what we wanted this special panel to do was focus on scientific merit and not on whether in fact there was a justified national security purpose which we took to be not the purpose ft this panel. So, that was changed in 13B, but other than that 13A is essentially as we had had it before, basically saying that informed consent should be a requirement of secret research. And then 13B is the recommendation for this special panel to introduce an additional layer of protections in the context of secret research involving human subjects. The language is essentially as it was before only we have substituted one task for this panel for another. So are there questions or changes for recommendation 13. And again if people have changes as they come to them and look at it again, obviously we'll entertain them. But right now, are we comfortable with 13? We're okay with 13. Recommendation 14 moves to intentional releases. We had a discussion if you recall last time in which we determined that we were not interested in drawing a distinction between intentional releases and routine releases, the issue was whether they were being done in secret. And so the major change that has occurred in this series of recommendations is that we have switched it to make it clear that what the relevant triggers here are that the release is not an accident and that it is to be done in part or in whole in secret. And then we kick in the protections. MR. GUTTMAN: A small question which we need the advice of the experts on, that the - MS. FADEN: We're on 14A. You want to look for it while -- MR. GUTTMAN: At Phil's suggestion, the function of the board was to advise in the particulars. The question is the balance between determining and advising. It's a technical question. MR. RUSSELL: Right. MR. GUTTMAN: Phil pointed out they can't determine. MR. RUSSELL: They can't determine, they have to advise. MR. GUTTMAN: Right. MS. FADEN: We can make that clear for both of those panels. In the same sense that we are advisory, they are not obligated to do. But the point is, if public record is kept even in secret, but if a record is kept of the advice of this committee and the government chooses to go against the advice of the committee, then that stands as part of the recommendation. Is that agreeable? If the issue is this panel doesn't have the authority to decide what should be done, but is charged with advising to the government about these functions, the language should go to both. Poor Ruth. MR. GUTTMAN: It sounds like Apollo XIII. MS. KING: I do this all the time. It's never crystal clear to her. MS. FADEN: No, it's very frustrating. MS. KING: It's very difficult to use these mechanisms. MS. FADEN: Are we comfortable with -- MR. RUSSELL: Are we on 14A? MS. FADEN: Yes, we're on 14A. MR. RUSSELL: I'm concerned about the definition of hazardous substances. I don't know how broad that is and what the definition of a hazardous substance is. MR. GUTTMAN: Isn't that one where, clearly, if anybody takes this seriously there are plenty of definitions in existing law. If anybody wants to put this into effect, I am sure they can key it in. MS. KING: I don't know the environmental regulations so I wouldn't dare speak to them. MR. GUTTMAN: There's plenty of confusing, conflicting and incongruous definitions and for us to try to draft something would be -- MS. FADEN: Well, I think -- MR. ROYAL: But it would be nice if we could say some existing -- MR. GUTTMAN: Well, we could say Clean Air Act, RCRA, CERCLA and that wouldn't be much help. MS. KING: Why don't we just say release of substances posing risk or try to say something about risk. Isn't that what we're interested in? MS. FADEN: You still got the same problem. MS. KING: But we don't fall into the trap of hazardous, which I do think is a term that's already used and has meaning, of being ambiguous if we had our own phrase. So nobody would say ah- ha! Here's a definition over here. MR. RUSSELL: I think the fundamental problem is the ambiguity when we've got a recommendation on how they're supposed to deal with it. And you can envision a whole bunch of industrial type activities that are classified that may or may not produce some level of environmental hazard. And I'm not sure I can understand the scope of this recommendation. MR. GUTTMAN: Well, the logic of it is in the discussion we had last time. Initially, one way to do it was to link it to the requirements of the existing environmental impact process, because that would be something that's already got a trigger. And it's got substantial, major federal actions triggering it. Then the question is well, what if that process went away or changed or didn't apply you'd still want to have this same thing. And I think Phil said we'd be in deep trouble if there was no environmental review in the country in general. MS. FADEN: Can I -- I'm sorry, Henry. MR. ROYAL: Phil, your concern it sounded like during the production of something that there might be something released as opposed to -- I mean I think this is supposed to be an intentional release as opposed to an operational release. MR. GUTTMAN: No, the other way around, last time. MS. FADEN: How about if we did this. Could we, without tying it to the legislative backdrop for environmental impact statements, say that the same sorts of things that would trigger an -- if it would in the current context trigger an the need to file an environmental impact statement and it was to be done in part or in whole in secret, then this gets triggered. And if that environmental impact statement law goes away or regulation goes away it's still giving a sense of the sorts of things -- MR. GUTTMAN: Well, we can write maybe, something in the rationale that gives a legislative intent that explains that we're trying to be reasonable. MS. FADEN: I hate to confuse things and go back to issues, but I want to revisit the Advise Authority business. I think I made a confused statement. Let's resolve this one and then I just want to point out I'm going to go backwards. Phil, are you comfortable with tagging it? I mean, I don't know anything about this -- MS. KING: This is what is difficult for all of us. We are all having a great deal of trepidation in going into areas which are technical and which we have no expertise. Now, there has been some staff work but we don't have anybody here who is an expert for us. So, we know what our intent is. We know we don't want an intentional release again. MS. FADEN: What if it's in secret? MS. KING: But that's classified of the sort that we discussed in the Green Run. And I think Phil is expressing with his discomfort with hazardous is that we don't understand if we're sweeping broader than what we intended to sweep. So, the best way to do that is not to use these terms like hazardous, but to explain what we are trying to reach. I'm only trying to reach things like the green run because I don't know about those other things. MR. GUTTMAN: Right. But then you get into the question of whether the green run was hazardous. MR. GLATSTEIN: Why we don't just say radioactive isotopes? MS. FADEN: No, no. I think the reality -- at least I'm speaking for myself now, if the next generation of releases is some other entity other than radiation, I don't really much care. MR. GLATSTEIN: Oh, you mean like biologicals? MS. FADEN: Yes. Now, I don't really much care. The concern is that we don't have -- MR. GUTTMAN: I see what you're getting at. MS. FADEN: -- secret releases without oversight protections. We're not saying there should never be a secret release. But analogous to secret human research, we want some other level of protection of the interests of the public. MR. GUTTMAN: Well, why don't you give some examples like isotopes or biologicals? MS. KING: Well, your emphasis, Ruth, is not on the substance, it's on the secrecy. MS. FADEN: That's correct. MS. KING: And what I think Dan is trying to say is that the Environmental Protection Agency is already taking care of unclassified -- you have to file an environmental impact statement. MR. GUTTMAN: No. What I'm saying is that there is a body of law, environmental impact law, which relates not only to major federal actions, but there's lesser kind of environmental assessment for lesser than a major act. So, some kind of review process. MS. FADEN: I think we have to get back and let the staff do some work and give us some options here. I think we know what the problem is and we have to figure out how to address it. And I don't think this is an area where we'll have a fruitful discussion because we don't know what we're doing. So, if we can get clear -- That's really what it comes down to. We know what we want to do, we don't know how to nail it down and Phil has rightly pointed us to the potential for great ambiguity here. MS. KING: Well, I think I know what I want to do and maybe it's more limited than what is intended here. And I want to state that. I'm not ready yet to go beyond what we've found objectionable about intentional releases because I am and always have been -- this is not anything that I know anything about or can speculate about beyond what we learned in our intentional release chapters. What I am concerned about is classification and review in the context of classified projects that are releases. It is less what is release that has become my trigger as the fact that it is released in secret. So, in part, the rethinking of this is to focus on classification and secrecy and try to strip out the language that deals with -- MS. FADEN: Well, okay. Then the issue is -- this betrays my ignorance. We started out with intentional releases that were done in secret. And you don't even have to have the word hazardous in it. MS. KING: Right. MS. FADEN: It's an intentional release that's done in secret, we want the special review. Then we had the discussion last month that said, hey, we don't care if it's an intentional release or a routine release. That was the sentiment of the group last time. If it's done in secret, it should trigger. MS. KING: That's right. MS. FADEN: Then, all you'd have to do is take out the word hazardous. But Phil, if your worry is -- I don't know how many routine releases currently occur in secret. I don't know if that's a common occurrence. Because we only investigated the intentional releases stuff. If we get rid of the word hazardous and say environmental releases, were the releases proposed to take place in secret or in circumstances where any aspect of the review process required by law is conducted in secret. The operating thing for us was not hazardous. The operating thing for us was secrecy. We didn't like the idea of stuff being dumped into the environmental was being done under the table. There may be good reasons why that should happen, but we want to make sure there's an extra level of protection. So, if we're comfortable with that we'll just get rid of the word hazardous. MR. GUTTMAN: I don't think you want to do that. MS. FADEN: Well, that's the problem. MR. GUTTMAN: Well, if somebody dumps water out the back door, then that's a release in the environment. I mean, that's a release. MS. FADEN: And it's done secretly? MS. KING: No, I think that the trigger is secrecy. Anything that is going into the environment that is secret -- MS. FADEN: And you want to have a trigger an environmental impact statement that's secret? Nancy. MS. OLEINICK: No. Because let me just take a hypothetical situation. We have a secret plan that nobody knows about, but the only thing they're going to dump out is -- MR. GUTTMAN: Is water, out the back door. MS. OLEINICK: Is water, right. And just because there is secrecy there should be no reason to have this whole process. MR. ROYAL: But I'm not sure about that because the secrecy is where the distrust comes from and the fact that you document by some independent panel saying that yes, we looked at this and we found out that all they're going to do is dump water out the back door, I think that would comfort the public. MS. FADEN: And the point is that unless you have this oversight, the public is going to think that's not just water that's dumped in there. They're going to find out about it and they're going to think, my god, what's in that water. That's Henry's point. If we've learned anything it's that when stuff is done in secret, the inference that people draw from that is it's something really nefarious. Otherwise, why would they do it in secret. So, all we're saying -- now this may go. MR. GUTTMAN: I don't think this is one of those things like hazardous. There are lots of definitions and lots of statutes and whoever gets this is going to sit and cut it in whichever seems reasonable. MR. RUSSELL: Let me point out there was a release of an organism called sceratia marsessions, -- MS. FADEN: That doesn't sound good, Phil. It does not sound good. (LAUGHTER) MR. GUTTMAN: We just had it for lunch. MR. RUSSELL: It was defined as not hazardous. And it was released in secret and whether or not it caused any illness or not is still arguable, but -- MR. KATZ: Mrs. Evans died probably from it. MR. RUSSELL: So, I think that if you left the word hazardous in there, you could define that one away. And that should have been reviewed. MR. GLATSTEIN: Why don't you substitute for hazardous, chemical, biological or radioisotopic? MR. GUTTMAN: It depends on your definition of chemical. MS. KING: Everything's a chemical. Water's a chemical. MS. FADEN: Is water a chemical agent? MS. KING: Yes. Of course it is. MS. FADEN: Alright. MR. GUTTMAN: We're not against water. MR. TUCKSON: I guess you can't do it be simply saying substances that have a level of risk significant to cause harm. MR. THOMAS: How do you know it's not a sufficient level until it's been reviewed? MS. FADEN: There's also two issues. There's Phil's issue -- MR. RUSSELL: That's an environment law. The trigger for an environmental impact statement is embedded in the law. MR. GUTTMAN: That's right. MR. RUSSELL: And I think we just use the EIS as our landmark, then we can add on anytime that get's triggered without having to define why it gets triggered. Then we need another level of review. MS. FADEN: Will that do it? MS. OLEINICK: I think so. That's the easiest definition. MS. KING: No. It doesn't deal with my level of discomfort. Now, I'm not just kidding. I sat on a recombinant DNA committee. One of the major issues when they began to do that research and they wanted to do an environmental release, was whether we were going to do an environmental release. That issue was resolved because in that case, a group of private scientists decided to surface the issue. But to me, that's what I keep thinking about when I'm thinking about this, and that is that what we have here is an analogous issue and what we are concerned about is supposed they had gone ahead with that first release and it had been secret, we would not want that to happen. We want what happened to have happened. So that the thrust that we're trying to get to. I do know, and this is my problem when you don't know an area, is that it was a matter of debate at the time, -- MS. FADEN: Whether -- MS. KING: whether those releases triggered -- MS. FADEN: An environmental impact statement. MS. KING: -- the environmental impact statement. It was subsequently resolved. But at the time, Dan, it was not known -- MR. GUTTMAN: That's right. MS. KING: But it was resolved in a court of law. We don't want that to happen either. Never mind. If the Committee is satisfied. MS. FADEN: No, I'm not. Okay. For me the trigger is secrecy. My only concern is that I don't know how much stuff is happening in secret. If there's a lot of water being dumped in secret so that this would be a bureaucratic nightmare, that would be a problem. Okay? But I don't know. MR. GUTTMAN: You could say potentially hazardous. MS. OLEINICK: Every plant is dumping water. There's no question about it. MS. FADEN: I don't know how many secret plants there are. MS. OLEINICK: I don't know how many there are. Maybe there are none, maybe there's a dozen of them. I don't know. But wherever they exist, they're dumping water. I can guarantee it. (LAUGHTER) MS. FADEN: Let me step back. Nancy, here's my thing, here's where I am. I would think that the principle that is at issue here is secret releases of anything. Because I agree with Henry about the issue of then it will come out later that it was secret and nobody will believe it was just plain, unadulterated water. The only objection would be a pragmatic one. If it turns out that out there the government is running tons of secret plans and this would be a bureaucratic nightmare to use Mary Ann's words, then that might give me pause. Not knowing that, on the presumption that the government is not generally in the business of dumping stuff in to the environment secretly, which I fervently hope but I don't know, then I would like it that this mechanism be triggered whenever that's supposed to happen. MR. GUTTMAN: Put another way, what we're really saying is that every plant that has an element of secrecy has to have a waste management plant that's reviewed by this board, probably. MS. KING: Well, I think that what we want to do is what Ruth just said, quite frankly. And that is -- MR. GUTTMAN: Which is not bad, necessarily. MS. KING: That you got to admit ignorance in the face of lack of knowledge which is a reasonable thing to do. (LAUGHTER) And what we want to do, because somebody else is going to try to do this, if we want to capture the principle in a recommendation, in the deliberations we want to explain the intent of the Committee. We want to say that the Committee was not composed of experts in environmental regulation. Intentional releases is in our charter and that's why we're speaking to it. We know enough from intentional releases to worry about what would be in place if the issue arose again where you had a classified release. And what we want is some system of review which we have recommended. MS. FADEN: That's great. And what we could do, if you like, is simply say that at minimum, if it was the kind of release that would trigger an environmental impact statement, for sure this would come into place. We would like to see it go more broadly, but we don't know about the practical implications because it's not our world. MS. KING: And admit it. And admit we don't know what the practical implications are. MS. FADEN: What a refreshing alternative! All right, that's great. Okay, we can do that. Is everybody agreeable with that? MR. GLATSTEIN: Fine. MS. FADEN: Henry? MR. ROYAL: I'm agreeable. I would just say that I don't think the broader construct is the problem that we're making it sound like it is because the trigger is the secret release. The fact that all these secret plants are releasing water, presumably they don't have any problems saying we release water. So, that would not come under review. It's the fact that they would be releasing something into the environment and not be willing to notify the public that they're releasing into the environment. MS. FADEN: Presumably, you don't hide the whole plant, you just hide what it's doing. MR. ROYAL: No, no. Remember, this is actually quite relevant. MS. FADEN: We've got hidden plants, too? MR. ROYAL: The old day of Hanford, the whole question, actually it's quite relevant, of the Columbia River and what was going on. They were afraid if they told people how much water, people could make deductions or inferences about plutonium production. MS. FADEN: But that would be a case in which you would then take it to this panel. And that would be your safeguard. MR. ROYAL: If you're taking up that much water, that should go to the panel. MR. GUTTMAN: Maybe it's an idea. MS. FADEN: We're going, we've got it. And when we see it and we hate it, we'll deal with it then. We have a profound statement to say about something about which we know nothing is a kind of awkward thing to do. But we're not going to do that because we have the brief for intentional releases and we speak out of the legacy of distrust that we know that that has generated. Can I revisit, just briefly, something on the classified research one. I did not mean to step back on that one and say that we we're going to advise the nod to authority. The vision here was that this was going to function like an extra level IRB. That the work could go forward unless this panel said the informed consent stuff is okay. The scientific acceptability is okay. And the issue of security clearances for the subjects has been satisfactorily addressed. MR. GUTTMAN: That was the question I was raising. MS. FADEN: That's why we took out of here the charge that the national security reason is good enough. That's not what this Committee's going to deal with. This Committee is only going to deal with the sort of stuff that an IRB would ordinarily deal with. Only it's an extra level of protection that's in the classified context. So just so everybody knows that one is going down that way. All right, now we're on to 14B which is Agency Oversight. MR. THOMAS: Can I ask one more question about 14A? MS. FADEN: Sure, 14A, yes. MR. THOMAS: Page 49, lines 17 to 19. I don't understand the qualifiers for testing for research purposes. Because the thrust of the recommendation is for planned or intentional. MS. FADEN: I think this paragraph should go. MR. THOMAS: It's archaic. MS. FADEN: Careful reading again. Duncan is getting points for picking up. Good job. MR. THOMAS: We dropped a little bomb shell there. MS. FADEN: It's a mistake. It's a hangover from the last version and should go. Nobody cannot say that people on this Committee read carefully. The scary thing is that you can't say later, I didn't read that part of the report. Fourteen B is Agency Oversight for this context of classified research stuff. MR. ROYAL: Is it realistic to use words like -- MS. FADEN: In perpetuity? Yes, they aren't my favorite words, either. MR. ROYAL: That sounds a little extreme. MS. FADEN: What's an alternative. We want to say that they have to keep them for a long time. MR. ROYAL: How about a hundred years. Some number, I don't care. MS. FADEN: Is there a convention for stuff -- Sue, can you help us here? If there's an important document is there some sort of -- MS. LEDERER: We still have a copy of the Declaration of Independence. MS. FADEN: Is there some sort of convention in terms of even government record keeping about how things are classified in terms of importance and how long they need to be maintained? MS. LEDERER: I can't answer that. MS. FADEN: Okay, so we don't know. MR. GUTTMAN: Actually there is for medical records, but it's longer period for different categories of things. MS. FADEN: Can we just tie into some of the categories and give it a high priority category. Instead of in perpetuity, just find out whatever the rules for retaining government records. It must have classes and we'll make sure it gets a class that requires retention for a long time. MS. KING: You're making a lot of big assumptions. MS. FADEN: You don't think it will happen. At least some agencies have it. It may not be government wide but at least some agencies. We know from having done the archival stuff. But at least some agencies. They have destruction policies. So we could flag it to one of them. And use the triaging they use for stuff you can destroy early and stuff you can't destroy for a long time. MR. ROYAL: And you have the same problem I think it was with 13B where it says on page 45, line 13. MS. FADEN: Page 45, line 13. Yes. So both of those will be replaced with some term of ours that fits with government record keeping that is to give our sense which would be for a long time. MR. ROYAL: Yes. MS. FADEN: Okay. PAUSE MS. KING: It's not going to happen because it's very costly to retain records. So, the reason I'm expressing some -- MR. ROYAL: There must be some categories of government records that we do want to keep for a long time. Even though it's expensive. MS. KING: I'm sure that's right. But, never mind. MS. FADEN: Well, we can recommend it and they can dump it down if they decide. I mean these are all recommendations. We want to give our sense that we think these are the kinds of records. MS. KING: We're not giving specific information about records because it's not an area that we've explored with enough detail to have a real good specific sense of the regs. We call them critical records. So, in effect what we're saying is two things. We have to determine what's critical and then determine the time. MS. FADEN: Right. Both of these obviously gives people interpreting these a lot of room. Well, we are going to continue with this issue because we are not moving into openness. If it's all right, I'd like to sort of march through this. And then we'll have done a lot in terms of clearing up the agenda for tomorrow. Susan, is that amenable. Do you want us not to do it because you wanted to work on it? MS. LEDERER: Well, I guess I will just say that I am somewhat dissatisfied with the lack of precision I think, in the recommendations having to do with openness and the archives and the archive and agency interactions. And I was planning to work on them tonight, but if you want to take the time to go through them now, I would still like to work on them. MS. FADEN: Here's another strategy. If you could tell us how you would like to change it, the group could endorse it. Then you could just do it and that will be the next revision. In other words, you could -- unless you and Suzanne haven't had a chance to think through the kinds of changes you would like. MS. LEDERER: We have a number of changes we would like to make. So I think I would prefer to defer the discussion until tomorrow. MS. FADEN: Are there any we can deal with at the moment, in the interest of time. MS. LEDERER: I don't think any of them conflict with what I take to be the basic point of these recommendations. But that we want to maintain an access of the American public to the records. MS. FADEN: Why don't we -- MS. LEDERER: But I think some of the ways that these are worded are so onerous, that they will never be implemented and I have as much stake as anyone in maximizing access to these records. MS. FADEN: Can we do this, see if this will work, Susan. We've got 18 and 19, recommendation 18 and 19, where I'm suspecting that's not the focus of your's and Suzanne's energy. One is the directed to the CIA and the other is -- MS. LEDERER: Right, right. MS. FADEN: Let us take up, as a group, -- this is a hangover from the last time. The way it is set up right now, the recommendations on openness have four parts to it. Fifteen deals with basically keeping an openness initiative and successful. That's where Susan is going to give us guidance about how to do it better. So we won't touch 15, until Susan works on it tonight. Sixteen, seventeen and eighteen don't speak to that. Recommendation 16 is directed to non-federal institutions and that's not the area that Susan's going to work on tonight. So I want to do the ones that she's not going to work on tonight, get them done with so that we have as much accomplished -- I'm trying to clean out stuff. Sort of like you go through a closet and you're not going to have dinner until the following closets are cleaned out. That sort of how I'm feeling right now. Recommendation 16 is directed at non-federal. The issues about records being kept and made available that are research records generated by essentially, grantees and contractors. Universities and private firms, okay? So, why don't we have a discussion of 16. MR. GUTTMAN: The context, basically what we're saying in the first one, which Susan is going to work on, is generally archivists think the best place for important records is the National Archives. But the real world is they're not there and they're not going to get there for a while. What can you do in the interim that we've learned from this committee to make things available as soon as possible. So, that if they're indexes, give them to the public, things like that. The other two, the contractor and the -- the last one is that our records should be kept in the National Archives which we think and hope is being done. The other two, the reason people have been asked why single out the CIA, et cetera, et cetera, is that to me, these are leveling the playing field recommendations. The first one we're saying let's get whatever can be gotten to the public that's still in the agencies to the public. We got two separate classes of records that we found. One is when things are in the hands of contractors and grantees, the public is going to say what difference does it make. It's paid for with taxpayer money. It's a whole area that the Freedom of Information Act doesn't deal with very well. In some cases as in the case of DOE there's special subregulation that says certain contractor records are federal records for the purpose of the Freedom of Information Act. And as Pat and others have pointed out, there are many good reasons why you don't want parity, but it's an area, where from the standpoint of the public, you want some consistent public policy as to what kind of access you have to that body of records. The other, is the CIA is a case, of all the cases we looked at, there are plenty of agency records that have been classified, the Defense Nuclear Agency is a good example, still are classified but the public has access to the framework of those records. Jim David knows the DNA records are in RGX in the Washington National Records Center, he even knows a lot of the titles. The CIA, by contrast, the public doesn't know even how they're organized. And we all recognize that a lot of those records aren't going to see the light of day and even the record structure may not. But we've got some inclinations from our own work and that of others that it's not even clear. that there are the same problems at the CIA that there are elsewhere. The government can't find its records. So we're saying, in that case, there is a question of the organization framework of the records themselves and the records are not visible. Somebody should look and see if this is well done. Now, we actually talked to the CIA about this, Gary Stern and I, and it seems to be relatively accessible. Their reaction, at least at one level, this is not Director Deutsch, but it would be very helpful if we had some clear ability to look at our records. The second two parts of this, the contractor and the CIA aren't singling out contractors and singling out the CIA, it's more of a parity or a leveling of the playing field in relation to the other agencies that we've had access to. MS. FADEN: So, should we take up 16 first. MR. GUTTMAN: Yes. But that's the context. MS. FADEN: It's important to see this framework this is supposedly intended to fulfil. MS. LEDERER: So does 16 refer to records that are maintained by University researchers and what kind of records are we specifically asking them to retain. MR. GUTTMAN: WE're not asking anybody to do -- What we're saying right now is, for example, if you wanted to get Dr. X's research notes. And if it was Dr. X who was the intramural researcher at the NH, they would be subject to the Freedom of Information Act. If Dr. X -- So, in other words, we're looking at the first question, the immediate question is to what extent are things not accessible to the public under the Freedom of Information Act which are not accessible because it happens to be a privately funded or a non-federal investigator. And, we're assuming that things like privacy and trade secrets and all those things, we're not changing that set of rules. MS. KING: What is the current legal regulation or legal framework for records retained? You see, you made a big assumption, that government- sponsored research to contractors, to private institutions, it wasn't clear to me whether should mean that these records should be open to the public, or in fact that determination has been met. This is a tricky area between public and private. MR. GUTTMAN: No, no. We want this study, we want this addressed. MS. FADEN: Right now, the recommendation doesn't say make them equal. It says somebody int he Interagency Group, go take a look at this. This is an issue, and try to figure out if we can come up with a good public policy that strikes a balance between the public's right to be able to have interest in having access to research records that are in the possession of universities but for work funded by the government, and the differently situated status of private contractors and grantees. Because they are differently situated. And we can't say, whole cloth, any university that functions like the Clinical Center at NIH should be required to keep every piece of paper. But, is there a way to strike a better balance. MR. GUTTMAN: There's actually immediate precedent. For example, in the case that we're dealing with, the Spokane newspaper filed a Freedom of Information Act request about General Electric which had run Hanford, had been overseeing some human radiation experiments int he sixties. So the Spokane newspaper said, under the Freedom of Information Act, we'd like all these documents. And the DOE ruling, the first level was under the Freedom of Information Act, you're only entitled to it if you've got an agency and agency records. General Electric is not an agency so it doesn't maintain agency records. Therefore you wouldn't get it. Turns out DOE put in a new rule under its contract laws that says under certain of our contracts, if a contractor generates such and such a document, it is a DOE record and therefore would be accessible. So, the point is, this is something that people at various levels are beginning to comprehend and work through the system. MS. KING: Is the new DOE requirement that records be kept as well as access be given. MR. GUTTMAN: That would be separate. That's the next question. MS. FADEN: Basically what happened, is the early iteration of this recommendation said create parity. The Committee sat back and said, can't do that. We haven't thought through all these issues. The private entities are not the same as the government. This could be a nightmare. This could be good. This could be bad. So, we have now stepped back and said there is this difference and the difference affected our own work. We couldn't get some stuff. And based on this, we figure other people are having this kind of problem too and from the perspective of the citizen, they don't care. But from the perspective of the entity, the government versus the university or a private firm, there cold be relevant differences that should affect what public policy is, can the government please review this and try to figure out what is fair. To strike a right balance. Now, the questions is whether this Committee thinks that this is an issue that deserves attention or not. Because we're not recommending a solution. The question on the table is whether we want to recommend that the government address this problem. MS. STEVENSON: I just want to get clear in my own mind, you don't know if there are any existing stipulations right now regarding, not access, but what these private institutions must keep and for how long. MR. GUTTMAN: Well, clearly there are under contract requirements. Whenever you enter into a contract with the government you've got -- MS. FADEN: I think what there is is tremendous variation. MS. STEVENSON: Right. So there may not be -- MR. GUTTMAN: They're probably all over the place. MS. STEVENSON: How long and how much you keep. So this would address both that and the access issue. Is that right? MS. FADEN: We could set it up that way. MS. STEVENSON: Because does it make any sense to make a rule about access if there's nothing to access? MR. GUTTMAN: That's right. The policy implications and so forth. MS. FADEN: But the point is, do we think -- we clearly don't have the -- we haven't thought through the problem, we can't make recommendations about how to resolve it. That's out of the question because we don't know. The issue is do we think this is an important enough consideration from the perspective of openness and access to the work of the government on the part of the public to say to the government, please address and see if you can't come up with a fair process. Susan? MS. LEDERER: I have very mixed feelings about this recommendation because record keeping, traditionally has very low priority for the government. From the records that actually exist, it makes sense to maximize access, so I fully endorse making indices and finding guides available and on line to people so they can at least identify what already exists. But it seems to me that this is asking for a great deal. To study the problem and then there are the implementation issues. This is a major task, it strikes me. MS. STEVENSON: Also, very expensive. MS. FADEN: All right. Let's hear -- MR. GUTTMAN: All these things you say are true, but the other side of it is in the real world we live in the government has been since 1945, especially in the research area, increasingly done by contractors. And there is no -- whatever difficulty there may be in keeping records, nobody's suggesting that all this data be given to the government to keep. MS. FADEN: I think it's more likely. MR. GUTTMAN: Maybe that's a policy solution. But in some respects, this is analogous in the openness area to what we're looking at back in 1974 with consent in the Wilson things. You do things on an intramural basis and everybody says what about the contractors. MS. KING: The residual discomfort I have is that it is an openness recommendation dealing with human research is getting to a broader issue. The place where contractor records are needed, in my opinion, and grantee records may be needed, is not in the area of human subject research. The big government, the big picture, about how government puts it's money out there and if we want access, where we think issues -- are not necessarily human research area. That does not mean that looking at our history that that wasn't a problem. But one of the issues with the current regulations in place as of 1974, and now with an IRB system, where we know that the costs of the regulatory burden to deal with human subject research, which we think is very important, we already know has been subject to a great deal of criticism. So, to add a requirement in human research is what's giving us some discomfort. Your argument to support the regulation is a much broader justification with which I have to confess I have some sympathy. Because the problem of getting access to government files and records across a lot of fields, is very difficult. So, the question for me boils down to, can I get the camel's nose under the tent. And that's sort of the way I see the function this is serving. So how much is it worth to go with the camel's nose under the tent? And that's the discomfort that you're feeling. I haven't heard anybody be upset with the broader goal of openness in government. MR. GUTTMAN: It's like apple pie. Only Pat King is -- MS. KING: We're not upset about it. That's not this recommendation is written. It is written to human subject research. MS. FADEN: But here's the issue. If you look at the openness recommendations themselves, some of them speak to human experimentation specifically or need not. I have some of the same reservations about this recommendation. One of the things that troubles me now is that the way it is structured right now, it's a big recommendation. It's a stand alone, big recommendation and I don't think it's in the same league with some of the other things we're trying to highlight. MR. GUTTMAN: From the openness perspective it may well be. MS. FADEN: But for the reasons that Pat has just articulated. But it strikes me that this general principle of recognizing that many of the records of interest to the nation, the result of government activity in the sense of the government having paid for it are in the hands of the private sector. And putting that part of 15, the General Openness issue, is the government using its contractors and grantees for a bunch of stuff, this is that general issue of people should have access to the documents of the government -- of the records that document the government's actions. And we got a problem because a lot of the government's actions are done indirectly by contractors and grantees. So this has got to be handled, but we don't know how exactly. It means that we're still making that statement but we're not giving it the prominence of a full recommendation. And we're kind of indicating that it's not simply in the human radiation area that we are concerned about this. That it's triggered in the human radiation area by research. MR. RUSSELL: The only area that this would impact is in relationship with the pharmaceutical industry. And they're collaborators in academia. That's where the biggest number of human subjects research that's being done. It has private sector interest, university interest and government funding. It's not just grants and contracts, it's cooperative R&D agreements. These are incredibly complex. In all of these there's an issue of confidentially of the industrially confidential data. It also speaks to the FDA issues. While I see the value in openness, I also see this is a very complex issue in federal acquisition regulations. It's an area that I'm very much afraid to tread in. MS. FADEN: Well, what we can do, if there is a way to include it as an important concern of the Committee and emphasize the sort of thing that Phil's just said. You start with this very nexus of federally funded research in the traditional sense, realize very quickly that it expands beyond that and expands to the sort of thing Phil's just described and expands to other areas that the government essentially pays for. Stuff that affect the lives of human beings. MR. RUSSELL: It pays for part of it. MS. FADEN: Part of it is the other issue. MR. RUSSELL: One of the problems is there may be a lot of industrial money involved as well as a lot or a little federal money. MS. FADEN: So, we can just leave it. It's going to take a lot of study for a long time. If there's a principle unfairness and there's a general principle of public access and it's got to be balanced against these other considerations and somebody's got to figure out how to do it. MR. GUTTMAN: So, what do you want to do with it? MS. FADEN: Well, it's going to go under 15 now. Rather than being a major recommendation of the Committee it would be under the general openness initiative stuff. And would be changed. Susan, if that's not dumping too much in there, but it would be in the list of things that we're saying should happen. Is that agreeable? MS. KING: I'm quite frankly not clear about what we've just done. And I'm sure it has to do with the time of day. MS. FADEN: We'll try it again. Dan is right about the basic principle and the problem. Then we start layering all these other considerations and qualifiers on top of it and what I'm hearing is, because of all of the reservations that we are raising, this does not rise to the level of an independent recommendation. Some of our things are stand alone recommendations. That's our big message. The way this is set up now is a big message, independent recommendation. What we could do is take it and put it as an area under the openness initiative recommendation that needs to be pursued. Which draws a different level of attention and priority from the perspective of the Committee and allow us to be a little broader in our discussion of the problem. Rather than saying of the ten things for the modern world that we want to have changed, this is one of them. Is that agreeable? It doesn't lose sight of the principle that Dan is reminding us that we've confronted in our work. But it doesn't make it like Pat used once, your eggs in your basket. It's within an egg rather than an egg in and of itself. It's a double or triple yolk egg as opposed to an egg egg. Is that agreeable? MR. GLATSTEIN: Yes. MS. FADEN: It would become a part under 15. MS. KING: You might also consider putting it with the Declaration of Independence type statements because it also belongs there. That one of the relationships between government and its citizens is openness, and that doesn't mean anything if you can't get access to records and information or undo roadblocks. MS. FADEN: All that kind of stuff. We were set up to advance an initiative in openness so that citizens could have access to the records of their government. A major ambiguity is what counts as records of the history of our government, given the relationship between the government and private sector. This is a looming problem and it's getting bigger and bigger with more private/public partnerships and so on. So, it fits very nicely under the openness initiative. Particularly, as we have more and more of these sorts of things, we're really going to have to think hard about what it means for citizens to have access to the records of their government. Now, we've got the CIA one which is 17. MR. GUTTMAN: I know what you're going to do on this one. MS. FADEN: I'm not doing anything right at the moment. MR. GUTTMAN: Why don't we put this under number 15? MS. FADEN: I don't know. MR. GUTTMAN: It's because nothing should stand alone. MS. OLEINICK: So what we're doing is first putting them together. MR. GUTTMAN: I could see Ruth's method a year ago on this one. I'm sorry, I didn't mean to interrupt. MS. FADEN: The floor is open on the CIA recommendation. MR. RUSSELL: The only thing that's a little bit bothersome is the governance issue here. The advisory committee recommends to the Interagency Working Group to provide for independent review of the CIA. Well, let me tell you a couple of things about that Dr. Russell or General Russell. I'm not sure what capacity we're discussing this. Citizen Russell. One is we've actually discussed this with the CIA, a funny exchange where they didn't understand what we meant. I got on the phone with Jim Warner and said all we want to do is make sure you know where your records are. He said, oh, yes, there are plenty of people that would agree with you about that. MS. FADEN: The CIA is a member of the Interagency Working Group. Our recommendations are supposed to go to the Interagency Working Group and then they divide it up. So on that technical matter, the Interagency Working Group could then decide to turn this one over to the member. MR. GUTTMAN: The analogy -- MS. KING: Just look at it this way. It's a good time to do something like this. We couldn't have gotten away with it a year ago. MS. FADEN: All right. I think if we look at the first lines, 1 through 6, it doesn't say what Dan just said to me. So, basically we're asking that the CIA get a record system up that they can figure out? MR. GUTTMAN: No, that there be somebody -- we're going to get a phone call from the CIA tomorrow. MS. FADEN: I think so. So let's figure out what we're trying to say here. MR. GUTTMAN: The intent is that, in contrast to the other agencies where there is some visibility, some but not total visibility, the CIA records system, has for reasons that are perfectly legitimate, kept in secret. So we want to make sure that there is some coherent framework by which those records can be retrieved by those who have reason to get them. Be they citizens or CIA officials. So there should be someone who is not the CIA, it could be the Inspector General of the CIA, somebody with some modicum of oversight. MS. KING: Are you saying that we know enough about the CIA to know that if internal to the agency, if the CIA wanted record retrieval it couldn't get it? MR. GUTTMAN: Certainly, we couldn't presume to say we know anything about the CIA with any great degree of confidence. Their system has been compartmentalized in a way as to make it difficult to find things. MS. KING: So you are saying that internal to the CIA, the right hand doesn't know what the left hand is doing. MS. FADEN: I think -- Can't we look at your 1 on page 62 and your 2 on page 64 and see if we can't recommend that? MR. GUTTMAN: We could. MS. FADEN: Just look at those two lines. The bolded stuff on 18-20 on page 62. MR. GUTTMAN: Yes. MS. KING: The first one looks good. MS. FADEN: It's straightforward. That those things that aren't classified should be made available. MR. THOMAS: The problem we seem to be having with the word independent. I'm not quite sure what that means. The discussion seems to say that the CIA could do this themselves. MS. FADEN: Right now it says independent. MR. GUTTMAN: Well, independent in the inside the Beltway doesn't mean what it means outside. So if an Inspector General did something that is considered to be independent even though it's of the agency? MS. KING: Yes. It's the person that's the agency watch dog. The best thing I could think of is like being an ombudsman, but they have more clout. MR. THOMAS: If that's what the word means, I'm happy with that. But I don't thing that's how the public is going to read that statement. They're going to be very dissatisfied when the CIA investigates itself. That's not independent. MS. FADEN: Well, why don't we get rid of independent for right now.. MR. GUTTMAN: We do mean independent. MS. FADEN: In what sense? MS. KING: I think that's why I was trying to understand the intent of the regulation because it makes a difference if what we're saying is that the CIA can't get access to its own records. It's another thing to say that the public can't get access to the CIA records. I thought, initially, until you started to explain it Dan, sorry Dan, -- MR. GUTTMAN: So I was persuasive! MS. KING: I thought initially what we were trying to do, to the extent possible, make available your legitimate requests. If that was a thrust, you actually have to have an outside group do something like that. MR. GUTTMAN: What we're saying generally that when you're talking about historical records to some significant sense, agencies don't know where there records are. That's why DOE has now gone out and done a road map for its records. And that's what DOD is doing. Obviously to a greater or lesser degree. So, in the case of the CIA we don't know where that is. If you look at a quote from the recent investigation in the bank business where one of the trust department investigators included, 'While we benefitted from extensive cooperation and assistance from the CIA, the CIA's ability to retrieve the information is limited. Records are compartmentalized to prevent unauthorized disclosure.' MS. FADEN: This is on page 63, lines 20 through 2 on the next page. MR. GUTTMAN: 'And then the CIA personnel assisting us didn't know where the records were.' MS. FADEN: Did they go on to say it should be fixed? MR. GUTTMAN: They were here just doing a limited investigation. So, what we're saying is that there is, in general, a real question looking at the nation's historical records, whether the government itself knows where it's records are so that they could use them, not just the public. Therefore, in the case of the DOE, we have a physical published road map of some big chunk of historical records. MS. FADEN: But the way this reads, it sounds as it that's quite intentional on the part of the CIA. MR. GUTTMAN: But it's intentional, the question now is, is it dysfunctional. MS. FADEN: That's why I wanted to go to what's in lines 18 through 20 which says basically somebody should look at the CIA records to ensure that appropriate documents that stuff that can be made publicly available, should be made available. MS. KING: Even when he explained it just then, he went back to the second thing. MS. FADEN: So, I would propose that appropriate documents would be documents that may be permissibly available to the public, should be made available. MS. KING: There are two ways to think of independent: Outside CIA and outside government. MR. THOMAS: I find it difficult to imagine that outside government having any feasibility because they simply couldn't know what they need to know. MS. FADEN: I was thinking of something like the Inspector General of the CIA. MR. THOMAS: All I'm asking for is that we use appropriate words to explain by what we mean by the Inspector General. And if we just say the Inspector General, that's fine. MS. LEDERER: Well, if you look on page 63, lines 4 through 6, why don't we use that language. 'The CIA's records keeping system should be reviewed to ensure that records are maintained. The review could be performed by the CIA Inspector General.' MS. FADEN: That's perfect. MS. KING: That should be a recommendation. MS. FADEN: So, let's look at that. It's page 63, lines 4, 5 and 6. Dan, are you okay with that? MR. GUTTMAN: I'm a little bit apprehensive. MS. FADEN: So is that okay, that 4, 5 and 6 becomes the recommendation. What about the other part of the recommendation? I'm going to get rid of the language in 17, so it would be 17A, would now be lines 4, 5 and 6 on page 63. Thank you, Susan. Now the issue is, do we want a specific thing that says which is on page 64, lines 3, 4 or 5 which we bumped up against, want in particular to be classified and made available.? MS. KING: Well, do we have some reason to believe that the classified documents are inappropriately classified? MR. GUTTMAN: Well, it's not a question -- I think that it said in the recommendation, if they were reviewed for declassification, most if not all the records could be declassified without -- MS. FADEN: Where are you? MR. GUTTMAN: I'm sorry, page 65, line 6 and 7. My understanding from Gary, with some exceptions, there shouldn't be problem with declassifying them. MS. KING: I don't think that's the issue. That doesn't go to the question that I asked. That tells me that maybe they're past the normal period that we would expect information to be declassified. We're saying declassify all the rest of these records. MR. GUTTMAN: Let me explain the context. I think the answer on the substance of the documents that by and large, they could, not just because of their dates, but because of what they contain, could be declassified. MS. FADEN: All right. Here's I think the context. We obviously bumped up against MK Ultra a bunch of times. MS. KING: But not every committee member on the Committee did. MS. FADEN: We bumped up as a committee to the issue MK Ultra and a bunch of points. We asked for and got a bunch of documents related to this declassified. We also had staff look at documents that remained classified. We believe in the openness initiative of the United States that is currently underway, that the MK Ultra records be bumped to the very top of the declassification pile for immediate, quick resolution and the making available to the public of everything possible. MR. GUTTMAN: To the extent that's permitted by -- MS. FADEN: We have not already judged. We are vouchsafing that there isn't a line in here that shouldn't be preserved for national security. We want what can be made available be made available at the earliest possible time. There's not a whole lot left because we know a lot of it was destroyed. Which is part of what makes the whole history so unsavory. MS. KING: Now, that covers MK Ultra; what about other programs involving human testing? MS. FADEN: There's a whole list of them on page 62 in the bold language: Bluebird, Artichoke, MK Delta, a whole bunch of secret human research stuff the CIA sponsored. And we're saying that it's really important in the interest of the nation to get this stuff declassified as quickly as possible. Our brief for doing this comes from this is common territory to the stuff that we dealt with. It leaves a cloud to have documents about secret research involving human subjects stay secret. That's not a good idea. Is that agreeable? So the CIA would take two forms, 17A where A says what Susan found, and 17B is revised framing about what we mean to have happen with records that bear on secret human experimentation programs. MS. KING: That's fine. I'm just laughing at 18. MS. FADEN: Eighteen? All right, what is the view on eighteen? MR. GUTTMAN: I hope it's not technically necessary. MS. FADEN: We've approved it already. MR. GUTTMAN: I don't think its necessary. I'll check with David Saumweber, our archivist, but I think it's already in the works. MS. FADEN: It's going to happen. MR. GUTTMAN: The truck hasn't left the office yet. MS. FADEN: This is the expectation that this is what is going to happen to the Advisory Committee Records. And we have already approved this recommendation. We're making it again. MS. KING: What I like is a special value -- MR. TUCKSON: Can't somebody else make that recommendation? MR. GUTTMAN: You can put that in the transmittal. MS. FADEN: The concern with 18, obviously is it's awkward to praise oneself. It's awkward to tell the world how important what we did was. MS. KING: I would like to stop after advisory committee and describe it. I understand why you want to make this recommendation, but it's a bit flowery. MR. GUTTMAN: The other way to do it Ruth, is just to put that the record will be, and then if anybody wants to contradict it, we've already had agencies review. MS. LEDERER: If it's already being done, why do we have to recommend it? MS. MASTROIANNI: At one point it was a significant issue. MS. FADEN: At one point it was of great value for the Committee to register that this was its desire. It now appears that that's how it's going to be. So we have two choices. We will determine whether there is a utility in retaining the recommendation without the patting on the back stuff. It would stop after the, 'collected or generated by the Advisory Committee.' If we think there is no need to retain it because it's already a given that it's going to happen, we'll just get rid of it. Sue? MS. LEDERER: How accessible are our records? Are we providing finding guides? MR. GUTTMAN: The answer is they're being prepared by archivists, so who knows. MS. LEDERER: Because if that were so, I would like to see that in the explanation that these will now be immediately available to citizens. That we're already done the work of organizing. MR. GUTTMAN: Actually, we've got it elsewhere in the report. MS. FADEN: But we could pull it in. MS. LEDERER: We're not adding another thing to the National Archives that's going to take a lot of money? MS. FADEN: It's already been done. MR. GUTTMAN: Well, the other side of it, is we only have one. MS. FADEN: I'm sorry, I'm confused about two recommendations. MR. GUTTMAN: Everything is now under one openness recommendation. MS. FADEN: What we're saying is, we did this and we'd like to see this preserved. If we don't need to do it because that's already the decision that's been made, fine. If there's a political utility in retaining this, we will say it without the patting on the back, but we will indicate that these records are in good shape. It's just a matter of housing them where the public can get to them. So recommendation 18 may or may not be here, depending on whether it is needed. Let me run through. Anna has carefully done this. And then we can decide if we want to use the next 45 minutes of not. So, what we have to do left are three backward looking historical findings. Finding 2, finding 11C and finding 16. We have recommendation 11D on sanctions for the future and the openness one Susan will bring back to us. We have chapter 4 TBI and radioisotopes. We have some remaining background recommendations that we didn't get to on the populations exposure. We didn't look at them at all. We have the discussion of process and if individual committee members are thinking about writing individual statements to give the rest of us a preview. And we have to approve the minutes. We're going to do 4 TBI and radioisotopes. Chapter 4, TBI and radioisotopes. We could try to march through some of the population recommendations now, if we thought we had the energy to do that. Or we can stop. MR. THOMAS: There's also the notification one. MS. FADEN: Oh, the notification one, yes that's a huge one. It's a lot to do tomorrow. MS. KING: I'll waive my time to talk about statements. MS. FADEN: But people have a need to hear. MS. FADEN: It's five hours, given that we're starting at 8:30 tomorrow and we're ending because people have to make flights. MR. KATZ: Could we meet at 8:00 tomorrow? MS. FADEN: No, we can't change the agenda, Jay because we're a public meeting and the public has to know when we start. If we start before or go beyond, we're violating our restraints. MR. KATZ: Oh, pick up some people from the street. MR. GUTTMAN: It will be the People versus Katz in litigation. MR. KATZ: Professor Katz. MS. FADEN: Could we try doing some population recommendations. I think if we don't we will regret it later because we will end up not having the time to do it. MR. GLATSTEIN: Let's do it. MS. FADEN: Let's do it. We need chapter 19. Recommendation 6. We have to do observational studies too, guys. There's no way we're going to do this all. Recommendation 6. Could you tell me the date of your draft? MR. THOMAS: July 13th. MS. FADEN: I have July 13th too, but I just think it was printed out differently. What page is recommendation 6 on in your copy? MR. THOMAS: Top of page 15. MS. FADEN: Thank you. Okay, can we start with recommendation 6. MR. THOMAS: The only thing I'd like to comment on is line 8. I'd like to see the words geographic area replaced by populations. Because some of the areas that are already covered by RECA are not geographically defined. MS. FADEN: So, what way -- MR. THOMAS: Just change the words geographic areas to populations. MS. FADEN: Where is that? MR. THOMAS: Line 8. MS. FADEN: Line 8? I've got another version. This ridiculous. Other comments on recommendation 6? Recommendation 7? PAUSE This recommendation does not include whether there should be a follow-up study. MR. GUTTMAN: It's not intended to be. MR. THOMAS: My recollection was that it was going to be part C of this one. MS. FADEN: That's right. We need to bring it forward. I thought we were going to have it as a separate recommendation because part of the motivation was not to advance the interest of atomic veterans, but to advance the interest of all of us. MR. THOMAS: Well, that's been the essence of the debate between Henry and me. And I don't think either Henry or I are saying that study will do a whole lot to advance scientific knowledge about low dose radiation risks. MS. FADEN: So, why -- MR. THOMAS: Henry's making a very strong case, not to put words in his mouth, but he says it's totally worthless from that point of view. It's purpose was more to help in setting public policy regarding fairness in compensation. Except that's a public policy issue, I think MS. FADEN: It belongs under here. MR. THOMAS: I believe it belongs here, and I think that's subtly different from just politics. MS. FADEN: No, no, no. I mean -- MR. THOMAS: But I think that's the essence of the difference between Henry and me. MR. GLATSTEIN: I think it can be if it can be done right. If they got the people who work there off the list. But if they can't do that, it's no good. MR. THOMAS: That's exactly the point. A bad study is not going to advance anybody's knowledge. MS. FADEN: I want to get clear on the rationale, because I guess I was totally confused. MR. THOMAS: Well, the rationale then is to help in establishing compensation policy. MS. FADEN: So, it's thought to improve fairness in public policy for the atomic veterans if this work was done. MR. THOMAS: That's my view. And for that reason I would argue that it belongs in this recommendation. Informal polls of the committee members, it isn't clear that the Committee really wants to say that. In which case, it's out entirely, in my view. MS. FADEN: I think the issue is the arguments. MR. GLATSTEIN: I agree with Duncan with the qualifier if it can be done and done well. If it can't be done well, it shouldn't be done at all. MS. FADEN: All right. One approach would be not to make a judgement and have a recommendation in here that if it's determined at an adequate level of validity, then it ought to be done because it might improve fairness in public policy. MR. THOMAS: This committee really can't evaluate its scientific merit, in my opinion. MS. FADEN: Fine. MR. THOMAS: But since there already is an IOM committee which is charged with making that evaluation, the natural thing is just to kick it to them. MR. ROYAL: One of my arguments is there already is this IOM committee so I don't know why we have to comment whether we are in favor of this committee or not in favor of it. The problem from the science aspect is that the average radiation dose that we're talking about is 600 millirems. And given that, during a lifetime, we're exposed to 21 rems of radiation, plus or minus 5 or 6 rems, and each of us are exposed to radiation in diagnostic procedures, plus or minus a few rems, the chances that you are going to be able to attribute disease to this 600 millirem dose due to being an atomic vet, when your radiation dose -- MS. FADEN: Let me just break this apart. Now we're getting into the scientific merit which we said this Committee isn't going to do. This IOM committee has or has not delivered itself of its opinion already? MR. THOMAS: Well, its delivered itself on part of the answer which has to do with the dosimetry question. I don't know whether there are still further reports to be expected from them. MR. RUSSELL: What's the charge to that committee, what's their basic responsibility, do you know? MR. THOMAS: It's my understanding that what was recently released was a subcommittee of the larger IOM committee charged with investigating the dosimetry question and they are still considering whether a further study should be undertaken. MR. GUTTMAN: Basically, the charge is to revisit the 1985 NAS study. MR. THOMAS: By revisit, do you mean redo or consider whether it should be redone? MS. FADEN: I suggest -- Can we look at the rest of this recommendation and hold off on the rest of this issue. So, we know there is a piece missing from what is the history of this Committee's discussion and whether that piece will remain out or stay in is open. So we will discuss the rest of this recommendation with that proviso. What needs to be change with what's here? MR. THOMAS: The only problem I have is on page 17, lines 20-21 where we are recounting some of the testimony that we've heard from the public. And the casual reader will spot that line and think that this is a recommendation from the Committee. MR. KATZ: Where are you? MR. THOMAS: Page 17. MS. FADEN: This is a disaster, because this is yet another draft again. MR. GLATSTEIN: I'm not sure I have the same copy. MR. THOMAS: Starting on -- I'm just going to read the introductory text. 'Witnesses before the Advisory Committee blah, blah, blah expressed strong concerns. Several concerns were repeatedly identified. The listing of diseases blah, blah MS. FADEN: So you want to change it to several? MR. THOMAS: It should be updated to include other cancers and autoimmune diseases. Now we are not making that recommendation, we are just reporting on what the testimony says. MS. FADEN: You want to change it so it's clearer? MR. THOMAS: I want to make if very clear that that's not a recommendation of the Committee. MS. STEVENSON: The first time I read this I felt the same thing. These are the opinions of the people that testified, not our opinions. MR. THOMAS: Yes. MS. STEVENSON: It does come through at the end. MS. LEDERER: But we could minimize the problem by rewording or moving it up to the top of this. MS. FADEN: The Committee does not have the time or the resources to pursue these concerns to determine their merit. What we're doing is a pass through. MR. THOMAS: And if we are trying to recount the testimony it would go a lot further than this. It would certainly include reproductive outcomes. MR. GUTTMAN: Maybe we -- should there be another category. MR. THOMAS: Actually, I don't remember very many people talking about autoimmune diseases. MR. GLATSTEIN: Well, I don't wish to refer to the dose reconstructions as questionable. I wish to refer to the them as irrelevant. MR. GUTTMAN: But you're not testifying before the Committee. MR. GLATSTEIN: I'm talking about what we're actually recommending. MS. FADEN: And what do you want it to say? MR. GLATSTEIN: I want to say irrelevant dose reconstructions. The only people that are benefitting from this are the contractors that are doing dose reconstructure. MR. GUTTMAN: There's got to be someone else that's benefitting. MR. GLATSTEIN: We're spending more money on that, over time, than it's worth. We're spending more money on that than on what we're paying out. MS. FADEN: Okay. MR. GLATSTEIN: Otherwise. MR. ROYAL: This is a fundamental problem and that is sometimes the motivation for doing the dose reconstruction and doing the epidemiologic study is not because they make scientific sense, but it's because there's political motivation. And if it's true there's not going to be good scientific value and it is more politically motivated. MS. FADEN: Is this about dose reconstruction? MR. ROYAL: I was responding to Eli's comment about it being expensive and not benefitting any body. MS. OLEINICK: They have to arrange for their own dose reconstructions before they can apply for compensation. MR. ROYAL: I don't know what you mean by arrange. As far as I know DNA does it. MS. FADEN: The DNA does it. It's a big burden. MR. GLATSTEIN: This is a catch 22. MR. THOMAS: Eli would rather have that money go to the claimant than to the contractor. MR. GLATSTEIN: I certainly would. MR. THOMAS: Even if there was a smaller amount of money dished out to a larger number of people. MR. GLATSTEIN: Yes, I would. MR. THOMAS: I think there's merit in that view. MS. FADEN: All right. I think what we should do here, is to say that thought should be given. MR. GLATSTEIN: Yes, I would like somebody to review it objectively. Not a Beltway bandit. MS. FADEN: And say it's worth it to spend the money this way. MR. THOMAS: I get really disturbed about compensation programs who spend most of their funds fighting claims and not dishing out money. MS. FADEN: Do we want to try to reformulate it then? MR. KATZ: Is it necessary to suggest that it be reviewed in the light of Eli's statement? But I take his opinion very seriously. Mary Ann, what do you think about Eli's. MR ROYAL: The last time we had to address this issue was dealing with the human radiation experiments. And we said the threshold is a value decision. And now we're talking about a value decision about how much to spend processing a claim and how much to send out. MR. GLATSTEIN: I'll settle for that. MS. FADEN: I think that's appropriate, but if we could flag it, that would be helpful. MR. THOMAS: I think it would be irresponsible that all atomic veterans be given across the board compensation. MR. GLATSTEIN: I'm not going to argue with that. MS. FADEN: That means that that bolded part will be rewritten and I'll get Eli and Duncan to work on it. We are concerned that the balance is in the wrong direction. This requires more knowledge to resolve this than we have had to opportunity to gain. MR. ROYAL: If I could imagine that I'm Ken, would Ken say that Congress already made this judgement by passing this law. MR. GUTTMAN: Ken would say, new information? Re- evaluate it? Sure. MR ROYAL: I would suggest that we consult. MS. FADEN: All of these will go by Ruth and Ken who are not here. If they have a very different perspective that has to be brought back to everybody else. MR. THOMAS: She's still here. MS. FADEN: On the assumption that she's not. And we should flag the ones that require particular expertise. Can we move on to recommendation 8 which is in the stronger form of the two that we were fighting. It recommends that it be amended. MS. STEVENSON: Is this what we voted on last time. MS. FADEN: Yes, remember it was about whether the law should be changed or should we consider that the law should be changed and we gave it the stronger language. MR. THOMAS: But since it's now directed to the Interagency Working group, the wording is quite appropriate, saying they should work with Congress to amend. MS. FADEN: We have to still do it that way. Lois? MS. NORRIS: I don't recall seeing anything on the chapter on uranium millers. MR. THOMAS: No, there's not. MS. FADEN: Okay, good point. MS. NORRIS: Similarly, for that matter, the stuff in the chapter leading to this recommendation is about three lines. MS. FADEN: So we can -- MS. NORRIS: Well, I'd like you to look at the chapter again. MR. THOMAS: Are you referring to the harm? MS. NORRIS: Not to the harm but to the background information. MS. FADEN: You want more evidence on the law. MR. THOMAS: Oh, on how the compensation system is not working. MS. FADEN: So the finding has more of an oomf behind it in its corresponding chapter. MR. GLATSTEIN: Maybe I'm the only one that feels this way, but think there is a need for a specific statement that says that these people had their civil rights abused. I see very little difference between this and Tuskegee. MS. FADEN: Tuskegee. MR. GLATSTEIN: Same state. But I don't see much difference between those two stories. MS. FADEN: Well, I think the Committee want to make a very strong statement that what happened to these people was wrong. MR. GLATSTEIN: Yes. MS. FADEN: We're going to make sure the language was plain enough. I don't know about the civil rights, I have to think about the language about that. MR. GLATSTEIN: The rest of the Committee might not feel so strongly. MR. KATZ: Human rights. MR. GLATSTEIN: Human rights. To me the analogies are quite striking. MR. THOMAS: Eli, would you take a look at the last paragraph of the supporting text. Where it talks about grave injustice. Is that sufficient or do you want it stronger? MS. FADEN: The grave injustice. MR. GLATSTEIN: I think this is a real black and white issue and we do a disservice if we don't acknowledge it. MS. FADEN: What I will do -- MR. GLATSTEIN: It's also because this is one there is no question that the fault here is on the governmental level. Just as in Tuskegee. MR. RUSSELL: You don't think the mine owners had a general responsibility here. MR. GLATSTEIN: I think a lot of people besides the government. But I think the AEC, the PHS did some despicable things. MS. LEDERER: Do you think they are equally culpable? MR. GLATSTEIN: Yes, I do. MS. KING: I will just say that not everybody on the Committee agrees with Eli. MS. FADEN: Where would you place -- MS. KING: I rehearsed all my arguments yesterday. Since everybody else thinks that the wrong is self-evident with which I disagree but I won't belabor it. I tried to explain yesterday but the response that I got was that it was self-evident. But if that's the way the Committee feels, then I'm going to object to it. I am not as convinced as Eli. MS. FADEN: I think in fairness I don't think that the response that you got was that it was self-evident. MS. KING: I was told by two Committee members that it ought to be self-evident. MS. FADEN: Then I would speak for myself that there is enough revealed to speak strongly. Eli, we're going to rewrite the uranium miners chapter to some extent any way to express this sentiment more clearly. MS. KING: Remember yesterday, the recommendation was unanimous, I will remind people where we left it. I would like to keep it that way. MS. FADEN: The reason that was important Eli, which is why I wanted your strong statement in the chapter rather than in the recommendation is so that we could be unanimous on the recommendation which is what's important. MR. GLATSTEIN: I don't wish to argue about it. MS. FADEN: Is that all right? MR. GLATSTEIN: That's fine. MS. FADEN: In the chapter there can be stronger statements by individual Committee members. MR. KATZ: If we quote the Declaration of Independence, I hope we have a footnote. What is self-evident? MS. FADEN: Ok, well. Let's take on the profound issues of the times. Do we want to take on the Marshall Islands recommendation now? MR. THOMAS: Well, the question is whether we still want to have a discussion of the chapter. MS. FADEN: I think we do. So let's not do the Marshall Islands recommendation now. And this may be as far as we can go. So, I think we should stop now and we'll pick up tomorrow. (Whereupon, the proceedings went off the record at 5:44 p.m.)