Republished by the LSU Medical Reseach Law Project

DR. SHAPIRO: We're going to have a small change in the agenda. I'm going to turn to Eric in a moment to discuss two of our proposed future projects: one which we call international research, and the second, federal oversight of human subjects, which, of course, covers a project which is partially done already but not completely done. And then, rather than go to the capacity draft right after that, we'll go back to yesterday's discussion and continue that somewhat further on the draft of human biological materials and see if we can resolve a few more outstanding issues before we turn to staff to produce the next draft. And then we will return to the capacity draft itself.

Jim feels that we ought to be able to deal with that in three hours today, given the status of that document. I think that's probably correct. Of course, that's already out for public comment. We have not received all. The 30-day period we allowed is certainly not over. We've begun to receive some comment, but those comments and the comments that come from our discussion today will have to be incorporated in the next draft in some appropriate way. So we will turn to that.

I should mention one other thing. Mary Claire King will be here somewhere between 12:00 and 1:00. She's scheduled at 1:00 to talk to us about genetic research and families and so on, which also of course will be part of the discussion on material we're going over right now.

Let's turn, first of all, to the international research project. Eric?

DR. MESLIN: Just very briefly before I let Alex Capron say any words. The Commissioners have had a 2-page draft, a proposed outline for this project for a couple of meetings. Regrettably, we've not been able to discuss it. It's under Tab 4.A in your briefing book.

Principally, this has been a proposal that we have been developing that focuses the Commission on the idea of whether existing rules and regulations within the federal oversight mechanism would either need to be amended, or altered, or revised to take into account developments in international research that the United States conducts or sponsors in other countries.

I'll let Alex say a few words. The only other thing to add there is that we've already begun on the staff side to be gathering information and developing some of our research background, so your discussion to go forward has not prevented us from at least familiarizing ourselves with the issues.

Alex, did you want to add anything?

MR. CAPRON: Obviously, this is something which is getting attention in other international fora. You have newly before you the agenda for the international summit in November, where the topic is the proposed topic for the delegates. I don't have anything to add beyond that.

DR. SHAPIRO: Are there any comments, questions, concerns, ideas people have, with several having read the outline which, of course, has been before us quite some time now although we've not had time to discuss it? If there are, this would be a good time, because otherwise, unless there are some concerns, we will go ahead and begin developing the materials and so on.

Jim?

DR. CHILDRESS: I like this very much. Do you want us, in terms of additional issues we think perhaps ought to be included, to raise some of those now, or send them to the staff?

DR. SHAPIRO: Yes.

DR. CHILDRESS: It seems to me that under Part 1.A, how the research is conducted, it would be useful to have some better sense of the kind of negotiation that goes on, not simply in terms of the collaboration in design of studies, but negotiation with all the parties involved.

And over under 2.A, it seems to me it's not merely protection from harms, but also the broad sense of protection from wrongs. A person might be exploited, for instance, without being harmed: one taking advantage of the person's situation. But it seems to me we ought to develop a broader heading for that, harms and other things we would consider to be wrong. And there ought to be some attention perhaps to consent under that heading as well.

With those few additions, it seems to me this is a very good plan.

I guess the second question would be, and maybe I missed this when it was presented earlier, but at this point what is the tentative plan for going about this? Are we going to have contract papers, commissioned papers, any thoughts so far from Alex or Eric?

DR. MESLIN: The plan now is that I have been in a bit of a holding pattern pending the Commission's agreement. I've identified a potential Project Director for this who we would bring in, presumably on an institutional arrangement from another university, who has already expressed some interest. We would, obviously, be delighted to have some commissioned papers that in consultation with Commissioners and staff, we could commission fairly quickly. But the plan is to make this a wholly contained project with the project lead and staff in place.

DR. SHAPIRO: Alta?

MS. CHARO: Although it's implicit in some of what's already in the outline, it would be good I think to pull out more explicitly issues about justice and equity in the sharing of the results of research. This has been a particular issue not only in the pharmaceutical development, but in the area of population genetics, which is one of the "frontier" areas of collaborative research where you have both the concerns about the ultimate products being shared adequately and, an additional concern also comes to mind that's not explicitly brought out here, and that is notions about collective ownership, referring back to yesterday's discussion, of certain kinds of resources including the resources of our own bodies and knowledge about our genomes. That might be a nice thing to bring out more fully, since I think that's also the way it's discussed in the international arena more so than in the U.S.

Once again, though, I would love to reiterate my desperate desire that we finish the current projects before we devote lots of resources to any new projects.

DR. SHAPIRO: Bernie?

DR. LO: I also like this a lot. I think it's a very important topic. Two comments, one in terms of suggesting additions. Under 2, we really are focusing primarily on the idea that we want to protect people from harm, and just as Alta wants us to pay attention to issues of justice, I think issues of beneficence are important. I think we need some discussion of what is our obligation to try and address pressing problems in other countries that don't have the technological resources to just conduct these studies on their own. I think there are issues that have to do with what the researcher's obligation is in planning a study to have thought about the availability of not just the results, but the interventions that are proven effective. I know it's a big topic in the international sphere, but I think there has been very little attention given to the role of the researcher. I think we should be looking at whether researchers, by virtue of wanting to study questions like HIV prevention in the developing world, [have] an obligation to start getting involved in these kinds of discussions, which may be a significant change in the role many researchers see.

My second comment has to do with making sure that we carve out a niche. There's so much else going on, as Alex pointed out, around the world, and I think we need to make sure we don't duplicate a lot of the things that are going on elsewhere but focus on what we uniquely can contribute and keep ourselves disciplined to look at that. It's going to be so tempting for us to try and rewrite CIOMS or Helsinki or something else, and that's not something I think we would be fruitfully doing.

MR. CAPRON: Certainly, one thing that came out of the meeting a couple of weeks ago on AIDS vaccine trials in Geneva was the sense that the CIOMS international guidelines do need to be rewritten and the willingness of CIOMS to put together a good international panel to do that with the encouragement and support of people from the WHO UN structure and perhaps from industry as well. So, I agree, we should not take on that task.

My sense is that Alta's concern is absolutely right, we have projects we have to finish. But there is also a pipeline effect. We need to have some of the beginning work done even if it doesn't take up Commission hearing time for another six months. It is just much more efficient to be prepared.

DR. SHAPIRO: David?

DR. COX: Very quickly. These remarks actually come from reading about that meeting in Geneva. I'm very keen on this issue of justice that Alta brought up. I think that without solving all of the different problems, that's an issue right now that, at least with respect to American involvement, U.S. involvement in research in other countries, is very poorly defined and could lead to some clarifications. Not that people aren't talking about it, but it's a very clearly defined issue on which there is little resolution. I think although I want to see us get our projects done now that we're working, that's one that I think I'm very interested in.

DR. SHAPIRO: Rachel?

MS. LEVINSON: I think we need also to consider within that the role of the U.S. government and possibly private sector and define those, delineate them.

On Bernie's first point, in addition to the resources, you should also think about the framework for decisionmaking in the host country, not just international standards but the standards in that country.

DR. SHAPIRO: Other issues?

[No response.]

DR. SHAPIRO: This is an area, of course, where there is a lot of attention now and there are a lot of other people, as Bernie and others have said, that are looking at this and we do want to find something we can say. One of the reasons for this, it came up in a conversation I had with Alex last night, is that this thing really generates hard dilemmas and it is not exactly easy to resolve them. So there is going to be ongoing discussion for a long time. This is something just by the nature of it that generates very serious dilemmas no matter which way you take it. And so I think it's an interesting but demanding topic despite all the attention that's been given to it.

DR. COX: But maybe the advantage, Harold, is that it will make tissue sample stuff seem simple and we can actually get on with it.

[Laughter.]

DR. SHAPIRO: Okay. Any other?

[No response.]

DR. SHAPIRO: Let me just ask a question, and I think I posed this question last night in some informal conversations, whether these various groups that have been looking at this have really thought carefully—this is a question, I don't know the answer to this—about the alternative set of what is it that generates the interest in doing this kind of work? That is, do people really analyze why it is that Company X goes there or Researcher Y goes there? And I just, while there's a lot of speculation about it in the newspapers and so on, I really haven't seen any really thoughtful analysis of that. I think myself, my own view is that that may have some clues in it which would help us think this through. I don't know, it's a provisional notion.

All right. We are going to go ahead in a preliminary way. We understand what our priorities are. Our priorities are to get these reports done. But we do need to get started and arrange for it. Any other questions on this?

[No response.]

DR. SHAPIRO: Okay. Let's spend a few minutes on the federal oversight of human subjects.

Eric?

DR. MESLIN: Very briefly, we first mentioned this idea in our Los Angeles meeting where we would combine some of our existing work, which includes the completion of the federal survey report. We will have an initial staff summary of that made available hopefully within the next couple of weeks, and then it is our intention to share that with the client agencies who were participating in that, and then use that material as part of a more broad project which combines not only some of our structural questions about the system, but also some of the enduring questions that have arisen as a result of the two IRB studies that have been put on the table, on the 11th and 12th of June, respectively, the Office of the Inspector General Report and the NIH evaluation.

The 1-page proposal you have before you is really a way to put together into one place a project that sort of synergizes what we've been talking about, and that by next April or May would be a report that provides NBAC's perspective on how the structure of the federal oversight system adequately functions and what needs to be done to keep it in good health for the years to come.

As I say, the first part of that is complete. We are writing a staff summary. We have already commissioned three papers for the second part. You have heard from both Dr. Charlie McCarthy and Dr. John Fletcher; their position papers were presented to you and are available. The third commissioned paper, by Tina Gunsalus the first draft has already been submitted to staff. Comments have been given back to her and the Commissioners will see the first draft of that paper probably within the next three weeks. So we will have three major pieces of work—

DR. SHAPIRO: What's it titled? What's the subject of that?

DR. MESLIN: Her paper is looking at alternative structures that might be available to us—us, being those who are considering this issue—meant to supplement what McCarthy and Fletcher have done.

MR. CAPRON: I thought her paper originally was looking at the industry side.

DR. MESLIN: It is including both. By alternative structures, it includes what ought to be done with respect to private research not currently defined. So, is it possible for us to include a structure that would involve both. And we would invite her to come to the September meeting in Washington along with federal agencies who would have a chance to review some of that material. Staff is already engaging in a comparative analysis of the OIG reports and others.

So there is a lot of work already being done, and it is our hope that we will be able to have our staff be led by a Project Director on that as well. I am confident that that project, which really is a kind of capstone to the two case studies of human biological materials and research on persons of mental disorders, would be completed by April.

DR. SHAPIRO: Alex?

MR. CAPRON: I just have a question. I think that the plan sounds excellent and, in an ideal world, should be the way we proceed. My question is only the first part of this was the part that, of course, had been begun before we existed because of the requirement after the radiation report for all the agencies within that year, and we found out that not all of them had done this before we got started, to report in about what they were doing. And it took up a good deal of our time prior to Dolly.

I have gathered that some of the agencies, since that's their major contact with us, have been unhappy with our lack of product on this particular area. Are we confident that through OSTP and so forth and the Science Council they will be persuaded that our plan of action of pulling that component in with these other two on IRBs and the whole oversight structure makes sense so that we don't get backbiting on this. Because this is certainly the right way to proceed but not if we're going to have incredible political headwind. In which case, we could issue the report in three pieces because, certainly, that first part is now much further along.

DR. MESLIN: I may want to let Jim Childress say something about that. But we have had a lot of conversation with federal agencies in the interim and presented a version of this plan to them. At this point, they seem to be very pleased with this kind of arrangement.

But, Jim, you may want to say something.

DR. CHILDRESS: Having taken part in one of those discussions, there was actually general enthusiasm about this, particularly because there's another component that Eric has mentioned before but perhaps wasn't as clear today, and that's not only that they would receive materials and then give feedback in September, but also the possibility of interaction with staff and any Commissioners who would be available prior to that. And that gives an opportunity for clarification and understanding.

DR. MESLIN: Rachel may want to add.

MS. LEVINSON: I think that's correct. I think that their concern wasn't the lack of product but the lack of interaction on development of the product. And we worked on trying to correct that in giving them the opportunity to review material that they hadn't seen previously. And there will be an ongoing effort to brief NSTC member agencies as this and other products come along and give them the opportunity to interact. The September meeting also provides that opportunity.

MR. CAPRON: Thank you very much.

DR. SHAPIRO: Okay. Any other? I find this is a very important project. I think this is a critical project for us. I will, before we meet next time, appoint one of our Commissioners to really head this from our Commission's point of view, quite aside from the staff work, because I think we really want to drive this forward. I think it's an extremely important aspect of it. And I do want it done by the middle of next year so that we'll have to go quickly on it. But I'll keep everybody up to date in the next few weeks as those arrangements are developed.

Let me return now to, although I said I was going to do this later, let me just try to get it off our agenda and we'll return back to the human biological materials.

I've been thinking about the comments made yesterday on the proposal we had before us regarding Belmont revisited. If I understand the comments that the Commissioners made, people were very concerned about using up staff time on this in view of other kinds of projects that we have in front of us, and I certainly understand that. On the other hand, my own view is we should not let the 20th anniversary go by without participating in some way.

So my proposal will be that we continue to plan something, but it will have to be something in conjunction with others and something that does not use our staff time, so that we don't pay that particular cost. And so we'll perform some kind of convening measure but rely on resources supplied by others as well to get this done. But I just don't think it's quite right to let the moment pass. So, with your permission, I'm going to pursue it with the understanding that this should not be a sink to use up staff resources, because I think that point was very well taken yesterday and I think it was pretty important, so I agree with that. But I don't want to abandon it, is my point.

Now there were Roman I and Roman II, and different views as to who was interested in I, if II follows, and so on and so forth, different combinations of interests. For the moment, I will proceed with I in conjunction with others. Of course, any Commissioner who wants to participate in this is more than welcome to do so. I don't mean to be excluding anybody from this.

Whether we, in fact, proceed to Roman II I think is still an open issue. We're not going to resolve that today. I don't want to take time this morning to talk about it.

So I will proceed, together with Jim, if he's willing, to consider just what kind of framework therefore we should use to mount such an effort, obviously in conjunction with others and having other sponsors as well.

Yes, Arturo?

DR. BRITO: I thought about this last night about the Belmont Report and revisiting it, and I think it is an important decision to make and I think it is important to revisit it. But I don't necessarily agree with what Alex was saying yesterday about having necessarily to do Roman numeral II because of time constraints. Ideally, it would be nice to do it, but I think it's more important looking at how Jim went up the three proposed parts of Roman numeral I. That number two in those three parts I would like to see a heavy emphasis on that, basically, interpretation, use, and the institutionalization of the principles of the last 20 years.

Because I think over and over we keep hearing this recurring theme from guest speakers and, honestly, from my own perception what a lot of problems are. It's nice to have principles, it's nice to have rules, but one of the problems we keep hearing over and over is that the implementation of the rules there's a problem with that. I think we would have a lot to add if we could just find out where the problems are—we know where some of the problems are though when implementing these universally agreed upon principles, where the roadblocks are. I think that's how we could contribute and I think that's something we could probably do in the amount of time we have, still looking at the history of the ethical decision made to make the Belmont Report, et cetera, but with the focus on number two under part one.

DR. SHAPIRO: I just want to make clear, in case I wasn't before, we're going to plan this within the context and constraints of not using a lot of our own resources to do it. Therefore, just what will come out of this will be a matter of negotiation between ourselves and others who will participate in this. But those comments are very helpful and we'll try to incorporate them.

Okay. Any other questions? Yes?

MR. CAPRON: Arturo has put a view on the record. I would like to be on the record on this issue.

DR. SHAPIRO: Sure.

MR. CAPRON: I think if we're going to spend any time doing one, it makes sense if it's connected with having an objective, and I don't know by what date, doing two. I also go back to Al Jonsen's statement that spending some time, the National Commission spending time on their principal discussion and getting a framework of Belmont on the table helped them in their other work. And I think we've gotten to the point where Belmont is not only a research document, but is a document the principles of which get cited more broadly. So that to the extent that we have a broader agenda, it would be relevant. And I think it would be a shame not to think about how we would go about number two. And this is not me volunteering, despite the way it's put here, to do it in any principal way. I just think that just having a celebration of the history of Belmont and its significance and so forth, while it's fine, if Princeton University Press wants to convene something so that they can publish a book or something, we should attend and maybe our name would help getting some of the fundraising for it. But I think that ceremonial aspect would be a lost opportunity for this Commission if we didn't go on to do it. I'll just put myself on the record that way.

DR. SHAPIRO: Thank you.

MS. BACKLAR: I want to second that, because I brought this up yesterday. If we're going to do it, I would like it to be useful.

DR. BRITO: Well, I didn't imply that it is just to be a celebration. What I'm saying is that I think there's heavy focus on the second part of the first Roman numeral, the implementation and what the problems have been.

DR. SHAPIRO: We will not engage in anything that is not useful.

MS. BACKLAR: Thank you.

[Laughter.]