UPDATE ON REPORT ON THE SURVEY OF FEDERAL AGENCIES By: Bill Freeman, M.D. DR. FREEMAN: Becoming the third report has given us room, time, to do more things that we need and want to do. We are greater than 90 percent at Phase I. That was a structural survey of every agency that has signed on, including some agencies that did not sign on that we found are doing research. We're greater than 70 percent at Phase II. That's a smaller number, looking at a range of various kinds or sizes, et cetera, of IRBs in those agencies that have them or in the mechanisms for grants and contracts, what are the procedures to make sure that grants are contracts are -- on these institutions that have the protections in place. You've seen in the past the general, broad conclusions. They remain. We continue the process, and I want to emphasize this, that every agency has reviewed our draft--or at least has been given an opportunity to review our draft; we can't make them do it--for the facts at the time of the survey and gotten back to us. They have that opportunity, and we will come to an agreement about what those facts are before the first draft about that agency gets to you. That review also includes any other modifications or suggestions they have. So if, for instance, there was a rumor that some agencies thought, well, maybe they didn't present themselves, didn't take it seriously when they interviewed them. There's plenty of opportunity to set the record straight. This is an iterative process, really, as long as it takes, and also for additional suggestions. Those suggestions, by the way, are coming in. We asked for those initially and I think it would be very helpful about how to implement the regulations. One of the things that was suggested a couple of meetings ago has been modified a bit. We aim, before the completion of the report, to have at one of the NBAC meetings -- invite Federal agency officials to come and talk about their suggestions about how to improve the implementation process of these regulations. They will also, of course, be able to make generic statements about our generic suggestions. We will not, we hope, get into defending or attacking any given agency. That's not the purpose of our report, or the purpose of that meeting, for that matter. Finally, staff have developed also over the holidays, given it was difficult to meet with people, possible general implications--and we're still in the process of this--for adoption or non-adoption of innovations by agencies. It's from the political science and sociologic literature. This may complement the papers by McCarthy, Fletcher and Gonzales about, they're primarily on location in the Federal Government for Federal oversight. This would be more, what are the functions or the processes that should be included in this entity, whatever it is and wherever it is, to maximize the innovation -- the acceptance -- excuse me, the adoption of these regulations that we have found have not been adopted 100 percent throughout the Federal Government. Of course, you'll be getting plenty of a chance to look at that in a draft. But we have found some information that I think has turned out to be very, at least at our first glance, very helpful. CHAIR CHILDRESS: Well, thanks very much, Bill, and other members of staff who have been working on this project over many months. Are there any questions or comments for Bill? (No response) CHAIR CHILDRESS: Okay. Bill, thanks very much, again, and to the staff working on this. I had got a note to ask Jonathan Moreno to say something about the TD case, and Jonathan came up to say that Jack Schwartz was the person to ask about the TD case. Jack, if you wouldn't mind just telling us where matter stand as that has evolved. MR. SCHWARTZ: Sure. Just a little recap on that. The TD case involved a challenge to the legality of regulations that had been issued by the Office of Mental Health in New York governing research participation by decisionally incapacitated people in mental health research. The original decision, the trial court decision, had invalidated the regulations on a rather narrow ground, namely that the regulations were not properly issued by the mental health office, but rather were within the authority of the New York Health Commissioner; not exactly a technicality, but a relatively narrow ground. When the case came to the intermediate appellate court in New York, that court agreed about this who has the authority question, but then went on to suggest that there were significant constitutional problems with the regulations. This intermediate appellate court decision suggested that there were constitutional reasons why individuals with decisional impairment could not be involved in non-beneficial research that posed greater than minimal risk, some extensive discussion in that opinion of constitutional and common law issues. The matter was brought to the New York Court of Appeals, which is New York's highest court. In a decision about three or so weeks ago, that court in essence vacated throughout the portions of the intermediate court decision that had dealt with the more interesting issues, the constitutional and common law issues. So the state of the matter is that the only thing that this case now stands for, it's the incredible shrinking case. It now stands for the narrow proposition that it was one official rather than another in New York State that has the authority to do these regulations, and the discussion of constitutional issues is now tossed out. So what happens next? The New York Health Commissioner presumably will do regulations. There's a task force at work in New York to provide advice to the health commissioner. Once those regulations are newly issued, then presumably the plaintiffs in the case, if they are dissatisfied with the new regulations, can start their challenge over again, again alleging the constitutional problems that they perceived before. But we are years, presumably, away from an authoritative decision on that matter. CHAIR CHILDRESS: Any questions about that? (No response) CHAIR CHILDRESS: Thanks very much. DR. MORENO: And I'd just say, as a member of that -- task force, we're waiting to see what you guys have to say about this too, as are the good people in Maryland. DR. CASSELL: There's a kind of circularity in the Maryland and New York task force and NBAC. CHAIR CHILDRESS: And it all comes back to you, Jon. We have scheduled a brief discussion of future Commission research activities. I wonder if Eric could lead us on that. We won't spend a lot of time on this, but notice the number of topics that were identified that have to do with research. So let's see if there's any feedback on that. DR. CASSELL: I cannot be the only person who has a certain feeling of both dej… vu and frustration in this discussion as we go around and around on subjects that were impossible to solve the last time around, and here we are again. Only we have done one significant thing, there is no question about it. We have added a surrogate. We have added a friend. That is no small matter. On the other hand, it seems to me that one of the things we always end up on, is we come back to the IRB. We're going to let the IRB do this and the IRB do that. Yet we all know, almost everybody who for any length of time has served on IRBs, and some of us have even chaired them for prolonged periods and we know their difficulties, that IRB members have variable knowledge of what they are actually doing and we know that there is even in some cases questions of good faith in IRBs, depending on where they are, and so forth. The point is, I cannot see how we can avoid the subject of research on IRBs toward -- toward a change in the IRB method. Now, having said that, I think it's a matter of discussion, what, in fact, does that mean. I think Eric already has some things going and we might have a discussion here, a brief discussion, to go home with. Well, what does that all mean; what do we want to do as a Commission? If we leave this subject and don't do something to change this, I think we would have been remiss. We had a dinner meeting last night that came to much the same conclusion. Eric? MR. MESLIN: Well, at the risk of belaboring the discussion, there was full Commission discussion on this subject yesterday. One of the decisions the group seemed to come to was that there was a general consensus that all of those topics were extremely interesting and relevant. It might be useful if you were to pick up Dr. Cassell's challenge of identifying the top two or three that you thought were most urgently pressing, and I think Arturo mentioned this yesterday as well, that we can do and that we can do well. Several of these have come up, including the IRB study, the study of international clinical trials. It may be useful for you just to ruminate once more about where you see the importance for the full Commission going forward, because we will revise this planning bucket document and recirculate it. Harold's wish yesterday before leaving was that we would pick this up at the next meeting of the full Commission, so don't feel constrained by a decision to come to closure today. DR. CASSELL: Then there's the other subject which is mentioned, and we have documents on, is it comes out of the paper on the capacity consent in neurobiological research, the Berg and Applebaum paper. My own direct investigative experience -- this paper is a sea of misunderstandings and poor definitions. The word judgment -- we're talking about people making a judgment. What people mean by a "judgment" is not at all clear through this. Repeatedly, everybody's experience is that people given consent forms frequently do not understand the content of their consent form, never mind remember it. That's already a different issue. But they do not understand the content of the consent form, medically ill as well as psychiatrically ill patients. Yet, we continue to do the same kind of thing as we did before. So I don't really know what the answer is. I would hate to leave this meeting feeling, well, okay, what you have to do, is every Commission has to sing the song and dance the dance, then wait for the next Commission to have some bright idea about what to do to solve it. But I actually think if we start with where we are going and continue research into the nature of the thing called consent, that we will have made a contribution, if it clarifies how we believe people should give consent to research and what safeguards we have for that consent. I have a side feeling that we are going to have to figure out what community means in this relationship and we haven't figured that out yet either. The fact that we haven't figured out all these things doesn't bother me in the slightest, if we pick them up. If we don't, then it's -- CHAIR CHILDRESS: And we do have a paper, a contract paper on community that will be circulated in the next few weeks after some minor revisions. PROFESSOR BACKLAR: It's interesting that in the remarks on the November draft, that NIMH seemed very much at sea and misunderstood our references to community -- show that we -- CHAIR CHILDRESS: Bill? DR. FREEMAN: I'm sorry. I didn't hear that well where I was. Is there a concern about people being at sea about the community; was that the statement? CHAIR CHILDRESS: That in the response from the National Institute of Mental Health to our November document, there were some expressions of concern about our invocation of community and how we were going to use that. DR. FREEMAN: CDC -- not in the mental health field, as far as I know, but CDC has just come out with a not-very-thick book about the role of community in research, which is some of the best that I have seen, and includes the Mohawk of Tanawaga in Montreal and their involvement in research, and others. I ought to be able to get copies for the entire Commission. There will be some perceptions from the point of view of community people and researchers who have worked with them about what that relationship can look like. CHAIR CHILDRESS: Can you get that to us fairly quickly? DR. FREEMAN: Hope to get it probably within a week. CHAIR CHILDRESS: Good. That would be helpful. Bette? MS. KRAMER: This is a question of process. I was wondering if it would be possible for the staff to do some research into the existence of some good material on issues like consent, such as what Bill refers to about community, because even in as a preliminary move we can make reference to those materials in our reports, and I think that that would be an addition. MR. MESLIN: Are you asking about research that's been done and the concept of community consultation and whether it's been affected? MS. KRAMER: Yes. But no consent. MR. MESLIN: Consent as a broad -- MS. KRAMER: Consent forms. The process of consenting to research. MR. MESLIN: We can certainly discuss that, sure. Let's do that outside. MS. KRAMER: All right. CHAIR CHILDRESS: Okay.