Welcome and Overview of Agenda

DR. SHAPIRO: We'll get the meeting started. I'd like to call our meeting to order.

Quite aside from the public comment section, which will come later on this morning, the sole item on our agenda today is further consideration of our report on research involving persons with mental disorders. We often call it the Capacity Report just as a shorthand. Let me say a few things by way of introduction and then indicate how I'd like to proceed through the day, what I hope for from today and what that means regarding our schedule with respect to the final approval of this report.

First of all, I would like to say that in many ways the public comment period has been extremely helpful. I want to go on the record to express my appreciation for the many thoughtful comments we received from a large variety of sources—interested parties who care about what it is that we will be recommending and are saying about this subject. So I am really grateful to all of those who took the time and effort to read what we had to say and respond to it in ways that seemed appropriate to them.

I also want to indicate for the record, however, that there are interests out there which are not beyond intimidation to try to make us adopt views which they espouse. And while people are welcome to say whatever they like to us, I am not especially moved. Indeed, my resolve is further increased by the kinds of intimidating vocabulary and conversations that some people have engaged in.

So that's a small thing. I mention it only to inform the Commissioners. It's not really critical. Much more important is the thoughtful public comment we have received, which I think is not only important but will certainly improve our final report.

Now let's go directly to the schedule. As you know from the e-mail that I sent you, I can't remember if I e-mailed or faxed you or did both, but I had hoped that we would go through all of our recommendations today and come to consensus on them if consensus was available; or if not, to just decide where the majority of the Commission stood on the issues, inviting minority opinions if any, and to add dissenting comments or personal statements of one kind or another to our report. I think we still will do that in part; however, as I've read the report carefully and considered carefully all the written comments that we got, it seems to me there are some outstanding issues which we may not be able to fully resolve today. And so while I'd like to go as far toward resolution as possible, I think we're going to have to do some redrafting and pass that back before the Commission before I would feel comfortable asking you to sign off on it. I very much regret that because I think it is time to have our say and see what impact it has and not wait indefinitely. There are lots of people out there who want us to hurry; there are other people who want us to wait. We have to have our own agenda here.

And so, my own thinking right now is, given the realities that we face and the necessity to give some thoughtful consideration to some issues, is that our final sign-off on this report probably will not come until our next meeting, which is scheduled in Miami for the 17th, I think. Arturo, is it the 17th?

DR. BRITO: The 18th, the 17th and 18th.

DR. SHAPIRO: The 17th and 18th. We have other items scheduled for that meeting, but I'm hoping really by that time, that meeting, that we'll have very short discussions of this report because the material which will be distributed in advance will have taken advantage of today's meeting. So I think while I'm disappointed in some sense that we can't reach decisions on everything today, I hope we'll reach decisions on a lot of issues today and then go from there and have a final sign-off probably at our next meeting in Miami.

I propose that we proceed in certain ways today. I don't want to begin by just going through the report chapter 1, chapter 2, and so on. I don't think that would be effective. What I want to do is I know many of you, as I, may have a large number of editorial suggestions, and there is some evidence in the current draft of word processor space where phrases and paragraphs sometimes find themselves in unusual places, and there are still a few like that here. But I really would ask us not to concern ourselves with that issue today; that is, we would be happy to incorporate or receive from you marked-up copies that are legible, or memos if that's a better way for you to communicate, which deal with all the editorial suggestions and we will go through them all and try to produce as good a document as we can. So I don't really want to consider those types of things unless they have some substantive implications for the issues that we're talking about.

I have gone through this page by page with Eric earlier this week and I have many such recommendations myself, and I'm sure many of you will have others. I'm very anxious that you give them to the staff so that we can incorporate them as fully and as clearly as possible.

Now as to today's meeting, there will be, as you'll see, a series of issues which we have to confront. But what I would propose we do is as follows. I want to go directly to the recommendations and that will generate other discussion. But I want to go directly to the recommendations and I really want to take the first seven or eight recommendations as the first items of our business. I want to see what, if any, concerns remain regarding those particular recommendations. We could take probably as a group recommendations 1 to 7 because it's only with recommendation 8 that we get into protocols with greater than minimal risk.

Once we do that, we'll go through that, that will be our first item of business. Then I want to move on to an issue which is not a recommendation but I think needs to be a recommendation, and that is we don't say anything directly in the recommendations themselves about minimal risk research. We have a lot to say about the text. But I was kind of surprised when I read it over myself that this was, in fact, the case. I think it's pretty clear what we want to say and I think we'll try to draft something during the day while we're here today about that. But I think the report lacks a recommendation regarding our saying directly what we think is appropriate minimal risk research. We'll try to draft that sometime during this morning but we might have some initial discussion of it early on this morning.

Then I want to go to the issue of the health care professional, which deals with when we think that is required and when we think that's simply something that IRBs might want to consider. That's unclear in my mind; I think it's unclear in the text, actually, because when we talk about it early on around page 86 or so we have a rather different characterization of it than we do on page 151 where we're dealing with guidance to IRBs. Don't take those pages seriously, those are all approximate. I don't have this locked in my memory in some photographic way. And so we'll deal with that and then we'll proceed on to other issues.

But that should give us a start. Let's try to be conscious today of the fact that we do want to make progress, we must make progress toward completing this. We must reach agreement on the great bulk of this before we leave today. If we come down to an issue where we think something needs to be redrafted or drafted, we'll take a recess and draft as opposed to just sitting around and discussing it further. We'll form one of our famous little buckets and we'll draft language and then come back and look at it. Because I just think we have to force ourselves into a discipline like that today in order to keep control on our path of march.

So with that, unless there are any questions, we'll just go directly to the recommendations and begin dealing with them. We're going to see what further comments and questions there are. As soon as we get a recommendation that seems to be coherent before us, we will just see what the sense of the Commission is on those recommendations. And, again, I'm not going to worry right now about the text that surrounds some of these recommendations.