STATEMENTS BY THE PUBLIC
                  Statement of:  Dr. David Shore
               National Institute of Mental Health
     DR. SHORE:  Good morning.  I'm here representing the NIMH,
taking the place of Rex Calgary, who has moved on to try and
serve as a liaison between the clinical research community and
the private sector, perhaps moving from a difficult job to an
impossible one.  We shall see.
     I just wanted to make four brief comments, and I'll try to
stay within the five minutes.  First of all, I wanted to let you
know that the intramural research program at NIMH has finished
their investigation of some of the allegations that were
presented to this group previously and that we have, as you call
it, a penultimate draft that we have delivered to Dr. Childress
conveying a number of action items.  If there are questions about
those as you look at them, please let us know and we will try and
clarify any of those issues.
     The second point I wanted to mention was that, as you heard,
December 2nd and 3rd of this year we did have a trans-NIH panel
meet to discuss some of these same clinically relevant issues in
research involving those with questionable capacity, uncertain
capacity.  We've certainly gone back and forth on the title
several times as well.
     This panel report is in draft at present.  It is circulating
to members of the NIH community and should go out to members of
the panel this coming week.  We would hope to have it available
for you by the end of this month.
     I can tell you that it will focus on guidance for IRBs, the
idea that there are already provisions in Federal regulations
that permit additional safeguards for certain populations in
situations in which there might be increased risk, and we are
going to try to make some clear recommendations as to how IRBs
might best take advantage of those additional safeguards.
     So if I can just say that perhaps we're not so much anti-legislation or anti-new regulation as we would like to take
advantage of some of the safeguards and protections that
currently exist and may be perhaps under-appreciated by some of
the local IRBs.
     The third point, is that we did have some concerns with the
November 1997 draft.  We greatly appreciate your sharing that
document with us and allowing our staff to take a look and make
comments.
     You all now have copies of the critiques of some NIMH staff
about that and, in particular, our concerns that the very
scholarly imbalanced text be reflected in the specific
recommendations.
     Unfortunately, these days generally executive summaries and
recommendations are read at the expense of thoughtful and
deliberative text. 
     Finally, I just want to echo the concerns of some of the
members of the Commission, that you continue to get input from
experts on clinical research, in particular involving those who
have done research involving individuals with psychiatric or
neurological impairments to inform the NBAC about some of the
clinical disorders and some of the nuances of clinical research.
     CHAIR CHILDRESS:  All right.  Thank you.
     Are there any questions or comments?
     (No response)
     CHAIR CHILDRESS:  Let me just ask one, if I could. 
Incidentally, regarding the response to the allegations, that
will be sent to all Commission members by the NBAC office next
week, or this week, I guess.  Tomorrow.  Today or tomorrow.
     But regarding the other draft which members of the
subcommittee, at least, had a chance to see, I guess one question
was whether, since a misunderstanding came up in the meeting
yesterday about whether what we were proposing in the
recommendations would apply to more than minimal risk research or
whether it was only to more than minimal risk research or also to
minimal risk research, it seemed to me that the response from the
National Institute of Mental Health actually thought that we were
making this apply to minimal risk research too, so some of the
things that would be excluded from your interpretation, actually,
would not be from ours.  I apologize, because there unclarities
in the document on that point.
     DR. SHORE:  Right.  At the end of the document that you
drafted, and of course that's the November '97 version to which
we had access, it did appear to, in effect, prohibit even minimal
risk research on those with questionable capacity to consent in a
case in which it was non-therapeutic or no direct benefit,
depending on which term you use.
     We believe that there are certain circumstances in which
greater than minimal risk research might be justified without
direct benefit, but we are certainly willing to concede that in
such situations additional safeguards should probably be
employed.
     I expect that we will advise IRBs as to additional steps,
perhaps independent monitors, that might be used to assure that
input from the family, from independent clinicians, et cetera, is
used to best advantage.
     But our major concern was that the version that we saw did
not appear to make the distinction between even minimal risk
research, asking a few questions of an individual or taking a
tube of blood and would appear to outlaw such studies which have
been so useful in finding the genetics of Alzheimer's disease,
for instance.
     CHAIR CHILDRESS:  And that has been clarified.  The revised
draft that we're working with also incorporates the input of
several subcommittee members who had the opportunity to attend
the conference in early December, a very beneficial conference. 
It was, indeed, for all of us.
     I guess one question would be whether you'd mind if we go
ahead and work with the draft of the recommendations that are
coming out from that meeting because, as you've heard our
schedule, we are trying to move forward, if you think it would be
appropriate for us to go ahead and least use that for our
reference at this point, would be helpful.
     DR. SHORE:  Perhaps we can compromise on what I may call our
penultimate draft, and I can make a promise to try and get that
to you, say, two weeks before you meet.
     I don't feel completely comfortable, of course, in sharing
with you a document that has not been vetted by the members of
the panel, but, as you may know, I'm not the most patient
individual myself so it is my desire to get this in final form as
soon as possible and get it to you immediately thereafter for
penultimate form.
     CHAIR CHILDRESS:  Anything else?
     DR. BRITO:  It would be helpful to have a specific example
of what you mentioned, that there are greater than minimal risk
research has been useful in the past, something that's been done. 
So if we could have specific, concrete examples of that, that
would be really helpful.
     DR. SHORE:  I mean, I would just say things like PET scans
in suicidal adolescents, spinal taps.
     DR. BRITO:  But the references and the publication. 
Appreciate it. 
     CHAIR CHILDRESS:  Thank you.
     Does anyone else wish to offer public testimony?
     (No response)
     CHAIR CHILDRESS:  All right.
     Let me then turn to Jack Schwartz.  Thank you, Jack, for
bearing with us in the modification of the schedule.  Jack will
provide an update on the Maryland Attorney General's Working
Group.  You have seen several drafts from this working group over
the last year, and we're glad to have Jack offer an update.