FUTURE COMMISSION RESEARCH ACTIVITIES
     CHAIR CHILDRESS:  Other points to be made about future
research and Commission research activities.  I guess one
possibility would be whether we want to recommend, in terms of
the list that Eric's committee provided, and that the Commission
went through, whether we want to make any recommendations about
priority.
     I don't recall that we actually set any priorities.  There
are some things that have a kind of immediacy about them that you
noted in your report and in your discussion.  But are there any
comments that you would like to make about that, since I assume
that the Ad Hoc Committee may well be providing further guidance.
     DR. CASSELL:  It was our hope that people would reflect on -- well, let me divide it up again.  We had two categories.  We
had an immediate set of problems and we discussed those, then we
had these larger issues, the limits of clinical medicine and
ownership of body is two examples of them, that people have to
sort of chew around and decide, is this a subject for us.
     It's easy to see that the report acts as though this
Commission will go on beyond its present allotted time, and it's
like time will be extended because of what we've already
discussed.
     The immediate needs will carry us to 1999 without -- but it
is our hope that people would pick up, particularly, Alta
Charo's, what does it mean to say?  I mean, we take it for
granted that people are giving a consent to have something done
to their body.  That implies a certain kind of relationship to
the body and -- spelled out what that relationship is.  That
would be an interesting subject.
     Certainly we can't even come near reproductive technology, I
would think, without beginning to clarify, what is the woman's
relationship to her body and to what it does, because those are
issues that bear directly on reproductive technology.
     The limits of clinical medicine issue is also -- it's a
question that we keep coming up against here but we bounce back,
and that's the question of progress.  Is scientific progress an
unlimited good?  As Alex pointed out, quoting -- it's a limited
good.
     There are greater goods.  I have a colleague at the head of
the table once who reminded me that saving lives was not the
highest good, that there were greater goods than that.  I think
freedom was one at the time.  These are issues that I think we
have to consider for the future to determine our work and set us
on a course that commissions have not yet started.
     CHAIR CHILDRESS:  So this is viewed as a process then.
     DR. CASSELL:  Yes.
     CHAIR CHILDRESS:  The question is whether we have anything
we want to suggest at this point, or simply, as Eric has noted,
reflect on this, since the question of priorities would be
addressed at subsequent Commission meetings.
     Anything you'd like to add?
     DR. BRITO:  My general feeling, talking to different people
in the Commission, is that the IRB problems -- I think almost
everyone that I've talked to agrees that that's probably -- they
agreed with your comments yesterday about that being a very
important issue, and I think we should proceed with that -- start
to proceed with that at some point in the future.
     The only problem with that, that's such a big topic that it
will take time.  In the meantime, that could be our big topic to
cover.  We could refer to the more focused topics and pick a few
to also do in between.
     CHAIR CHILDRESS:  -- it seems to me that we should have at
the February meeting an update from the two groups currently
studying IRBs and begin to plot with staff sort of what's the
better move and what might be done.  So I think that's an
important thing we could recommend to the Commission as a whole,
depending on what comes in.
     DR. BRITO:  And the topic of limitations of clinical
medicine, et cetera, even though it's something I'm very
interested in, I'm not sure how much that deviates from what our
goal is to protect substantive research.  I don't know.  I'm just
tossing that out.
     DR. CASSELL:  I think everybody should recognize that us
education freaks on this Commission know that issues of IRB bring
up issues of education and issues of investigator information,
and so forth.  So for all of us, these are sneaky ways of
bringing in the --
     (Laughter)
     CHAIR CHILDRESS:  Diane?
     DR. SCOTT-JONES:  I would just like to follow that with a
comment that I've been reflecting a lot of the references to the
IRB today and yesterday, and even though I agree with the general
sentiment that there are lots of problems with the IRBs, I think
that we can't really consider IRBs without also considering the
regulations with which they have to work, the guidance that
they're given, which also are problematic.
     Then on the other end, the researchers who want to move
forward their research without delay, who also make demands on
the IRB, so in some ways IRBs may be caught in the middle without
appropriate guidance, without clearly defined regulations, and
then on the other hand being perceived as obstructionist by
persons who want their research to move forward without any
delays.  So I think we need to look at both of those ends at the
same time.
     DR. CASSELL:  Let me make it clear, I agree with you
entirely in that I would say that it isn't IRBs, per se, it's the
process of institutional review.  It's the process of
institutional review which adds -- investigators in the
institution with pressures on the --
     MR. MESLIN:  Since it appears that in the report yesterday,
which was divided into two components, a set of procedural issues
and a set of substantive programmatic issues, has at least been
50 percent dealt with.  Many of the process issues were addressed
yesterday by the full Commission and I think agreed to to a
substantial extent.
     Would it be helpful to the commissioners if, before the full
Commission meeting in February, staff would prepare a brief memo
summarizing these items in the program and listing, if you will,
what the kinds of research projects might arise from those, if
you will, topical areas?
     We could go so far as to offer a provisional priority for
you to respond to, or it could simply be in a non-lexical order
and give it to you alphabetically.
     But now that you've dealt with many of the process issues,
we'd be pleased to provide that list of the sort of seven, eight,
or nine items, with a brief descriptor of what we think you might
mean by those topics.
     DR. CASSELL:  I would find that enormously helpful.
     CHAIR CHILDRESS:  Good.  I agree.
     Trish?
     PROFESSOR BACKLAR:  Maybe I missed this,
but -- if you would need to talk about putting this report --
     CHAIR CHILDRESS:  Well, my assumption, at least -- I can't
remember what we said about it.  But my assumption was that we
wouldn't do that before the next draft.
     PROFESSOR BACKLAR:  Well, I wasn't thinking that.
     CHAIR CHILDRESS:  Yes.  But I think the -- agreement to do
that.  Is that right?
     DR. BRITO:  That's what I thought.
     CHAIR CHILDRESS:  I agree.
     DR. BRITO:  I forget when the conversation takes place
sometimes, but we're almost ready -- or 60 days before --
     PROFESSOR BACKLAR:  I was talking about -- what you
suggested -- report.
     DR. BRITO:  For the Web site.
     CHAIR CHILDRESS:  Yes.  Maybe I'm wrong, but if there's no
objection, I thought we had come to an agreement on that.
     PROFESSOR BACKLAR:  Yes.  I'm sorry.  Yes.
     CHAIR CHILDRESS:  But if there are any objections to that, I
think --
     Anything else you would like to raise, Bette?
     MS. KRAMER:  Jim, to return to the prior subject, there was
one issue that was mentioned some time ago that wasn't captured
in the list that Eric presented yesterday.  That was the use of
genetic tests -- making genetic tests available to the public, in
fact, encouraging the public to make use of genetic tests before
there is an approved therapy.
     CHAIR CHILDRESS:  Eric, was that considered as a --
     DR. CASSELL:  I didn't hear that.  I'm sorry.
     CHAIR CHILDRESS:  Could you repeat that?
     MS. KRAMER:  I mentioned to you last night the use of
genetic tests before there's an approved therapy.
     DR. CASSELL:  That was not brought up, but certainly you can
raise it now.  As I said last night when we discussed that, there
was quite a lot of literature about that a number of years ago.
     There was a consensus at that time about genetic testing
which has crumbled away in the intervening years because first
more tests have come up and the genetics' star is shining -- the
simplistic genetics' star is shining.  So it might very well be
that we have to revisit that.
     MS. KRAMER:  I have great concern about that because of some
of the advertisements, the strong advertising campaigns that are
under way by certain institutions urging women, particularly, to
get tested for breast cancer, for BRZ-1-2, and these women are
going in there assuming that there's something that can be done. 
I mean, it's a problem.  I think we need to consider it.
     CHAIR CHILDRESS:  This may well be, and maybe we can ask
staff to include -- other comments that have come out about other
things.  I would note that the list, actually, of immediate
concerns, as well as long-term, that list focuses more on the
research side of our dual mission than on the genetic side.
     The use and management of genetic information is one of our
two major concerns.  This would seem to me to fit quite
appropriately under that, and perhaps would add a bit more of the
genetics side to the list of topics to look at over time.
     DR. CASSELL:  Well, now that we have more staff, and really
a highly professional staff, that seems to me to be something
that could be reproduced as a document, as a contract document, a
discussion of genetic testing in its place and so forth, which
then, after we have reviewed it, goes out under the NBAC seal.
     NBAC pointing out the problems of genetic testing, where we
do not have to raise it as something to occupy two or three
meetings of the Commission.  In other words, it's something we
ask to be done because we recognize its importance, yet we don't
put it on our meeting agenda to occupy us to do it.
     CHAIR CHILDRESS:  Or if we look at it, we'd decide whether
it's something we should put on our agenda to look at.
     DR. CASSELL:  Yes.
     MR. MESLIN:  I would only suggest that, procedurally, my
sense of how we might want to think of going forward, is once
we've produced the list, if you will, the grocery list or wish
list of the topics that we think would be appropriate for NBAC to
consider, be it within our current mandate or in an infinite
mandate, we would then try and prioritize those items in a
systematic way.
     Then following that, you would hopefully be able to rely on
each other and staff to offer the best method for proceeding,
whether they be a series of contracted papers or working groups
that will provide the necessary data for the Commission to start
deliberating.
     There would be nothing that would prevent a paper on this
subject, but there would be nothing to prevent a Commission paper
on any of the subjects that are currently in that planning
bucket.
     You might also wish to consider, and this will come up
probably in the memo that we prepare for you, that there has been
an awful lot of work done by the National Human Genome Research
Institute and the Department of Energy.  A major task force has
issued its report.  There is an awful lot that has been going on.
     When Francis Collins, the director of the Genome Institute
spoke at the first NBAC meeting, I think he provided an overview
of many of those subjects.  Staff would probably be delighted to
go over that initial listing and flesh out in more detail what
those potential topics would be.
     CHAIR CHILDRESS:  Are there other points that you would like
to make as we move closer to adjournment.
     (No response)