FUTURE COMMISSION RESEARCH ACTIVITIES
     DR. CASSELL:  Yes.  We have to use the microphone Chanteuse-style.  
     Your committee for this was Alex and myself, and Alta Charo,
and David Cox, and Eric Meslin, and Henrietta Hyatt-Knorr, and so
it is Eric M. and Eric C. now on e-mail so that we distinguish
each other.  
     We divided our concerns into two.  One was -- one had to do
with commission process and the other with actual program
suggestions that we thought might be useful.
     The first part of it was we thought there was considerable
sentiment for not breaking up into two large groups and meeting
separately again.  We are by my own experience and other people's
reports a very congenial commission and we get a lot of work done
around the table and we have a lot of different talents, and we
thought we really would do better if we could try and stay
together.  There are some days maybe that is not possible but in
general we thought that might be a helpful matter. 
     In addition to that there was also sentiment for having
longer meetings less frequently.  We have a meeting monthly and
we are hardly finished with one meeting and then we are already
into the next and we are really not quite ready, we thought, so
we hoped we could prevail on our chair to consider possibly
changing our schedule somewhat.  We thought we would be more
productive if we did that.  These are all matters for discussion.
     But there is another aspect of the same thing and that is we
are -- when we did the cloning report we were -- we did not have
the amount of staff that is usual for a commission and so here we
are we were all commenting on drafts that had not yet become
drafts and they went back and forth, and in and out, and then --
a very unusual way of writing a report.  It has to be one of the
most unusual way in writing a report that I have ever seen.  
     Whereas, we now have excellent staff and staff in-depth and
we thought that this would also allow for a much better use of
staff, all of whom are really expert now, to circulate drafts, to
make proposals, to do the research so that we have something in
hand and we are working on that before we get to a meeting and
even as was just suggested a lunch so that we are at several
levels.  We are hearing one thing that is maybe ready for a
couple of meetings down the line and another thing and so forth. 
And that is something that we are able to do now because of the
richness of staff which comes from other more direct richnesses.  
     There is some question about whether we have to have one
kind of report.  Whether, in fact, the reports that we now
circulate among ourselves in draft form -- is there a reason for
circulating those reports publicly?  I think they are part of the
public record, aren't they, so that, in fact, anybody who wants
to comment on them could do that by testifying in front of us but
there might be reason for having public comment on drafts even
that we circulate outside and that would enable people who cannot
come to our meetings to make comments and allow us to be enriched
by those comments. 
     We also might -- and this is an issue that allows us to
decide, well, what do we actually do.  We have a policy
assumption.  There is no question about that.  We are to come up
with public policy but by the way we are constituted and by our
natural bents we also have an academic function.  Does one kind
of report meet both those needs the best?  Are there things that
we might do strictly as a policy recommendation report and other
things where we want greater depth and background and greater
academic depth because we know we are talking to the bioethics
and scientific community in a different voice than we might do to
policy makers?  
     We also -- some of my committee members felt that we have
not clarified yet what kind of a commission we are, whether we
are primarily a regulatory -- suggest regulation and policy or
whether we are a standard setting commission, or whether we are a
problem solving commission like the Institute of Medicine does,
or whether we are a reflective research organization which is
related to science because that is what our mission is but on the
other hand we are able to bring to that a somewhat Neitszchean
understanding that there are other issues and uncertainties and
troublesome things in the world and moral life that a commission
like this is meant to reflect on and bring back into the
scientific world.  We thought that we might well be able to do
that.
     A somewhat similar matter is the question of whose ears we
speak to.  Do we speak to the President?  Are we speaking
primarily to legislators?  And I think Harold will be able to, if
he wishes to, address that more directly.  Just who are we
talking to?  And must we -- in that same sense are we only one
thing, which is the same as I said earlier.
     Now, I think Alta Charo felt that because we had finished
the cloning report and we are getting out the stuff we are in now
that this was a good time to reflect about how we saw ourselves
as a commission.  
     My own sense of watching from the outside is that we have --
we are being successful in the way commissions work and that
gives us a bigger chance to self-define and write a ticket, an
intellectual ticket which most commissions do not get a chance to
do because they are having too much trouble fighting with each
other.  We ought to take that -- and I think Alta is correct
about that.
     So let me pause for a moment and then go on to what we --
what was really our goal as far as a committee to see what
program items we might come up with rather than deciding we need
a new garage or whatever. 
     We thought that as we discuss this in our telephone
conversations jointly and separately, though I must say because
of me we really did not have one large conversation or one large
conference.  I could not make the one we were supposed to have
because my medical students and my office staff were having
Christmas parties and I was not going to be very functional.  
     We thought that we ought to make a distinction between
larger and what we call big ticket items.  For example, the
problem of the ownership of the human body, which we will come
back, and I put here smaller but I do not really mean smaller as
much as more sharply focused, such as those concerned with IRB
function.  And I do not think we want to see ourselves doing
solely the latter, should IRB's do a new structure for IRB's or
new regulations but we would like to see us doing both these
kinds of -- taking on these kinds of problems.
     However, we do have immediate concerns that we think should
at relatively center stage.  The first of these is the
Institutional Review Board problem.  We mention it again and
again and again.  It comes up.  We are dissatisfied.  Every one
of the problems which we heard in the testimony on the
decisionally impaired subjects also had a failure of an IRB and a
failure primarily because of lack of education or structural
concerns.  
     So it is very hard for us not to take -- should this still
be the way moral concerns in biomedicine are handled and, if so,
are there changes to be made so we ought to take on that
directly.  Also, it seems to be ideally -- subject ideally suited
for the staff level we have been talking about where the
background research can be done.  We can set up studies that
might have to be done and then come in with something which would
be a basis on which to make decent decisions.
     There is another question which is in the literature at the
present time and that is the ethics of research done by United
States investigators in other countries.  We all know that the
transmission of HIV was addressed in studies done in Africa not
using placebo -- or using placebo controls in a fashion that
would never have happened in the United States at this time and
rising an outrage, which is a very simple posture, a very easy
posture to take, rising an outrage for editorialists at the New
England Journal.  
     Marcia Angel is wonderful but there is greater depth that
could be brought to that problem than has been brought so far and
we are the people, I think, that could do that.  While it is
important to address it, in a funny way we are back to the Ugly
American problem in reverse.  Right after the Second World War
and across national boundaries medical care we were one thing. 
Here we are again back to that same problem and it is an
interesting one and worth review.       There are people
incidently who will be very happy to testify in front of us good
people and hold sharply different views. 
     The privacy and confidentiality issue in genetics and the
whole issue of privacy and confidentiality is back in front of
us.  We have been dancing around it today.  In our first meeting
or two we had some exchange about it.  I personally feel that it
is unsolvable at the present time.  The problem of how to solve
confidentiality in medical care and medical records is -- I
cannot see how to get a handle on it.  
     On the other hand it is possible for us to take up a problem
not so much with a solution in view as with a way of delineating
this is what the problem is, it is in these different kinds of
situations, and we have done it when we have laid out the
problem.  We can now step back from it and let there be public
debate about it as we have laid it out.
     There is an interesting -- opportunity is offered by the
fact that the 20th anniversary of the Belmont Report is coming up
in April of 1999.  So the topic that you will find listed in this
report is the Belmont Report Revisited.  
     An in-depth discussion of the adequacy of its conceptual
framework or -- adequacy is not right.  The changes in its
conceptual framework of the paradigm shift that has occurred
since 1979 in the latter progress in research ethics and the
public consciousness.  As I note, it would be a good thing to see
this happen and come out at the same time as the anniversary.  I
have a personal thing that I am supposed to be writing something
about the change over those 20 years and this will allow me to
put it off yet for another -- anyway I think that is a subject
that we might give consideration to.  
     A number of us feel very strongly about the issue of
education.  This has come up repeatedly in relationship to the
knowledge that IRB members bring to their work and to the
failures of investigators, the young ones and more experienced
ones, because they simply do not know enough about research
ethics or ethics in general.  The media is very poorly informed
about issues of ethics and policy makers, legislators and the
public at large.  There is not only the issue of ethics.  It is
the issue of science education in general that came up through
the cloning report.  
     We think that this again is an area where staff background -- and we begin to find out who is doing what.  What foundations
are out there who have money to do studies on education?  What
government bodies are doing it or think they are doing it and so
forth?  Just as in other areas we think we have to lay out a fair
amount of information and background studies before we tackle it
but we feel very, very strongly about it.  
     Bette Kramer and I spoke about it earlier today and she may
want to comment. 
     And then there are some other problems that have been
mentioned.  Gene patenting, bioethical issues in behavioral
research.  I have these lower down on the list because there is
limit but behavioral research does not fit well into the
biomedical model.  It has always had discomforts in IRB's and yet
an alternative is not clear.  And then there is compensation for
research related injuries which also keeps coming up and
subsiding back down again.  I think because nobody can figure out
what to do.
     There are larger areas.  The right to health care.  The
previous national commission articulated the successful --
previously successful one -- articulated years ago that there was
a -- that the nation had an ethical obligation to ensure
equitable access to medical care.  It is now 20 years later. 
Lots of things have changed.  Inequity persists and grows, in
fact, and while it is a problem there is a question of whether we
should take it up and if we took it up towards what end and what
resolution, and what will become out of it.
     Alta Charo raised the question about the interesting issue
about who owns the body as a larger question.  There are major
cultural differences in what your relationship to your body is in
terms of ethics and the law.  In Orthodox Judaism you do not own
your body.  You have not got the right to refuse resuscitation. 
It is not your's to refuse.  The Mormons are also the same way. 
You do not -- you inhabit, you are a guest in the body and the
body is God's.  Those are just two of the views.
     I think most people are very confused about how they feel
about their body on whether they own it or not or whether it is
an it or a them, and yet those matters have direct bearing on
tissue samples, on the consent to research, on legal issues that
are poorly resolved that we might take up. 
     And there is a question I have listed here called the limits
of clinical care.  
     It has something to do with the issue of progress actually,
Zeke, that we talked about before.
     There is no question that there has been enormous progress
in the resuscitation of newborns who previously would have died,
in multiple births where previously there would have been no
survivors we now have the septuplets, and yet we do not have any
real idea of what about the others.  What about the kids who did
not come out and go on and become the president?  Of their class
of course.  And what about the other ones?  What has happened to
them?  What social resources are used?  What are the obligations
society has to them?  They are a sort of byproduct of progress. 
In fact, if we saw it all laid out we might not think progress
was so wonderful in relationship to them.  The same thing with
the multiple births. 
     I am struck by the number of elderly or old elderly.  They
are now called people in their -- in late '80s and '90s who are
extremely functional.  I have numbers of patients I look at and I
wonder how come you are alive.  What are you doing alive?  And I
know why they are alive.  They have a cut down the center of
their chest.  They have had an angioplasty or two.  They had a
carotid enterectomy and they are out there and functioning.  
     But not every one of them made it and a lot of them ended up
in intensive care units for long periods of time with nobody
knowing how to stop it.  That is also an issue that might be
taken up and begun to be explored because I promise you
physicians do not have the faintest clue about how to stop those
things unless they do it covertly.  Yet we sure do know how to
start.    So those are some of the issues. 
     Finally, as the very last one, and for good reason, I have
reproductive technologies.  I put it last because I think that it
has so many pitfalls that until we have more muscle as a
commission, until we have been more successful and maybe more
callous is a good way to put it, I think we might be careful
about stepping in there where there is so much can happen in
relationship to the public.
     That is our report.  
     DR. SHAPIRO:  Well, Eric, thank you very much and thank the
others who participated in outlining some of these issues for us.
     I am going to turn to the commission in a moment.  We have
perhaps 15 minutes to discuss this or give initial reactions.  As
I have said, we will read new versions of this as we go along and
gradually hone in on an agenda.
     Let me just say a word about the process side.  Perhaps the
easiest to resolve and perhaps even the least important.  
     First of all, as you pointed out, having the staff we have
now it would be perfectly feasible for us to meet as a group
generally and to meet for longer times less often.  I am very
sympathetic.  That is a lot easier for everybody.  
     I just wanted to note that in attempting to put together our
calendar over the last few years it has been almost impossible to
find two days we could get a majority of the commission
available, any two days, so that I am perfectly willing to try. 
I think, in fact, it is a good idea.  I accept the notion it is a
good idea to do that.  We will give that a try if others on the
commission agree because I do think, myself, it is a very good
idea and a better way to go about it.  So I accept the
recommendation speaking personally. 
     If other members of the commission agree we will just go
ahead and try once more encouraging everybody to really make an
effort to help us out and give us the two days when that is
necessary but I like the idea in general.
     Regarding -- I will just give you my own personal reaction
regarding the nature of the reports.  I do not think, myself, and
I think that was the tenor of your remarks if I understood them,
that there is any need to decide on one versus the other.  I
think we are going to speak in different ways at different times
and different kinds of reports depending on the subjects and
perhaps even the different audiences.  
     So I much prefer, myself, to preserve flexibility in that
respect and focus on the problem and decide given this problem
who should we be speaking to first, in what way and in what
format, and so on and so forth.  
     I take it that was really the committee's view also.
     DR. CASSELL:  Yes, that is our general feeling.
     DR. SHAPIRO:  But maybe we could start off with the easier
part of this and just address what Eric has referred to as the
process issues if I can phrase them that way and see and just get
a general sense if people would.  To take a specific item I would
like to meet for longer times but a fewer number of meetings. 
That really means two days every second month just to take an
example rather than one day every month as another example.  
     How do people feel about that?
     COMMISSIONERS:  Yes. 
     DR. SHAPIRO:  Let me ask an easier question.  Does anybody
dissent from that?  
     Okay.  We will give that a try.  Please make an effort to be
helpful to us with your calendars and we will look at this year's
schedule because we do not feel -- I do not feel committed to it. 
We can easily cancel a few meetings this year and make the ones
we have longer.  We will be back to you.  Eric and the staff will
be back to you on that issue.  
     DR. MESLIN:  If I may, though, it might be useful before we
leave that question to consider whether you do want to meet next
month, which we had tentatively asked you to put on your
calendars.  A meeting that was scheduled to be in Los Angeles. 
You have heard from this morning's discussion that there is a
strong desire to get a high quality research product out to you,
the stored tissue report, and I suspect you will hear a similar
sentiment this afternoon and after tomorrow's subcommittee of the
Human Subjects Committee on the report on subjects of
questionable decision making capacity.  
     You may either want to speak now or think about this and
speak fairly soon because we have made some tentative
arrangements to meet in L.A. sometime around the 5th or 6th or
6th and 7th of February.  It may turn out that it would be easier
and make more sense to forego the February meeting and meet in
March, which would give us two months to produce the kinds of
things that we have been talking about.      So I just flag that
for you to consider.
     DR. SHAPIRO:  Steve?
          DR. HOLTZMAN:  Do we or do we not also have on the
schedule a meeting on the 23rd of February?
     DR. MESLIN:  We do not.  We had asked you to reserve a
couple of dates in February and the date that we had more firmly
settled on were the earlier dates.  
     DR. SHAPIRO:  Carol?
     DR. GREIDER:  I would like to address the issue of the
February 6th meeting.  I feel like at least for the Genetics
Subcommittee there are a number of issues where we have put off
discussing substantive components of putting in specific
recommendations in specific boxes in our matrix that we really
have to discuss before we can write a report.  We do not have the
substance yet of a number of those important issues and so I
think foregoing a meeting at this point would not be productive
because we cannot be doing work in the meantime to write up our
reports if we do not have the answers to what we are going to
recommend.
     DR. SHAPIRO:  Let me -- let's not try to resolve this
sitting here right now but we will over the next day's
interaction with members of the committee and the subcommittees
decide specifically about the February meeting.  We may do
everything from have a full commission meeting or if that does
not seem desirable and it does seem desirable for the genetics
group to get there then we might have that.  We might cancel both
depending on what is decided and go to March.  
     We cannot avoid dealing with the question that you have
raised obviously but let's not try to settle this here.  I do
have the sense that at least we should try to structure our
meetings going forward to the extent that is possible and
feasible around roughly day-and-a-half meetings half as
frequently as we currently plan.
     Okay.  That is very helpful. 
     We will go ahead and try to organize ourselves that way if
we can.  
     Let's go on.  There are other issues which we can come back
to on process but I think that was perhaps the most important of
the ones. 
     Let's go on to the issue of program and the various
suggestions that Eric made and let's see if there are any members
of the commission who have any reaction to that. 
     Arturo?
     DR. BRITO:  I just wanted to make a comment about general
functions as something that Eric mentioned.
     I thought that we had decided during the cloning report that
we were not a regulatory body and maybe I am confused, maybe we
just decided for that particular topic.  But you mentioned that
one of the issues is that -- what is our function and I thought
we were more of a suggestive body basically depending on what
audience we are making suggestions to but not a regulatory.  Has
that been -- there has been a change of heart amongst some of the
members or you just want a clarification?
     DR. SHAPIRO:  No, there has not.  Even if we wanted to be,
we could not be, but I do not think -- my sense is no.  I did not
interpret the comments Eric made that way.  I interpreted them as
the question of whether we should be suggesting regulation to
whoever the regulatory bodies are but that is how I interpret
what Eric was saying.
     DR. BRITO:  Okay.  
     In terms of the specific topics I want to say that they all
sound very apropos obviously but it would be very ambitious to
tackle them all.  One of the ones that is very focused that I
think we should tackle right now and has been raised before is
the research being done by this country in other countries,
particularly pharmaceuticals particularly with the HIV studies
because I think there is a lot of room there where we could
contribute both pro and con and reasons for placebo and not
placebo, et cetera.  I think that is something we could tackle in
a short amount of time and do a reasonably good job. 
     Then the education I think is also very important to do
because I think there is a lot of misconceptions about
suggestions we make or other bodies make particularly from the
media and I think that is where we should start with the
educational process. 
     And then the behavioral research.  We had mentioned before,
and I do not know if that has just been lost somewhere, about
addressing the issue of research with children or involving
children.  I think this is where maybe we could tie it in
particularly because I think there is a lot of problems with
behavioral research lacking in children for various reasons so I
think that is where we may be able to tie that in if we decide
not to address that specifically at this point.
     DR. SHAPIRO:  Thank you. 
     Jim?
     DR. CHILDRESS:  I very much like the list of immediate
concerns and I think I would also note that several of these the
Humans Subjects Subcommittee has raised at different points as
important for us to cover.  I would also mention that a few of
these may have a higher status than this indicates.  For
instance, gene patenting, as I recall, was one of the things we
were asked to look at by -- perhaps even in our charter.  
     DR. BRITO:  The President, yes. 
     DR. CHILDRESS:  Certainly the -- I think one of the
documents that established us.  So one question would be whether
we need to give that greater attention.
     In addition, the Institutional Review Boards discussion is
one that we have been holding off until we can get the materials
from the two studies that are underway but the document from the
Clinton Administration on Building Public Trust indicated that we
would make a report on this within a year.  That year is now
passed but it is certainly something I think we need to attend
to.
     The Belmont Report Revisited I think is a great opportunity
for us to think through, particularly in relation to a concern
that Zeke Emanuel raised at our very first meeting, whether these
principles are too individualistic and perhaps need to
incorporate greater sense of community.  This is something that
runs throughout our discussion of human subjects research as well
as the tissue samples report.  I hope that we could do that over
the next year. 
     DR. SHAPIRO:  Thank you. 
     Bernie?
     DR. LO:  I also like the list a lot.  I think it is very
rich.  I would like to pick up on something you said, Eric, in
terms of what is the audience we are aiming for.  What is the
opportunity to change something, whether it is policy or just the
way people look at a problem?  
     I guess I would ask the question a different way.  Where do
we have an opportunity to make a difference?  We could write a
really nice report but where is it going to make a difference in
terms of changing policies, changing practice or changing how
people think?  Is there a group of people out there that want to
hear what we have to say? 
     So far all the things we have done we have been lucky in
that the audience was preexisting so people wanted to hear about
cloning.  There are a lot of people who want to hear about stored
tissue samples.  There are a lot of people who want to hear about
research on people with questionable decision making capacity.  I
think it would be nice to pick a topic where there are some
people out there who want us to say something and are likely to
at least listen to us even if they do not follow our advice. 
     DR. SHAPIRO:  Thank you. 
     Other comments?  
     David?
     DR. COX:  So Eric spoke for me in a way being a member of
the group but I would just like to say that out of all of these
the one that is highest for me is this revisiting the Belmont
Report.  I say that because as the National Bioethics Advisory
Commission that if we can look and ask what the foundation of
this country's bioethics -- if it has changed one way or another
then that is an extremely important task.  So I am -- it is a
favorite one of mine. 
     DR. SHAPIRO:  Let me make a comment about that particular
one as I have thought about it, that is the Belmont Report 1999,
I guess is it's -- right, was it '79?  Yes, 1999.  That actually
is around the corner in terms of doing something thoughtful and
meaningful.  We can devote a certain amount of time to that
because I think it is so important but we will be limited in the
amount of time. 
     What I thought about in terms of that is we might take the
lead in sponsoring some work in that area, whether it is a volume
of essays or whatever it is, we could work on it, to which some
members of this group may choose to contribute as opposed to
issuing a so to speak new -- that is not what was suggested --
Belmont Report.  Those are the things I think we have to think
through but I agree with you, David and Eric, and the others who
have thought about this that we should not let that event pass
without some kind of event, some kind of response.  I think that
is right.  
     Yes, Bette?
     DR. KRAMER:  I would hope that with all the specific
subjects that we address that we will not let go of this factor
of education.  I think Bernie just mentioned where is the
audience.  Well, I think it is incumbent upon us to seize the
opportunity that we have and the obligation I believe we have to
enlarge the audience.  The only way we are going to be able to do
that is by providing or fostering some educational efforts.  
     I think that Eric mentioned that he feels the issues of
privacy and confidentiality are insolvable at this time and that
what we can do is lay it out.  But insofar as we do not enlarge
the audience to whom we are speaking it is not going to be
helpful.  
     DR. SHAPIRO:  Thank you.  
     Let me ask a question of Arturo. 
     Arturo, I did not quite understand what you were referring
to when you referred to research with children or involving
children and you tied that to behavioral research in some way.  I
just could not quite articulate or draw in my own mind exactly
what kinds of things you were thinking about.  
     DR. BRITO:  Initially we decided not to address the issue of
children, research in children, because there are regulations in
the Common Rule that are somewhat vague but they are there.  
     DR. SHAPIRO:  Right. 
     DR. BRITO:  And we went just with decisionally impaired.  
     Then in discussing -- but in the context of discussing that
we have discovered basically or I have discovered or some of us
have discovered basically the main issue right now, the main
criticism of research that involves children is that children are
not being included enough in mental health research, behavioral
research, because the regulations -- at least in this country the
regulations are, although vague, they -- research has not
attempted to involve them in that because of the risks, et
cetera.  And that has become questionably unethical in itself not
to include children. 
     So I understand from behavioral researchers that maybe --
     DR. SHAPIRO:  Maybe one of the things we could at least
consider is revisiting the existing regulations regarding the use
of children and see whether those could be expanded, changed,
reshaped or somehow supplemented in ways that would be helpful
but okay.  I just was not clear exactly what you were suggesting. 

     All right.  Let me suggest that what we will do is -- this
will be on our agenda every meeting.  Probably not for an overly
lengthy period of time.  But we will come to our next meeting
whether it happens to be in February or some other more distant
date with what we consider an update or some suggestions that are
associated with each of these, dropping some, adding some, and we
will just contribute to the discussion and see where it takes us. 
     Is that satisfactory to everyone?  
     Okay.  Thank you very much. 
     Let's go on to our next topic, which is the report from the
Human Subjects Subcommittee regarding decisional impaired and
people with questionable decision making capacity.  This is
subject, of course, we have visited at enough numerous meetings. 
Now we have a report.
     I want to thank Jonathan again and others who contributed to
it.  Jim and others who contributed to that.  At least my own
observation is that each one of these drafts has made important
improvements and are very responsive to a number of issues raised
here so I want to thank you, Jim, for that and thank Jonathan and
others who have worked on it.  
     So, Jim, let me turn to you now to sort of take us through
this discussion.