NEXT STEPS
                       THOMAS MURRAY, Ph.D.
     DR. MURRAY:  We have an hour and a quarter.       We have
one public statement scheduled to be provided, so we will need to
reserve five or so minutes for that.  And I think in all curtesy
to that--and to that person--we should not wait until the end but
try to do it, in fact, about the scheduled time, which was 4:30
p.m.
     Among the things we need to do before we leave today are
decide how we want to use our time tomorrow in the full
committee.
     If you look at your agenda for tomorrow--if you don't have
it handy I can remind you what it is--we have--  
     Harold will welcome everyone at 8:00 a.m.  
     We basically have until 9:30 a.m. to conduct our preliminary
discussion.  
     We have two individuals, Susan Old from the National Heart,
Lung and Blood Institute and Patricia Barr from the National
Action Plan on Breast Cancer, who are expected to make comments
and engage us in conversation.  And that will go on until about a
little after 10:00 a.m.
     After the coffee break, we will then have until 11:30 a.m.,
which is the time for public statements.
     At that point, we are finished for the day, at least as our
subcommittee, so we need to use that time well tomorrow.
     So as I calculate it, we have for ourselves roughly an hour
and 20 minutes, and then about another hour and 10 minutes.  We
have about two and a half hours to do our presentation, when we
are not actually also engaging scheduled speakers.  So we want to
use that time well.
     And before we quit today, we need to figure out who is going
to, how we want to use it and who do we want to lead the
conversation.  Do we want to divide up responsibility for
different issues or different portions?  So I will give you that
warning.
     Eric Meslin has also asked me to raise a couple of points,
and I will do that.
     One is whether or not--I think we did address this--whether
or not we want to have a specific model consent form that we
endorse or whether instead we should talk more generally about
the elements of appropriate consent.
     My recollection is we talked about it--we discussed that--and decided not to press a specific model consent form.  Is that
correct?  Does everyone agree with that?  Not as a statement of
fact, but as something we actually would want to do.
     MS. KRAMER:  I think we had raised the possibility of maybe
including in the report four or five examples of consent forms
that had been presented to us.  I don't think we resolved it, but
we raised that possibility.
     DR. MURRAY:  Yes.  I think we did talk a little bit.
     Steve, did you--  No. 
     Carol?
     DR. GREIDER:  I just wanted to mention that it was pointed
out to me by Elisa Eisman that, in her final report on the stored
tissue samples inventory, she has collected a large number of
sample informed consent forms.  And I don't know if anyone else
got this final report, but there are a number of them in there if
we want to look through those to continue the discussion.
     DR. MURRAY:  Right.  Yes.  I got my copy about 10 minutes
ago when Elisa handed it to me, so I haven't had--  And she
pointed out that there are those examples of consent forms.  
     And we have the material from the National Action Plan and
from the Primer(?) Conference and some other materials that we
may wish to at least certainly refer to.
     Bernie?
     DR. LO:  I guess I would be in favor of not trying to
develop a model form because I think that is going to change over
time and it is going to go through iterations.  People are going
to test forms, find out some things work, and some things don't. 
And I think we are better off sticking to the goals and
principles rather than specific forms.
     DR. MURRAY:  I don't hear any descent from that position.
     Steve?
     MR. HOLTZMAN:  Just you can go one step beyond goals and
principles to the elements.
     DR. MURRAY:  Yes.
     MR. HOLTZMAN:  Right?  I think it would be very useful.  The
elements of the consent that are important.
     DR. MURRAY:  Yes.  The consensus I thought I was agreeing
with was something short of designing or voting on a specific
model consent, but rather talking in somewhat more general terms
about what consent forms ought to be like.
     DR. MIIKE:  There is also a practical obstacle, which is
that we are suggesting general consent.  I mean, the consent
varies according to the situation.
     DR. MURRAY:  Okay.  So I think we are in full agreement on
that, and I feel very comfortable defending our position on that.
     Another point that Eric has asked me to raise with you is to
consider whether to regard the stored tissue report; to publish
it first as a "interim report," with a comment-limited, specified
comment period, or whether to publish it, I presume
alternatively, as our report?
     Now, I have a view on this, but I want to hear what the
other commissioners say.
     DR. MIIKE:  Can you say that again.  As an interim?
     MS. KRAMER:  Can you say that again.
     DR. MURRAY:  Eric, why don't you--since you proposed this--why don't you describe what you have in mind?
     DR. MESLIN:  It occurs--  At least it occurred to me and
some others that a report of this import, one that is being
waited on by a number of organizations and which we have
promised, cannot hope to enjoy the input from all possible
commentators and that, since there is no specific deadline to get
it out, except for as soon as we can in the highest possible
quality fashion, that it might be useful to disseminate an
interim or draft report which contains all of the deliberations
and our recommendations and allow for a period of public comment,
to be decided on as a reasonable amount of time, that would allow
as many people as possible the opportunity to read it, to think
about it, and to provide whatever comments or input that they
felt appropriate.
     That public accountability model I think is very useful, but
it also I think provides an opportunity for the commissioners to
hear views that they might not otherwise have heard by
individuals who could not come to the meetings, who weren't able
to provide written documents.  These would certainly be seen as
comments and would be considered before the commission issued its
final report shortly thereafter.
     MS. BACKLAR:  I think it is a great idea.
     DR. MURRAY:  Harold?
     DR. SHAPIRO:  I also am strongly supportive of that idea. 
And we have a model which I think worked very well and that is
the Canadian group, what is called the Tricouncil, which
publishes various drafts up on the Web, and it was
extraordinarily improved from draft to draft, at least as I feel
it.
     And I think it was mainly comments from people who hadn't
had an opportunity to be at the meetings, hadn't fully understood
exactly what the recommendations were until they could see them
laid out that way.  And so there is an easy way to get it around
now.  And I think it would lend an awful lot more credibility and
probably increase the quality of the final document.
     DR. MURRAY:  Bette?
     MS. KRAMER:  Well, it would also, if we in fact go forward
with the public opinion survey, enable us to incorporate anything
that we learned from that in the final report.
     DR. MURRAY:  Then the final report would be maybe in our
lifetime.  I mean, it is a while before I think we are going to
have a public opinion survey to incorporate.
     MS. KRAMER:  No.  I am sorry.  I don't understand.  Which is
going to be further into the future.
     DR. MURRAY:  The wait until we get the results of the
opinion survey, while I think it is within our lifetime--
     I guess I don't have the same enthusiasm for doing it as an
interim report.  I understand the arguments, and some of them I
find pretty good for doing it that way.  People are looking for
guidance from us.  And are we going to say, "Well, here is our
guidance, but it is not really our guidance because it is only an
interim report and we might change things."
     And it will mean, quite frankly, that a considerable portion
of our energies after this report, when we are working on the
next one, will have to go back and revisit this report.  And I am
very concerned about the time and the attention of commission
members so I think there is a trade-off that we need to be
conscience that we would be making if we chose this strategy.
     DR. SHAPIRO:  Tom, I think you are right.  It is a trade-off.  But, one, I think the staff can be very heavily involved in
dealing with this at the response level, and then bring some
changes to us if there are any at that time.  And, you know, I
think your point is a good point.  I mean, I certainly understand
it.  But I think on balance that we would still be well served.
     I don't think we should give a long period for comments.  I
think we give a relatively short period for comments.  I don't
know what that means.  I haven't thought that out.  But it is
weeks, not months, that I have in mind.  But I understand the
point.  It does cost some--
     DR. MURRAY:  Let me actually mention one other virtue of
doing it as an interim report.  People are more likely to read it
if there is a chance that they can actually make suggestions that
will help shape, that will help modify it.  That--  I have to
grant that as maybe one of the strongest arguments in favor of
doing it as an interim report.
     DR. COX:  Yes.  And, Tom, that is actually the point that I
was going to bring up.  I am in favor of an interim report, but
for that purpose.  Because if Eric Cassell was here he would call
it education.  And by calling it an interim report, you are going
to get many more--hopefully--people involved.  
     I am pessimistic in terms of how useful the input is going
to be because it is going to be not from people we haven't heard
before, but it is going to be from all of the people we have
heard from before, and we already know what they have to say. 
But that perhaps at least it gives the opportunity of education
and having more people involved.  
     So I quite agree with your points in terms of the downside--and for me it is a fine line--but I am more in favor of it being
an interim primarily for this education part.
     DR. MURRAY:  Carol?
     DR. GREIDER:  I agree.  I think that if we can really
publish it on the Web where people could really have access to
it, then it would be a very useful thing to be able to get
comments back.  
     I mean, I always circulate anything before I publish it to
colleagues to get comments from them.  
     If we couldn't publish it in something that is quite that
accessible, I would be less in favor of having a draft report
that is just a paper report that is going to be difficult for
people to get a hold of anyway.
     DR. MURRAY:  Bernie?
     DR. LO:  Yes.  I will just put my vote in for having an
interim report and getting feedback.  I think patient advocates
and the scientists are going to have to live with the report, so
we should give them a chance to give us some feedback.
     DR. MURRAY:  If we publish it on the Web, that will
certainly make it available to people with access and
sophistication about getting--using--the World Wide Web.  Will
that get to all, you know, most of, if not all, of our relevant
publics?  To scientists I expect it would.  Would the consumer
groups, public groups, be able to do that?
     DR. LO:  I think a lot of the people would be able to, sure.
     DR. MURRAY:  Yes.
     DR. SHAPIRO:  We order pizzas on the Web.
     (Laughter.)
     DR. MURRAY:  We order pizzas on the Web.
     MS. KRAMER:  You know, Tom, I suspect if there is a group
that wants to pass it around to their particular audience, they
can always--  There is nothing to stop them from publishing it
themselves or printing it.
     DR. MURRAY:  Right.  Right.  Well, this sounds like I seem
to be the only one who has dug--  I haven't exactly dug my heels
in.  I am being dragged along though.   I think it might be well
then to mention this tomorrow to the full commission, do you
think?  I would rather not have it take up part of our brief
substantive time, but as we talk about strategies for
publication, if we could mention this as a possible strategy
that, if it worked well, I suppose could be a model for other
reports where it was equally suitable.  I am not making a
judgement whether it would always be suitable, but I am--   Okay. 
I think actually we have gotten an answer to that question then.