STATEMENTS BY THE PUBLIC
                          DR. MARK SOBEL
               CHIEF OF MOLECULAR PATHOLOGY SECTION
                    NATIONAL CANCER INSTITUTE
     DR. SOBEL:  Well, I would like to take just a minute of your
time to urge you to consider the implications of your definition
of community.
     It seems to me, after listening to the discussion this
morning, that your definitions are very blurred.  And you might
have very good intentions to just have some consent and advice
involved, but just remember that whatever recommendations you
make will eventually get written into some codified regulation
and, as a employee of the federal government, I can tell you that
the impact of that can be quite severe.
     So if you are not careful in your definition of community,
and especially in terms of defining disease as a community group,
I could certainly see where you basically will not have any
distinction between 1a, 1b and 1c, and that--  Oh, I am sorry. 
1a, 2a and 3a.
     That, in fact, almost everything that we are talking about
could eventually be defined as some community group.  And there
will be implications for that.
     The other issue I would like to bring up.  There was a
discussion about decisionally-impaired and perhaps included in
that might be pediatric samples and, again, I would urge you to
think of the implications of that because you don't want to put
roadblocks into doing research on the health of the children of
this nation that would impact on the good of the nation, so you
want to--      There are special informed consent procedures
right now in place for research subjects that are children, but
when tissue blocks are derived from patient samples who are
children, think of the implications of that in terms of how
research can proceed on pediatric samples.
     DR. MURRAY:  Are there any--  Mark, would you, for the
record, state your name and affiliation?
     DR. SOBEL:  Mark Sobel, Chief of Molecular Pathology
Section, National Cancer Institute.
     DR. MURRAY:  Thanks very much.  I requested that be done. 
There may be a question or two for you.
     MR. HOLTZMAN:  Yes.  Mark?
     DR. MURRAY:  I am sorry.  We are going to make you--  This
is aerobic testimony.  You are going to have to keep going back
and forth.
     (Laughter.)
     DR. SOBEL:  I was told to limit my statement.
     DR. MURRAY:  You did a beautiful job.  
     Steve?
     MR. HOLTZMAN:  So, Mark, when I go in to give a surgical
procedure, under current ways of doing things, I sign a consent
which also includes the right to use the tissue in research.  
     So when my son goes in for surgery, and given that he is
five and a half he doesn't sign the consent for surgery, I do.
     DR. SOBEL:  That is right.
     MR. HOLTZMAN:  Do I currently sign a consent which also
includes the use of his tissue in research as well?
     DR. SOBEL:  Presumably, you are signing the same consent
form for your child that you are signing for yourself.
     MR. HOLTZMAN:  Okay.
     DR. SOBEL:  Under current--  Under the current system.
     MR. HOLTZMAN:  Okay.
     DR. SOBEL:  So that--
     MR. HOLTZMAN:  So that there is nothing you have said so
far, that if we come up with a different level or type of consent
for me, the adult, if I just extended it in the same way--
     DR. SOBEL:  Yes, but that is for the future.
     MR. HOLTZMAN:  --in my role as guardian.
     DR. SOBEL:  I am talking about the already-stored samples
before your own commission report comes out.
     MR. HOLTZMAN:  Right.  We haven't made any decision--
     (Simultaneous discussion.)
     DR. SOBEL:  --those samples.
     MR. HOLTZMAN:  And we haven't made any decisions.
     DR. SOBEL:  But I just wanted to bring that up just to think
about that.  I think, for the future, you can really work out a
very nice scheme with adequate protections, but the issue here
this morning has been the samples that have been collected before
this report comes out.
     MR. HOLTZMAN:  Right.  But I have--  Are you inferring that
we have been suggesting there would be a distinction?
     DR. SOBEL:  Well, it did get raised by Pat Backlar that we
should keep in mind how to handle samples from individuals who
were decisionally impaired.  And my question was are you going to
include underage as part of that category, and what are the
implications of that?
     DR. MURRAY:  Trish?
     MS. BACKLAR:  But aren't there protections already in place
when you are dealing with research with children?  I mean, I
assume--
     DR. SOBEL:  Yes.  But we are talking about--  No.  We are
not talking about interactive research here; we are talking about
the use of archive samples that are already stored.  And in most
cases I am going to talk to right now--  
     Let us consider the case of the clinically obtained samples. 
The child comes in--not for a prospective research study--but the
child comes in for surgical treatment or medical treatment of a
condition and there is residual tissue left over at the end of
that medical procedure that is not necessary for medical/legal
reasons.  Will you--  Do you want to consider that tissue as part
of the general scheme here, or are you going to make a separate
category for it?  
     I think that question got raised this morning and I just
wanted to define that a little bit more carefully because you run
the risk of impeding research on pediatric samples which would
definitely affect progress on child health.
     MS. BACKLAR:  Even though that parent may have consented?
     DR. SOBEL:  Well, my personal view is that that would be
adequate, but you raised the issue of whether that would be
adequate, and I think you are going to have to consider that. 
And so I just wanted to get that issue right up front for you to
really define a little bit better.  
     I would prefer that you not separate that out because the
parent did give consent for the procedure, and included in that
was some implied or minimal--or whatever you want to call it--consent for general research, but I wanted to really--  
     You wanted to bring this issue up for each of these
considerations, and I wanted to put that up front in terms of
what the implications of that categorization would be.
     DR. MURRAY:  Thank you very much, Mark.  
     We have been at it, more or less, continuously for almost
four and a half hours.  It is time for a lunch break.  We will
reconvene at 1:00 p.m.  I understand, thanks to the generous
spiritedness of the NBAC staff, that it should be safe to leave
belongings in this room while we go to lunch.
     Henrietta?
     MS. HYATT-KNORR:  Yes.  (Inaudible.)
     DR. MURRAY:  Oh.  If you are here on business and you
haven't checked out of the hotel, please do so now.
     (Whereupon, at 12:00 noon, there was a luncheon recess.)                A F T E R N O O N    S E S S I O N