STATEMENTS BY THE PUBLIC
                          DR. MARK SOBEL
                   MOLECULAR PATHOLOGY DIVISION
                    NATIONAL CANCER INSTITUTE
     DR. SOBEL:  I am Mark Sobel of the Molecular Pathology
Division of the National Cancer Institute.
     I would like to address three issues based on the discussion
that you have had this afternoon.
     One is an issue that Dr. Shapiro brought up that I don't
think you have really followed up on, and that is who decides
what box things go into?  And I would like to provide to you an
example that occurs at NIH for intramural scientists, which is
that the intramural scientist does not have the right to decide
what box it goes into.  
     There is a triage system, which we call the Office of Human
Subject Research, which I think exists in many institutions as
well.  Before it goes to the IRB, there is the determination, by
somebody--a third party--that it is or is not exempt from further
review.  And I think the commission might want to consider such a
recommendation to be included as part of this mechanism.
     The second issue is related to the discussion this afternoon
about genetic information, whether or not it is separate or
distinct from medical information.  And I would urge you to
include the general feeling that, in this report, that genetic
information is just like other medical information.  And there
are many examples of non-genetic research that are potentially
stigmatizing or harmful and vice-versa. 
     However, it has been pointed out that there are some
specific cases which are potentially more dangerous or harmful to
subjects.  And I would urge you to consider looking at the
National Cancer Institute's guidelines for giving out
certificates of confidentiality which outlines a series of
specific types of research that might be potentially harmful and
that might lead toward the granting of a certificate of
confidentiality.  
     And they have a nice booklet now that they have just come
out with that summarizes the rationale that could be used, and
you could refer to that.
     Finally, I would like to address the most contentious issue
for this afternoon, which is the firewall concept.  
     The pathology consensus group did state that there might be
situations in which researchers might come up with information
that they feel would be potentially advantageous to the research
subject, however the research was performed in an anonymous
manner.  And it was always a possibility that the firewall might
be breached. 
     At the time we proposed an IRB or some clinical review board
be in place to consider such specific requests but, once that
request was made, that would really involve, if it was future
research as Dr. Cox pointed out for a subset of patients, that
would really involve a new proposal requiring specific informed
consent for getting new information or new samples from people.
     And in the case of patients or research subjects that would
like information that they think might be clinically relevant to
them, I would urge you to limit that scenario because, as most
researchers know, most research in the early stages is quite
speculative and we really don't know what the penetrance and what
the real meaning of it is.
     And so I think we need to educate the public and you need to
include in your report information for the public that stresses
that, in the long term, research does people good, but in the
short run there are very often misunderstandings and
misinterpretation of research data.     And that is the whole
point of peer review and letting things incubate in the
literature until there is a consensus so that there should be
rare situations when it would be necessary to go back to the
research subject with clinically relevant information.
     The reason that CLEA(?) was passed was to protect the public
from the misuse of research data that was performed in non-certified tests or with tests that really do not meet the
requirements of test validity and test utility.
     DR. MURRAY:  Thank you, Mark.
     I can't help but note that we probably have helped to create
that problem.  How many times have we read an article that
reports some very, very basic science discovery that says it
might lead to a cure for cancer? Right?  And subjects read that
and they don't see all the steps in between.  So we have to
shoulder some of the responsibility for that particular
misperception on the public's part.