X-Message-Number: 6652
From: John de Rivaz <>
Newsgroups: sci.cryonics
Subject: Re: Senate Bill 1898: What it means to pathologists
Date: Tue, 30 Jul 1996 12:35:19 +0100
Message-ID: <>
References: <4tjk7s$>
Found on <sci.med.pathology>. It may interest some people here:
>>>>>>>>>>>>
On June 24, a senate bill was introduced to protect the genetic
privacy of individuals (Genetic Confidentiality and Nondiscrimination
Act of 1996, SENATE BILL 1898). This bill, recognizing the negative
effects on individuals whose privacy is invaded by unscrupulous
persons using collected DNA, puts restrictions on the collection
and use of DNA. (All good!)
Summarizing the bill, DNA cannot be collected or stored without
the voluntary approval of the individual. Furthermore, research
cannot be conducted without the informed and voluntary approval
of the individual. In the case of DNA of deceased individuals,
the researcher must have in place a means of conveying the results
of genetic testing to the family members of the deceased, and the
family members must have a mechanism of refusing this information,
if they prefer.
The proposed legislation defines DNA sample as:
(7) DNA SAMPLE- The term `DNA sample' means any human
biological specimen from which DNA is intended to be extracted,
or DNA extracted from such specimen.
How does this effect pathologists?
First, all stored (paraffin) tissue blocks contain DNA and,
when used for any DNA studies, would fall under the restrictions
of the bill. In fact, it may seem far fetched, but since DNA
is extractable from tissue blocks, the bill, literally interpreted,
would result in restrictions regarding how pathology departments
store surgical and autopsy tissue blocks.
Most pathologists consider their autopsy and surgical pathology
blocks to be the property of the pathology department, to be used
freely for research endeavors. This would end. All research on
tissue blocks would have to receive approval from the patient whose
DNA is used (not an easy task for a project with hundreds of
samples). Work on autopsy blocks would have to develop some way
to inform families of results (even harder), and would have
to get approval from the Institutional Review Board for any and
all projects (also not so easy).
In the past, anonymous and autopsy samples were considered
a special category of scientific endeavor. If a patient sample
were collected anonymously, then nobody could be hurt by the
research findings, right? Well, anonymity is no longer permitted
under the proposed legislation. The patient
must be informed of the use of the DNA and must give approval.
The patient can also change his/her mind and withdraw approval.
At the same time that the researcher must keep in touch with the
patient whose DNA is used, the researcher must also maintain
the confidentiality of the results of the work. In my opinion,
it is difficult to maintain confidentiality while at the same time
maintaining communication with the patient. The best way of
maintaining confidentiality is to establish anonymity from the
outset.
All pathologists will be profoundly effected if this
legislation passes without modification. Whenever a researcher
comes to your pathology department, requesting a tissue block, the
pathologist will need to assure that the provisions of the
bill are observed. The responsibilities of the person in
charge of a DNA sample collection are specified in the bill.
Most retrospective studies involving genetic studies will
be impossible, because it will be virtually impossible to get
the required consent forms from patients that are long gone.
The days of pulling a few blocks and following through on a new
idea.....will be over. Only well-defined, prospective studies will
have much chance of being approved by the Institutional Review
Board. And prospective studies tend to take years to develop
and carry through and are often much more expensive than retropspective
studies.
These are just my interpretations of the bill. I am not a
lawyer and have no expertise in this or any other kind of
legislation. I urge all pathologists to review the proposed
Sentate bill and form their own interpretations. I would be
very interested to hear the opinion of others, either in this
newsgroup or as private e-mail communications.
The entire bill can be read at Web site:
http://www.ncgr.org/gpi/GCNA/thebill.html
Jules Berman
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* Publisher of Longevity Report *
John de Rivaz * Fractal Report *
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