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To: Multiple recipients of list HUM-MOLGEN <HUM-MOLGEN@NIC.SURFNET.NL>
Subject: ETHI: consent/specimens
From: Hans Goerl <GENETHICS@delphi.com>
Date: Tue, 12 Mar 1996 07:41:46 -0500

We have received multiple responses to this inquiry. Those which are not
apparently duplicative are included with this message. I have also appended
a message on roughly the same subject which was posted to another newsgroup
several months ago.   Obviously this is a hot issue right now. If somebody
from NIH will send me a copy of the proposed NIH-OPPR rules, I shall post
them to HUM-MOLGEN's www site.

It is also interesting to note that despite the fact that we have
subscribers from 58 or so countries, the responses came from only two
countries, France and the US. Presumably archival specimens are being used
or have been protected in other countries and it would be appreciated if
those from other countries with knowledge of the appropriate regulations,
rules or discusions would forward them.

Hans Goerl
ETHI editor

        I have had some experience with this issue here at the genome
center and in an American Society of Human Genetics subcommittee on
informed consent.  I refer you to the document that resulted from an
NIH-CDC conference on informed consent for research on stored samples.
(Clayton-Wright, et al. JAMA 1995 274(22) 1786-92) This paper discusses the
issue quite thorougly though it has been controversial.  For your study,
the bottom line is that it is reasonable to  use such material for studies
like you describe if the samples are anonymized prior to analysis.  The
Clayton-Wright paper gives a rigorous (and in my view, correct) definintion
of anonymous and anonymized.  There are two caveats, however.  If you
completely consume the specimens some would argue that you are destroying a
resourse of potential value to the patient from whom it was drawn.  Since
it was drawn for clinical (not research) purposes, you could be foreclosing
future clinical use that might be of benefit.  The second argument is if
the research deals with a sensitive issue and it is conceivable that a
significant cohort of the "subjects" might object.  Race and IQ, for
        From a scientific point of view, anonymizing or stripping
identifiers and forgoing consent offers a potential advantage as consent
can bias gene frequency studies.  If particular subgroups (ethnic,
geographic, socioeconomic, etc) participate have different participation
rates, it could possibly distort your data.
        I recommend that you put together a proposal to anonymize the
specimens and present that to your IRB (or equivalent) in light of the
paper noted above.  In addition you may wish to review the statement by the
American Board of Medical Genetics on this topic (Am J Hum Genet 1995,
57:1499-1500).  If there are other problems or issues with this approach, I
would welcome further direct discussions with you.
With warm regards,

Leslie Biesecker, MD
National Institutes of Health
National Center for Human Genome Research
Building 49 Room 4A80
Bethesda, MD  20892-4470
Telephone: 301-402-2041
Fax: 301-402-2170

In my view, using newborn screening samples for research is highly
problematic since they were obtained for an entirely different reason.  If
you are going to retain identifiers, you must obtain informed consent.  If
you remove identifiers irretrievably, then it is more acceptable to use the
samples without obtaining consent.  There is some controversy about what is
meant by irretrievable removal, but the main point is that no one should be
able to identify the particular baby.  In particular, it is completely
inappropriate to do the study and then go contact the family with specific
informationa bout their child.

Ellen Wright Clayton
Vanderbilt University

In France, such studies have been strictly forbidden by the National Ethics
Committee, on the basis of the idea tha no informed consent could be
Segolene Ayme

This issue of whether and how  previously collected tissue samples can be
used for genetic research has become quite controversial in the United
States.  A CDC/NIH Task Force completed a report on the question, which was
published in the December 13, 1995 issue of the Journal of the American
Medical Association (Clayton, et al.).  This report would make it difficult
to use previously collected samples for such research.  The report prompted
a great deal of concern and was the subject of a special meeting at NIH,
reported in a news story in the January 26, 1996 issue of Science
(Marshall).  It seems to me that the three main questions are as follows:

1.      Must a researcher get additional informed consent to use truly
anonymous (not linkable to an individual by anyone, on the current research
or not) previously collected samples for genetic research?

2.      Must a researcher get additional informed consent to "anonymize"
previously collected samples and then use them for genetic research?

3.      For newly collected samples, can a research get general informed
consent for future research or must the informed consent be limited to only
those particular and specific investigations foreseen (and described) at
the time?

These issues are important and I cannot make an informed guess about how
they will be resolved.  Professor Robert Weir and Jeffrey Murray at the
University of Iowa are holding a two week seminar on just these issues at
Iowa this June.  They might be able to provide you with more references,
information, or ideas.  Professor Murray's e mail address is

I don't mean to imply by this answer that the US experience is the only
relevant experience, but it is the only experience I know anything about.

I hope this is of some help.

Hank Greely
Professor of Law
Stanford University

I serve on the IRB for the University of Pittsburgh Medical Center as well
as on a task force addressing IRB concerns for genetics studies. If all
identifiers are stripped from the samples, they can be used for mutation
screening studies. Under these circumstances, informed consent is not
necessary. Your IRB should receive a protocol from you so that they are
informed of the study, but it should be made clear that your study design is
 conforming to the most recent recommendations of OPRR which do not

require informed consent when the samples are completely anonymous.
Michael B. Gorin, M.D. Ph.D.
Assistant Professor
Departments of Ophthalmology and Human Genetics
University of Pittsburgh Sch. of Medicine and Grad. Sch. of Public Health

Mail address: Dept. of Ophthalmol. - 8th floor,
The Eye & Ear Institute Building
203 Lothrop Street, Pittsburgh, PA 15213
Office: (412) 647-2211   FAX: (412) 647-5880

X-Sender: raspritz@facstaff.wisc.edu

Dear Dr. Frydman,

In fact, in the U.S. there are new NIH OPRR rules for using stored or banked
specimens.  I will be attending a special NIH workshop later this month to
consider how these new rules can be implemented.  I just received the packet
of materials today, and so I have not read the new rules yet.  However, I
would suggest that, at least in the U.S., new rules may render prior
experiences with IRBs obsolete.

Richard A. Spritz
Medical Genetics and Pediatrics
University of Wisconsin

EDITORS NOTE: The message below was sent to another newsgroup several months
ago in response to a comment about about using  archived, specimens for
research. Since the original sender did not post it to this list, I have not
identified him or her.

I know that there are probably stacks of lawyers who will disagree with me
... after all, by disagreeing with me they create a market for their
services ... but when it comes toi archived specimens, unless they are sold
or used for commercial production purposes (e.g., in the case of a cell
line), I don't consider informed consent necessary for unforeseen clinical
testing purposes.  While such testing may be for the validation of a new
commercial product, the archived specimen is normally of no further use to
the patient.  He or she can't sell it ... they'd have no idea of how or to
whom ... and who would buy it?  And who can value the 100 or 200 microliters
that may be used for a clinical trial.  It really has no significant
commercial value.  Additionally, the specimen has essentially been abandoned
by the patient anyway.

I know that there will always be somebody seeing something sinister in the
use of these specimens .... or trying to derive some material gain from them
.... but with the vast majority of patients, there is no issue here ... only
with their attorneys.

Again, however, there are cases, such as those where the material is a cell
line used to provide a commercial product, or in the case of materials from
miscarried baby, and other extremes, where informed consent is important.
 Routinely, however, only ambulance chasers will make an issue.

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