You are perfectly right Chuck. For those of you who subscribe to the
Washington FAX, this issue was addressed today with Mark Yessian from the
HHS Office of the IG coming down on the side of separation in order to
avoid even the appearance of conflict of interest. He commented that this
was a point of contention in the Duke case. Unfortunately small institutions
have a difficult time doing just that. Kari Hastings
----------
From: Herbert B. Chermside [SMTP:xxxxxx@VCU.EDU]
Sent: Friday, January 28, 2000 2:06 PM
To: xxxxxx@HRINET.ORG
Subject: Re: IRB and Clinical Trials
OPRR seriously questions that an institutional officer whose job can
be
seen to be an attempt to increase the amount of research the
institution
does, especially human research, can avoid a conflict with the
responsibility of protecting all of the interests of human subjects.
In
more than one case OPRR has formally or informally required that
these
responsibilities be separated. Some might question that this is a
real
conflict, and others might question the assumption that a
professional
cannot manage both responsibilities without conflict, but the wise
view is
probably that the mere appearance of a possible conflict
(particularly when
that appearance is in a regulator's eye), is sufficient to cause the
institution to give strong consideration to institutionalizing a
separation
of these responsibilities.
The concept of Conflicts of Interests is not limited to individuals;
institutions may have conflicts, or may create them by their
internal
organization.
Chuck
At 09:48 AM 1/25/00 -0600, you wrote:
>Good morning!
>
>My question is related to the conduct and business of clinical
trials and
the management of IRB's. I had an investigator ask an intriguing
question
and want to hear from you all. This investigator has made reference
to
conflict of interest and ethics. I would appreciate any and all
responses
whether to this listserv or directly to me.
>
>Question: In a centralized research administration office, do you
think
there is a conflict of interest or any ethical problems if the
person
responsible for the management of the IRB also be involved in the
pursuit
of clinical trial business?
>
>Thank you.
>
>
>Thane J. Peterson
>Director of Research
>Iowa Health System
>1215 Pleasant, Suite 305
>Des Moines, Iowa 50309
>
>515-241-5725
>515-241-4185 FAX
>
>WWW.IHSDESMOINES.ORG
>
>
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Herbert B. Chermside, CRA
Director, Sponsored Programs Administration
Virginia Commonwealth University
PO BOX 980568
Richmond, VA 23298-0568
Express Delivery Only:
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Richmond, VA 23219
Voice: 804-828-6772
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OFFICE e-mail xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://views.vcu.edu/ospa/
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