Chuck,
I'm with you on this one, and I would say it wouldn't have to be limited to
just clinical trials. I was having this conversation with Carey Conover
(NCURA folks will know her and Ada Sue as the "Goddesses of IRBs") earlier
this week. The issue is the perception (and from my experience in the
Federal world, one should even avoid the perception). An institutional
officer whose job it is to sign proposals may not be seen as having a "good
separation of duties" whereby they can also have an influence on the IRB
process.
Pat
-----Original Message-----
From: Herbert B. Chermside [mailto:xxxxxx@VCU.EDU]
Sent: Friday, January 28, 2000 11:06 AM
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:
Sanger Hall, Rm. 1-073
11th & Marshall Streets
Richmond, VA 23219
Voice: 804-828-6772
Fax 804-828-2521
OFFICE e-mail xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://views.vcu.edu/ospa/
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