Re: IRB and Clinical Trials Peter J Dolce 28 Jan 2000 17:34 EST

But the slope is a slippery one.  The IRB is a peer reivew body and most of
them are employed by the same organization as the PI.  Isn't such a
situation rich with opportunities for conflict of intrest, even if we place
the IRB function under an institutional exec who's neutral (or even
suspicious of) research involving human subjects?  The guidelines were set
up to give local control and local responsibility for protection of human
subjects, and that requires a degree of trust in the integrity and
competence of local people.  We could avoid conflicts of interest by means
of a system of central IRBs unconnected to our institutions--but many of us
are troubled by the idea that an IRB at a remote site can judge whether
subjects somewhere else are adequately protected.

-----Original Message-----
From: Hastings, Kari L [mailto:xxxxxx@PARTNERS.ORG]
Sent: Friday, January 28, 2000 2:40 PM
To: xxxxxx@HRINET.ORG
Subject: Re: IRB and Clinical Trials

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:
 Sanger Hall, Rm. 1-073
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 Richmond, VA  23219
 Voice:  804-828-6772
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