Re: IRB Membership Renner, Michael 02 Feb 2001 04:56 EST

Nancy -

Here's my opinion: I think you've raised a valid concern.

First, the issue of providing continuity and institutional memory is
important, and shouldn't be taken lightly. Many of us, myself included, have
seen committees accidentally redefine themselves or simply become
ineffective when such steadying influences are missing.

On the other hand, if your office budget is even partially derived from IDC
recovery, then you do have a conflict of interest. I doubt than many
auditors of the type you're likely to face are agile enough that this issue
would come up and pose problems for you, but it's a problem.

On the other hand, the conflict of interest only extends to those proposals
which might generate indirect cost funds. If the proposal traffic through
your IRB doessn't include large numbers of such proposals, you might be able
address the issue appropriately by recusing yourself from considering those
proposals, while continuing the serve on the committee and voting on
proposals for which you don't have such a conflict.

Thanks for raising the issue that many of us should probably think about.
Good luck!

Michael Renner

------------------------------------------------------------------------
Michael J. Renner, Ph.D.
 Interim Associate Vice President, Academic Affairs
Professor of Psychology
West Chester University
West Chester, PA 19383

xxxxxx@wcupa.edu
Telephone: 610-436-3310
Fax: 610-436-2763
http://www.wcupa.edu/_facstaff/facdev/
"The path of least resistance is always downhill."
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-----Original Message-----
From: Nancy Peterson [mailto:xxxxxx@WINONA.MSUS.EDU]
Sent: Thursday, February 01, 2001 11:43 AM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] IRB Membership

I'm repeating some info that recently appeared on the NCURA Region
IV listserv.  I thought I'd get some responses from a broader group
of research administrators.

The following is finding #47 from the Division of Compliance Oversight
from OHRPhttp://ohrp.osophs.dhhs.gov/references/findings.pdf

"Conflict Resulting from Office of Research Support ( Sponsored
Programs) Serving as a Voting Member of the IRB.  HHS Regulations at 45
CFR 46.107(e) stipulate that no IRB member may participate in the
initial or continuing review of any project in which the member has a
conflicting interest.  OHRP finds that the Director of the Office of
Research Support ( ORS) ( OR that indiivulas from ORS whose duties
create a real or apparent conflicting interest should not serve as
voting IRB members."

Here's my dilema.

I serve as an ex-officio voting member of our IRB.  We are not a research
intensive university, but we apply the IRB-related federal regulations to
all research activities regardless of source of support.  Most of the
proposals we review are not externally funded.  (In fact we've had only
a handful in the past 10 years.)  We do not have an IRB office or staff
person.  The faculty serving on the IRB are volunteers.  By default, I
provide continuity and guidance to the IRB.

My salary is covered by institutional funds, but office operating
expenses are allocated based on the amount of indirect costs the
institution receives.  If a proposal was submitted to the IRB that was
also being submitted to a funding agency, I would exclude myself from
voting on that particular proposal as a possible conflict of financial
interest.

Does anyone see any conflict in a Sponsored Research person serving as a
voting member on an IRB if they exclude themselves from voting on research
protocols involving possible federal funding?

**************************************************************************

Nancy Kay Peterson
Director of Grants & Sponsored Projects
Somsen Hall Room 202-C
Winona State University
Winona, MN  55987

Phone:  507.457.5519
Fax:       507.457.2415
xxxxxx@winona.msus.edu
http://www.winona.msus.edu/grants/

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