Re: IRB Membership Barbara Gray 01 Feb 2001 14:14 EST

Nancy and all,

College of Charleston (a Single Project Assurance institution) is in the same
position, except I have not excused myself from voting on protocols that may
be federally funded.  Except for legal counsel (ex-officio member) who is also
now our acting provost and no longer regularly attend meetings, I am the only
person who has been with the committee the whole time and carries the
"institutional memory" of why we do things the way we do.  Human subjects
regulations are so complex that members often do not fully understand them and
will make unwise suggestions.  I am there to pull them back on track, and
having a voting voice helps in that process.  (I am not a voting member of the
IACUC, and I find that somewhat frustrating.)  When we have submitted SPAs, my
name has always been on the list of members.  That has never been questioned
by OHRP.  I think until it is, we will continue to do business as usual,
except that I must think about possible financial conflict of interest.

Barbara

Nancy Peterson wrote:

> 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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--
==================================================================
Barbara H. Gray, Director
Office of Research & Grants Administration
College of Charleston
66 George Street
Charleston, SC  29424
Campus Location:  407-G Bell Bldg.
Office: 843.953.5673  Desk: 843.953.5885  Fax:  843.953.6577
e-mail:  xxxxxx@cofc.edu   URL: http://www.orga.cofc.edu/
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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
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