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Re: IRB Membership Nancy Peterson 02 Feb 2001 09:52 EST

Re our discussion on IRB Membership, one RESADM participant referred me to
a Wake Forest determination letter
http://ohrp.osophs.dhhs.gov/detrm_letrs/dec00m.pdf that said an "Authorized
Institutional Official" could not serve as either a voting or non-voting
member of the IRB.  However, I am not an "authorized instititutional
official."

The finding #47 from the Division of Compliance Oversight (
http://ohrp.osophs.dhhs.gov/references/findings.pdf) refers to a "Director
of the Office of Research Support," but does not specifiy whether or not
that individual an "authorized Institutional official."    Hence, I see no
problem with serving as a non-voting member.  The question is whether I can
be a voting member and simply excuse myself from voting on the handful of
proposals involving possible grant funding. (Again, my salary is paid by
the institution and increases are negotiated by my collective bargaining
unit.  The only possible financial conflict of interest is that my office
operating expenses -- which aren't exactly substantial, since I'm a
one-and-a-half person office -- are allocated based on F&A costs received.)

I'll present the question and everyone's responses at the next IRB meeting
and follow the advice of the membership.

"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."

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

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/

 "Doug
 Wilkerson"           To:     <xxxxxx@WINONA.MSUS.EDU>
 <xxxxxx@m        cc:
 co.edu>              Subject:     IRB Membership

 02/02/01
 06:36 AM

Nancy,

I think I also posted this response on the NCURA IV listserv, but I think
you should look at the December 22, 2000 "determination letter" sent to
Wake Forest University by OHRP.  It is posted on the OHRP website.  In this
letter, OHRP clearly states that Jay Moskowitz, their vice provost for
research should not be a voting OR non-voting member of their IRB.  I, too,
serve as an ex-officio member of our IRB, but "just to be on the safe
side", I'm going to "kick myself off".

Doug Wilkerson, Ph.D.              Phone:   (419) 383-4252
Assoc. Vice Pres. for Research  Fax:     (419) 383-4262
Professor of Pharmacology         E-mail:   xxxxxx@mco.edu
Research & Grants Admin.          Web: www.mco.edu/research
Block Health Sci. Bldg., Rm. 148
3035 Arlington Ave.
Toledo, OH 43614-5804

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