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(Previous discussion continued)
Re: IRB Membership Herbert B. Chermside (20 Nov 2003 08:43 EST)

Re: IRB Membership Herbert B. Chermside 20 Nov 2003 08:43 EST

At VCU there is no representation of any sort by Sponsored Programs on any
of our several IRB's.  This is in part because of OHRP's concerns that an
OSPA may be charged with increasing research activity and therefore have a
COI, a desire to encourage support of a protocol for the reason of
obtaining that additional research support.  (It is my personal opinion
that there is not such a COI, because an OSPA is charged with
administrative, not advocacy, functions; nevertheless there may be an
appearance of COI to super-cautious outsiders who co not have an
understanding of an OSPA role in an institution.)  Both OSPA and Office of
Research Subjects Protection report to the Vice President for
Research.  The offices work together to ensure that there is a clear record
cross-connecting IRB protocol records and Sponsored Program proposal/award
records.  Occasionally OSPA answers a technical question regarding a
proposal/award.  This cross-connection allows OSPA to communicate to the
sponsor certifying or reporting IRB actions, for purposes of "one stop
shopping"; OSPA certifies IRB review and approval, and communicates with
the sponsor when IRB takes and action requiring notification of sponsor,
e.g., a suspension of a previously approved protocol.

Chuck

At 05:06 PM 11/19/2003, you wrote:
>-----Original Message-----
>From: "Schoen, Alexander" <xxxxxx@WINTHROP.ORG>
>To: xxxxxx@HRINET.ORG
>Date: Wed, 12 Nov 2003 09:24:38 -0500
>Subject: [RESADM-L] IRB Membership
>
>Good Morning,
>
>I am interested in knowing how many Sponsored Programs / Grants personnel
>are involved in their institutions' Institutional Review Board.
>
>Does your Sponsored Programs/Grants office administratively run the IRB?
>OUR SPONSORED PROGRAMS OFFICE IS EX-OFFICO ON THE IRB
>
>Is a representative of the Sponsored Programs/Grants a member of the IRB?
>IN A NON-VOTING ROLE
>
>Does a representative of the Sponsored Programs/Grants sit in on the
>meetings for informational purposes? YES
>
>Does your Sponsored Programs/Grants office have no involvement with the
>IRB? ONLY AS INDICATED ABOVE
>
>In our institution, I am not a member of the IRB, but attend meetings and
>provide information on related clinical trial agreements as needed.
>
>I look forward to your responses.
>
>Thank you,
>
>Alex
>-----------------------------------------
>Alexander Schoen
>Director, Office of Sponsored Programs
>Winthrop-University Hospital
>222 Station Plaza North, Suite 510
>Mineola, NY  11501
>Phone: (516) 663-8997
>Fax:     (516) 663-9718
>xxxxxx@winthrop.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:
 Biotech One, Suite 113
 Virginia Biotechnology Research Park
 800 East Leigh Street
 Richmond, VA 23219
Voice:  804-828-6772
Fax     804-828-2521
OFFICE e-mail   xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://www.research.vcu.edu/ospa.htm

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