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Re: IRB Membership Barbara L. Pifel (20 Nov 2003 12:54 EST)

Re: IRB Membership Barbara L. Pifel 20 Nov 2003 12:54 EST

At Weill Medical College of Cornell University our process tracts
VCU.  There is no representation of any sort by Sponsored Programs (Grants
and Contracts) on our IRB for the same reason(s) that Herb very eloquently
described below.  Our IRB, IACUC and Conflict of Interest function is
headed up by Jeff Cohen, Associate Dean for the Responsible Conduct of
Research, who was formally with OHRP.  Our intellectual property activity
is process through the Cornell Research Foundation because of COI
considerations.  That activity is headed up by Brian Kelly Vice President
for Technology Transfer here at the Cornell Medical Campus.  Jeff, Brian
and I are a cohesive team that interacts very well.  Here, it works
extremely well because of the collective wealth of experience and knowledge
of the team.  It's wonderful when you can bounce things off one another as
various issues come up that cut across the three areas.

Barb

At 08:43 AM 11/20/2003 -0500, Herbert B. Chermside wrote:
>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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