Alexander,
What no one has brought up so far, is perhaps what is at the essence of
your question. Does the sponsored research office's
involvement/participation/financial support of IRB activities constitute
a conflict of interest. I don't think there is a definitive answer, but
it is a question that institutions must consider in evaluating the
structure, support, and reporting chain for the IRB and IACUC. Does the
role of the sponsored research office in which external funding is
typically an assessment measure and a basis for the institution's
budgeting decisions for the department create a conflict in objectivity?
Does the role of the sponsored research office in supporting/ensuring
programmatic performance meets the expectations of the sponsor create a
conflict? These are not simple questions and neither are answers, which
are impacted by institutional resources, scope of the institution's
research protocols, and the organization's reporting structure.
At the University of Kentucky the Office of Research Integrity, which
administers the institution's IRBs and IACUCs, reports directly to the
Vice President for Research. The sponsored research office has a
cooperative working relationship with the office, but does not control
the office's resources, nor are we in any way involved in the protocol
review or decisions. I like the UK model, but part of this is based on
the quality of the UK's leadership in the Office Research Integrity -
Ada Sue Selewitz. Conversely, having observed other organizational
structures where there was not an adequate linkage between the sponsored
research office and protocol review, where protocol review seemed less
than adequate, I could probably equally argue that the office should be
involved. The answer is institution specific , but the potential for
conflict must be evaluated in the decision.
Kris
__________________________________________
Kris E. Rhodes, MS CRA
Associate Director
Office of Sponsored Projects Administration
University of Kentucky
213 Kinkead Hall
Lexington, KY 40506
Phone: 859-257-4826; Fax 859-323-1060
-----Original Message-----
From: Schoen, Alexander [mailto:xxxxxx@WINTHROP.ORG]
Sent: Wednesday, November 12, 2003 9:25 AM
To: xxxxxx@HRINET.ORG
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?
Is a representative of the Sponsored Programs/Grants a member of the
IRB?
Does a representative of the Sponsored Programs/Grants sit in on the
meetings for informational purposes?
Does your Sponsored Programs/Grants office have no involvement with the
IRB?
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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