See responses below.
-----Original Message-----
From: Schoen, Alexander [mailto:xxxxxx@WINTHROP.ORG]
Sent: Wednesday, November 12, 2003 8:25 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?

The Human Protections Administrator (HPA) reports to me (director of the
preaward office), and staffs the IRB.

Is a representative of the Sponsored Programs/Grants a member of the IRB?

No.  That is, the HPA is administratively housed in the sponsored programs
office, but his responsibilities pertain only to the IRB; he's not involved
in grants or contracts administration.

Does a representative of the Sponsored Programs/Grants sit in on the
meetings for informational purposes?

No.  However, the HPA interacts with sponsored programs officers before and
after the meeting for details such as, "Which grant funds this project?"
"Does the contract for this trial say anything which contradicts the consent
form?" etc.  Since the sponsored programs officers and the HPA are
physically housed in the same space, this works nicely; also our data base
links IRB reviews and history with the source of funding, and the paper
files (we still keep them, alas) are housed in the same location.

Does your Sponsored Programs/Grants office have no involvement with the IRB?

As described above.  In summary, the Human Protections Administrator who
staffs the IRB is administratively and physically housed in the sponsored
programs office, but his responsibilities are distinct from those of
sponsored programs officers.  This arrangement gives him access to the
financial and administrative information associated with each protocol
before the IRB while (hopefully) preserving the IRB's independence from
institutional interference.

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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