Re: IRB Approval Jon Hart 13 May 2005 15:30 EST

As Organization B has done nothing wrong, I see no reason that it should be
put on hold for Organization A's problems, if B's project can continue
without A's.

Jon Elizabeth Hart, MPA, CIP
Senior Director, Sponsored Programs Administration
Senior Director, Human Subjects Protections Program
The Rockefeller University
1230 York Ave., NY, NY 10021-6399
tel:  (212) 327-8054; fax:  (212) 327-8400
email:  xxxxxx@rockefeller.edu

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of
Jessica T. Kleinberg
Sent: Friday, May 13, 2005 2:19 PM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] IRB Approval

Scenario:
Organization "A"  receives federal funding for a project requiring IRB
approval.   There is second organization "B" that is a named as a
collaborator in the grant, doing the same project.  Organization A  flows
down the federal funding to B with a subcontract.    The project is
ongoing.  At the beginning of the project both A and B had approval of the
project by the IRB for their own particular organizations.

Sometime into the project Organization A's work is suspended by their own
IRB.   After the IRB hearing, the suspension remains in effect until a full
audit of the study and research files has been performed.   A check finds
that Organization B's project approval by their own IRB remains valid.

Question:
Should the entire federal grant be placed on hold, no expenditures until
the suspension is lifted, including the subcontract with Organization B?
Or, is it ok to continue funding the collaborator out of the federal grant?
(in reality Org B has done nothing wrong).

Any insight would be appreciated!

Jessica Kleinberg, CRA
Asst. Director, Sponsored Programs
Health Research, Inc.
One University Place
Rensselaer, NY 12144
(518) 431-1265
(518) 431-1234 (Fax)
xxxxxx@health.state.ny.us
www.hrinet.org

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