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Re: IRB Approval Ruth Tallman 16 May 2005 09:53 EST

I agree with Jon.  If the work of "B" is not dependent on the progress
of the work by "A", "B" should be able to keep working.  However, if the
problems with "A" threaten the continuation of the grant, it may be wise
to look at the bigger picture.

Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA  18015
Phone:   (610)758-3024
FAX:       (610)758-5994
E-mail:   xxxxxx@lehigh.edu

Jon Hart wrote:

>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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