Here is how I see this case:

It is not simply a matter of who has or has not done something wrong.
It is also a matter of who has the responsibility to document that
appropriate protections are in place.

As Organizational A is the grantee, it is up to Organizational A to
submit a valid IRB approval to the funding source.  Org B must submit
one to Org A but not the funding source.  Org A's approval should cover
not only Org A's activities but should also be positive assurance that
Org A is ensuring that Org B has the appropriate protections in place as
well. This is because Org A as the grantee has the responsibility to
ensure protections of human subjects throughout all aspects of the
conduct of a project, including its subcontractors/collaborators.  As
the funding source requires documentation from the grantee, i.e. Org A,
if Org A's approval is suspended, it seems to me that the funding source
may consider that human subjects involvement in the grant as a whole
must be suspended. If I were a part of either Org A or B I would be on
the phone with grants management and OHRP immediately.

John

John R. Baumann, Ph.D.
Associate Vice Chancellor for Research
Director, Office of Research Services
5100 Rockhill Road  (US Postal Service)
5211 Rockhill Road (Courier Service)
Kansas City, MO 64110
xxxxxx@umkc.edu
816.235.1303 (v)
816.235.6532 (f)

-----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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