(1)  We require copies of approval letters from IRB/IACUC and some sort
of documentation regarding training.  This usually takes the form of a
letter from the grants office or copies of the on-line certificates.

(2)  No solutions here.  Our experience is the grants office is usually
the last to know if something will be funded at the prime, but the
investigator usually gets some word via his/her collaborator.  It is
really the investigator's responsibility to stay on top of the
situation, so that the research doesn't get delayed.

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 Dolce, Peter J
Sent: Friday, August 08, 2003 11:31 AM
To: xxxxxx@HRINET.ORG
Subject: [RESADM-L] Regulatory review and subcontracts

1. When your organization is the prime in a project that involves human
subjects or animals at a subcontractor's site, do you require the sub to
send documents showing that the sub's IRB or IACUC has approved the
project and/or certificates that sub's key personnel have completed IRB
training? Or do you settle for the clause in the contract that specifies
the sub will comply with human subjects and animal care regs?

2 . NIH now permits IRB and IACUC reviews to be done as just-in-time
procedures.  If you're the prime applicant in a project, NIH sends
you--the PI and the sponsored programs office--various communications
from which you can tell whether the project is likely to be funded, and
these can trigger the regulatory review.  If you're a subcontractor, you
don't see these. We've encountered several situations where we learn a
project will be funded only when a subcontract arrives in our office;
the regulatory review may thus delay the start of the project.  Any
solutions?

Peter J. Dolce, Ph.D.
Director, Office of Research Support Services
Meharry Medical College
1005 D. B. Todd Boulevard
Nashville, TN  37203

Phone 615 327 6703
Fax 615 327 6716

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