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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