We have dealt with both issues at Rutgers. To answer your first question, we
did require that the subgrantees submit all their IRB approvals and training
certs before we would execute the sub and cut a PO. In discussion with
other administrators prior to implementing this "rule", and also as a
subgrantee utilizing human subjects, it not a policy I've seen followed
elsewhere. We did find that it delayed project start-ups and have recently
decided that the clause in the sub itself and the execution of the sub by
the subgrantee clearly denotes their responsiblity for compliance with the
CFRs. Our compliance unit is still responsible for collecting the
documents, but we don't hold up the sub and PO waiting for them to arrive.
On the second issue, unfortunately the answer is yes we've seen delays.
There have been occassions where our PI and perhaps the subgrantee didn't
know they were supposed to obtain IRB approvals or that funding was
impending. Part of that solution is currently in development. We're
working on a brief "neon flag" that we can attach to the proposal when it
goes back to the PI that will remind them that they need IRB approval for
themselves and their subs prior to the award being made. That way they
can't say they didn't know about it, which seems to be the typical PI
response.
Here's the question. Our compliance unit has informed us that they must
have a full grant proposal to match with each protocol submission. Now that
just in time is in place, at what point do you collect the grant proposal to
match up with the protocol? At the time of grant submission or at the time
that the protocol is submitted to the IRB/IACUC?
Thanks in advance for the answers.
Maryellen O'Brien
Assistant Director
Grant and Contract Administration
Office of Research and Sponsored Programs
Rutgers University
Cook College
88 Lipman Drive, Room 125
New Brunswick, NJ 08901
Ph: 732-932-1000, Ext. 567
Fax: 732-932-8135
Email: xxxxxx@orsp.rutgers.edu
Web: http://orsp.rutgers.edu
-----Original Message-----
From: Dolce, Peter J [mailto:xxxxxx@MMC.EDU]
Sent: Friday, August 08, 2003 12:31 PM
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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