Thanks Maryellen. In response to your question--give the proposal to the compliance office simultaneously with the protocol so that there's less chance the proposal will be lost by the time the protocol comes in. But isn't the compliance office keeping duplicate records of the IRB and IACUC--i.e., don't the IACUC and IRB match protocol with proposal? (Not that duplicate record-keeping is unusual) -----Original Message----- From: O'Brien, Maryellen [mailto:xxxxxx@ORSP.RUTGERS.EDU] Sent: Friday, August 08, 2003 11:47 AM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Regulatory review and subcontracts and another que stion to add to the discussion 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 This e-mail and any files transmitted with it may contain information that is PRIVILEGED, CONFIDENTIAL, and exempt from disclosure under applicable law. It is intended only for the individual(s) or entity named above. 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