The timing of proposal review by IRB is generally a problem. There are differing attitudes toward what the review is all about at differing institutions. Our institution encourages IRB submission on, say, an NIH proposal needing IRB approval (with a medical school we are big on NIH), at the latest as soon as the PI gets a positive "pink sheet". Earlier if the PI has reason to think IRB review can be controversial. And the proposal goes in with the FIRST IRB review on the project. There is no way we can wait any longer than "pink sheet" time and have the IRB review done in time for the JIT request. Thus the IRB has met the letter of the law and looked at the proposal. It is my personal opinion that the look the proposal is given does not meet the goals that should be met for proposal review. As our proposal review is made only with the first IRB review on a project, we do not necessarily deal with the situation where there are multiple IRB reviews and each alone stands scrutiny, but viewed collectively they would not be approved, and the proposal does not necessarily lead the IRB to look collectively. The completely facetious example is four protocols, each finding that removal of a limb is ethical, and no one sees that each of the four protocols is applied to the same subject, resulting in a quadraplegic. Chuck At 12:47 PM 8/8/2003 -0400, you wrote: >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. If >you are not an intended recipient of this e-mail, you are hereby notified >that any unauthorized use, dissemination or copying of this e-mail or the >information contained in it or attached to it is strictly prohibited. If >you have received this e-mail in error, please delete it and immediately >notify the person named above by reply e-mail. Thank you. > > >====================================================================== > Instructions on how to use the RESADM-L Mailing List, including > subscription information and a web-searchable archive, are available > via our web site at http://www.hrinet.org (click on "Listserv Lists") >====================================================================== > > >====================================================================== > Instructions on how to use the RESADM-L Mailing List, including > subscription information and a web-searchable archive, are available > via our web site at http://www.hrinet.org (click on "Listserv Lists") >====================================================================== Herbert B. Chermside, CRA Director, Sponsored Programs Administration Virginia Commonwealth University PO BOX 980568 Richmond, VA 23298-0568 Express Delivery Only: Biotech One, Suite 113 Virginia Biotechnology Research Park 800 East Leigh Street Richmond, VA 23219 Voice: 804-828-6772 Fax 804-828-2521 OFFICE e-mail xxxxxx@VCU.EDU Personal e-mail xxxxxx@vcu.edu http://www.research.vcu.edu/ospa.htm ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
