Re: IRB Membership Barbara L. Pifel 20 Nov 2003 12:54 EST
At Weill Medical College of Cornell University our process tracts VCU. There is no representation of any sort by Sponsored Programs (Grants and Contracts) on our IRB for the same reason(s) that Herb very eloquently described below. Our IRB, IACUC and Conflict of Interest function is headed up by Jeff Cohen, Associate Dean for the Responsible Conduct of Research, who was formally with OHRP. Our intellectual property activity is process through the Cornell Research Foundation because of COI considerations. That activity is headed up by Brian Kelly Vice President for Technology Transfer here at the Cornell Medical Campus. Jeff, Brian and I are a cohesive team that interacts very well. Here, it works extremely well because of the collective wealth of experience and knowledge of the team. It's wonderful when you can bounce things off one another as various issues come up that cut across the three areas. Barb At 08:43 AM 11/20/2003 -0500, Herbert B. Chermside wrote: >At VCU there is no representation of any sort by Sponsored Programs on any >of our several IRB's. This is in part because of OHRP's concerns that an >OSPA may be charged with increasing research activity and therefore have a >COI, a desire to encourage support of a protocol for the reason of >obtaining that additional research support. (It is my personal opinion >that there is not such a COI, because an OSPA is charged with >administrative, not advocacy, functions; nevertheless there may be an >appearance of COI to super-cautious outsiders who co not have an >understanding of an OSPA role in an institution.) Both OSPA and Office of >Research Subjects Protection report to the Vice President for >Research. The offices work together to ensure that there is a clear record >cross-connecting IRB protocol records and Sponsored Program proposal/award >records. Occasionally OSPA answers a technical question regarding a >proposal/award. This cross-connection allows OSPA to communicate to the >sponsor certifying or reporting IRB actions, for purposes of "one stop >shopping"; OSPA certifies IRB review and approval, and communicates with >the sponsor when IRB takes and action requiring notification of sponsor, >e.g., a suspension of a previously approved protocol. > >Chuck > > >At 05:06 PM 11/19/2003, you wrote: >>-----Original Message----- >>From: "Schoen, Alexander" <xxxxxx@WINTHROP.ORG> >>To: xxxxxx@HRINET.ORG >>Date: Wed, 12 Nov 2003 09:24:38 -0500 >>Subject: [RESADM-L] IRB Membership >> >>Good Morning, >> >>I am interested in knowing how many Sponsored Programs / Grants personnel >>are involved in their institutions' Institutional Review Board. >> >>Does your Sponsored Programs/Grants office administratively run the IRB? >>OUR SPONSORED PROGRAMS OFFICE IS EX-OFFICO ON THE IRB >> >>Is a representative of the Sponsored Programs/Grants a member of the IRB? >>IN A NON-VOTING ROLE >> >>Does a representative of the Sponsored Programs/Grants sit in on the >>meetings for informational purposes? YES >> >>Does your Sponsored Programs/Grants office have no involvement with the >>IRB? ONLY AS INDICATED ABOVE >> >>In our institution, I am not a member of the IRB, but attend meetings and >>provide information on related clinical trial agreements as needed. >> >>I look forward to your responses. >> >>Thank you, >> >>Alex >>----------------------------------------- >>Alexander Schoen >>Director, Office of Sponsored Programs >>Winthrop-University Hospital >>222 Station Plaza North, Suite 510 >>Mineola, NY 11501 >>Phone: (516) 663-8997 >>Fax: (516) 663-9718 >>xxxxxx@winthrop.org >> >> >>CONFIDENTIALITY NOTICE: >>This transmission is intended only for the individual or entity to which >>it is addressed and contains information that is confidential. If you >>have received this communication in error, please notify the sender at the >>email address above and delete this email immediately. This information >>has been disclosed to you from confidential records and is protected by >>federal and state law. This information may include confidential mental >>health, substance abuse, alcohol abuse and/or HIV related >>information. Federal and state law prohibits you from making any further >>disclosure of this information without the specific written consent of the >>person to whom it pertains, or as otherwise permitted by law. Any >>unauthorized further disclosure in violation of the law may results in a >>fine or jail sentence or both. A general authorization for the release of >>this information may not be sufficient authorization for further disclosure. >> >> >>====================================================================== >> 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") >====================================================================== ====================================================================== 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") ======================================================================