Re: IRB -- consent forms Eric C Lewandowski 22 Mar 2000 15:04 EST
Mary-- We require external funding to be reported on our protocol form, but not on any consent form. At the moment, I can't envision why potential subjects would need to know -- as a function of their involvement -- on a research project that (A) the project is externally sponsored, or (B) the source of the sponsorship. I suppose that federal sponsorship confers something of an "added protection" to subjects by virtue of the direct potential for agency/program audit. Still, it seems to me that the most salient protection afforded subjects is the professionalism of the investigators and the conscientious oversight of the institution as represented by the HS review process. At any rate, I couldn't find anything in 45 CFR 46.116 or .117 that specifically addresses your question. You may want to talk with someone (Jeff Cohen?) at OPRR. --Eric Eric C. Lewandowski, CRA Director, Grants & Sponsored Programs (and IRB administrative co-chair) Youngstown State University One University Plaza Youngstown, Ohio 44555-2377 On Tue, 21 Mar 2000, Mary T. Spina, CRA wrote: > A question to those of you involved in your institution's IRB committee: > > If a project is supported by external funding, does your IRB > require/request that the consent form include a statement indicating this, > informing the research participant of the funding agency? If so, why? If > not, why not? Our IRB is discussing the pros and cons. > > Thanks for your help on this. > - Mary Spina > ************************************************************* > Mary T. Spina, CRA > Director, Sponsored Research > Illinois Institute of Technology > 3300 South Federal Street, MB/301 > Chicago, IL 60616-3793 > Phone: 312.567.3035 > Fax: 312.567.6980 > email: xxxxxx@iit.edu > http://www.iit.edu/colleges/grad/sresearc.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") ======================================================================