Re: IRB Question Kristy Ford 26 Jan 2009 17:23 EST
Unfortunately, I do not have a specific regulation to site, but you are correct. The informed consent should absolutely be on the letterhead of the institution conducting the study, which is the college in your case. It is your institution's project and your funding for completion of the project. The hospital is simply a recruitment site. Kristy Kristy Ford Grant Management Manager Financial Reporting Administration Memorial University Medical Center Savannah, GA 31404 (912)350-6379 >>> "Chowfin, Sunita" <xxxxxx@ACPHS.EDU> 1/26/2009 4:46 PM >>> Hi all, I have such as basic question, but I can't find any rules or regulations to clarify how the following should be handled: We have a researcher who will be recruiting subjects, under a sponsored study, at a local hospital. All other work and analyses will occur on-site here. The local hospital approved the protocol first, and has approved the informed consent on their letterhead. On review here, I raised the question as to whether the text of the informed consent should be transferred to our document for our stamp; i.e., cut and paste the language from the other institution's consent into our form. My concerns were that the study is being conducted under the auspices of the College, so I didn't want it to be suggested to subjects that the local hospital was responsible for the study or that our researcher was an employee there. Most here believe that the consent is OK using other institution's form. Which is OK? If I'm (hopefully) correct, are there any guidelines or CFRs you can cite, so I have documentation to substantiate my request? Thanks. Sunita M. Chowfin Grants Administrator & IRB Coordinator Office of Grants Administration Albany College of Pharmacy and Health Sciences O'Brien Building, Room 115 106 New Scotland Avenue Albany, NY 12208 (518) 694-7144 . Office (518) 694-7058 . Fax ***New Email Address:*** xxxxxx@acphs.edu<mailto:xxxxxx@acphs.edu> ====================================================================== 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") ======================================================================