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>
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