Sunita

Your "basic" question raises several important issues.

It is not clear from your posting whether the hospital has an IRB. If it does, then there is an question of which IRB has oversight responsibility for the protocol. If the hospital IRB approved the protocol, then it was assuming some responsibility for it.

So, it is not so much a question of letterhead as it is of informing prospective research participants about who is responsible for the study. Most IRBs require that the informed consent document include the name and phone number of a contact person, such as the IRB chair, to whom a research subject can make a complaint or voice a concern about a study.

Also, the fact that the hospital approved the consent document with the hospital's name on it suggests that someone there MAY have made a determination that the hospital is "engaged in research".

How were patients at the hospital identified as potential subjects? Did a doctor at the hospital make names available (HIPAA alert!) or were people approached while they were waiting to be seen in a clinic?

The hospital and its IRB (if it has one) should be consulted about changing the letterhead because the cut and paste version of the ICD would not be the version that was approved.

Bob Bienkowski

--
Robert S Bienkowski, PhD
xxxxxx@guthrie.org

-------------- Original message ----------------------
From: "Chowfin, Sunita" <xxxxxx@ACPHS.EDU>
>
> 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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