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Re: human subjects question Sarah Archibald 27 Apr 2007 14:57 EST

Although this does appear to be a program evaluation, nurses are still
being interviewed. This protocol will probably be exempt under CFR Part 46
Section 46.101(b)(2). However, since humans essentially are involved, the
IRB should review and make a determination of the protocol. Better to err
on the side of caution.

Sincerely,
Sarah N. Archibald
Compliance Administrator
University of Maryland College Park

> I have a PI that will be receiving federal funding (if an award is made).
> She plans to interview nurses about a pilot nurse training program that is
> being used in several medical settings. She wants to find out from the
> nurses who have participated in the training program what factors they
> think
> might facilitate or hinder the broader dissemination of the training
> program
> to other sites. A larger implementation study will follow.
>
>
>
> We have conflicting views of this project from an IRB perspective. Some
> think that it should be reviewed by the IRB because nurses are being
> interviewed, others think that since it is just "program evaluation" it
> does
> not need to be reviewed by the IRB.
>
>
>
> Anyone with some guidance to share?
>
> Pamela F. Miller, Ph.D.
> Director, Office of Sponsored Projects
> The University of San Francisco
> 2130 Fulton Street
> San Francisco, CA 94117-1080
> TEL  415-422-5368
> FAX 415-422-6222
> EMAIL xxxxxx@usfca.edu
>
>
>
>
>
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