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Re: IRB question Marianne Woods 15 Jan 1997 10:53 EST

I entered into a similar agreement when I was in California. You enter
into an agreement, which spells out liability, etc. The non-profit is
subject to all of your rules and regs. Therefore, yearly monitoring of
the protocol is needed, procedures for storage of confidential records is
needed, etc. Since most non-profits have never done this before and can
be somewhat lax about implementing regulations you have to be very
specific about what their responsiblities will be, etc. This is more of a
headache than you can imagine. Good luck.

On Tue, 14 Jan 1997, Research Administration Discussion Group wrote:

> The Univ. of Maine's Protection of Human Subjects
> Board was contacted by a non-profit organization
> in the State of Maine with a request for assistance.
> This non-profit organization recently received a
> grant from the CDC, but the grant evidently has a
> research component involving the use of human
> subjects.  At this point, the only information I
> know is that the topic is "partner violence," and
> includes the use of focus groups and questionnaires.
>
> This organization does not have an IRB, and OPRR
> suggested that they link up with a local university
> to get a review and approval by a human subject's
> board.
>
> I called OPRR and asked what the University's
> responsibilities/limitations were when conducting
> a review for someone outside the University.  I
> was told we would assume the same responsibilities
> and liabilities as if the project were being
> conducted by a member of our university.
>
> Does anyone have any advice?  Has anyone undertaken
> such a review?  If so, did you enter into a formal
> agreement about issues of responsibility and liability?
> What monitoring of the project did you do?
>
> Thanks for any help; I'd love to talk with anyone with
> experience in this area.
>
> Gayle Anderson
> Assistant to the IRB
> University of Maine
> (xxxxxx@maine.maine.edu)
> 207/581-1498
>

------------------------------------------------------------------------
Dr. Marianne Rinaldo Woods
Director
Office of Sponsored Projects
University of Texas at Dallas
Phone: 972-883-2313
Fax: 972-883-2310
E-mail: xxxxxx@utdallas.edu
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