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Re: Relationship between IRB and Institutional Research Lawrence Waxler 02 Mar 2004 09:12 EST


Sounds like you have lot of politics and opinion wrapped up in the mix
of things.

First of all, your institution should not be using source of funding as
a criteria for review. There are many projects that are probably taking
place that are funded with internal funds, non-federal funds, and are
occurring within your classrooms, that meet the test for review. If you
are ignoring these, you are making an institutional statement about the
protection that you are providing to subjects in those studies.

Also note that it is the IRB that determines exemptions, not your
Associate VPAA. And, it is only the IRB, not faculty or departments,
that can grant exemptions based upon the specific project. I would
suggest that you have an annual review of the kind of projects that your
IR office is undertaking and give them a clear set of guidelines as to
what does not need to be reviewed. Any project that strays from those
guidelines needs to be reviewed. It may be that the IRB finds the study
exempt or eligible for expedited review, but it is only the IRB that can
make that determination.

Lastly, a blanket exemption, without some regular review, is an
invitation for disaster.

Larry Waxler, Director
Office of Sponsored Programs
University of Southern Maine
P.O. Box 9300
Portland, ME  04104-9300
Telephone: 207-780-4413
Telefax: 207-780-4927

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