Bruce Steinert, PhD, CCRA
Administrative Director, Clinical Trials Center
ENH Research Institute
Evanston Northwestern Healthcare

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On
Behalf Of Robert Bienkowski
Sent: Tuesday, October 18, 2005 11:28 AM
To: xxxxxx@HRINET.ORG
Subject: Re: [RESADM-L] Department-Level IRBs

I agree with John Baumann and Nancy Peterson that this is a bad idea.
(In addition, there is the matter of what to do about the boxes that are
checked on your institution's FWA.)

However, there is one special set of circumstances in which this can
work and that is for protocols that are deemed (by whoever is empowered
by your SOPs to do it) exempt from IRB review. There really is no such
thing as "exempt research:" The regs only say that some types of
research are exempt from complying with 45CFR46. But this does not mean
that the institution has no responsibility to oversee the research or
protect research subjects who might be enrolled in these studies. Under
these circumstances, it would be very appropriate to specify that the
work should be carried out according to the APA Standards.

Regards
Bob Bienkowski

--
Robert S Bienkowski, PhD
xxxxxx@att.net

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