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Re: Department-Level IRBs Barbara Gray 18 Oct 2005 13:56 EST

At my previous institution, we allowed investigators to incorporate
their own disciplinary ethical codes within their IRB protocols.  The
biggest conflict we saw with IRB and APA is written informed consent.
APA advocates written informed consent for all research.  Particularly
in cases of research exempt from 45CFR46, like anonymous surveys, our
IRB preferred that there not be a written consent as it introduced a
potential for compromising the anonymity of the respondents.  In cases,
our correspondence to the investigator recommended that written informed
consent not be used but the investigator could opt to do so to meet APA
guidelines.  I think our IRB would have only ever opposed the APA
guidelines if completion of a consent form in and of itself would place
the respondent at risk.  (An example of this might be an "anonymous"
survey of patients in a community AIDS clinic where the mere signing of
one's name to a consent form identifies the participant as having
AIDS.)  Your Psych department may wish to do a pre-review of human
subject protocols (which, if done correctly, could ultimately save your
IRB and staff the extra work of returning incomplete or poor quality
applications), but, for all the reasons indicated already, I would be
very hesitant to set up a second "departmental" IRB.
Barbara Gray
Desert Research Institute
Reno, NV

Robert Bienkowski wrote:

>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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