Re: irb at pui question Kim Moreland 30 Mar 2000 11:49 EST

Peggy,

This is the response from our IRB Coordinator at the University of Kansas:

The use of data from incarcerated subjects would make this a full board decision, and the board should consider under what circumstances the data were gathered, including seeing a copy of the survey, consent form, and other pertinent data.  If the incarceration facility has an IRB it would be good, if possible, to see what the IRB's comments on the survey were.  The question didn't indicate what was asked in the survey, other than to state it was a satisfaction survey, so it would be essential to look over the survey too.  If the incarceration facility doesn't have its own IRB, then the student's IRB is required by OHRP regs to incorporate prisoner input (or input from someone who would be a spokesperson for prisoners) when reviewing such research.

That's my short answer.

Just as a sidelight, although there are specific sections dealing with added protections relating to research dealing with prisoners, children, and pregnant women, no such added protections, other than a few sentences in the regs, have yet been developed with research involving people for whom ability to give informed consent may be limited due to limitations in their mental capacity.  I have always found that to be a little odd.

David Hann

Kim Moreland, Director
Contract Negotiations and Research Compliance
The University of Kansas
Center for Research, Inc.
2385 Irving Hill Road
Lawrence, KS  66044-7552
Phone:  785/864-7431
Fax:  785/864-5049

>>> xxxxxx@USI.EDU 03/29/00 04:56PM >>>
I need help on a quick IRB question.  Student research at a state
incarceration facility, using existing data: the facility conducted a
satisfaction survey in the past.  My student wants IRB permission to analyze
the data, but the faculty sponsor is concerned about
student/faculty/University liability if any of the prisoners later claim
they were coerced to complete the survey.  The guidelines concerning
prisoners seem pretty clear that this does not qualify for exempt status.  I
guess we need to get informed consent, even though it's existing data.  Does
anyone out there in RESADM-L land have any wisdom on this for my concerned
faculty sponsor?

As usual, much appreciate the shared experience.
Peggy

Peggy F. Harrel, Ph.D.
Director, Graduate Studies and Sponsored Research
University of Southern Indiana
xxxxxx@usi.edu
812-465-7016
http://www.usi.edu/gradstud/gradstud.htm
http://www.usi.edu/gr&res/ogsr.htm

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