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Re: IRB question Robert Bienkowski 08 Mar 2007 14:27 EST

The federal regulations do not require that minutes of IRB meetings be made publicly available. Many institutions label the minutes "confidential" and restrict their distribution to those with a need to know (eg, the institutional official). (If the institution is state-supported, then minutes might be available to anyone either as a matter of course or by invoking a state freedom of information law. Even in these circumstances, however, there are usually provisions for redacting the documents.)

I have not heard of an IRB declining to know the name of the PI out of concern about bias. One of the many factors an IRB must weigh when evaluating a protocol is the ability of the investigator and the investigator's team to carry out the work and to respect the rights of research participants. Indeed, some IRBs require the investigator to present the protocol at the meeting and answer questions about it. Many IRBs have adopted an SOP that requires any member with a conflict of interest (which might include being biased for or against the proposal or the investigator) to recuse him/herself from participating in deliberations about the proposal.

Bob Bienkowski

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

 -------------- Original message ----------------------
From: "Brown, Leesa" <xxxxxx@SEATTLEU.EDU>
> My IRB asked me to find out if other IRBs include the name of the PI on
> the protocol in the agenda and meeting minutes.  They are worried about
> keeping the PI's name confidential because our meeting minutes can
> include everything we think is wrong with a protocol.  I think this is
> public information but I said I would send out an e-mail.
>
> They also wonder if they should even know the name of the PI when they
> are reviewing a protocol because they want to remain unbiased.
>
> Any opinions would be appreciated.
>
> Thanks!
>
> Leesa Brown
> Sponsored Research Officer
> Seattle University
> 901 12th Ave
> Seattle, WA  98122
>
> 206-296-6161
>
> Sponsored Research Office web site:
> http://www.seattleu.edu/academics/grants
>
>
>
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