Re: IRB Compliance Robert Bienkowski 13 Oct 2006 10:56 EST

The regs do not distinguish between research conducted by students and research conducted by faculty or other degree-qualified persons.
It should be emphasized that student research has significant potential to cause harm to research subjects and so there really is no justification for allowing professors to tell students not to worry about the IRB.
The person who submitted your FWA to OHRP may or may not have checked a box saying whether all research at your institution would be subject to the federal regs or only government-sponsored research.
If the box is checked (ie, if the institution agrees that all its human research will be subject to federal regulations) and if OHRP discovers serious non-compliance, then they have the potential to suspend funding until the institution gets its act together. Even if funding is not suspended, the institution may still find itself the subject of investigative reports in your local media.
I should emphasize that these matters should not be seen as only something for the IRB is concerned about; the modern view is that the entire institution is responsible for the protection of human subjects.
Finally, the person who signed your FWA should be made aware of the commonly used altenative terms for institutional offical: "designated felon" and "go-to-jail-guy."

Bob Bienkowski

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

 -------------- Original message ----------------------
From: Jami Peelle <xxxxxx@KENYON.EDU>
> To expand on Dave McGinnis' Question on non-compliance:
> I would like to know what  consequences colleges are
> imposing/implementing for non-compliance in the case of non-government
> regulated "human subjects" research. For instance, a case where the
> college has broadened the range of  its IRB 's mandate to include
> student research projects and the supervising faculty member does not
> make the students go through the prescribed training or submit a
> proposal to the IRB.
>
> Thanks!
> Jami
>
> --
>
> Jami Peelle
> Faculty Grants and Fellowships Coordinator
> Edelstein House
> Kenyon College
> Gambier, Ohio 43022
>
> 740.427.5748
> Fax 740.427.5301
>
> xxxxxx@kenyon.edu
>
>
>
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