Hi

1.  My comment was not about IRBs in general but about the guidelines
for science fairs to which I was responding.  It is clear in the quote I
included from those guidelines that all human research needs vetting and
approval.

2. With respect to IRBs more generally, if the IRB (or some designated
individual in the IRB) makes the exempt determination, then in fact all
human research needs vetting by the IRB.

Take care
Jim

James M. Clark
Professor of Psychology
204-786-9757
204-774-4134 Fax
[EMAIL PROTECTED]

>>> [EMAIL PROTECTED] 04-Dec-06 6:08:40 AM >>>
Jim Clark wrote:

But for the IRB, _all_ projects involving human participants must be
reviewed, no matter how inocuous.

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Not necessarily.

This point has been clarified in the IRB listserv. Obviously, exempt
research does not need IRB oversight. But, the question is: Who
decides
whether a project is exempt or not?

Most institutions' policies and procedures regarding human subjects
research
identify the IRB as the entity that should make this type of
determination.
Thus, typically, the head of the IRB or a member assigned to carry out
expedited reviews examines the exempt protocol, confirms its status,
and
gives the green light (assuming that it is, in fact, exempt). However,
that
procedure is not mandated by federal policy. For institutions that do
not
have an IRB or a policy regarding such situations, then an investigator
(or
his/her supervisor; I guess it would be the teacher in the case of
high
schools) can make that determination.

I think that, given our current climate, it is in the best interests
for
investigators to have the IRB make an exempt determination.

Miguel






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