Bob's comments are right on target - there should never be a 'double-
standard' where human subjects research is concerned!

I would add that the approach should be one of 'corrective actions' rather
than punishment - it puts the focus on taking measures so that the non-
compliance does not re-occur at your institution.  Of course, there can be a
very wide range of non-compliance, some of which may not involve any harm
to participants, so the corrective actions can run the gamut.  Usually it would
involve both specific and systemic corrections; ie, additional education to the
researcher(s) involved, improved IRB policies, sometimes notification to the
participants, etc.  Also, above a certain threshold, there is a reporting
requirement to OHRP, FDA, funding agencies, etc as applicable.

I would look at the policies of those institutions that have been accredited by
AAHRPP, as Bob mentioned.  That is an excellent source of good policies for
addressing non-compliance!

Teri Grosz, MS, CIP
IRB Director/Research Compliance & Training Officer
North Dakota State University

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