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IRB Issue Gary Talarchek 02 Mar 2004 17:05 EST

Good afternoon,
Our IRB has been discussing an issue that has two opposing views.  First
some background: Since our university is a PUI, most research protocols
that come to the IRB concern behavioral/social science research, usually
involving questionnaires, tests, or inventories (some of which are
copyrighted).  Our IRB applies the Common Rule (45CFR46) on all
projects, whether federally funded or not.
One position holds that the IRB should verify that PIs have permission
to use copyrighted items (questionnaires, tests, etc.) in research.
Since the IRB is the only university body that approves most social
science research, the IRB's approval is equivalent to university
approval to the community outside our walls.  Therefore, the IRB must
make sure that the research is legal and ethical with respect to
copyright laws.
The other view holds that the IRB's charge is only concerned with human
subjects as described in the Common Rule and other ethical or legal
issues, while real issues, are not the responsibility of the IRB.  Other
standing committees and ad hoc committees have jurisdiction over animal
care and use, conflicts of interest, and other ethical issues related to
university compliance. The fact that no other part of the university is
not checking on copyright compliance, does not necessarily make it a
responsibility of the IRB.  PIs have that responsibility, just as
faculty have other responsibilities within their classes.
Has your IRB considered this issue?  If your IRB polices copyrights,
what kind of verification do you require from PIs?  How does your
university (or the university's IRB) educate PIs (both faculty and
students) on this issue?  Is education a substitute for enforcement?
Basically, I am looking for information on practices at other
universities before presenting this to university attorneys.

--
Gary M. Talarchek, Ph.D.
Director of Grants and Research
Loyola University New Orleans
6363 St. Charles Avenue
New Orleans, LA 70118
Voice: 504-864-7244
Fax: 504-864-7270

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