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Re: IRB Issue Herbert B. Chermside 03 Mar 2004 08:57 EST

The University has legal, regulatory and public policy reasons for ensuring
that all research is ethical and is carried out to a high professional
standard.  The IRB should be concerned with matters impinging on human
research subjects.  Some of these issues may be recognized by IRB and
referred elsewhere for primary resolution, with IRB retaining further
responsibility only asd to the impact on human research subjects.

An example is Conflict of Interests.  Typically an institution has a
process for evaluating COI.  Regulation requires some process where NIH and
NSF research funds are involved, but good institutional management should
extend it more broadly.  A COI may be recognized first by an IRB, because
they get the first information on it.  The resolution should probably be by
another process, which is initiated by IRB or any other body recognizing
it. But IRB still has responsibility for oversight of implementation of
resolution so far as human research subjects are concerned.   An example is
IRB finding a COI and referring it to COI process; COI process determining
requisite and appropriate management, such as clear disclosure to all
parties; IRB then ensuring that there is disclosure in consent forms; other
disclosures (in publications, etc.) should be ensured by processes under
the general COI process.

Legal and ethical in relation to copyright laws should not be an IRB
responsibility if there is no risk to subjects  However, IRB, as well as
all other institutional groups and individuals, should be alert to all
risks they detect and refer the matter to the responsible party.  IRB is
not trained and skilled, for example, in the compliance with copyright
laws, but some members may have the knowledge to recognize a matter that
needs review.


At 05:05 PM 3/2/2004, you wrote:
>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
>Instructions on how to use the RESADM-L Mailing List, including
>subscription information and a web-searchable archive, are available
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Herbert B. Chermside, CRA
Virginia Commonwealth University
PO BOX 980568
Richmond, VA  23298-0568
Voice:  804-827-6036
Fax     804-828-2051

 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at (click on "Listserv Lists")