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Re: compliance position James R. Brett 31 Jul 2002 11:20 EST

I think Ann Womack has nailed it.  Separation of IRB/IACUC from SRO is very
much dependent on the level of effort at the institution.  Clearly, the
person who is interested to do the job of supporting the bids for external
funding with blinders to the involvement of human or animal subjects is
inherently compromised vis-a-vis the rigorous examination of research
protocols.  While this may not manifest itself as deliberate promotion in
disregard of protection issues, it may easily happen that issues are
overlooked or that the pressure of time may become a factor weighing in
favor of SRO activities and against IRB/IACUC activities.  But, I think
this is probably germane to the research intensive and research extensive
domains and highly dependent on the number and magnitude of potential
conflicts of commitment.

For institutions like mine (and Ann's) where the vast majority of human and
animal subjects research is funded from within the institution, where very
few funded projects are encountered in IRB/IACUC, the necessity for
isolation of the IRB/IACUC functions from the SRO diminishes rapidly.  The
loss of coordination and authority is usually greater than the loss of real
or apparent independence of judgment.

Moreover, the SRO is not in most institutions just a hustler of grants and
contracts.  The personnel in these offices have many functions which put
them into the position of reading, interpreting, and applying a formidable
array of regulations and guidelines.  These "regulatory" functions are,
perhaps, not of the same "gravity" as issues encountered by IRB/IACUC, but
they are serious issues with the potential for making or breaking careers
and institutional reputations.

I would suggest, therefore, that SRO personnel be given presumptive credit
for integrity across the range of these duties.  In fact, the most
egregious cases exposed to date, the negative and distorting influences
have emanated not from individuals within SRO or within IRB/IACUC, but from
others who have much stronger influence on the institutional ethos.

Jim

Anne Womack wrote:

> Larry Wexler makes an excellent point in saying the position
> should have some distance between it and the SRO (although it's
> not always possible---it isn't here, for instance).
>         For instance I was very surprised a few years ago to learn that
> most of the animal- and human-subject research projects
> performed on our campus are never connected to proposals to
> funding agencies at all.  I learned that our office only sees a
> fraction of that activity by way of proposals.
>
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--
James R. Brett, Ph.D., Director,
Office of University Research
California State University, Long Beach
562-985-5314  562-985-8665 fax
http://www.csulb.edu/~research/

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