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IACUC Dilemma/Grad Students Working in Other Agencies Barbara Gray 17 Dec 2003 14:48 EST

Colleagues,
I posted the following query on the AALAS IACUC listserv but only got
one response. Perhaps some of you have dealt with the same issue and can
provide some insight. Any help will be appreciated!
Thanks.
Barbara

************
Our IACUC has been struggling with an issue about graduate student
research with animals at other governmental agencies that we haven't
been able to solve to everyone's to everyone's satisfaction, so I'm
looking for guidance.

BACKGROUND: The College of Charleston has a marine research laboratory
at a multi-agency research complex that also houses several federal and
state agencies. Many of our graduate students work at these other
agencies and are involved in ongoing vertebrate animal research there
(fish and turtles primarily) during the early stages of their academic
programs. None of the other governmental agencies has an IACUC or a
formalized in-house protocol review program. However, scientists at
those agencies do utilize certain standard research protocols and have
obtained the required permits to collect animals for research purposes.

As students progress through their academic programs, their routine work
at these agencies often leads to the formulation of a thesis project
which will be carried out at the agency as a subproject of the agency's
larger research program. When we established our IACUC, we determined
that all animal protocols, regardless of funding source, should be
reviewed and approved in accordance with PHS guidelines and AWA. Our
policy further states that all animal work done by our students must be
approved by either our IACUC or another institution's IACUC.

Since these other governmental agencies do not have IACUCs, our students
working with animals there must submit their research protocols to our
IACUC for approval before beginning their thesis research. However, we
do not allow students to serve as PIs on animal protocols; the agency
research scientist under whom the student works must be the PI of
record. Most of these agency researchers have non-paid adjunct faculty
appointments at the College. However, short of never again assigning a
student to him/her (thus cutting off access to a qualified but
inexpensive labor pool), the College has no real control over the agency
researcher and cannot implement sanctions for noncompliance or animal
mistreatment. In the event that the animals would be housed at those
agencies, the College IACUC also has no jurisdiction over their facilities.

Our IACUC will not approve a protocol retroactively since it is
impossible to ensure appropriate care and use after the animal activity
has already occurred. Many of the students working at other agencies
have already collected some data that will be used in their theses
before they formalize the thesis research proposal and prepare an
application for IACUC approval. So the IACUC is asked to approve a
protocol for an animal activity that has already begun but has not yet
been completed.

Some graduate faculty members suggest that, at the moment he/she
determines the thesis topic, the student should stop all work with the
animals until IACUC approval is obtained. In reality, this may not be
very practical. For instance, if sampling is to occur at certain
intervals and the student's assistance as a paid worker of the agency is
required when it is time to sample, it would be impractical--and perhaps
detrimental to the research--to tell the student that he/she cannot now
assist in the collection because the thesis protocol has not yet
received CofC IACUC approval.

It seems we have created a real dilemma for ourselves. So we are now
questioning whether indeed graduate students doing animal research under
the jurisdiction of another entity (that does not have an IACUC) should
be required to submit their protocols for thesis research to our IACUC
for review and approval. Faculty members in the graduate programs are in
favor of the students preparing protocol applications and going through
the CofC IACUC process for the educational benefit. But some IACUC
members question why they should be reviewing the studen's' research at
all when it is being done in another agency as part of a larger research
project over which they have no jurisdiction. Educational benefit for
the student may be a positive thing, but is that the primary role of the
College's IACUC and should the IACUC be trying to take responsibility
when it has no authority to ensure compliance?

We are toying with the idea of developing Memoranda of Understanding
with the various government agencies that will address such issues as
liability, health and safety of the students, humane animal issues,
ability to publish non-IACUC approved studies, ability of our IACUC to
enforce regulations at a site over which they have no authority (if
any), procedures for handling problems that may arise, etc.—and so are
looking for model MOUs, if any exist, that would be applicable to our
situation. Any other thoughts about how we're dealing with our graduate
students would be most appreciated!

Thanks.
Barbara

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Barbara H. Gray, Director
Office of Research & Grants Administration
College of Charleston
66 George Street
Charleston, SC  29424
Campus Location:  407-G Bell Bldg.
Office: 843.953.5673  Desk: 843.953.5885  Fax:  843.953.6577
e-mail:  xxxxxx@cofc.edu   URL: http://www.orga.cofc.edu/
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