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Re: IACUC protocol expirations Pamela Tazik 16 May 2005 15:13 EST

Our IACUC sympathizes with the investigator on scheduling however, we
refer to Lab Animal  ( Vol. 32, No. 9, October 2003, pg. 35) article,
"Frequently asked Questions about the Public Health Service Policy on
Humane Care and Use of Laboratory Animals", question #8.  The question
inquires about the possibility for an administrative extension and the
response is "NO".  The answer was "The IACUC may not extend the
three-year approval by any means other than IACUC review and approval
using the procedures of IV.C.2 (PHS Policy)  When IACUC approval
expires, it is not longer valid. Continuation of animal activities
beyond the expiration is a serious an reportable violation of PHS
Policy".  Here PI's are reminded that the grant submission may be sent
as a "Just-in-time" for their grant submission animal assurance.  For
situations where there may be animals in house, we have recently
developed a Holding Protocol and written a policy for transfer of
animals in the event a PI does not comply with a request for full
resubmission.  If the PI elects to submit a new protocol at a later date
then it is treated as a "new" protocol and receives a new number, etc.
The PI usually takes this option if the study is currently inactive and
there are no animals currently in house.

The web site for Lab Animal is http://www.labanimal.com and I think I
have seen reference to this at the OLAW web site.

Jean Garrett
Administrative Assistant
Office of Research

Phone:  601-815-5006

>>> xxxxxx@UMBC.EDU 05/13/05 02:46PM >>>
Some IACUC-related advice and pearls of wisdom, please.

I sent an expiration notice to a PI in advance of the end of the third
year of the protocol approval. The PI tells me of two large grant
applications due between now and end date and doubts to be able to get
the
renewal done before then. A one-month extension is being requested,
past
the end date, to submit the renewal.

I speak to the chair, providing information of the PHS policy that says
an
extension cannot be granted, since review and approval must be done at
least once every three years. And, our internal procedures say that
too.

The chair retorts by saying the function of the IACUC is to make sure
the
animals are treated humanely without causing the experimenters to tear
out
their hair (no problem there).The chair wants to treat this as a
non-significant change in the protocol and wants me to ask the PI to
file
a request for an extension that involves no changes in the treatment
of
the animals (assuming there are no changes). The chair feels we are
fulfilling the spirit of the regs in overseeing the humane treatment
of
the animals.

I agree with the spirit, but that doesn't resolve the fact that the PI
will be out of compliance (and be reportable to OLAW) if the research
continues past the end date with approval.

Help!

Thanks!

Tim

--
Timothy Sparklin, MSW, CIM
Administrator, Human and Animal Research Protections
The Graduate School, University of Maryland, Baltimore County
410-455-2737
Human Research Protections Program (IRB): www.umbc.edu/irb
Animal Protections Program (IACUC): www.umbc.edu/iacuc

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