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

======================================================================
 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 http://www.hrinet.org (click on "Listserv Lists")
======================================================================