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 ====================================================================== 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") ====================================================================== ====================================================================== 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") ======================================================================