Clarification of PHS Policy

Adopted by the University Committee on Animal Resources

Regarding Three Year Reviews of Animal Protocols

Because of a recent policy clarification from the Office of Laboratory Animal Welfare (OLAW) UCAR has been required to modify our policy about granting protocol extensions. Principal Investigators are currently sent a letter three months before the expiration date of a protocol reminding them that a 36-month review is due. If the PI does not provide a protocol in time for review, the existing protocol expires. If the project is still active, the PI often requests an extension so that research can continue while review takes place (or, if the award is ending, so that the project can be finished). OLAW's clarification* makes it clear that such extensions are not allowed.

The UCAR staff is implementing the following procedures immediately. This Policy is for all animal research, regardless of funding:

• A letter requesting submission of forms for 36-month review will be sent to the PI four months prior to the expiration date of protocol. If the PI does not plan to renew the protocol, he/she should notify UCAR.
• UCAR must receive the 36 month review which consists of a complete, up-to-date protocol, at least 60 days before the expiration date. This review must take place even if there have been no changes in the protocol or the research described.
• On the day of expiration, the protocol will be terminated. UCAR will check to see if the PI has animals in house under that protocol. The PI will no longer be allowed access to these animals, and all experiments on them must stop immediately. The PHS Guide states "When IACUC approval expires, it is no longer valid. Continuation of animal activities beyond the expiration is a serious and reportable violation of the PHS Policy."

Clarification of Annual Reviews of Approved Protocols

The University Committee on Animal Resources is also required by PHS Policy to conduct "continuing reviews of each previously approved, ongoing activity." The mechanism we use for this continuing review is the Annual Protocol Review (APR). This procedure has also been modified to comply with OLAW's clarification of the PHS Guide.

• Principal Investigators are sent the APR one month prior to the anniversary date of the approval of an animal protocol. If the PI has not returned the APR by the expiration date, the protocol will be terminated. UCAR will check to see if the PI has animals in house under that protocol. The PI will no longer be allowed access to these animals, and all experiments on them must stop immediately. The PHS Guide states "When IACUC approval expires, it is no longer valid. Continuation of animal activities beyond the expiration is a serious and reportable violation of the PHS Policy."

If you have any concerns about this procedure, please contact the UCAR Office.

*The Office for Laboratory Animal Welfare (OLAW) provides the following clarification of the policy of animal protocol review every three years: "For PHS purposes, IACUC review following the provisions at IV.C.2 of the PHS Policy must be accomplished at least every three years. 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. When IACUC appproval expires, it is no longer valid. Continuation of animal activities beyond the expiration is a serious and reportable violation of the PHS Policy."