University of Wisconsin-Madison

Policy Number: 2002-014 [PDF]

Adoption Date: 03/15/2002

Effective Date: 03/15/2002

Expiration Date: ongoing

Review Date: Annually in January

Policy on the Protocol Renewal Process

Purpose: The purpose of this policy is to provide guidelines for College/School Animal Care and Use Committees (ACUCs), investigators, and the Research Animal Resources Center (RARC) personnel to efficiently carry out protocol renewals. This policy will provide a uniform process for renewals and make it clear that protocols must be renewed prior to their expiration in order for research under that protocol to continue.

Policy:

1. Public Health Service regulation mandates that Animal Care and Use Protocols must be renewed every three years. To accomplish this requirement, RARC will send a letter to each PI (via Campus Mail) three months before their protocols are scheduled to expire. This correspondence will advise them that they must submit a renewal protocol to RARC so that it can be approved prior to their expiration date. If a PI does not respond to the first letter, a second letter is sent out five weeks later (via US MAIL), again notifying the PI that their protocol will expire. To guard against the chance a PI does not receive the notification due to extended absence from their office (e.g. illness, sabbatical, etc.) the Chairperson of the PI's department is copied on the second letter. If a PI still does not respond, RARC will email the PI 30 days before the expiration date notifying them that their protocol will expire. This will be their final notice to submit a renewal protocol. A list of non-renewed protocols will be sent to the responsible attending veterinarian and the Facility Manager/Department Chair monthly.
2. Submitted renewal protocols will be scheduled for review at the assigned committee's next appropriate ACUC meeting. At that meeting the protocol is then approved, approved pending response to the committee's questions, or deferred until the full committee reviews the PI's response to the committee's questions.
3. If there are questions from the protocol review, the PI will be so informed, and will have a maximum of two weeks (may be shortened by individual ACUC's) to respond. Such response will be in the form of a protocol rewrite which incorporates and highlights (bold) those response(s).
4. If a PI fails to respond to the ACUC's questions within the required time frame, RARC will notify the ACUC at the next monthly meeting. The ACUC may then withdraw the approval. Such approval withdrawal mandates that all animal research covered by that protocol must end immediately. RARC will immediately notify the PI, the responsible attending veterinarian, and the Facility Manager/Department Chair of such approval withdrawal. An investigator wishing to restart the research will have to submit a new protocol, which will undergo the full approval process.

Prepared by: R. Lane

Reference Minutes: 03/15/2002, amended 10/18/2002, amended 6/27/07