Policy Title: 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.
- Public Health Service regulation mandates that Animal Care and Use Protocols must be renewed every three years. To accomplish this requirement, PIs and PI-selected designees (e.g., "protocol writers" in ARROW) will be notified by RARC or by the ARROW system at least three months before each protocol is scheduled to expire. This correspondence will advise them that they must submit a renewal protocol so that it can be approved prior to their expiration date. If a PI does not respond to the first notification, a second notification will be sent at least two months before each protocol is scheduled to expire. If a PI still does not respond, RARC or the ARROW system will notify the PI 30 days before the protocol expiration date that the protocol will expire. This will be the final notice to submit a renewal protocol. 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 will be copied on this final notification.
- Submitted renewal protocols that are received by the deadline(s) identified in the above notifications will be scheduled for review at the assigned committee's next legally convened ACUC meeting or for Designated Review. Results of the ACUC review will be communicated to the PI in a timely manner to avoid protocol expiration.
- If modifications are required by the ACUC for approval, the PI will have a maximum of two weeks (may be shortened by individual ACUCs) to respond. Such response will be in the form of a protocol rewrite which incorporates and highlights (bold) those response(s), or displays the responses accordingly within the ARROW system.
- If a PI fails to respond to the ACUC's questions within the required time frame, the protocol will expire on its expiration date. Upon expiration RARC will within 24 business hours notify the PI, the responsible attending veterinarian (senior program veterinarian), and the Facility Manager / Department Chair. An investigator wishing to restart the research will have to submit a new protocol, which will undergo the full ACUC review and approval process.
Author: R. Lane, H. McEntee
ePublication Date: 03/15/2002
History: amended 10/2002, 6/2007, 8/2014