University of Wisconsin-Madison

Policy Number: 1999-007 [PDF]

Adoption Date: 09/02/1999

Effective Date: 09/02/1999

Expiration Date: ongoing

Amended: 9/1/2006

Review Date: Annually in January

Complete Protocol Submission Policy

Purpose: This policy describes the requirements for animal use protocol submission, approval, and maintenance for all UW-Madison Principal Investigators (PIs).

Policy:

1. A UW-Madison animal care and use protocol that has been reviewed and approved by at least one Animal Care and Use Committee and is in active status is required before any research, teaching, or outreach activity can be performed.
2. Animal Welfare Act Regulations and Public Health Service Policy require annual reviews and 3-year renewals to maintain active status of animal protocols. UW-Madison PIs are required to abide by these regulations and follow established administrative processes for compliance. See All Campus Policy 2002-014 on Renewals and Annual Reviews.
3. The Principal Investigator (PI) for a UW-Madison animal care and use protocol must meet the criteria stipulated in All Campus ACUC Policy 2000-013, “Principal Investigator Status.”
4. UW-Madison animal care and use protocols must be submitted by the PI to the Research Animal Resources Center (RARC) for processing.
5. A PI may designate one (1) individual in his or her laboratory per protocol as having authority to act as an administrative alternate for the purposes of submitting amendments to protocols, rewritten protocols responding to ACUC review questions, annual continuing review forms, and three-year renewals. The identification of a designee does not in any way reduce or remove the responsibilities of the PI to adhere to the terms in the approved protocol.
   
   
6. Only the PI or his/her designee may submit amendments to protocols, rewritten protocols responding to ACUC review questions, annual continuing review forms, and three-year renewals.
7. Investigators or their designees are required to submit responses to committee questions or requests for additional information within the timeframe stipulated by the individual ACUC, normally not to exceed two (2) weeks. The deadline will be based on receipt, by the investigator, of the request and review questions. Once modifications to the protocol are accepted, the investigator, within two weeks, must submit a finalized version of the protocol. This finalized version shall contain all changes to the protocol with such information incorporated into the appropriate question(s). Such submission shall be considered a requirement for protocol approval.

Prepared by: R. Lane, H. McEntee

Reference Minutes: 09/02/99, 03/15/02, 07/07/06, 08/04/06, 09/01/06