Policy Number: 1999-007-io
Policy Title: 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 with the exception of noncontact observation of wild animals in their natural habitat that does not materially affect the animals (see item 8 below).
  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 APAC Policy 2002-014 on Renewals and Annual Reviews.
  3. Only one individual may be named as Principal Investigator (PI) on a UW-Madison animal care and use protocol. That individual must meet the criteria stipulated in All Campus APAC 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 two (2) individuals in his or her laboratory per protocol as having authority to act as designees for the purposes of submitting amendments to approved protocols and rewritten protocols responding to ACUC review questions. 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. In the ARROW system, these individuals are assigned to the role "protocol writer" by the PI. Additional individuals may be identified with the role "email contact" for clerical purposes, but this role does not have submission privileges within ARROW.
  6. Only the PI or his/her designee may submit amendments to approved protocols and rewritten protocols responding to ACUC review questions.
  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.
  8. Studies involving noncontact observation of wild animals in their natural habitat that does not materially affect the animals must be described in writing in a waiver request (http://www.rarc.wisc.edu/forms/files/protocol/WildlifeWaiver.pdf) and submitted to the Chief Campus Veterinarian or designee. The Chief Campus Veterinarian or designee will make a determination if the animal aspect of the study requires ACUC oversight as required by the Animal Welfare Act Regulations and PHS Policy.

Author: R. Lane, H. McEntee
ePublication Date: 09/02/1999
History: 3/2002, amended 9/2006, amended 4/2012, amended 8/2014