Animal Program: Complete Protocol Submission

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Policy Number:
UW-4112
Old Policy Number:
1999-007-io
Responsible Office:
Research Animal Resources and Compliance

University Policy

Rationale/​Purpose:

To describe 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 (ACUC) 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 the active status of animal protocols. UW–Madison principal investigators are required to abide by these regulations and follow established administrative processes for compliance. 
  3. Only one individual may be named as principal investigator on a UW–Madison animal care and use protocol. That individual must meet the criteria stipulated in All Campus APAC UW-4114 Principal Investigator Status for Animal Care and Use Protocols, "Principal Investigator Status."
  4. UW–Madison animal care and use protocols must be submitted by the principal investigator to the Research Animal Resources and Compliance (RARC) for processing.
  5. A principal investigator may designate two individuals in their 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 principal investigator to adhere to the terms in the approved protocol. In the ARROW (Application Review for Research Oversight at Wisconsin) system, these individuals are assigned to the role of "protocol writer" by the principal investigator. Additional individuals may be identified with the role of  "email contact" for clerical purposes, but this role does not have submission privileges within ARROW.
  6. Only the principal investigator or their 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 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, or of zoo animals that does not materially affect the animals, do not require an ACUC-approved protocol.
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:

ARROW (Application Review for Research Oversight at Wisconsin) 

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
IACUC Administrator -- IACUC Administrator, iacuc_administrator@rarc.wisc.edu, (608) 262-1238
Effective Date:
09-02-1999
Date Issued:
09-02-1999
Revised Dates:

03-01-2002, 09-01-2006, 04-01-2012, 08-01-2014, 12-01-2018

Retrieved:
04-18-2024 13:01:47