Policy Title: Policy on Protocol Non-Compliance
Purpose: This policy establishes guidelines for addressing instances of regulatory, policy or procedure non-compliance by all individuals at the University of Wisconsin-Madison who are engaged in the care or use of animals for teaching, research or outreach. Such non-compliance issues would include, but not be limited to: conducting research with animals without an approved protocol in place; violation of the methodologies, procedures, numbers, and conditions of the approved protocol; violation of requirements of the Animal Welfare Regulations or the Public Health Service Policy on Humane Care and Use of Laboratory Animals; disregard of instructions of an attending veterinarian or violation of a veterinary standard; or violation of animal program policies authorized by the Institutional Official, Animal Care and Use Committees, or the Attending Veterinarian. Documentation of the source of authority for these activities is found in Appendix 1.
- UW-Madison upholds the fundamental principle that using animals is a privilege and not a right. As per the 8th edition of the NRC Guide for the Care and Use of Laboratory Animals (2011), using animals is a privilege granted by society to the research community with the expectation that such use will provide either significant new knowledge or lead to improvement in human and/or animal well-being.
- It is recognized that isolated instances of non-compliance can occur as the result of simple and minor error with no intent to circumvent applicable requirements. As such, ACUCs have the discretion to determine that a full investigative process and formal corrective measures are not required in particular circumstances. Thus, this policy is not intended to eliminate the ability of an investigator to immediately correct a simple and minor oversight or error in conjunction with the pertinent ACUC. Rather, this policy is intended to address serious compliance issues that, in the determination of an ACUC and in specific cases the IO, go beyond a simple and minor oversight. It is important to note that all compliance errors regardless of magnitude must be self-reported as soon as they are identified (see point 4 below for information regarding to whom reports must be made, and policy 2012-050-v “Adverse Event Reporting”), even though no formal investigation or corrective measures by the ACUC may be deemed appropriate.
- An allegation of non-compliance is typically reviewed and resolved by the pertinent School/College ACUC. In exceptional instances relative to animal welfare, an allegation of non-compliance may be reviewed and resolved by the IO. It may be advisable to involve representative from the University’s Office of Human Resources in discussions of allegations of and potential consequences for non-compliance. .
- When an incident of non-compliance becomes suspected or known, it shall be reported to the Chair of the School/College ACUC or to an Attending Veterinarian (AV). The AV is the Chief Campus Veterinarian (CCV) or a Senior Program Veterinarian (SPV) employed by the Research Animal Resources Center (RARC) or Wisconsin National Primate Research Center (WNPRC). Instances of suspected noncompliance may alternatively be reported to the Principal Investigator, or a Facility Manager, who in turn must inform the Chair or the AV. Instances of suspected non-compliance may also be reported as provided in policy 2003-017-io, “Whistleblower Policy.”
- If the non-compliance issue presents a potential immediate animal health or welfare risk, the Chief Campus Veterinarian (CCV) or a Senior Program Veterinarian (SPV) employed by the Research Animal Resources Center (RARC) or Wisconsin National Primate Research Center (WNPRC) must be immediately contacted in order assess the situation and take any action determined to be appropriate to alleviate risk to the animals. The AV may suspend activities using animals by an individual who presents, in the judgment of the AV, an immediate threat to animal health or welfare. See the companion SOP for Attending Veterinarian (link below).
- The School/College ACUC Chair will advise the individual(s) involved that an instance of non-compliance has been alleged, and will also ensure that the IO, the Chief Campus Veterinarian, and the Senior Program Veterinarian are aware that individual(s) involved has been notified of the alleged instance of non-compliance. See the companion SOP for ACUCs (link below).
- The IO possesses independent authority to investigate alleged instances of non-compliance relative to animal welfare and to implement corrective measures (including imposing additional corrective measures to those imposed by an ACUC), if in his/her judgment an ACUC has not sufficiently investigated or addressed the instance of non-compliance or the allegation involves a matter of critical importance to UW-Madison’s animal care and use program. However, in no event may the IO weaken any corrective measure imposed by an ACUC. See the companion SOP for the Institutional Official (link below).
- The investigation of an allegation of non-compliance and the imposition of any corrective measures by an ACUC or the IO, and the process for seeking reconsideration of the findings of an investigation and any corrective measures imposed, shall be in accordance with the Standard Operating Procedures for this policy (see links below).
- All ACUC actions regarding allegations of non-compliance will be reported to the IO by the School/College ACUC Chair or designee.
The following summarization is intended to provide the Animal Care and Use Committees (ACUCs) and the Institutional Official (IO) with a synopsis of the sources which provide the committee and/or the IO with the authority to suspend or terminate animal use and related activities.
Relevant Authorities: The USDA Animal Welfare Act Regulations (AWARs) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) charge Animal Care and Use Committees (ACUCs) with the responsibility and authority to:
- Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees. AWAR sec. 2.31(c)(4); PHS Policy sec. IV.B.4.
- Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities. AWAR sec. 2.31(c)(7); PHS Policy sec. IV.B.7.
- Suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the approved protocol, the AWARs, the Guide for the Care and Use of Laboratory Animals, the institution’s PHS Assurance, or the PHS Policy. The ACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the ACUC and with the suspension vote of a majority of the quorum present. AWAR ss. 2.31(c)(6) and (d)(6); PHS Policy ss. IV.B.8., IV.C.6.
The AWARs and PHS Policy further provide that:
- An institution’s attending veterinarian shall have appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care. AWAR sec. 2.33(a)(2)
- If the ACUC suspends an activity involving animals, the Institutional Official (IO), in consultation with the ACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to APHIS and any Federal agency funding that activity. AWAR sec. 2.31(c)(7); PHS Policy sec. IV.C.7.
- The ACUC shall notify principal investigators in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure ACUC approval. If the ACUC decides to withhold approval of an activity, it shall include in its written notification a statement of the reasons for its decision and give the principal investigator an opportunity to respond in person or in writing. AWAR sec. 2.31(d)(4); PHS Policy sec. IV.C.4.
- The ACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator. AWAR sec. 2.31(d)(4)
- Proposed activities and proposed significant changes in ongoing activities that have been approved by the ACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the ACUC. AWAR sec. 2.31(c)(8); PHS Policy IV.C.8.
Further amplifying and clarifying the AWARs and PHS Policy are various federal and university guides and policies. These include:
- The Guide for the Care and Use of Laboratory Animals, 8th Edition, which confirms that using animals in research is a privilege granted by society to the research community. The Guide is formally established as University research policy by Board of Regents Policy Document 4-3.
- Chancellor Martin’s Reiteration and Clarification of UW-Madison Policy Relating to the Authority of Attending Veterinarians, dated September 11, 2009, confirms the authority of attending veterinarians over all aspects of animal care and treatment, including the authority “to intercede in any activity involving the use of animals for research or teaching purposes which in their judgment jeopardizes animal welfare or compliance with federal or university policies,” and confirms that the IO “has been delegated full institutional authority to act on behalf of the University to ensure compliance with [campus policy on authority of attending veterinarians] and all other university and federal policies and regulations relating to the care and use of animals on campus,” and “is authorized to make ultimate decisions affecting the University’s animal welfare assurance and compliance with federal regulations.”
Author: R. Lane, H. McEntee, B. Barker, B. Griffiths, B. Daly, N. Connor, J. Welter
ePublication Date: 12/14/1999
History: Amended 5/2004, 10/2006, 9/2008, 3/2009, 5/2011; 2/2013, 8/2017