Policy Number: 1999-008-io
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-c "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 and Compliance (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 Research Animal Resources and Compliance (RARC) or Wisconsin National Primate Research Center (WNPRC) must be immediately contacted in order to 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.
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