Animal Program: Protocol Noncompliance

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Policy Number:
UW-4113
Old Policy Number:
1999-008-io
Responsible Office:
Research Animal Resources and Compliance

University Policy

Rationale/​Purpose:

To establish guidelines for addressing instances of regulatory, policy, or procedure noncompliance by all individuals at UW–Madison who are engaged in the care or use of animals for teaching, research or outreach. Such noncompliance 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.

Policy:
  1. UW–Madison upholds the fundamental principle that using animals is a privilege and not a right. As per the 8th edition of the National Research Council (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 wellbeing.
  2. It is recognized that isolated instances of noncompliance can occur as the result of a simple and minor error with no intent to circumvent applicable requirements. As such, Animal Care and Use Committees (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 institutional official (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 whom reports must be made to and Adverse Event Reporting), even though no formal investigation or corrective measures by the ACUC may be deemed appropriate.
  3. An allegation of noncompliance is typically reviewed and resolved by the pertinent school/college ACUC. In exceptional instances relative to animal welfare, an allegation of noncompliance may be reviewed and resolved by the institutional official. It may be advisable to involve a representative from the university’s Office of Human Resources in discussions of allegations of and potential consequences for noncompliance.
  4. When an incident of noncompliance becomes suspected or known, it shall be reported to the chair of the school/college ACUC or to an attending veterinarian. The attending veterinarian is the chief campus veterinarian or a senior program veterinarian employed by Research Animal Resources and Compliance (RARC) or the 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 attending veterinarian. Instances of suspected noncompliance may also be reported as provided in policy Whistle Blower Policy and Posting.
  5. If the noncompliance issue presents a potential immediate animal health or welfare risk, the chief campus veterinarian or a senior program veterinarian employed by RARC or the 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 attending veterinarian may suspend activities using animals by an individual who presents, in the judgment of the attending veterinarian, an immediate threat to animal health or welfare. See the companion Standard Operating Procedures (SOPs) for Attending Veterinarians. 
  6. The school/college ACUC chair will advise the individual(s) involved that an instance of noncompliance has been alleged, and will also ensure that the institutional official, the chief campus veterinarian, and the senior program veterinarian are aware that the individual(s) involved has been notified of the alleged instance of noncompliance. See the companion SOPs for ACUCs.
  7. The institutional official possesses independent authority to investigate alleged instances of noncompliance relative to animal welfare and to implement corrective measures (including imposing additional corrective measures to those imposed by an ACUC) if in the official's judgment an ACUC has not sufficiently investigated or addressed the instance of noncompliance or the allegation involves a matter of critical importance to UW–Madison’s animal care and use program. However, in no event may the institutional official weaken any corrective measure imposed by an ACUC. See the companion SOPs for the Institutional Official.
  8. The investigation of an allegation of noncompliance and the imposition of any corrective measures by an ACUC or the institutional official, and the process for seeking reconsideration of the findings of an investigation and any corrective measures imposed, shall be in accordance with the SOPs for this policy (see external references below).
  9. All ACUC actions regarding allegations of noncompliance will be reported to the institutional official by the school/college ACUC chair or designee.
Related UW-Madison Policies:
External References:

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:
12-14-1999
Date Issued:
12-14-1999
Revised Dates:

05-01-2004, 10-01-2006, 09-01-2008, 03-01-2009, 05-01-2011, 02-01-2013, 08-01-2017, 10-01-2018

Retrieved:
04-18-2024 00:36:59