Handbook of Policies and Procedures (IACUC/HOPP)
Section 8: Animal Welfare Concerns And Non-Compliance Situations
- 8.0 Evaluation of Animal Care and Use Concerns
- 8.1 Methods for Reporting
- 8.2 Procedures for the Investigation of Animal Care and Use Concerns
- 8.3 Non-Compliance with IACUC Protocol, Policies, Procedures, or Decisions
- 8.4 Consequences of Non-Compliance
- 8.5 Reporting Requirements
To help ensure that laboratory animals receive humane care, use or treatment in accordance with the highest ethical standards, laws, regulations and policies governing animal research, the IACUC must review and, if warranted, address any animal-related concerns raised by the public or institutional employees. Procedures must be established to ensure that concerns are communicated to the IACUC. The Committee must review each concern in a timely and systematic manner and, when necessary, take prompt, appropriate corrective actions.
To facilitate communication, there are a number of options available to communicate concerns about animal care and use at The University of Texas at Austin, or to report instances of suspected non-compliance with laws, rules, regulations and policies. The names and phone numbers of contact persons including the Attending Veterinarian, the Director of the Office of Research Support, and University Compliance Services should be posted in or near the entrance to animal facilities and are listed on the ARC website, readily available to institutional employees. This information has also been provided to participants in the AALAS Learning Library “3198: Orientation” training module.
Although written concerns are more convenient to handle, complainants may not be willing to submit them in this manner. In such cases, the individuals who receive concerns should document them fully to ensure that the issues are clear and to prevent misunderstandings.
Requests for anonymity should be honored to the extent possible. This includes protecting the confidentiality of those who report concerns as well as anyone against whom allegations are directed, while allegations are under investigation. The policy of the University is to prohibit unlawful retaliation against employees as a consequence of good faith actions in the reporting of, or the participation in an investigation pertaining to, allegations of wrongdoing.
Concerns may include situations or activities ranging from those in which animals are reported to be in immediate, actual or perceived jeopardy to those in which violations of the AWRs or institutional Animal Welfare Assurance are alleged to be occurring but animals are not in apparent danger. They may focus on allegations of past policy and procedure violations or protocol non-compliance.The course of action taken by the IACUC should be driven by the potential significance of the alleged situation. For example, conditions that reportedly jeopardize the health or well-being of animals should be evaluated immediately. To cope promptly with such situations, the Attending Veterinarian is authorized to halt procedures which they believe do not comply with institutional policies until the IACUC can be convened and consider the matter formally. Similarly, situations that may involve potential criminal activity or human safety should be reported promptly to the institution's law enforcement or occupational health and safety officials. Allegations of other ongoing policy or procedural matters may not require such same-day attention, but should not be deferred merely as a matter of convenience. Emergency meetings may be necessary in these cases to ensure prompt consideration of concerns.
Upon receipt of a concern, the IACUC Chair should convene a meeting of the Complaint Assessment Subcommittee (CAS) comprised of IACUC members designated by the Chair. The CAS can either meet in person, or via email discussion. After initial review of the complaint, the CAS will determine whether it requires further investigation and immediate action, further investigation but no immediate action, or no action. Once this decision has been made, the CAS should determine which individuals or other institutional or non-institutional offices may require notification at this time.
If immediate action appears warranted because animal or human welfare may be compromised, the IACUC should notify the IO and proceed accordingly. Veterinary medical intervention, suspension of a research activity, and/or notification of appropriate safety, occupational health, or other officials, are examples of actions that may be taken immediately to protect animal or human welfare. In accordance with the AWRs, if an activity is suspended, the IO shall report that action to APHIS and any federal agency funding that activity. If the PHS supports the activity in any way, the IACUC, through the IO, must promptly notify OLAW.
Should the IACUC determine that further investigation is required, the CAS should conduct the investigation and report back to the IACUC. It is important to avoid actual or perceived conflicts of interest in this process.
The IACUC should charge the designated person or group with its requirements for information gathering and impose a completion date. The assigned completion date will depend on the IACUC’s determination of whether immediate remedial action may be required. The nature of the information required will vary depending on the circumstances, but often involves:
- Interviewing complainants (if known), any persons against whom allegations were directed, and pertinent program officials;
- Observing the animals and their environment; and
- Reviewing any pertinent records, (e.g., animal health records, protocol, and other documents).
The CAS should provide a report to the IACUC, which summarizes:
- The concern(s),
- The results of interview(s),
- The condition of animals and their environment, and
- The results of records and other document reviews.
The report should also contain:
- Any supporting documentation such as correspondence, reports, and animal records,
- Conclusions regarding the substance of the concerns vis-à-vis requirements of the AWRs, the PHS Policy, the Guide, and institutional policies and procedures, and
- Recommended actions, if appropriate
Upon receipt and evaluation of the report, the IACUC may request further information or find that:
- There was no evidence to support the concern or complaint,
- The concern or complaint was not sustained, but
- related aspects of the animal care and use program requires further review or
- other institutional programs may require review, or
- The concern or complaint was valid.
Protocol non-compliance occurs when procedures or policies approved by the IACUC are not being followed. Examples include performing unauthorized surgery, unauthorized persons participating in a research project, or injecting drugs that the IACUC has not approved. When faced with protocol noncompliance, the IACUC’s first step, if possible, should be to find a way to bring the protocol into compliance.If allegations of animal mistreatment or protocol non-compliance are verified, the IACUC can apply sanctions. If, in the opinion of the IACUC, sanctions are not appropriate, they need not be applied. A clearly minor and unintentional misinterpretation of an IACUC policy that has created no problem for an animal is an example of where a verified allegation of protocol non-compliance might lead to an explanation, not a sanction.
Subsequent actions of the IACUC may include:
- Implementing measures to prevent recurrence;
- Notifying the IO and the AV of its actions;
- Notifying funding or regulatory agencies, as required; and/or
- Notifying the complainant, any persons against whom allegations were directed, and pertinent program officials (appropriate supervisory and management staff, the public affairs office, institutional attorneys, etc.).
Examples of institutional sanctions that have been devised include:
- issuing letters of reprimand;
- mandating specific training aimed at preventing future incidents;
- monitoring by the IACUC or IACUC-appointed individuals of research, testing, or training that involving animals;
- temporary revocation of privileges to provide animal care or to conduct research, testing, or training that involves animals, pending compliance with specific, IACUC-mandated conditions;
- permanent revocation of privileges to provide animal care or to conduct research, testing, or training that involves animals; and
- recommending to the IO that institutional (e.g., reassignment, termination of employment) sanctions be imposed.
The IACUC is empowered to suspend a project if it finds violations of University policy, PHS Policy, the Guide, Assurance, or Animal Welfare Regulations. Suspension may occur only after review of the matter at a convened meeting of a quorum of the IACUC, and a vote for suspension by a majority of the quorum present. Further, the IACUC must consult with the Institutional Official regarding the reasons for the suspension. The Institutional Official is required to take appropriate corrective action, and report the action and the circumstances surrounding the suspension to OLAW. Because an IACUC action to suspend a project is a serious matter, the action must be reported to OLAW promptly.
Failure by research personnel to follow Federal and/or University regulations, guidelines, policies and/or procedures may require reporting to the appropriate institutional, local, state and/or Federal agencies. Violations may include, but not limited to
- Serious or continuing non-compliance with the PHS Policy;
- Serious deviations from the Guide for the Care and Use of Laboratory Animals; and
- IACUC suspensions.
The Principal Investigator and protocol personnel must report any serious or continuing non-compliance with an IACUC protocol, policies, procedures, decisions, or deviations from the Guide. The report should be on University/departmental letterhead, addressed to the IACUC Chairperson, and emailed (preferred) to IACUC@austin.utexas.edu or mailed to the Office of Research Support. The self-report of non-compliance should include the following information:
- relevant grant or contract number(s);
- full explanation of the situation, including what happened, when and where, the species of animal(s) involved, and the category of individuals involved (e.g., principal or co-principal investigator, technician, animal caretaker, student, veterinarian, etc.);
- description of actions taken by PI to address the situation; and
- description of short- or long-term corrective plans and implementation schedule(s).
The IACUC, through the IO, will submit an annual report to OLAW by January 31 of each year. The University’s reporting period is January 1 – December 31. The report will include:
- Any change in the accreditation status of the University (e.g. if the University obtains accreditation by AAALAC or AAALAC accreditation is revoked), any change in the description of the University’s program for animal care and use as described in the Assurance, or any change in the IACUC membership. If there are no changes to report, the University will provide written notification that there are no changes.
- Notification of the dates that the IACUC conducted its semiannual evaluations of the University’s program and facilities (including satellite facilities) and submitted the evaluations to the IO.
The IACUC, through the IO, will promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:
- Any serious or continuing non-compliance with PHS Policy.
- Any serious deviations from the provisions of the Guide.
- Any suspension of an activity by the IACUC.
All investigations by the CAS and/or the IACUC will be reported internally at the completion of the investigation to the following individuals, as appropriate:
- Principal Investigator (PI)
- PI’s Department Chair
- PI’s School Director and/or College Dean
- Chair, IACUC
- Vice-Chair, IACUC
- Director, Office of Research Support
- Director, Animal Resources Center
- Director, Office of Sponsored Projects (if project is externally funded)
- Associate Vice President for Legal Affairs
- Director, University Compliance Services
- Vice President for Research
In accordance with applicable policies, guidelines and regulations, upon request, the University will make available to the public all IACUC meeting minutes and any documents submitted to or received from funding agencies with the latter are required to make available to the public. Redaction of proprietary and private information is allowed but “must be done so judiciously and consistently for all requested documents.” In addition, the IACUC will adhere to requirements for providing copies of documents as specified in the Texas Public Information Act.