Animal Welfare Concerns and Non-Compliance Situations

Evaluation of Animal Care and Use Concerns

To help ensure that laboratory and other research 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.

Methods for Reporting

To facilitate communication, there are a number of options available to communicate concerns about animal care and use at A&M-Commerce, or to report instances of suspected non-compliance with laws, rules, regulations and policies. The names of contact persons including the Attending Veterinarian, the Chair, and RCO are listed on the IACUC website. Reports may also be made using the Animal Use Concern Report form posted at the ORSP website at: 

http://www.tamuc.edu/research/compliance/IACUC-Animal-Research/IACUC_forms.aspx 

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 A&M-Commerce 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.

Procedures for the Investigation of Animal Care and Use Concerns

Initial Evaluation and Actions:

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 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 he/she believes 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.

The Role of IACUC Chair

Upon receipt of a concern, the IACUC Chair should convene a meeting of the IACUC. The IACUC can either meet in person, or via email discussion. After initial review of the complaint, the IACUC 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 IACUC 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. If an activity is suspended, the IO will report that action to any federal agency funding that activity. If the PHS supports the activity in any way, the IACUC, through the IO, must promptly notify OLAW.

Investigation

The IACUC should conduct further investigation as required. It is important to avoid actual or perceived conflicts of interest in this process.

The IACUC should charge a 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, protocols, and other documents).

The IACUC should review:

• The concern(s);
• The results of interview(s);
• The condition of animals and their environments; and,
• The results of records and other document reviews.

The review 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 Animal Welfare Regulations, the PHS Policy, the Guide and institutional policies and procedures; and,
  • Recommended actions, if appropriate.

Outcomes and Final Actions

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 compliant was not substantiated; but,

o related aspects of the animal care and use program requires further review; or,

o other institutional programs may require review; or,

• The concern or complaint was valid.

Non-Compliance with IACUC Protocol, Policies, Procedures, or Decisions

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, changing methodology during the study, 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.

Consequences of Non-Compliance

Subsequent actions of the IACUC may include:

• Implementing measures to prevent recurrence;
• Notifying the IO 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.).

Institutional Sanctions

Examples of institutional sanctions include:

• Counseling;
• 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 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.

Suspension of Animal Activities

The IACUC is empowered to suspend a project if it finds violations of A&M-Commerce 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 if necessary.

Reporting Requirements

Failure by research personnel to follow Federal and/or A&M-Commerce regulations, guidelines, policies and/or procedures may require reporting to the appropriate institutional, local, state, and/or Federal agencies. Violations may include, but are 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.

Principal Investigator Reporting

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 A&M-Commerce/departmental letterhead, addressed to the IACUC Chairperson, and emailed (preferred) to the Research Compliance Officer (RCO). 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 the PI to address the situation; and,
• Description of short- or long-term corrective plans and implementation schedule(s).

IACUC and IO Reporting

All investigations by 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 Director and/or College Dean
• Chair, IACUC
• Director, Office of Research and Sponsored Programs (ORSP) (if project is externally funded)
• Institutional Official

Response to External Requests for Information

In accordance with applicable policies, guidelines, and regulations, upon request, A&M-Commerce will make available to the public all IACUC meeting minutes and any documents submitted to or received from funding agencies. 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.