IACUC

 

Reporting Concerns

 

Guideline for Reporting and Assessment of Adverse Events, Unexpected Outcomes and Injury, and Animal Welfare Concerns

 

Background: Animals involved in research may be subject to events that have the potential to adversely impact their health or welfare. These events must be promptly reported to the Institutional Animal Care and Use Committee (IACUC).

 

Definitions:

Adverse event – An unexpected incident that negatively affects the health or welfare of animals.

Unexpected outcome – An unanticipated result of IACUC-approved animal activities. Examples of IACUC-reportable unexpected outcomes may include, and are not limited to:

  • Animal morbidity or mortality occurring at a higher frequency than expected.
  • Unanticipated debilitating defects discovered after creating or breeding genetically modified animals.

Expected outcome - An anticipated result of IACUC-approved animal activities. For example, a certain percentage of morbidity or mortality may be expected with a particular procedure, such as a surgery or disease model. These outcomes do not need to be reported to the IACUC if they fall within the anticipated frequency of occurrence and the procedures are conducted as approved in the Animal Use Protocol (AUP).

Animal welfare concern – A condition or situation that has the potential to jeopardize the health or well-being of animals, including suspected mistreatment and misuse.

Noncompliance – A deviation from policies or procedures without prior approval.

OLAW-reportable – A PHS non-compliance or reportable event. The PHS defines noncompliance as serious or continuing noncompliance with the PHS Policy, serious deviations from the provisions of the Guide, or any suspension of a protocol by the Institutional Animal Care and Use Committee. Reportable events include conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals.

AAALAC International-reportable – A significant adverse event relating to the animal care and use program. Examples include internal or external reviews/inspections that document these events, investigations by national oversight bodies, and other serious incidents or concerns that negatively impacted animal well-being.

Internal Reporting: Principal Investigators (PIs) or research personnel must immediately notify the veterinarian or LAR Staff of any unanticipated animal injury, illness, or research outcome that impacts animal welfare. Prompt notification is essential to prevent unnecessary pain or distress as well as to prevent the spread of any disease. Euthanasia decisions will typically be made by the PIs in consultation with the Attending Veterinarian (AV). However, some events may require immediate action by the Attending Veterinarian or Laboratory Animal Resources Staff (LAR), delegated by the AV, to protect animal health and welfare. Adverse events, unexpected outcomes, and animal welfare concerns must be promptly reported to the IACUC.

 

The process of reporting and assessment includes the following:

Procedures for LAR Staff:

  • During normal working hours (8:00 a.m.–5:00 p.m.), LAR Staff will contact the PI immediately via all available contact numbers and email address provided by the PI.
  • For adverse events/injury, if after 30 minutes there is no response by phone or email, LAR Staff will contact the Attending Veterinarian or Alternate Veterinarian. The Veterinarian will take appropriate action.
  • If this is an extreme emergency, LAR Staff will contact the Attending or Alternate Veterinarian and then call the PI. The Attending or Alternate Veterinarian or their representative will take appropriate action. LAR Staff will notify the PI by email of action taken by the Veterinarian.

 

Procedures for Principal Investigators and Research Personnel:

  • Contact a member of the LAR Staff or the Veterinarian in the vivarium or, if warranted, call one of the emergency numbers posted on the vivarium office door and can also be found HERE
  • The PI may wish to treat or euthanize the animal based on the severity of the situation and its effect on the research. The veterinarian or the LAR Staff should be notified of this decision as soon as possible.
  • As soon as possible after resolution, the event must be reported, in writing, to the IACUC at iacuc@olemiss.edu. Please include the relevant protocol number, a brief description of the event, and the resolution.

 

Procedures for the IACUC:

  • Once an adverse event or unexpected outcome has been reported to the IACUC office, the IACUC Research Compliance Specialist notifies the IACUC Executive Committee (IEC). The IEC consists of the IACUC Chair, the AV, the Assistant Vice Chancellor for Research Integrity, and Compliance, and one additional IACUC voting member.
  • The IEC reviews the reports and determines if the event/outcome constitutes an animal welfare concern (see section above). If the event/outcome is not an animal welfare concern, the event/outcome and resolution are reported at the next convened IACUC meeting.

 

Reporting Animal Care and Welfare Concerns:

The University will ensure that individuals reporting perceived sub-standard care or noncompliant research animal use are protected in compliance with federal regulations and AAALAC guidelines and prohibit discrimination against or reprisal for reporting violations of regulations or standards under the Animal Welfare Act. Concerns may be reported onymous or anonymously.

If you have concerns about research animals used in a study, you can contact any of the following individuals:

If you wish to report anonymously, you can report your concerns via the following methods:

Dr. Harry Fyke, Attending Veterinarian
The University of Mississippi
B-104 TCRC
University, MS 38677

Assessment of Animal Welfare Concerns:

  • Once an animal welfare concern has been reported to the IACUC office, the IACUC Research Compliance Specialist notifies the IACUC Executive Committee (IEC). The IEC consists of the IACUC Chair, the AV, the Assistant Vice Chancellor for Research Integrity, and Compliance, and one additional IACUC voting member. The IEC reviews and determines if the report warrants formal investigation.
  • If an investigation is warranted, the IACUC Chair promptly informs the committee and appoints an individual or subcommittee to investigate the concern. This may include convening an emergency meeting if immediate actions are necessary.
  • The individual or subcommittee responsible for the investigation will follow UM’s Reporting Research Animal Concerns Policy.
  • At a convened meeting of the IACUC with a quorum present, the individual or subcommittee responsible for the investigation will report the results of the investigation with recommendation for action. The IACUC will:
    • Review the final actions,
    • Develop a corrective and preventative action plan, if applicable, and
    • Decide whether external reporting is required.
  • If external reporting is required, the IACUC submits a final report to the Institutional Official (IO), through the Assistant Vice Chancellor, that includes an explanation of the event and, if applicable, the corrective and preventative action plans.

The Assistant Vice Chancellor is available to consult with IACUC regarding whether a specific event should be externally reported.

 

External Reporting to OLAW: In addition to the final report to the IO, PHS Policy requires assured institutions to promptly report non-compliance or reportable situations. The IACUC office handles reporting to OLAW.

OLAW Prompt Reporting Examples

  • Conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals.
  • Conduct of animal-related activities without appropriate IACUC review and approval.
  • Failure to adhere to IACUC-approved AUPs.
  • Implementation of any significant change to IACUC-approved AUPs without prior IACUC approval
  • Conduct of animal-related activities beyond the expiration date established by the IACUC.
  • Participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained.
  • Failure to ensure death of animals after euthanasia.
  • Failure of animal care and use personnel to carry out veterinary orders.
  • IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution's Animal Welfare Assurance.

 

External Reporting to AAAALAC International: Similarly, the AAALAC International Rules of Accreditation require prompt reporting of significant adverse events related to the animal care and use program. The IACUC office handles reporting to AAALAC International.

AAALAC International Prompt Reporting Examples

  • Inadequate veterinary care.
  • Conditions that resulted in unexpected animal harm or deaths (e.g., accidents or errors, equipment failures, natural disasters).
  • Significant animal rights activities (e.g., protests, property damage).
  • Inappropriate euthanasia techniques or failure to confirm euthanasia.
  • Substantiated complaints or reports regarding animal welfare concerns.

 

 References:

  1.  PHS Policy on Humane Care and Use of Laboratory Animals
  2. OLAW NOT-OD-05-034 – Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals
  3. AAALAC International – Rules of Accreditation
  4. AAALAC International FAQ – Managing and reporting adverse events and Management in Animal Facilities

 

 

 

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