IACUC Procedure 001: Protocol Deviations, Adverse Events, and Animal Welfare Concerns- What to Report, When to Report, and How It’s Handled
1. Purpose: This procedure provides guidance on the reporting and review of all incidents (5.1), including protocol deviations (5.2), adverse events (5.8), and animal welfare concerns (definitions in section 5 below). It outlines what should be reported, when reporting is expected, and how the IACUC evaluates, manages, and resolves these incidents. In addition, this procedure describes the requirements for reporting events to the applicable funding, accrediting, or regulatory agencies (where applicable).
2. Scope: This procedure applies to all personnel involved in animal care and use at OHIO and covers all reported incidents, regardless of how they are received. All incidents are reviewed through this process and assessed by the IACUC to determine appropriate investigation, corrective actions, and any required regulatory reporting (1).
3. Timeline for Reporting:
If You Observe… | What to Do | Timeline |
Protocol Deviation | Submit a Deviation Report in Cayuse (If you have not transitioned to Cayuse, follow the Interim Procedure for email reporting) | As soon as noted, generally within 24 hours of observation. |
Adverse Event | Submit an Adverse Event Report in Cayuse (If you have not transitioned to Cayuse, follow the Interim Procedure for email reporting) | |
Animal Welfare Concern | Report via
|
3.1 Important Note for Researchers: An adverse event is generally characterized by being unexpected; that is, not described in the Adverse Consequences section of the approved IACUC protocol. Researchers must report incidents that fall outside of what was described in the protocol.
- An adverse event may also include situations where outcomes differ meaningfully from what was described in the protocol, even if the type of event was anticipated. This includes differences in frequency, severity (intensity), duration, or number of animals affected compared to what was originally outlined.
- When in doubt about a protocol deviation or adverse event, researchers are encouraged to err on the side of reporting and consult with the ORC at compliance@ohio.edu or 740-593-0664 for guidance.
4. Section 2: IACUC Review and Assessment Process
4.1 IACUC Subcommittee Review
4.1.1 If an urgent animal safety or welfare concern is identified prior to subcommittee review, the Attending Veterinarian (AV) or designee will assess the situation promptly. The AV has authority to evaluate, treat, remove animals from experiments, implement measures to relieve pain or distress, or perform euthanasia as needed.
4.1.2 Office of Research Compliance (ORC) staff will consult with the IACUC Chair or Vice-Chair, the AV, and, as needed, the LAR Director or University Counsel. Individuals with conflicts of interest must recuse themselves.
4.1.3 The subcommittee will gather preliminary information, including:
- Who: Individuals involved (name, role)
- What: Animals involved, description of issue, procedures, equipment
- When: Date(s) Where: Location
- Why/How: If known
4.1.4 The IACUC Chair will notify the PI/Co-Investigators of the allegation or request a response, as appropriate.
4.1.5 The subcommittee will determine whether the issue meets applicable reporting criteria under NIH-OLAW (PHS Policy) and, when applicable, USDA Animal Welfare Act (AWA) regulations.
NIH-OLAW (PHS Policy) reportable situations (3) (4) (include:
- Serious (5.7) or continuing noncompliance (5.6) with PHS Policy
- Serious deviations from the Guide for the Care and Use of Laboratory Animals (7)
- IACUC suspension of an activity
USDA (AWA) reportable situations (6) include (as applicable):
- Serious or continuing noncompliance with AWA regulations
- Conditions that have adversely affected animal health or welfare
- IACUC suspensions of USDA-covered activities
4.1.6 The subcommittee will also assess whether reporting to AAALAC (9) is warranted (e.g., animal harm/death, inadequate veterinary care, procedural errors, equipment failure, significant animal welfare concerns, or serious human health risks related to the program).
4.1.7 Subcommittee investigation outcomes and actions taken will be shared with the IACUC at the next convened meeting.
4.1.8 Incidents that cannot be fully investigated by the IACUC Subcommittee, or for which additional input on corrective actions is desired, will be forwarded to the full committee.
4.2 Full Committee Review:
4.2.1 The IACUC will investigate to determine the cause of the incident. This may include but is not limited to: interviews, protocol review, or site visits.
4.2.2 The investigation scope may expand to related protocols to determine whether the issue is isolated or systemic.
4.2.3 The IACUC will develop and oversee a corrective action plan, which may include:
- Training or retraining
- Policy/procedure updates
- Increased oversight
- Protocol amendments
- Suspension of activities
- Required reporting to oversight agencies
4.3 Communications:
4.3.1 ORC will coordinate the communication of official IACUC determinations, unless otherwise directed. As appropriate, communications may also include Dean(s), Department Chair(s), and other institutional leadership.
4.3.2 ORC will coordinate reporting to regulatory agencies, as required. ORC will lead this process and work with the IO to ensure submissions are completed in accordance with agency requirements.
4.4 Appeals Process:
4.4.1 The PI may appeal within 14 days by submitting a signed, written request to ORC (compliance@ohio.edu).
4.4.2 Appeals must include justification and any new information. Previously available but unsubmitted information will not be considered.
4.4.3 Appeals are reviewed at the next convened meeting. The PI may be invited to present. A decision will be communicated within 5 business days.
4.4.4 Sanctions remain in effect unless modified by majority vote of the IACUC.
5. Definitions:
5.1 Incident- A collective term used at OHIO to describe protocol deviations, adverse events, and animal welfare concerns.
5.2 Deviation- Any change, divergence, or departure from the study design or procedures defined in the protocol or associated attachments (i.e., experimental design, permits, etc..).
5.3 Adverse Event- Unexpected incidents that lead to harm, or endanger the well-being of animals and humans at a research facility (10).
5.4 Ethics Point- EthicsPoint is a comprehensive and anonymous telephone-based reporting tool that assists university faculty and staff in working together to address fraud, waste, and abuse of university resources while helping to cultivate a positive work environment. Link to EthicsPoint
5.5 Noncompliance- the failure or refusal to comply with a regulation or to deviate from protocol procedures approved by the IACUC
5.6 Continuing Noncompliance- Is typically defined as a situation that meets any of the following criteria:
- The investigator(s) has committed the same or similar instance of non-compliance repeatedly after having been notified of this type of noncompliance by the IACUC
- The investigator has failed to respond within a reasonable timeframe to a request from the IACUC to resolve an instance of noncompliance;
- A pattern of frequent instances of documented noncompliance across one or more of an investigator’s protocols
5.7 Serious Noncompliance- Cases where the noncompliance is a failure or refusal to comply with a regulation, the IACUC approved protocol, continuing noncompliance, and/ or conditions that jeopardize the health or well-being of animals. (refer to Appendix I below).
5.8 Adverse Event- unexpected incidents that lead to harm, or endanger the well-being of animals and humans at a research facility (10).
6. References & Resources:
- Institutional Animal Care and Use Committee Guidebook 2nd Edition (Pages 11 & 178)
- PHS Policy- PHS Policy on Humane Care and Use of Laboratory Animals | OLAW (nih.gov)
- The Code of Federal Regulations- 9 CFR, Part 2, Subpart C 2.32(c) (4)
7. Appendices:
Appendix I- Examples of Reportable Situations (3) (4)
- conduct of animal-related activities beyond the expiration date established by the IACUC;
- failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
- failure to maintain appropriate animal-related records (e.g., identification, medical, surgical, husbandry);
- conduct of animal-related activities without appropriate IACUC review and approval;
- failure to adhere to IACUC-approved protocols;
- failure to report unanticipated adverse events to IACUC;
- participation in animal-related activities by individuals who are not listed on the approved protocol and have not been determined by the IACUC to be appropriately qualified and trained;
- failure to monitor animals post-procedurally as necessary to ensure well-being;
- failure to ensure death of animals after euthanasia procedures;
- failure of animal care and use personnel to carry out veterinary treatments;
- IACUC suspension that results in the temporary or permanent interruption of an activity due to noncompliance;
- Conditions that jeopardize the health or well-being of animals.
Appendix II- Investigation Preliminary Report Template (3) (4)
Please include each of the items below:
- Name and contact information of person reporting
- Name of institution
- Assurance number
- Funding component and if contacted (for situations related to PHS-supported activities)
- Brief description of incident (e.g., species, category of personnel involved, dates, times, animal deaths)
- Plan and schedule for correction and prevention (if known)
- Timeframe for final report from the Institutional Official
Appendix III- Investigation Final Report Template (3) (4)
Please ensure that the final report contains each of the items below:
- Preliminary report
- Explanation of incident: Explain in detail what happened, when and where, the species of animals(s) involved, and the category (but not the names) of the individuals involved.
- Corrective actions
- Grant/contract number: Include the relevant grant or contract number (for situations related to PHS-supported activities).
- Impact on PHS-supported activities:
- Compliance with terms and conditions: If the incident involved PHS-supported activities and was not compliant with the terms and conditions of grant award, confirm that the situation was reported to the funding component and that all unauthorized costs initially paid from the grant have been removed and covered by other sources (see also NOT-OD-10-081). Or, certify that no unallowable costs were charged during the noncompliant period.
Appendix IV- Corrective Action Plan Template (4)
The corrective action plan must include the following elements:
- A description of both short term and long-term corrective actions
- Clear assignment of corrective action tasks to a responsible party or individual
- A timeline for the completion of each task
- Once, the corrective action tasks are completed, the committee must review the plan and determine effectiveness
7. Change History:
| Version Number | Details of Change | Approval Date |
|---|---|---|
| 1.0 | New IACUC Procedure | 04/13/2023 |
| 2.0 | Removed “prohibiting the use of data collected during an approval lapse or process deviation.” from the list of potential corrective actions/remediation.
| 11/08/2023 |
| 3.0 | Added direct link to anonymous reporting system EthicsPoint. Change to 4.2.4- Description of corrective action plan evaluation | 08/05/2024 |
| 4.0 | Updated Section 3. Timeline for Reporting to clarify prompt reporting requirements and make updates to reflect new Cayuse workflows. | 05/22/2025 |
| 5.0 | Substantial Re-write:
| 9/08/2026 |