Concerns Involving Animal Care and Use

IACUC Policy: 017-06, Effective Date: 10/2002, Last Revision: 03/18/2026

Overview/Purpose

The Ohio State University expects all faculty, staff, students, and volunteers, acting in good faith, to report suspected or actual wrongful conduct associated with the use and care of animals. The Institutional Animal Care and Use Committee (IACUC) is required by regulatory agencies to review, and if warranted, investigate reports of concern involving animal care and use.

Non-compliance, whether unintentional or intentional, can occur when IACUC protocols, policies, procedures, or decisions are not followed. Principal Investigators (PIs) are responsible for the actions of all those who work under their supervision; IACUC protocol PIs are responsible for the actions of all protocol team members. Non-compliance can range from minor protocol deviations to a significant infraction impacting animal or human welfare. The IACUC is responsible for identifying non-compliance issues and ensuring appropriate corrective actions to prevent recurrence.

Definitions

• 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.
• Unexpected adverse event or outcome: Unexpected illness, injury, or death of animals used in research or teaching that was not specifically identified in the IACUC approved protocol or IACUC approved SOP/SMP. Examples of IACUC-reportable unexpected outcomes may include, and are not limited to:
  • Animal morbidity or mortality occurring at a higher frequency than expected.
  • Unexpected illness or injury of animals used in research or teaching.
  • Unanticipated debilitating defects discovered after creating or breeding genetically engineered/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 should be indicated in the IACUC-approved protocol and 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.
• Non-compliance: The failure (intentional or unintentional) to comply with applicable federal, state, or local laws or regulations, IACUC policies, SOPs, or SMPs, or an approved IACUC protocol, other requirements or determinations of the IACUC, or University policy regarding research or teaching involving animals.
• Allegation of non-compliance: A report of non-compliance.
• Confirmation of non-compliance: A determination of non-compliance pursuant to this policy.
• Minor non-compliance: Deviations from an approved IACUC protocol or policy that do not pose immediate risk to animal welfare, human safety, or the environment and do not violate federal regulations.
• Serious non-compliance: Non-compliance events that either (1) cause, or present a substantial risk of, harm to animals or personnel, or (2) demonstrate disregard for oversight requirements that undermines the integrity of the institution's research oversight system. This includes conduct of any activity that is not approved by the IACUC.
• Continuing or recurring non-compliance: Repeated incidents of non-compliance (serious and minor) that degrade oversight integrity. The committee will consider historical data associated with a protocol, PI, or lab member within a 36-month period when considering classifying non-compliance as continuing or recurring.
• Corrective actions: Remediation steps intended to prevent recurrence of non-compliance. Corrective actions may be proposed by PIs in consultation with the IACUC, the IACUC Chair, and/or Attending Veterinarian (AV) outlining how non-compliance resolution will be achieved. Corrective actions are aligned with the severity of the non-compliance incident and intended to bring the PI back into compliance with regulatory requirements, ethical standards, or institutional policies.

Requirements

Concerns about animals' health and safety or non-compliance with IACUC protocols, procedures, or policies must be reported to the IACUC, the AV, anonymous reporting line, or IACUC Support Office. Contact information is posted in the core animal facilities and on the Animal Care and Use website. The IACUC Support Office may directly receive notification of anonymous hotline concerns involving animals, and/or concerns involving animals may be forwarded to the IACUC Support Office via the Human, Animals, and Laboratory Investigations Office.

Allegations of animal concerns/non-compliance are investigated by the IACUC in accordance with standard procedures.

Reporting Requirements for Adverse Events

• Unanticipated adverse events and outcomes related to research and teaching activities must be reported promptly by the PI to the IACUC along with the plan to mitigate recurrence, if applicable. To do this, the PI or research team should email the IACUC Office (iacucinfo@osu.edu, 614-292-4494). Reporting unanticipated events and outcomes is not intended to penalize a PI or research team. Rather, such reporting is intended to support continuous improvement of practices and ensure animal health and welfare.
• Clinical concerns unrelated to research or teaching activities (e.g. scrapes, cuts, fight wounds in rodents, ulcerative dermatitis, barbering) that occur at routine levels for the species do not require notification to the IACUC. The veterinary staff must notify the IACUC if the concerns exceed routine levels based on their professional judgement.
• IACUC staff will consult with the IACUC Chair or Vice-Chair and the AV to determine the next steps based on the initial information provided.
• If further information is needed, an IACUC member, appointed subcommittee, or IACUC staff member may discuss the event with appropriate personnel. If the incident is related to non-compliance, the event will be referred to the non-compliance review process.
• The IACUC will be informed of all reports of unanticipated adverse events or outcomes at the next convened meeting to determine if additional information or further action is needed.

Reporting Requirements for Non-compliance

• Although anyone may report non-compliance, PIs must report instances of non-compliance that have occurred in their lab. Reporting should be made within 48 hours of the compliance issue being identified. To do this, the PI must contact the IACUC Office (iacucinfo@osu.edu).
• As part of this reporting, the PI must explain the incident and describe any corrective and preventive actions that have been taken to remedy the issue and prevent a recurrence. Within the report, the PI must indicate:
  • The date(s) of the non-compliance.
  • A description of the protocol deviation, and any relevant background as to why the deviation occurred.
  • An explanation of whether the non-compliance resulted in animal welfare concerns.
  • A description of documentable self-corrective measures that have been or will be taken to prevent future non-compliance.
• Voluntary self-reporting non-compliance (i.e. unprompted by ACUP personnel) is strongly encouraged and will be taken into consideration during the IACUC discussion of the non-compliance event.
• Allegations and investigations of non-compliance will remain confidential to the extent permitted by Ohio law, consistent with the need to conduct an adequate investigation.
• The University will take reasonable steps to protect persons who file reports in good faith from retaliatory actions based on such filing, in accordance with the OSU Whistleblower Policy 1.40.
• The person named in the allegation and the Principal Investigator of the study, if applicable, will be notified if an investigation is warranted.
• The IACUC Chair or Vice-Chair, AV, or Institutional Official (IO) may temporarily stop any activity involving the use of animals and impose corrective actions on an investigator's research and/or secure critical documents at any time if necessary to assure animal or human health and safety.
• A decision to suspend or terminate a protocol may be made by the IO or by the IACUC at a convened meeting.
• Non-compliance determined to be serious and/or continuing or any suspension or termination of IACUC approval must be reported to OLAW, USDA, AAALAC, funding agencies and others (e.g., Sponsored Programs) as necessary, in accordance with The Ohio State University's OLAW Assurance and Federal Regulations.

Applicable Regulations

• Animal Welfare Act and Regulations
• Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
• Guide for the Care and Use of Laboratory Animals, Eighth Edition
• AVMA Guidelines for the Euthanasia of Animals
• Guide for the Care and Use of Agricultural Animals, Fourth Edition

Additional Information/Guidance

• Ohio State Whistleblower Policy 1.40 (03/01/06)
• IACUC SOP "Procedure for Investigating Concerns Involving Animal Care and Use"