Reporting Unanticipated Outcomes Impacting Animal Welfare (IACUC)

Purpose

Boston University (BU) is committed to observing Federal policies and regulations and the Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards for the humane care and use of animals. The intent of this policy is to describe the procedures for reporting unanticipated outcomes that affect animal well-being.

Covered Parties

This policy is applicable to all persons responsible for conducting research, teaching, training, breeding, and related activities, hereinafter referred to collectively as “activities”, involving live vertebrate animals conducted at or under the auspices of Boston University.

University Policy

It is the responsibility of the Principal Investigator (PI) to promptly report any unanticipated outcomes that impact animal well-being to the IACUC or Attending Veterinarian (AV). An unexpected outcome is not described in the protocol and was not anticipated during the planning of the activities. Failure to report unexpected outcomes may be considered noncompliance.

Examples of unexpected outcomes include, but are not limited to:

• Unanticipated phenotype of genetically modified animals
• Physical restraint resulting in lesions, illness, or behavioral changes
• Increased postoperative mortality
• Increased morbidity or mortality after administration of a hazardous agent
• Equipment failure resulting in harm or death
• Unexpected mortality

Not all unanticipated problems involve direct harm to animals. Unexpected events may increase the risk of harm to animals without directly harming them or may not cause any detectable harm or adverse effect, however both circumstances represent unanticipated outcomes and must be promptly reported.

In the event of unanticipated death, animals should be preserved by refrigeration as soon as possible to allow for necropsy.

Procedures

The PI or their designee must notify the IACUC or AV as soon as an unanticipated outcome is identified or suspected. While the PI has primary responsibility for reporting such concerns, unexpected outcomes should be reported by Animal Science Center (ASC) staff or other research staff.

The AV and the IACUC will work with the researcher to assess the outcome and develop a plan, as needed, for revising the IACUC protocol to ensure the well‐being of the animals. In the interval between notification of the unanticipated outcome and the IACUC’s decision, the AV will make an assessment of the health of the animal and consult with the PI to gather relevant information. During this interim period, the AV is authorized to make final decisions regarding care and the humane endpoints for the animal.

Responsible Parties

Principal Investigators are responsible for: preparing and submitting applications; making modifications in applications in order secure IACUC approval; ensuring adherence to approved protocols; ensuring humane care and use of animals: ensuring that all personnel have completed required training; and reporting any unanticipated outcomes or adverse events to the IACUC.

The Institutional Animal Care and Use Committee and the Attending Veterinarian are responsible for overseeing implementation of and ensuring compliance with this policy.

Defined Terms

Unexpected outcomes: are any unanticipated effects resulting from research, teaching, training, breeding, or related activities, that are not anticipated or described in the protocol, that affect animal welfare.

Related Policies and References

Guide for the Care and Use of Laboratory Animals, Eighth Edition

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Animal Welfare Act and Animal Welfare Regulations

Authority of the Attending Veterinarian

Review and Approval of Materials Submitted to the IACUCInstitutional Animal Care and Use Committee IACUC oversee...

History

Effective Date: 02/06/2024
Next Review Date: 02/05/2027