Boston University Institutional Animal Care and Use Committee (IACUC) Policy: Pilot Studies

Purpose

Boston University (BU) is committed to observing Federal policies and regulations and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards for the humane care and use of animals. This policy provides guidance on pilot studies. Adherence to this policy is mandatory unless a specific exception has been approved by the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition.

Covered Parties

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

University Policy

The Guide for the Care and Use of Laboratory Animals states that when novel studies are proposed or information for an alternative endpoint is lacking, the use of pilot studies is an effective method for identifying and defining humane endpoints and reaching consensus among the PIPrincipal Investigator View Boston University's policy on... Full Definition, IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition, and veterinarian. A system for communication with the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition should be in place both during and after such studies (Guide, p 28).

BU follows the Guide pilot study requirements.

Guidelines

It is acceptable to ask for animals that will be used in pilot experiments. Experiments can be used to perfect technique, demonstrate feasibility, or provide a justification for proceeding with larger, more tightly controlled experiments. Another justification to the use of pilot studies could be to estimate variability. The value so obtained can then be used to calculate group sizes in upcoming experiments by power analysis.

A. Responsibilities

B. Procedures

For any new technique, or when new endpoints are proposed, an investigator may need to show that it can work on a small number of animals before requesting a larger number of animals.
An Animal Use Protocol Application must be completed and submitted to the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition office for review and approval.
A pilot study may be requested by the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition during protocol review.
For new procedures:
1. If little is known about a specific procedure, the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition may approve and oversee a pilot study designed to assess both the effect of the procedure on the animals and the skills of the research team.
2. The investigator must report to the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition, in writing, the findings of the pilot study via email to IACUC@bu.edu or upload into an electronic IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition management system.
3. If the study will continue as a larger study, the protocol that contains the pilot study must be amended to include the larger study. The amended protocol will not be approved by the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition until the results of the pilot study are known.
For alternative endpoints:
1. a. The use of a pilot study is an effective method for identifying and defining humane endpoints and reaching consensus among the PIPrincipal Investigator View Boston University's policy on... Full Definition, IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition and veterinarian.
2. For such studies, a report must be made, in writing, to the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition during and after the study. Based on the report, the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition will determine if the alternative endpoint can be used on a larger scale.

Responsible Parties

Principal Investigators are responsible for: preparing and submitting applications; making modifications in applications in order secure IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition approval; ensuring adherence to approved protocols, and ensuring humane care and use of animals.

It is the responsibility of the IACUCInstitutional Animal Care and Use Committee IACUC oversee... Full Definition to assure that the number of animals to be used in an animal use protocol is appropriate. The Animal Welfare Program and the Institutional Animal Care and Use Committee are responsible for overseeing implementation of and ensuring compliance with this policy.

References

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

History

Effective Date: 09/03/2024
Next Review Date: 09/02/2027