Pilot Studies (IACUC)
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.
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.
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 PI, IACUC, and veterinarian. A system for communication with the IACUC should be in place both during and after such studies (Guide, p 28).
BU follows the Guide pilot study requirements.
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.
- It is the responsibility of the investigator to propose a pilot study, as deemed necessary, and to communicate to the IACUC the results of any pilot study completed.
- It is the responsibility of the IACUC to assure that the number of animals to be used in an animal use protocol is appropriate.
- 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 IACUC office for review and approval.
- A pilot study may be requested by the IACUC during protocol review.
- For new procedures:
- If little is known about a specific procedure, the IACUC 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.
- The investigator must report to the IACUC, in writing, the findings of the pilot study via email to IACUC@bu.edu or upload into an electronic IACUC management system.
- 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 IACUC until the results of the pilot study are known.
- For alternative endpoints:
- a. The use of a pilot study is an effective method for identifying and defining humane endpoints and reaching consensus among the PI, IACUC and veterinarian.
- For such studies, a report must be made, in writing, to the IACUC during and after the study. Based on the report, the IACUC will determine if the alternative endpoint can be used on a larger scale.
C. Responsible Parties
It is the responsibility of the IACUC 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.
Effective Date: 10/5/2021
Next Review Date: 10/4/2024
First Approved: 6/3/2014