Policy on the Review and Approval of IACUC Mandated Pilot Studies

This policy defines the process for reviewing, approving, and following-up on pilot studies required by the U-M’s Institutional Animal Care & Use Committee (IACUC) before proposed activities can be initiated.

This policy applies to research, teaching, and testing activities involving animals conducted under the auspices of the University of Michigan (U-M). It applies to field research and all campus locations, including Ann Arbor, Flint, and Dearborn.

1. Pilot study – for the purpose of this policy, a pilot study is a preliminary “…study used to test proposed research protocols, data collection instruments, sample recruitment strategies, and other research techniques in preparation for a larger study,”¹ and is required by the IACUC before proposed research can be approved
2. Full Committee Review (FCR) – review at a convened meeting of a quorum of the IACUC

When pilot studies are required by the IACUC before research can be initiated, the associated IACUC protocol application(s) must be reviewed using the FCR process.

During deliberation, the IACUC may define the pilot study design, the number of animals to be involved, and the level of oversight required (e.g., veterinary involvement). The results of the pilot study must be provided in a report to the IACUC before the proposed research can begin.

The provisions of this policy are under the direction and oversight of the U-M’s IACUC.