Perspectives on implementing veterinary clinical studies committees.

To address the limitations of traditional IACUC review of clinical research studies involving client-owned animals, the AVMA issued a policy describing the use of a veterinary clinical studies committee (VCSC), analogous to an institutional review board, as a way to ensure the adequate review and oversight of such studies. While IACUC composition, review, approval processes, and responsibilities are well established, uniform guidance for VCSCs is not readily available and not included in the guidance for IACUCs. In this manuscript we describe suggested best practices for scientific and ethical review of veterinary clinical research studies, regardless of the specific research setting.

Humane Intervention Points: Refining endpoint terminology to incorporate non-euthanasia intervention options to improve animal welfare and preserve experimental outcomes.

Consideration of The Three R's (Replacement, Reduction, and Refinement) is essential when setting Humane Endpoints; however, a common interpretation assumes that Humane Endpoints are timepoints to perform euthanasia. This interpretation is not always consistent with the three Rs. There are many available intervention options that - when used to respond to pain, discomfort, or distress - facilitate application of the three Rs while achieving experimental goals.

Recommendations for Ethical Review of Veterinary Clinical Trials.

Ethical review of both human and animal research is critical to ensuring that studies are conducted with due regard to the welfare and safety of enrolled subjects and to the integrity of the data. However, differences exist in laws, policies, and best practices between human and animal studies. Ethical review is required for most human studies.

A CTSA One Health Alliance guidance on institutional review of veterinary clinical studies.

Harmonized institutional processes and reviewer training are vital to maintain integrity and ethical rigor of the veterinary clinical research pipeline and are a prerequisite to future work that might establish centralized or single-site ethical and regulatory review to ease initiation of multi-center studies. Funded by a CTSA One Health Alliance (COHA) pilot award, a diverse working group of veterinary clinicians and institutional representatives was convened in February 2020 to develop a guidance document detailing broadly agreed upon practices for ethical review and approval of veterinary clinical studies conducted in the United States.The working group defined key areas of need for consensus, developed a set of associated guidelines, and circulated these for review by COHA's fifteen member institutions.