Abstract
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. Six focus areas were identified by the working group and included vital items of protocol review, composition of the review committee, post-approval monitoring and adverse event reporting, consideration of special circumstances such as satellite sites and the use of healthy veterinary subjects in research, and the informed consent process.This document outlines a broadly agreed-upon framework through which to approach vital items associated with veterinary clinical study protocol review and approval. These approaches represent current best practice in the review and approval of veterinary clinical studies, and can serve as a guidance for veterinary clinician-scientists and regulatory experts, to ensure robust and ethically conducted studies that can contribute to the advancement of both animal and human health.
Highlights
With increasing collaborative initiatives across the landscape of human and veterinary medicine, a unique opportunity exists for a comparative medicine approach that leverages natural disease in veterinary patients to positively impact translational medicine efforts such that both animals and people benefit
It is clear that groups reviewing veterinary clinical studies must consider some aspects of the regulatory framework surrounding the use of animals in research, but they must examine ethical questions similar to those articulated by the National Institutes of Health (NIH) as vital during human trial review and approval as well as have a clear understanding of the practice of and regulations associated with veterinary medicine
This document represents a collaborative effort by Clinical and Translational Science Awards (CTSA) One Health Alliance (COHA) member institutions to define best practices for veterinary clinical study review and approval by institutional review boards and to highlight areas of need for resource development
Summary
With increasing collaborative initiatives across the landscape of human and veterinary medicine, a unique opportunity exists for a comparative medicine approach that leverages natural disease in veterinary patients to positively impact translational medicine efforts such that both animals and people benefit. It is clear that groups reviewing veterinary clinical studies must consider some aspects of the regulatory framework surrounding the use of animals in research, but they must examine ethical questions similar to those articulated by the National Institutes of Health (NIH) as vital during human trial review and approval as well as have a clear understanding of the practice of and regulations associated with veterinary medicine. This means that robust and efficient review and approval of veterinary clinical studies requires an understanding of complex regulatory, scientific, and hospital/ethical issues. Are procedures for reporting clearly defined? To whom will minor versus serious adverse events be reported and with what frequency? How will reporting across sites be handled? What criteria will determine if a patient is removed from the study? What criteria might necessitate the study being halted entirely?
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