Establishment and use of veterinary clinical studies committees
The AVMA believes that all veterinary clinical research conducted on client-owned animals should be performed with oversight that ensures the safe and ethical treatment of veterinary patients, while providing appropriate disclosure to, and eliciting informed consent from, clients.
Research on client-owned animals that is federally funded requires oversight by an Institutional Animal Care and Use Committee (IACUC). For projects that fall outside the purview of the IACUC, a Veterinary Clinical Studies Committee (VCSC) should be convened to ensure the research is conducted in accordance with ethical standards. Shelters, humane societies, and other private research entities that conduct clinical research on animals in their care should likewise establish a VCSC to review research protocols. An IACUC may serve as a VCSC or the two committees may be separate. When the two entities are separate, the VCSC should work closely with the IACUC, when applicable, to address any gaps in expertise and oversight relevant to veterinary clinical studies.
A VCSC should review and provide written feedback on study proposals and protocols before the study start date with a goal of ensuring the validity of the study, confirming the safe and ethical treatment of animals involved in the study, preventing conflict of interest issues, and reviewing the qualifications of the study personnel. Further, the VCSC should review and provide regular feedback on protocols, e.g. annually, and also review and approve any changes or amendments that are needed during the course of the study. The VCSC should evaluate the potential risks and benefits of the proposed study particularly if there are no anticipated benefits to animal's health. The VCSC should also evaluate the appropriateness of the informed consent process and any incentives used to encourage enrollment. After study initiation, the committee should weigh the justification for, and validity of, any suggested modifications to study protocols and provide written feedback as necessary. The committee should be consulted and provide written feedback regarding adverse events that might be associated with the study.
The VCSC should include at least one person familiar with veterinary clinical practice and with the informed consent process and ethical concerns. In addition, at least one person not affiliated with the entity performing the study should be included. The committee should consult with clinicians familiar with the veterinary field of study if that expertise is not within the committee. Members of the VCSC associated with studies being reviewed should recuse themselves from the review.