FDA creates guidance on informed consent for companion animal studies

Unlike clinical studies involving humans, veterinary clinical studies involve a patient population that can’t provide informed consent or understand the risks associated with a study.

Currently, no federal laws, including the Animal Welfare Act, regulate the informed consent process or address the ethical management of clinical studies that enroll pets.

A dog and his owner consult a veterinarian

But according to a July 2021 Frontiers in Veterinary Science review, “The incorporation of an ethical review is key to reassuring the public that the research studies have been designed and will be conducted with the utmost regard to the safety and well-being of humans and/or animals.”

On September 14, the U.S. Food and Drug Administration (FDA) announced draft guidance that will help animal owners understand the risks and benefits associated with clinical study participation when considering whether to enroll their companion animal. Public comment is open until November 14.

Informed consent is a documented process by which an animal’s owner or authorized person voluntarily confirms their willingness to allow their animal to participate in a particular study after being informed of all aspects of the study that may be relevant to their decision to participate. The owner is given enough information and time to allow for an informed decision.

Draft Guidance for Industry (GFI) #282, “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies.

This guidance provides recommendations on what should be included in informed consent forms (ICF) for researchers conducting studies that enroll client-owned companion animals, such as dogs, cats, and horses.

The FDA’s Center for Veterinary Medicine (CVM) recommends that all studies conducted with client-owned companion animals use an ICF and be conducted in accordance with Good Clinical Practice (GCP) guidelines. The latter is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. FDA CVM also recommends that animal drug sponsors consider using the components of the ICF as described in the guidance during development of their drugs.

Dr. Jessica Bertout, a cancer biologist, and co-founder of the Companion Animal Studies for Translational Research Alliance (CASTR Alliance), and Dr. Kathryn Shelton, associate professor in the Department of Comparative Medicine at MD Anderson Cancer Center in Houston, both serve on the AVMA Council on Research (COR).

The AVMA indicates in its “Establishment and Use of Veterinary Clinical Studies Committees” (VCSC) policy that VCSC oversight should include, among other steps, an evaluation of the appropriateness of the informed consent process, any compensation provided to owners, and the study-related risks and benefits to the patient.

“At our recent meeting, the COR agreed that the proposed FDA guidance on informed consent for companion animal studies will help fill gaps in practice standards for the conduct of studies enrolling client-owned animals,” Drs. Bertout and Shelton said. “An FDA guidance document on informed consent will be a useful resource to aid sponsors in drafting ICFs and VCSCs in reviewing them.”

Additionally, the AVMA policy, which was drafted in collaboration with the AVMA Animal Welfare Committee (AWC), indicates that the VCSC should be composed of veterinarians primarily involved in clinical practice and should work cooperatively with an institutional animal care and use committee (IACUC).

Members of the COR and the AWC composed an article published in the September 2023 issue of JAVMA describing suggested best practices for scientific and ethical review of veterinary clinical research studies, regardless of the specific research setting.

The authors say that to provide appropriate scientific and ethical review, and considering that federally funded animal research requires written Office of Laboratory Animal Welfare (OLAW) assurance and oversight by an IACUC, “we suggest, for situations in which an institution does not own or house laboratory animals, that the VCSC incorporate the relevant roles and responsibilities of an IACUC. As such, the VCSC would then meet the requirements set forth by PHS for oversight of the studies and OLAW assurance.”

More detailed comments on the draft guidance also will be shared with the FDA.

“Overall, the guidance is a needed step towards further shaping the future of clinical research and the One Health approach, with the ultimate goal of improving health care,” say Drs. Bertout and Shelton.

The Clinical and Translational Science Award One Health Alliance (COHA), comprising veterinary colleges partnered with human medical and other colleagues through a National Institutes of Health (NIH) Clinical Translational Science Award (CTSA), has a Clinical Studies Subcommittee that previously developed an informed consent template for use in veterinary clinical studies.

Comments can be submitted electronically or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.