FDA's draft guidance for informed consent with clinical studies is available

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Draft guidance aimed at helping ensure that animal owners understand the risks and benefits of their pet participate in clinical studies, when considering enrollment, is now available from the FDA. The Draft Guidance for Industry (GFI) #282 “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals” outlines the basic elements of informed consent for animal drug clinical studies.

According to the FDA, informed consent is a documented process by which an animal’s owner, or someone acting on their behalf of the owner, voluntarily confirms the owner’s willingness to allow their animal to participate in a particular study, after having been informed of all aspects of the study that may be relevant to the owner’s decision to participate. An animal drug sponsor or investigators that are responsible for conducting the study should ensure that the owner is provided with adequate information and time to allow for an informed decision about whether they want to voluntarily participate in a clinical investigation.

This draft guidance provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals (dogs, cats, and horses).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.

CVM recommends that animal drug sponsors consider the components of the ICF as described in the guidance during the development of their drug. Sponsors are encouraged to contact CVM to discuss the ICF, and these discussions may be particularly important for novel drug classes, novel dosage forms of new animal drugs, or previously unapproved uses or new conditions of use of an approved animal drug (for example, novel routes of administration or target animal species).

The FDA is accepting public comments on the draft guidance for 60 days, starting September 15, 2023. Electronic or written comments on the draft guidance should be submitted by November 14, 2023, to ensure that the agency considers those comments from the public before work begins on the final version of the guidance.

Comments can be submitted electronically via the Federal eRulemaking Portal, or by writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All submissions received must include the docket number (FDA-2023-D-2654) for the draft guidance.

Reference

FDA Seeks Public Comment on Guidance Related to Informed Consent for Companion Animal Studies. News release. September 14, 2023. Accessed September 14, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-seeks-public-comment-guidance-related-informed-consent-companion-animal-studies?utm_medium=email&utm_source=govdelivery