September 14, 2023

Today, the U.S. Food and Drug Administration is announcing the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies.

Informed consent is a documented process by which an animal’s owner – or someone acting on behalf of the owner – voluntarily confirms the owner’s willingness to allow their animal(s) 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 investigator (the individual responsible for all aspects of the conduct of the study at their study site) 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This draft guidance provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals (dogs, cats, and horses).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The FDA is accepting public comments on the draft guidance for 60 days from the date of publication in the Federal Register, starting September 15, 2023. The public should submit either electronic or written comments on the draft guidance by November 14, 2023, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. 

Comments can be submitted electronically via the Federal eRulemaking Portal, or in 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 No. FDA-2023-D-2654 for “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals.”  

For more information:

• GFI #282, “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals”