FDA Seeks Public Comment on Guidance Related to Informed Consent for Companion Animal Studies

Today, the U.S. Food and Drug Administration is announcing the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand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 Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed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