2023-19951: Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #282 entitled "Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals." As used in this guidance, informed consent is a documented process by which an owner or owner's agent 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. A sponsor or investigator should ensure the owner is provided with adequate information and time to allow for an informed decision about voluntary participation 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 This draft guidance provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals (dogs, cats, and horses). FDA's Center for Veterinary Medicine (CVM) recommends all studies conducted with client-owned companion animals use an ICF and be conducted in accordance with Good Clinical Practice (GCP) guidelines.
The agency’s own summary, as published.
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