CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals September 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2023-D-2654
• Issued by: Center for Veterinary Medicine

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 guidance provides recommendations on ICFs used for studies that enroll client-owned companion animals (dogs, cats, and horses).  CVM recommends all studies conducted with client-owned companion animals use an ICF and be conducted in accordance with Good Clinical Practice guidelines.

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All written comments should be identified with this document's docket number: FDA-2023-D-2654.

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