U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals
  1. Search for FDA Guidance Documents


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


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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


Contact Point
Steven Fleischer
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-110
Rockville, MD 20855
Back to Top