GUIDANCE DOCUMENT
CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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
- Docket Number:
- FDA-2023-D-2654
- Issued by:
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Guidance Issuing OfficeCenter 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.
Questions?
- Steven Fleischer
- Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-110
Rockville, MD 20855
- steven.fleischer@fda.hhs.gov
- 240-402-0809