Description
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.
Scope & Applicability
Product Classes
3Investigational Veterinary Product risks to study animals.
The test article being evaluated in the clinical investigation.
The category of products covered by this guidance.
Stakeholders
4The owner's decision to terminate participation at any time.
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Regulatory Context
Attributes
2The practice of keeping treatment assignments hidden from certain personnel or owners.
Recommended style for ICFs to ensure owner understanding
Identified Hazards
Hazards
2Risks to human users including any zoonotic concerns.
Human user safety should be considered a component of the ICF.
Related CFR Sections (2)
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 21CFR50.20§ 50.20 General requirements for informed consent.
Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An invesRead full regulation →
Related Warning Letters (4)
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
See Also (8)
- Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry (Status: Final)
- Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry (Status: Draft)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry (Status: Final)
- IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry (Status: Draft)