Obtaining informed consent in veterinary clinical trials mini review

Area of Science:

• Veterinary Medicine
• Clinical Trials
• Regulatory Affairs

Background:

• Informed client consent is crucial for ethical companion animal clinical trials.
• Current practices for obtaining consent may vary.
• The United States Food and Drug Administration (FDA) oversees veterinary drug and device development.

Purpose of the Study:

• To analyze the implications of the FDA's draft guidance on informed consent for companion animal clinical trials.
• To highlight potential changes in consent document procedures and content.
• To assess the impact of new guidance on veterinary research and client engagement.

Main Methods:

• Review of the September 2023 draft guidance document released by the FDA.
• Analysis of specific requirements for obtaining informed consent from animal owners.
• Examination of proposed changes in consent form formatting, language, and required elements.

Main Results:

• The FDA's draft guidance introduces detailed specifications for informed consent in companion animal trials.
• Key areas addressed include consent acquisition timeframe, document presentation, and mandatory content.
• Implementation requires additional investigator effort but may improve owner understanding and trial enrollment.

Conclusions:

• The new FDA guidance necessitates adjustments in how informed consent is managed for veterinary clinical studies.
• Compliance with the draft guidance could enhance owner engagement and potentially boost clinical trial participation.
• These changes aim to ensure ethical standards and improve the quality of evidence generated from companion animal research.