Source: AVMA

The U.S. Food and Drug Administration (FDA) has released draft guidance, open for public comment until November 14, aimed at helping animal owners understand the risks and benefits of enrolling their companion animals in clinical studies. The guidance, titled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” addresses the lack of federal regulations governing the informed consent process in Veterinary clinical studies.

The FDA’s Center for Veterinary Medicine recommends using informed consent forms (ICFs) and adhering to Good Clinical Practice guidelines. The American Veterinary Medical Association (AVMA) supports the FDA’s initiative, highlighting the importance of ethical review to ensure the safety and well-being of animals and humans. The AVMA suggests that the guidance will fill gaps in practice standards and aid sponsors in drafting ICFs. The AVMA also emphasizes the role of Veterinary Clinical Studies Committees in evaluating the informed consent process, compensation, and study-related risks and benefits.

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