# Obtaining informed consent in veterinary clinical trials mini review

## TL;DR

This paper discusses new FDA guidance on obtaining informed consent for veterinary clinical trials involving companion animals.

## Contribution

The paper highlights the FDA's draft guidance and its potential impact on veterinary clinical trial practices.

## Key findings

- The FDA guidance specifies how, when, and what to include in informed consent for companion animal trials.
- The guidance may increase owner compliance and clinical trial enrollment.
- Investigators will need to adapt to new requirements for consent documentation.

## Abstract

In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.