PDF(Pubmed)
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In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained.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.
摘要：
2023年9月，美国食品和药物管理局（FDA）发布了指南草案，以就如何获得伴侣动物临床试验的知情客户同意发表评论。本指南有可能大幅改变兽医社区知情同意书的编写和提交给客户的方式。它不仅提供了有关如何获得所有者的知情同意的细节，而且还提供了应获得同意的时间表，同意书中的格式和语言，以及这些同意书中所需要素的详细信息。这些变化将涉及调查人员的额外努力，以确保合规性，但可能导致所有者依从性增加，并增加临床研究的入学率，并为所有人带来后续益处。
