ABSTRACT:This article describes oversight mechanisms for clinical research that have developed substantially over the last few decades, including institutional review boards and data safety and monitoring boards. LeRoy Walters and others in the 1970s in the US thoughtfully described the importance of fundamental ethical principles and the application of bioethics to clinical research. Dr. Walters’s important essay and work with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research helped identify and explain ethical principles that guide research. These principles, subsequently enunciated by the Commission in the Belmont Report, remain central to our understanding of the ethics of clinical research and are the foundation of our regulations. In this article, I review some history, successes, and challenges of IRBs and DSMBs to exemplify the significance of understanding and applying ethical principles to the design and conduct of clinical research, and to honor Dr. Walters’s contributions.

中文翻译：

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临床研究监督中的生物伦理学：机构审查委员会以及数据和安全监控委员会。

摘要：本文介绍了在过去几十年中已取得实质性进展的临床研究监督机制，包括机构审查委员会以及数据安全和监视委员会。LeRoy Walters等人在1970年代的美国深思熟虑地描述了基本伦理原则的重要性以及生物伦理学在临床研究中的应用。沃尔特斯博士的重要论文以及与美国国家生物医学和行为研究人类保护委员会的合作，有助于确定和解释指导研究的伦理原则。这些原则随后由委员会在《贝尔蒙特报告》中阐明，仍然是我们对临床研究伦理学理解的核心，并且是我们法规的基础。在本文中，我回顾了一些历史，成功经验，