Grady Christine
Kennedy Inst Ethics J. 2019;29(1):33-49. doi: 10.1353/ken.2019.0009.
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.
本文介绍了过去几十年中得到显著发展的临床研究监督机制，包括机构审查委员会和数据安全与监测委员会。20世纪70年代，美国的勒罗伊·沃尔特斯等人深入阐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他与保护生物医学和行为研究人类受试者国家委员会的合作，有助于确定和解释指导研究的伦理原则。这些原则随后由该委员会在《贝尔蒙报告》中阐明，至今仍是我们理解临床研究伦理的核心内容，也是我们各项法规的基础。在本文中，我回顾了机构审查委员会和数据安全与监测委员会的一些历史、成就和挑战，以例证在临床研究的设计和实施过程中理解和应用伦理原则的重要性，并纪念沃尔特斯博士所做出的贡献。
