Ehni Hans-Jöerg, Wiesing Urban
Professor, Institute of Ethics and History of Medicine, Gartenstrasse, 47, 72074 Tübingen, Germany,.
Professor and Managing Director, Institute of Ethics and History of Medicine, Gartenstrasse, 47, 72074 Tübingen, Germany, Germany,.
Indian J Med Ethics. 2017 Jul-Sep;2(3):165-168. doi: 10.20529/IJME.2017.046.
On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.
2016年12月6日，国际医学科学组织理事会发布了其指南的新版本，标题为《涉及人类的健康相关研究国际伦理准则》。在本文中，我们简要描述了修订过程以及这些准则的结构和内容。我们概述了其中一些主要准则，例如关于社会价值、试验后获取以及风险效益比的准则。在我们的总体评估中，我们得出结论，CIOMS准则成功地以堪称典范的方式在保护健康相关研究中的人类受试者与促进此类研究活动之间取得了平衡。这些准则将关键原则与基于研究伦理最新进展的应用指南相结合。因此，它们为研究人员、伦理委员会以及健康相关研究中的其他利益相关者提供了及时且不可或缺的指导。
