Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
Korean J Anesthesiol. 2012 Jan;62(1):3-12. doi: 10.4097/kjae.2012.62.1.3. Epub 2012 Jan 25.
Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.
临床研究在过去几十年中得到了极大的扩展，因此人们对保护人类受试者的伦理准则越来越感兴趣。本综述按时间顺序总结了第二次世界大战以来的历史丑闻和社会反应，以强调我们必须从历史中吸取教训。还简要描述了涉及人类受试者的研究的国际伦理准则，以便了解临床研究的情况。总结了机构和研究者在人体研究中保护研究对象安全和福利的任务和责任。接下来，作为有争议的话题，安排了几个有争议的伦理问题和见解。本简要回顾和总结旨在突出重要论点，并向机构审查委员会（IRB）提出建议，以促进我们向前推进时临床研究中伦理的未来发展。
