随着临床研究的广泛开展,各参与方都逐渐意识到开展临床研究需要符合伦理规范的重要性。 本文首先介绍了国际公认的临床研究伦理规范及我国伦理委员会所遵守的国内法律法规。并进一步阐述了按照伦理法规和准则,伦理委员会需对临床研究重点审查3 个方面:科学性、伦理性及质量的保证,包括如何评价临床研究风险受益比、何为恰当的知情同意过程、受试者招募和隐私保护及信息保密的合适措施、持续伦理审查的要求、研究信息的公开注册与结果公布及为保证质量的相应规定的应用等。 同时指出了我国临床研究中未能遵守伦理规范的常见问题。

With the widely conduct of clinical research, various players involved in clinical research have realized that it is vital to comply with the ethical guidelines. The present article begins with the introduction of the current internationally recognized ethical principles and the national regulation. In addition, the application of these ethical principles and regulation in the 3 key aspects of ethical review including science, ethics and quality assurance are highlighted. For instance, how to assess the risk/benefit ratio, the appropriate informed consent process, subject recruitment/privacy and confidentiality protection,the requirements of the continuing review, and research registration, publication and dissemination of results. Lastly, the common noncompliance findings in China are discussed.