临床研究结果发布的伦理审查辨析

《涉及人的生命科学和医学研究伦理审查办法》对于临床研究结果的发布提出了伦理审查和知情同意告知的要求。探讨临床研究的结果发布可以最大程度实现临床研究的价值，包括有利于实现临床研究的透明性，有利于增强公众的信赖，有利于落实研究参与者的知情权，并分析了研究结果发布在隐私保护、发布形式、发布时间、科研诚信和学术不端方面带来的潜在伦理问题。建议伦理委员会从隐私风险最小化、发布形式规范化、发布时间合理化三方面进行伦理审查，同时给出了加强多部门协作和跟踪审查以及参与学术不端治理的伦理审查策略建议。

Analysis of Ethical Review on Release of Clinical Research Results

The Measures for the Ethical Review of Life Science and Medical Research Involving Humans firstly set forth requirements for ethical review and informed consent notification for the release of clinical research findings. This paper discusses how the results release of clinical research can maximize the value of clinical research, including the transparency of clinical research, the enhancement of public trust, and ensuring the informed rights of research participants. It also analyzes the potential ethical problems caused by the release of research findings in the aspects of privacy protection, release form, timing, research integrity and academic misconduct. The ethics review committee should conduct ethics review from three aspects: minimizing privacy risks, standardizing release forms and rationalizing release timing. Additionally, it also gives ethical review strategy suggestions on strengthening interdepartmental collaboration, follow-up review, and participating in academic misconduct governance.