摘要：

【目的】分析国家法规和行业规范在指导医学期刊临床研究科技伦理审核时遇到的问题,并尝试提出解决办法。【方法】总结归纳4项法规和规范中涉及的临床研究科技伦理审核内容,包括:国家卫生健康委员会等部门颁布的《关于印发涉及人的生命科学和医学研究伦理审查办法的通知》、中国科学技术协会发布的《科技期刊出版伦理规范》、国际医学期刊编辑委员会发布的Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals、临床试验报告的统一标准工作组发布的随机对照研究报告规范CONSORT 2010。分析其在实际应用中遇到的问题。【结果】4个法规和规范中涉及的科技伦理审查内容主要包括伦理原则和研究方法两部分。医学期刊对伦理原则的审核执行较好,但将研究方法作为科技伦理审核的内容尚属空白,此外还面临多学科交流沟通欠缺、如何符合国情等问题。【结论】在学会组织下,以期刊为主导,形成多学科工作组,制订医学期刊临床研究科技伦理审查清单,有助于提高科技伦理审查水平,助力我国医学期刊高水平发展。

关键词: 法规, 规范, 临床研究, 科技伦理审查

Abstract:

[Purposes] To analyze the problems encountered in the scientific ethical review of clinical research in medical journals under the guidance of national regulations and industry norms, and try to come up with solutions. [Methods] The contents of scientific ethical review of clinical research in four regulations and norms were summarized, these were Measures for Ethical Review of Life Science and Medical Research Involving Human Beings promulgated by National Health Commission and other departments, Ethical Guidelines for Publication of Scientific Journals released by China Association for Science and Technology, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals released by International Committee of Medical Journal Editors, CONSORT 2010 released by Consolidated Standards Of Reporting Trails Working Group. The problems encountered in practical application were analyzed. [Findings] The content of scientific ethical review in the four regulations and norms mainly includes two parts: ethical principles and research methods. The review of ethical principles was well carried out in medical journals, but there was still a gap in taking research methods as the content of scientific ethical. In addition, there were still problems such as lack of multidisciplinary communication and how to conform to national conditions. [Conclusions] The authors suggested that under the organization of the society, a multidisciplinary working group should be formed to formulate a list of scientific ethical review for clinical research in medical journals, which will good for the the level of scientific ethical review and the high-level development of medical journals in China.

Key words: Regulations, Norms, Clinical research, Scientific ethical review