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国际医学期刊编辑编委会(International Committee of Medical Journal Editors,ICMJE)对生物医药期刊投稿有统一的规定,凡是发表涉及人体的科学研究成果,均需出具受试者参与试验的知情同意证明,该研究也应得到有关机构伦理委员会的审查和批准,论文的最后需附是否存在利益冲突的声明。1999年国家药监局颁布实施的《药品临床试验管理规范》第17条规定,临床试验方案中应包括各方承担的职责和论文发表等方面的内容。2007年卫生部发布的《涉及人的生物医学研究伦理审查办法(试行)》第
The International Committee of Medical Journal Editors (ICMJE) has uniform provisions for submission of biomedical journals. Any publication of scientific research involving the human body needs to produce a certificate of informed consent of participants participating in the trial. The research should also be reviewed and approved by the agency’s ethics committee, and the final statement must be accompanied by a statement of whether there is a conflict of interest. Article 17 of the Code of Practice on Clinical Trial of Drugs promulgated and implemented by the State Food and Drug Administration in 1999 stipulates that the clinical trial program should include the contents of duties and articles published by all parties. In 2007, the Ministry of Health issued the “Involved Human Biomedical Research Ethics Review (Trial)”