病例报告的伦理审查辩护及审查要点

The Defense and Key Points of Ethical Review of Case Reports

目前国内外均无有关病例报告伦理审查的法律法规、伦理准则和监管要求,病例报告是否需要伦理审查,在不同地区、不同国家、不同医疗机构存在不同的规范,国内外不同期刊的规定也不一致。通过对病例报告发表是否需要伦理审查批准的讨论,总结当前病例报告发表存在隐私保护和知情同意的问题,提出病例报告伦理审查要点,包括病例报告的科学性,患者隐私保护,知情同意以及利益冲突管理,以使病例报告合乎伦理规范,促进医学科学发展。

At present, there are no laws and regulations, ethical standards, and regulatory requirements related to ethical review of case reports at home and abroad. Whether ethical review is required for case reports, there are different norms in different regions, countries and medical institutions, and the provisions of different journals at home and abroad are also inconsistent. Through the discussion on whether the publication of case reports needs ethical review and approval, this paper summarized the problems of privacy protection and informed consent existing in the publication of case reports, and proposed the key points of ethical review of case reports, including the scientific nature of case reports, patient privacy protection, informed consent and conflict of interest management, with a view to making case reports conform to ethical standards and promoting the development of medical science.