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《临床传统医学和药理学》学术研究实施与报告的推荐规范-生物医学伦理
Recommended Guidelines for the Implementation and Reporting of Academic Research in Clinical Traditional Medicine and Pharmacology
生物医学伦理
Biomedical Ethics
总览：遵循国际医学期刊委员会（ICMJE） 对生物医学类稿件的统一要求（ICMJE Recommendations）。
Follow the International Committee of Medical Journal Editors (ICMJE) recommendations for biomedical manuscripts.
在报告涉及人类受试者、其数据或生物材料的研究时，作者应声明该研究已获得相应机构和/或国家研究伦理委员会的批准（或豁免），并注明伦理委员会名称，同时证明研究符合《赫尔辛基宣言》及其后续修订版所规定的伦理标准或同等伦理标准。若存在研究是否符合《赫尔辛基宣言》或同等标准的疑虑，作者必须阐明其研究方法的依据，并证明独立伦理委员会或机构审查委员会已明确批准研究中存在争议的部分。若研究获得伦理审批豁免，此情况亦应在稿件中详细说明（包括豁免理由）。
When reporting a study that involved human participants, their data or biological material, authors should include a statement that confirms that the study was approved (or granted exemption) by the appropriate institutional and/or national research ethics committee (including the name of the ethics committee) and certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. lf doubt exists whether the research was conducted in accordance with the 1964 Helsinki Declaration or comparable standards, the authors must explain the reasons for their approach, and demonstrate that an independent ethics committee or institutional review board explicitly approved the doubtful aspects of the study. lf a study was granted exemption from requiring ethics approval, this should be detailed in the manuscript (including the reasons for the exemption).
1.临床试验：
1.Clinical trials:
当论文的主体以人为研究对象时，作者应说明其遵循的程序是否符合机构或国家人体试验委员会制订的伦理学标准及赫尔辛基宣言（2013 年修订版），提供经过伦理机构批准的伦理批件的复印件，包括伦理委员会的名称、批件中的批准序列号。
When the subject of a paper's research involves human subjects, the author should state whether the procedures followed comply with the ethical standards established by institutional or national human research ethics committees and the Declaration of Helsinki. A copy of the ethics approval document issued by the ethics committee should be provided, including the name of the ethics committee and the approval serial number.
所有研究人员应当确保人体研究的实施计划和报告符合 2013 年修订的《赫尔辛基宣言》的要求。所有作者都应当征求独立的地方、区域或国家审查机构（例
如，伦理委员会、机构审查委员会）批准其实施研究。如果研究的实施是否符合《赫尔辛基宣言》 的要求受到质疑，则作者必须解释采用其研究方法的理由，并证明地方、区域或国家审查机构已明确批准了受到质疑的那部分研究。CTMP承认在世界卫生组织（WHO）国际临床试验注册平台（International
Clinical Trials Registry Platform，ICTRP www.who.int/ictrp/network/ primary/en/index.html）上的任何一家一级注册机构（包括含 24 项必填条目的试验注册数据集）， 或在WHO ICTRP 的数据提供者 Clinical Trials.gov上完成的可公开获取的注册。CTMP要求在文中刊出临床试验注册号。
All researchers should ensure that the implementation plans and reports of human research comply with the requirements of the Declaration of Helsinki. All authors should seek approval from an independent local, regional, or national review body (e.g., ethics committee, institutional review board) for the conduct of their research. If the compliance of the research implementation with the Declaration of Helsinki is questioned, authors must justify the rationale for their research approach and demonstrate that the local, regional, or national review body has explicitly approved the contested portion of the research. CTMP acknowledges that any primary registry on the World Health Organization (WHO) International Clinical Trials Registry Platform by any registry (including trial registration datasets containing 24 mandatory items) or a publicly accessible registration completed on Clinical Trials.gov, a data provider of WHO ICTRP. The ICMJE recommends that journals publish the clinical trial registration number at the end of the abstract and CTMP requires the publication of clinical trial registration numbers in the text.
临床试验注册是临床试验在CTMP上发表的基本要求。在稿件的标题页上，请注明试验注册机构名称及试验注册号/标识符。
Registration of Clinical Trials is an essential requirement for publication of clinical trials in CTMP. On the title page of your manuscript, provide the name of the trial registry and the registration number/identifier of the trial.
可接受的网络临床试验注册机构包括以下：
Acceptable web-based clinical trial registries include the following:
前瞻性研究作者需要在 WHO 认可的临床试验注册平台注册，并提供注册号。随机临床试验报告应遵循《试验报告统一标准声明》（CONSORT声明）http://www.consort-statement.org 的建议。简而言之，该声明包含一份检查清单和流程图，旨在提升随机对照试验报告的质量，并提供统一标准。
2.动物实验：
2. Animal Experiments:
报告动物实验时，作者应该说明是否遵循了单位和国家有关实验动物管理和使用的规定。动物研究伦理指南详见国际兽医学编辑协会《关于动物伦理与福利的作者指南共识》。所有应用脊椎动物和（或）无脊椎动物进行的研究均需提供动物伦理申明的描述，需相应的伦理委员会提供伦理批件或说明是否遵循了机构或国家制订的实验动物管理与使用指南。
When reporting animal experiments, authors should state whether they have complied with institutional and national regulations governing the management and use of laboratory animals. For detailed ethical guidelines on animal research, refer to the International Society of Veterinary Medical Editors' Consensus Statement on Guidelines for Authors Concerning Animal Ethics and Welfare. All studies involving vertebrates and/or invertebrates must include a description of the animal ethics statement, accompanied by ethical approval documentation from the relevant ethics committee or a declaration of compliance with institutional or national guidelines for the management and use of laboratory animals.
3. Case Report
患者享有隐私权，不应在没有获得知情同意的情况下受到侵犯。可辨认身份
的信息包括姓名和首字母缩写或住院号，都不应在书面描述、照片或遗传谱系中
公开，除非出于科学的目的该信息是必需的，并且患者（或其父母或监护人）签
署知情同意书，同意发表。论文发表时应省略非必要的能识别患者身份的细节。对身份识别特征可做“去识别”处理。
Patients have the right to privacy, which should not be violated without informed consent. Identifiable information, including names, initials, or hospital identification numbers, should not be disclosed in written descriptions, photographs, or genetic lineages unless such information is essential for scientific purposes and the patient (or their parent or guardian) has signed an informed consent form authorizing its publication. Non-essential details that could identify the patient should be omitted. Identifying characteristics features may undergo “de-identification” processing.
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