中华医学会系列杂志关于伦理委员会的审批以及知情同意的规范

162中华消化外科杂志2021年2月第20卷第2期Chin J Dig Surg.FJniary2021.\()1.20.No.2
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读者•作者•编者
中华医学会系列杂志关于伦理委员会的审批
以及知情同意的规范
在临床试验研究中涉及人体数据的研究时，应该在文中说明所采用的试验程序是否已经通过伦理审查委员会（单位或国家）的评估，并著录其审批文号;如果没有正式的伦理委员会.则应在文中描述该研究是否符合2013年修订的《赫尔辛基宣言》（/en/30publications/10policies/b3/index.html）的要求。

通常情况下，涉及人的研究包括以下几种：
⑴针对个体采取干预措施，获得相关安全性和（或）有效性的信息:如药物、医疗器械、手术疗法、健康宣教等。

⑵与个体直接接触,通过采血或组织标本、访谈或调查问卷等形式收集个人信息：
⑶收集既往保存的个人信息，涉及隐私且可辨别个人身份。

中华医学会杂志社
2018年5月。