摘要
赫尔辛基宣言是一篇高度文字概括的重要文献,临床医生在进行临床研究前必须仔细阅读,完全理解,以便认真遵照执行。在这篇解读内,作者逐项作了详细解释,并指出了每项的重要意义。解读强调研究者对知情同意必须告知患者哪项检查与研究有关,在研究中不应有违背患者意愿的过度检查,切不可以为签署了知情同意,研究者就可以为所欲为。对于安慰剂的使用,解读强调与"金标准"对照是首选,以安慰剂甚至不治疗作比较必须十分慎重。解读最后还对研究注册有详尽的说明,并介绍了我国临床研究的注册中心,注册可以帮助研究者查新、完善设计,以及统一评价标准。
Helsinki Declaration is an important document with highly generalization.Clinicians must read it carefully and fully understand it before conducting clinical research,so as to implement it carefully.In this interpretation,the author explains each item in detail and points out the significance of each item.The interpretation emphasizes that the researchers must inform patients about which examination is relevant to the study.In the study,there should be no overexamination against the patients’will.Although the informed consent is signed,the researchers can not do whatever they want.For the use of placebo,the interpretation emphasizes that the"gold standard"control study is the first choice,and comparison with placebo or even without treatment must be cautious.At the end of the interpretation,there is a detailed description of the research registration,and it introduces the registration center of clinical research in China.Registration can help researchers find new ideas,improve design,and unify evaluation standards.
作者
张咸伟
Zhang Xianwei(Department of Anesthesiology,Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology(HUST),Wuhan City,Hubei Province 430030,China)
出处
《中华疼痛学杂志》
2020年第2期96-101,共6页
Chinese Journal Of Painology
关键词
赫尔辛基宣言
伦理准则
临床研究注册
Helsinki declaration
Codes of ethics
Clinical research registration
