世界医学协会《赫尔辛基宣言》:涉及人类受试者的医学研究伦理原则  

World Medical Association Declaration of Helsinki:ethical principles for medical research involving human subjects

作　　者：吴文瑶(译) 张谨(译) 郑华(译) 张咸伟(译)[1] Wu Wenyao;Zhang Jin;Zheng Hua;Zhang Xianwei(Department of Anesthesiology,Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology(HUST),Wuhan City,Hubei Province 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院麻醉科,武汉市430030

出　　处：《中华疼痛学杂志》2020年第2期92-95,共4页Chinese Journal Of Painology

摘　　要：世界医学会《赫尔辛基宣言》是全世界医学研究都必须遵循的伦理学原则,医学科学的进步离不开以患者为对象的临床研究。在此过程中,如何才能不损害患者的利益,不伤及患者的身心健康,是极为重要的问题。这篇宣言内,明确指出只有在临床研究的意义超过患者所承担的风险时才能进行,并详细规定了对患者利益的保护、研究计划的设计、伦理委员会的建立、患者及其家属的知情同意、安慰剂的使用,以及研究后论文的发表等诸项。我国医生在临床研究时必须严格遵守此宣言的规定。The World Medical Association(WMA)Helsinki Declaration is an ethical principle for medical research throughout the world.Advances in medical science are inseparable from clinical research targeting patients.In this process,it is extremely important to avoid harming the interests of patients,and damaging the physical and mental health of patients.The Declaration clearly points out that clinical research may only be conducted if the importance of the objective outweighs the risks to the research subjects,and specifies the protection of the interests of patients,the design of the research plan,the establishment of the ethics committee,and the informed consent of the patient and family members,the use of placebo,and the publication and dissemination of the results of research.Doctors in China must strictly abide by the provisions of this Declaration in clinical research.

关 键 词：赫尔辛基宣言 治疗 临床研究性 伦理准则 

分 类 号：R47[医药卫生—护理学]