摘要
2023年2月底,国家卫生健康委员会、教育部、科技部及国家中医药管理局新发的《关于印发涉及人的生命科学和医学研究伦理审查办法的通知》,在坚持了《涉及人的生物医学研究伦理审查办法》的基本原则和制度框架前提下,结合国内伦理工作实际情况,对审查的细节和程序进行了优化完善。基于《涉及人的生物医学研究伦理审查办法》,《涉及人的生命科学和医学研究伦理审查办法》扩大了伦理审查适用范围,业内不同专家就审查范围的变化进行了细节的讨论,并基于该变化,提出了涉及可能需要相应调整的审查程序,供读者参考。
At the end of February 2023,the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission,the Ministry of Education,the Ministry of Science and Technology,and the State Administration of Traditional Chinese Medicine.It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans,and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review.Based on the Ethical Review Measures for Biomedical Research Involving Humans,the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review.Different experts in the field have discussed in detail the changes in the scope of review,and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers reference.
作者
贾敏
訾明杰
王维东
刘强
陆麒
韩梅
JIA Min;ZI Mingjie;WANG Weidong;LIU Qiang;LU Qi;HAN Mei(Medical Ethics Committee,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;World Federation of Chinese Medicine Societies,Beijing 100101,China;Ethics Committee,Renji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200001,China;Deheng Law Firm,Beijing 100033,China)
出处
《中国医学伦理学》
2023年第10期1122-1126,共5页
Chinese Medical Ethics
基金
北京市医学伦理管理和审查质量提高项目“医疗卫生机构伦理委员会秘书能力提升培训体系研究”(科教处2023lunli04)。
关键词
伦理审查
适用范围
生物样本
信息数据
行为
信息处理
信息保护
Ethical Review
Scope of Application
Biological Sample
Information Data
Behavior
Information Processing
Information Protection
