摘要
由2020版中国《药物临床试验质量管理规范》的相关解读入手,从脆弱的概念、原因、群体和个体以及具体情形来阐明脆弱受试者的概念,澄清"脆弱"的相对性。参考国内外法规和伦理原则,并结合现有伦理审查实践要求,梳理涉及脆弱受试者的伦理审查要点。通过分析精神障碍患者、儿童和青少年、孕产妇、老年人等不同类别脆弱人群的特殊考虑,呈现将科研伦理原则落实于临床研究项目伦理审查,根据各自脆弱的原因采取针对性的解决措施,最终实现对脆弱受试者权益和安全的保护。
This paper begins with the interpretation of Good Clinical Practice of Version 2020.It clarifies the meaning of vulnerable subjects and its relativity of "vulnerability" from the concept,causes,groups and individuals,as well as specific circumstances.Referring to the domestic and foreign regulations and ethical principles,and combining with the existing requirements of ethical review practice,this paper forms main points for ethical review involving vulnerable subjects.By analyzing the special considerations of different vulnerable groups,such as patients with mental disorders,children and adolescents,pregnant women,puerperae,the elderly etc,this research implements ethical principles in the ethical review of clinical research,takes targeted solutions according to the reasons of their own vulnerability,and protects the rights and security of vulnerable subjects at length.
作者
沈一峰
王谦
白楠
王春水
翟晓梅
SHEN Yi-feng;WANG Qian;BAI Nan(Shanghai Mental Health Centre,Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China)
出处
《医学与哲学》
2020年第14期12-18,共7页
Medicine and Philosophy
基金
2018年国家重大新药创制科技重大专项资助项目(2018ZX09734005)
2019年上海市科学技术委员会资助项目(19MC1911100)。
关键词
受试者保护
脆弱受试者
伦理审查
精神障碍患者
subject protection
vulnerable subjects
ethical review
patients with mental disorders
