涉及精神障碍患者临床研究的伦理审查要素  

Ethical Review Elements for Clinical Research in Patients with Mental Disorders

作　　者：马琼芳[1] 嵇宏亮[1] 徐美英[1] 温秋卿 姚水宝 MA Qiongfang;JI Hongliang;XU Meiying;WEN Qiuqing;YAO Shuibao(Office of the Ethics Committee,the Third Hospital of Huzhou,Huzhou 313000,China)

机构地区：[1]湖州市第三人民医院伦理委员会办公室,浙江湖州313000

出　　处：《中国医学伦理学》2018年第11期1419-1421,共3页Chinese Medical Ethics

基　　金：浙江省医院可持续发展华润三九研究项目:精神病专科医院人文服务管理的研究(2015ZHA-HRSJ209)

摘　　要：精神障碍疾病可能会影响患者理解知情告知的能力,也可能会影响其做出是否自愿参加临床研究的理性决定能力。而临床试验规定需在受试者知情同意的情况下才能开展,因此在对涉及精神障碍患者参与临床研究,但不能充分给予知情同意时,严格的伦理审查显得尤为重要。通过对涉及精神障碍患者临床研究的伦理审查要素进行分析,以期更好地开展精神障碍患者参与临床研究的伦理审查工作。Mental disorders may affect patients＇ ability to understand informed consentand may affect their ability to make rational decisions about whether they voluntarily participate in clinical research. However, the clinical trial requirements must be conducted with the informed consent of the subjects. Therefore, rigorous ethical review is particularly important when the patients with mental disorders participate in clinical research but can＇ t adequately give informed consent. This paper analyzed the ethical review elements of clinical research involving patients with mental disorders, in order tobetter carry out ethical review for patients with mental disorders participating in clinical research

关 键 词：精神障碍 临床研究 伦理审查 

分 类 号：R-052[医药卫生]