精神科临床研究知情同意实施过程的受试者权益保护  

Protection of Subjects' Rights and Interests during the Implementation of Informed Consent in Psychiatric Clinical Researches

作　　者：贾京津[1] 胡昌清[2] 翟屹民[3] 王小婷 丰雷[2] 王巍巍[2] 滕红红[1] 

机构地区：[1]首都医科大学附属北京安定医院伦理委员会,北京100088 [2]首都医科大学附属北京安定医院国家精神心理疾病临床医学研究中心,北京100088 [3]首都医科大学附属北京安定医院药物临床试验机构办公室,北京100088 [4]北京市西城区广内社区卫生服务中心保健科,北京100033

出　　处：《中国医学伦理学》2017年第5期567-571,共5页Chinese Medical Ethics

基　　金：北京市优秀人才青年骨干个人项目(2014000021469G230);北京市医管局青苗人才(QML20161903);北京市新世纪百千万人才工程B类-基于量化评估的治疗在抑郁症全程治疗中的作用;北京市西城区卫生计生委青年科技人才培养项目-北京市广内地区产后抑郁症现状及其影响因素研究;北京市医院管理局重点医学专业发展计划(扬帆计划)-心境障碍(ZYLX201607)

摘　　要：随着精神科临床研究的开展逐渐增多,医学伦理问题日渐引起人们的关注。尽管伦理审查中已对知情同意进行了严格规定,然而面对精神疾病患者这一特殊人群,临床实施过程中仍面临各种问题和挑战。根据相关法律法规,结合精神科临床研究特点,从以下方面论述了精神科临床研究中知情同意实施过程中的受试者权益的保护问题:为受试者提供安静、舒适、相对独立的知情同意环境,保证受试者者充分的知情同意时间,选择具有资质的研究者进行知情同意,保证的知情同意过程有效进行,指导受试者正确签署姓名及日期。With the widely development of psychiatric clinical researches, the ethical issue has been con- cerned gradually. Although the ethical review has strict rules on informed consent, there are many problems and challenges on informed consent implementation because of the special mental illness population. According to the relevant laws and regulations, combined with the characteristics of clinical psychiatric researches, this paper dis- cussed the protection of subjects＂ rights and interests during the implementation of informed consent in psychiatric clinical researches, from the following aspects： providing a quiet, comfortable, and relatively independent environ- ment for the participants to ensure informed consent, guaranteeing full informed consent time, choosing qualified researchers for informed consent, ensuring the effective process of informed consent, and guiding the subjects to correctly sign their names and the date.

关 键 词：精神科 临床研究 知情同意 受试者 

分 类 号：R-052[医药卫生]