临床研究中艾滋病受试者权益保护的主要问题和对策

发布时间：2018-03-20 10:43

本文选题：临床研究　切入点：艾滋病　出处：《中国新药杂志》2017年17期 　论文类型：期刊论文

【摘要】：目的:通过对临床研究艾滋病受试者的深入调研,分析艾滋病受试者权益保护的实施现状,探索可能的影响因素并提出相应的建议。方法:选取2014年4月—2014年10月北京2家三级甲等医院临床研究的130例艾滋病受试者,收集性别、年龄、学历、年收入、参加临床研究的经历、对自身权益的认知、态度、行为选择等指标,对数据进行统计学分析。结果:临床研究对艾滋病受试者做到了较好的保护,但艾滋病受试者知情同意的签署仍存在干扰因素且其隐私保护存在死角。结论:主要原因在于艾滋病受试者对自身权益和临床研究认知的缺乏、艾滋病受试者个性化治疗的需要与临床研究标准化方案的矛盾、受试者权益保护存在风险漏洞等。针对这些问题,参考被调查者的意见,本研究建议通过加强培训、伦理审查和过程监管,并出台相关政策以改善临床研究艾滋病受试者权益保护的现状,从而更好地保护受试者权益。
[Abstract]:Objective: through the clinical research of AIDS research subjects, analysis the status of implementation of AIDS protection of subjects, to explore the possible influence factors and put forward corresponding suggestions. Methods: from April 2014 to October 2014 2 in Beijing three hospitals clinical study of 130 cases of AIDS subjects collected, gender, age. Education, annual income, to participate in the clinical research experience of their own interests, cognition, attitude, behavior and other indicators, the data were statistically analyzed. Results: the clinical research on HIV / AIDS subjects do better protection, but AIDS subjects signed informed consent and the interference factors still exist in the privacy protection are dead conclusion: the main reason lies in the lack of AIDS subjects on their own interests and clinical study of cognition, need and clinical AIDS subjects personalized treatment research standard scheme spear The shield, the subjects risk vulnerabilities of rights protection and so on. To solve these problems, reference respondents opinion, this study suggests that by strengthening training, ethical review and process supervision, and the introduction of relevant policies to improve the status of AIDS clinical research to protect the rights and interests of the subjects, the rights of subjects from better protection.

【作者单位】：首都医科大学附属北京地坛医院;首都医科大学附属北京佑安医院;首都医科大学;
【基金】：首都卫生发展科研专项资助项目(2014-4-2175)
【分类号】：R95

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