本文選題：臨床研究　切入點：艾滋病　出處：《中國新藥雜志》2017年17期 　論文類型：期刊論文

【摘要】：目的:通過對臨床研究艾滋病受試者的深入調研,分析艾滋病受試者權益保護的實施現(xiàn)狀,探索可能的影響因素并提出相應的建議。方法:選取2014年4月—2014年10月北京2家三級甲等醫(yī)院臨床研究的130例艾滋病受試者,收集性別、年齡、學歷、年收入、參加臨床研究的經(jīng)歷、對自身權益的認知、態(tài)度、行為選擇等指標,對數(shù)據(jù)進行統(tǒng)計學分析。結果:臨床研究對艾滋病受試者做到了較好的保護,但艾滋病受試者知情同意的簽署仍存在干擾因素且其隱私保護存在死角。結論:主要原因在于艾滋病受試者對自身權益和臨床研究認知的缺乏、艾滋病受試者個性化治療的需要與臨床研究標準化方案的矛盾、受試者權益保護存在風險漏洞等。針對這些問題,參考被調查者的意見,本研究建議通過加強培訓、倫理審查和過程監(jiān)管,并出臺相關政策以改善臨床研究艾滋病受試者權益保護的現(xiàn)狀,從而更好地保護受試者權益。
[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.

【作者單位】： 首都醫(yī)科大學附屬北京地壇醫(yī)院;首都醫(yī)科大學附屬北京佑安醫(yī)院;首都醫(yī)科大學;
【基金】：首都衛(wèi)生發(fā)展科研專項資助項目(2014-4-2175)
【分類號】：R95

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本文編號：1638729