药物临床试验研究者视角下的受试者权益保护情况调查研究——以北京某三甲医院药物临床试验机构的调查研究为例

发布时间：2018-10-20 07:53

【摘要】：目的:了解受试者权益保护的实施现状,探索分析可能的影响因素并提出相应的建议。方法:以药物临床试验机构的研究者作为调查对象,通过对北京某三甲医院药物临床试验机构中取得药物临床试验质量管理规范的医护人员进行现场问卷调研,共发放问卷150份,回收138份,运用SPSS 17.0进行数据统计分析。结果:调查发现,药物临床试验受试者权益保护情况整体较好。但研究者因临床任务重、接受培训不充分、药物临床试验研究性质与临床治疗性质的区别等原因,导致受试者权益保护方面仍有一定欠缺,尤其是受试者的知情同意权和隐私权的保护有进一步完善和严谨的必要。结论:针对这些问题,结合调查者的意见,研究建议通过改制设岗、明确立法、加强监管以及强化培训等措施来加强对药物临床试验受试者权益的保护。
[Abstract]:Aim: to understand the present situation of the protection of subjects' rights and interests, to explore and analyze the possible influencing factors and to put forward corresponding suggestions. Methods: a questionnaire survey was carried out among the medical staff who obtained the quality management standard of the drug clinical trial in a third class hospital in Beijing by taking the researchers of the drug clinical trial institution as the investigation object. A total of 150 questionnaires were sent out, 138 were recovered, and SPSS 17.0 was used for statistical analysis. Results: the results showed that the protection of subjects' rights and interests was better in clinical trials. However, due to the heavy clinical tasks, inadequate training, the difference between the nature of drug clinical trial research and the nature of clinical treatment, there are still some deficiencies in the protection of the rights and interests of the subjects. Especially, the right of informed consent and the protection of privacy are necessary. Conclusion: in view of these problems and combined with the opinions of the investigators, the study suggests that the protection of the rights and interests of the subjects in clinical trials of drugs should be strengthened through the measures of reforming the system and setting up the post, making clear the legislation, strengthening the supervision and strengthening the training.
【作者单位】：首都医科大学附属北京地坛医院;首都医科大学;
【分类号】：R969.4

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