【摘要】：目的:了解受試者權益保護的實施現(xiàn)狀,探索分析可能的影響因素并提出相應的建議。方法:以藥物臨床試驗機構的研究者作為調查對象,通過對北京某三甲醫(yī)院藥物臨床試驗機構中取得藥物臨床試驗質量管理規(guī)范的醫(yī)護人員進行現(xiàn)場問卷調研,共發(fā)放問卷150份,回收138份,運用SPSS 17.0進行數(shù)據(jù)統(tǒng)計分析。結果:調查發(fā)現(xiàn),藥物臨床試驗受試者權益保護情況整體較好。但研究者因臨床任務重、接受培訓不充分、藥物臨床試驗研究性質與臨床治療性質的區(qū)別等原因,導致受試者權益保護方面仍有一定欠缺,尤其是受試者的知情同意權和隱私權的保護有進一步完善和嚴謹?shù)谋匾�。結論:針對這些問題,結合調查者的意見,研究建議通過改制設崗、明確立法、加強監(jiān)管以及強化培訓等措施來加強對藥物臨床試驗受試者權益的保護。
[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;
【分類號】：R969.4

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相關期刊論文 前3條

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本文編號：2282524