【摘要】：知情同意權(quán)是臨床試驗受試者最基本的權(quán)利之一,實踐中侵犯受試者知情同意權(quán)的案例頻頻發(fā)生,我國現(xiàn)有的法律法規(guī)已無法滿足保護(hù)受試者知情同意權(quán)的需要,這就促使對受試者知情同意權(quán)的相關(guān)問題進(jìn)行分析完善,以達(dá)到保護(hù)受試者知情同意權(quán)的目的。本文在對知情同意權(quán)的來源與內(nèi)涵進(jìn)行敘述后,分析了受試者知情同意權(quán)在我國臨床試驗領(lǐng)域所面臨的問題和原因。在此基礎(chǔ)上,借鑒外國先進(jìn)經(jīng)驗,針對我國實踐中問題提出相應(yīng)的完善建議,構(gòu)建一整套保護(hù)受試者知情同意權(quán)的法律法規(guī)機(jī)制,使得知情同意權(quán)在臨床試驗領(lǐng)域能夠有效貫徹實施,最終達(dá)到保護(hù)受試者知情同意權(quán)的效果。
[Abstract]:The right of informed consent is one of the most basic rights of the subjects in clinical trials. The cases of violating the right of informed consent of the subjects occur frequently in practice. The existing laws and regulations of our country can no longer meet the needs of protecting the right of informed consent of the subjects. This promotes the analysis and perfection of the subject's right of informed consent, in order to protect the subject's right of informed consent. After describing the origin and connotation of the right of informed consent, this paper analyzes the problems and causes of the right of informed consent in the field of clinical trials in China. On this basis, draw lessons from the advanced experience of foreign countries, in view of the problems in practice in our country, put forward the corresponding perfect suggestions, build a whole set of laws and regulations to protect the right of informed consent of the subjects. So that the right of informed consent can be effectively implemented in the field of clinical trials, and finally achieve the effect of protecting the right of informed consent.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：D922.16;D923
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本文編號：2321727