【摘要】：美國是保護(hù)受試者權(quán)益立法的先行者,也有著較為成熟的制度經(jīng)驗(yàn)。但該國的法制經(jīng)驗(yàn),也是在認(rèn)真反思其歷史教訓(xùn)的基礎(chǔ)上獲得的。其在反思塔斯基吉事件等科學(xué)丑聞的基礎(chǔ)上,出臺(tái)了包括通用規(guī)則在內(nèi)的一系列法制建設(shè)舉措,確立了包括知情同意及倫理審查在內(nèi)的受試者權(quán)益保障體系。近年來,聯(lián)邦政府針對(duì)通用規(guī)則的最新修正案中,又表現(xiàn)出強(qiáng)化受試者權(quán)益保障及提高倫理審查效率的取向。美國受試者權(quán)益保障立法的歷史進(jìn)程,可為我國的有關(guān)法制建設(shè)提供正、反兩方面的鏡鑒與啟示。
[Abstract]:The United States is the forerunner of legislation to protect the rights and interests of subjects, and has more mature system experience. But the country's legal experience is also based on careful reflection on its historical lessons. On the basis of reflecting on the scientific scandals such as the Tuskegee incident, it has introduced a series of legal construction measures, including general rules, and established a system of safeguarding the rights and interests of subjects, including informed consent and ethical review. In recent years, the federal government's latest amendment to the general rules shows the orientation of strengthening the protection of subjects' rights and interests and improving the efficiency of ethical review. The historical process of the legislation on the protection of the rights and interests of the subjects in the United States can provide both positive and negative lessons for the construction of the legal system in China.
【作者單位】： 青島大學(xué);國家自然科學(xué)基金委員會(huì);
【分類號(hào)】：D971.2
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本文編號(hào)：2191624