翟晓梅 怎 样使生物医学研究符合伦理－历史教训与伦理准则？.pptVIP

不能给出同意的人国际协调会议—临床试验管理规范 非治疗性试验可在由合法监护人代理同意的情况下对受试者进行非治疗性试验。但要遵守的条件： 受试者可预见的风险较低 对受试者福利的负面影响最小并且较低 不能给与同意的人：欧盟临床试验管理规范（GCP） 对不能给与同意的人，如痴呆，精神病患者等，只有在我们有根据认为病人的直接受益超过风险时（即具有直接的好处），我们才可以应用这些医疗产品进行试验（如，医疗器械、药物） 。 欧洲委员会：公约 受试者可以是不能给与同意的人， 即使参与研究没有可预期的直接的受益，也允许他们参加试验 如果研究的目的是通过对个体疾病的科学研究，可使病人个人疾病或症状得到重大改善，这将最终有助于其他受同样疾病或症状折磨的人 美国：免除知情同意的要求 研究的风险不大于最低风险 即使合法监护人同意 儿童：欧盟临床试验管理规范 仅当病人可从临床试验中直接受益… 只有研究的疾病是与未成年人有关的疾病，或由于病情本身的性质只能在未成年人身上进行试验时，儿童才可以成为受试者。 儿童：美国 美国 — 风险最小化 — 试验受试者直接受益 — 可能获得关于受试者疾病或症状的可普遍化 的知识 不过，人们也允许接受略高于最低程度的风险 Thank you very much for your patience！ * And Claude Bernard, in 19th Century, who echoed Maimonides’ very severe restrictions on using human beings as subjects for the sake of knowledge. Yet how relevant are these injunctions to research today, since there was little done then that resembled contemporary research—even Jenner’s famous work on vaccination against smallpox in the 1790s had an ad hoc quality. But there was a line between principles and practice, even then. * And Claude Bernard, in 19th Century, who echoed Maimonides’ very severe restrictions on using human beings as subjects for the sake of knowledge. Yet how relevant are these injunctions to research today, since there was little done then that resembled contemporary research—even Jenner’s famous work on vaccination against smallpox in the 1790s had an ad hoc quality. But there was a line between principles and practice, even then. * * As important as the Nuremberg Code may seem and as prominent as it was when announced, it apparently had almost no affect on the conduct of research in the United States in the first two decades after it was handed down, nor was it extensively discussed in medical journals. Why was that? First, US practices didn’t match Nuremberg testimony Second, the horrors of the concentration camps seemed irrelevant to academic researchers in US (not criminals) Third, saw work as mainstream as part of “war on disease” (carry ove