人体伦理培训研究.pptx

涉及人体实验的伦理培训 涉及人体研究的历史回顾 纽伦堡公约（1947) 赫尔辛基宣言（1964） 贝尔蒙报告（1979） 涉及人的生物医学研究伦理审查办法（2007） Nuremberg Code (1947) During the Nuremberg War Crimes Trials: 23 German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.” Nuremberg Code (1947) As part of the verdict, the Court enumerated some rules for Permissible Medical Experiments, now known as the “Nuremberg Code”. These rules include: voluntary consent experiment yielded results for good of society benefits outweigh risks ability of the subject to terminate participation Declaration of Helsinki (1964, ’75,’83,’89,2000,2008) 重要原则之一是：任何情况下，社会和科学的利益不能超越受试者个人的利益和福利。 The Willowbrook Hepatitis Study New York (1963-1966) Conducted on mentally retarded, institutionalized children Involved systematically infecting the children with hepatitis Parents were coerced into consenting Jewish Chronic Disease Hospital New York (1963) Cancer Experiments Injection of live cancer cells Hospitalized elderly patients Indigent subjects were injected with live cancer cells without their knowledge or consent Tuskegee Syphilis Study Study of untreated syphilis in the black male Conducted by the U.S. Public Health Service from 1932 to 1972 Subjects not told that they had syphilis, nor offered effective treatment once it came available The Belmont Report (1979) 尊重和保护受试者（Respect for persons） 尊重和保护受试者的隐私，受试者自主决定同意或者 不同意受试的权利，严格履行知情同意程序，不得使 用欺骗、利诱、胁迫等不正当手段使受试者同意受试， 允许受试者在任何阶段退出受试； The Belmont Report (1979) 受益（Beneficence） 对受试者的安全、健康和权益的考虑必须高于对科学和 社会利益的考虑，力求使受试者最大程度受益和尽可能 避免伤害； 公平性（Justice） 筛选受试者的标准必须基于公平的原则，而不能基于性 别、种族、易于获取、易受控制或处于易于妥协地位。 公平性还体现在不论贫富贵贱都具有参与获益研究的同 等权利。 黄金大米事件