医学科研伦理精编PPT课件.ppt

　　伦理审查程序 （一）申请 （二）审查 （三）回避 “申请”与“重新申请” 提交材料： （1）伦理审查申请表 （2）研究或者相关技术应用方案 （3）受试者知情同意书 当项目的实施程序或者条件发生变化时，必须重新获得受试者的知情同意，并重新向伦理委员会提出伦理审查申请 审查 通过审查可以做出批准、不批准或者作必要修改后再审查的决定。 做出的决定应当得到伦理委员会三分之二委员的同意。 指定一个或几个委员进行审查。 申请项目经伦理委员会审查批准后，在实施过程中进行修改的，应当报伦理委员会审查批准。在实施过程中发生严重不良反应或者不良事件的，应当及时向伦理委员会报告。 回避 伦理委员会委员与申请项目有利益冲突的，应当主动回避 无法回避的，应当向申请人公开这种利益 人体实验的道德原则中维护受试者利益指 A.人体实验的危险应该是很小的 B.人体实验的危险不能超过实验带来的利益 C.人体实验应该是没有风险的 D.人体实验应该以不损害人们的健康为前提 E.人体实验应该预测到所有的风险和预测的价值 人体实验的道德原则，不包括 A.有利于医学和社会发展 B.必须实事求是 C.维护受试者利益 D.严谨的科学态度 E.受试者知情同意 在人体实验中下列做法不合乎伦理的是 A.应特别关照弱势人群的权益 B.受试者可以选择退出试验，但退出后不得要求研究者对其有关情况保密资料 C.如果受试者承担的风险超过所获收益，就不应该进行试验 D.必须首先对受试者的收益、风险和负担进行评估 E.病人作为受试者退出人体试验后，其疾病的治疗不应受到影响 医学科研中的道德含义 医学科研中的道德要求 人体实验的含义和类型 人体实验的道德价值 人体实验的道德原则 人体实验的伦理审查 * * 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. * * In 1966, two decades after Nuremberg, two things occurred. One was the publication in June 1966, of Dr. Henry K. Beecher’s famous New England Journal of Medicine article on “Ethics and Clinical Research,” in which he briefly set forth 22 examples of unethical studies (drawn from a much longer list he had compiled from articles published in an unnamed, prestigious journal over the previous year). He emphasized that these troubling examples came from “leading medical schools, university hospitals, private hospitals, governmental military departments [and] institutes, Veterans Administration Hospitals, and industry.” Also in 1966, Surgeon General Stewart announced that all NIH studies would have to undergo prior examination and approval by panels charged with ensuring that subjects were appropriately protected–