本书以医学研究中受试者权益保护问题为视角，运用辩证唯物主义的分
析方法、比较法、实证分析法等多种研究方法，分析了医学研究受试者权益
保护的基本理论及基本原则，明确了受试者权益保护的内容和范围，厘清了
受试者权益保护中的法律关系与法律责任，研究了受试者权益保护的主要管
理制度。同时，对特殊受试者的权益保护及多中心临床试验中的受试者权益
保护问题进行了探讨。
样章试读
目录
- 目录
第一章受试者权益保护概述 ·················································· 1
第一节受试者权益保护的渊源与历史 ·············································· 1一、早期的医学研究与典型的人体试验 ········································ 1二、第二次世界大战中的人体试验和《纽伦堡法典》 ······················ 2三、战后人体试验与《贝尔蒙报告》 ··········································· 4四、受试者权益保护现状与发展趋势 ········································· 10第二节伦理法律规范概况 ··························································· 12一、国际伦理规范 ································································· 12二、部分国外法规指南 ··························································· 27三、国内法规指南 ································································· 32
第二章 受试者权益保护的理论基础········································39
第一节伦理基础 ······································································· 39一、医乃人学 ······································································· 39二、敬畏生命 ······································································· 41三、个体道德权利辨析 ··························································· 41四、医学公正 ······································································· 43五、固有的伦理冲突之后的道德选择 ········································· 44第二节法理基础 ······································································· 46一、关于受试者甘冒风险的正当性 ············································ 47二、关于受试者的弱势地位 ····················································· 48三、关于心智不全者的受试 ····················································· 50四、关于受试者权益的人权属性 ··············································· 51第三节伦理与法律的结合 ··························································· 52一、人类思想史上有关道德与法律关系的争论 ····························· 52二、法律与道德之间存在着本质联系 ········································· 54三、人体试验必须实现法律与伦理道德的结合 ····························· 56
第三章受试者权益保护的基本原则········································60
第一节人体试验目的纯正原则 ····················································· 60一、人体试验目的的双重性 ····················································· 60二、人体试验目的纯正原则的提出 ············································ 60三、人体试验目的纯正原则 ····················································· 61第二节知情同意原则 ································································· 62一、知情同意权的提出 ··························································· 62二、人体试验的知情同意原则 ·················································· 64三、知情同意特殊问题的处理 ·················································· 66第三节受试者利益首要原则 ························································ 68一、受试者利益首要原则的提出 ··············································· 68二、人体试验的受试者利益首要原则 ········································· 68三、特殊问题：人体试验资源的适当保护 ··································· 69第四节程序公正原则 ································································· 70一、程序公正原则的提出 ························································ 70二、人体试验的程序公正原则 ·················································· 71三、伦理审查委员会的设置 ····················································· 73
第四章受试者权益保护中的法律关系·····································75
第一节法律关系概述 ································································· 75一、法律关系的概念、特征和种类 ············································ 75二、法律关系的构成要素 ························································ 77三、法律关系的运动 ······························································ 80第二节医学临床试验的法律关系 ·················································· 81一、医学临床试验的界定 ························································ 81二、医学临床试验的法律关系 ·················································· 85
第五章受试者权益及其范围·················································96
第一节受试者权益概述 ······························································ 96一、从权利的一般属性看受试者权益 ········································· 96二、受试者权益的应然性与实然性 ············································ 97三、人体试验立法宗旨、原则与受试者权益 ································ 98四、受试者权益类型界定 ························································ 99五、受试者权益界限与权利冲突 ·············································· 100第二节受试者的人格权 ····························································· 102一、一般人格权 ··································································· 102 二、法定人格权 ··································································· 104第三节受试者的其他权利 ·························································· 108一、利益分享权 ··································································· 108二、损害救济权 ··································································· 109三、权益保护优先权 ····························································· 110
第六章受试者权益保护中的法律责任 ··································· 112
第一节民事法律责任 ································································ 112一、民事法律责任 ································································ 112二、侵害受试者权益的侵权责任的构成要件 ······························· 113三、侵害受试者权益的侵权责任承担主体及责任承担方式 ············· 121第二节行政法律责任 ································································ 125一、行政法律责任概述 ·························································· 125二、违法实施人体医学试验侵害受试者权益应当承担的行政责任 ···· 127第三节刑事法律责任 ································································ 130一、刑事法律责任概述 ·························································· 130二、侵犯医学研究受试者权益应承担的刑事责任 ························· 132
第七章特殊受试者的权益保护 ············································ 135
第一节儿童与未成年人 ····························································· 136一、儿童药物试验的必要性及国际发展趋势 ······························· 136二、部分儿童研究的案例回顾 ················································· 137三、儿童药物试验的有关概念 ················································· 139四、儿童药物试验的伦理问题 ················································· 140五、我国儿童临床试验现状与存在问题 ····································· 143第二节孕妇与胎儿 ··································································· 144一、风险受益的特殊问题 ······················································· 145二、涉及孕妇或胎儿研究的科学与伦理要求 ······························· 145三、直接针对孕妇健康研究的伦理问题 ····································· 146四、直接针对妊娠研究的伦理问题 ··········································· 146第三节精神或认知障碍者 ·························································· 146一、涉及精神或认知障碍者研究的有关概念 ······························· 146二、涉及精神或认知障碍者研究的伦理问题 ······························· 147第四节囚犯 ············································································ 148一、部分囚犯研究的案例回顾 ················································· 148二、涉及囚犯研究的伦理问题 ················································· 149
第五节其他特殊受试者群体 ······················································· 151一、终末期患者 ··································································· 151二、健康志愿者 ··································································· 152三、福利机构人员 ································································ 153四、少数民族 ······································································ 154
第八章受试者权益保护管理制度 ········································· 157
第一节伦理审查制度 ································································ 157一、伦理审查模式 ································································ 157二、伦理审查若干具体制度 ···················································· 159
第二节知情同意制度 ································································ 165一、知情同意的基本要求 ······················································· 165二、知情同意的免除 ····························································· 167
第三节伦理监管制度 ································································ 168一、对伦理委员会的监管 ······················································· 168二、对受试者保护的评估与认证 ·············································· 169
第九章多中心临床试验中的受试者保护 ································ 172
第一节多中心临床试验概述 ······················································· 172一、我国多中心临床试验增多的原因分析 ·································· 172二、多中心临床试验的我国相关法规 ········································ 176三、国际多中心临床试验问题事件 ··········································· 177
第二节多中心临床试验引发的伦理问题思考 ·································· 180一、“双重标准”问题 ···························································· 180二、知情同意问题 ································································ 182三、试验后获益问题 ····························································· 183四、多中心临床试验的伦理审查模式 ········································ 185
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