疫情时代HCT中的刑事法律风险分析——以受试者同意为视角  

Criminal Legal Risk Analysis of HCT in Pandemic Era——From the Perspective of Subject’s Consent

作　　者：邢丽珊 郑延谱[1] Xing Lishan;Zheng Yanpu

机构地区：[1]北京师范大学法学院

出　　处：《医学与法学》2023年第1期65-73,共9页Medicine and Jurisprudence

摘　　要：HCT因其快速且有效的特点而被适用于抵抗新冠病毒的相关研制之临床医学试验中,但需要特别接受社会伦理及个人权利保障的审视。在尽快推进医疗人体试验、使其在安全范围内实现维护公共利益与保护个人权利之平衡的风险环境中,HCT因其特殊性而在客观上存在诸多刑事法律风险,其中要规避的核心是违反受试者的同意权,故试验操作主体应当尊重受试者的自主选择权,以缓解个人权利保护与实现公共利益间的冲突;而受试者同意原则不仅涉及到伦理委员会的合规审查这一前提,而且还能将其作为正当性抗辩理由以应对相关刑事法律风险。Due to its rapid and effective characteristics,HCT is suitable for clinical trials related to the development of COVID-19 resistance,but it needs to be examined by social ethics and the protection of individual rights.In the risk environment of promoting medical human trials as soon as possible to achieve the balance between safeguarding public interests and protecting individual rights within the safe range,HCT objectively has many criminal legal risks due to its particularity,among which the core to be avoided is violating the consent right of the subjects,so the test operators should respect the subjects’independent choice to ease the conflict between the protection of individual rights and the realization of public interests.And subject consent principle not only involves the premise of compliance review by the ethics committee,but also can be used as a justification defense to deal with the relevant criminal legal risks.

关 键 词：新冠疫情 人体试验 医疗技术 刑事法律风险 受试者同意 

分 类 号：D923[政治法律—民商法学] D924.3[政治法律—法学]