Medical Ethics, Department of Clinical Sciences, Faculty of Medicine, Lund University, BMC I12, 22184 Lund, Sweden.
Regen Med. 2020 May;15(5):1647-1660. doi: 10.2217/rme-2019-0126. Epub 2020 Jul 1.
Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells cannot be taken out of the patient's body if the patient wants to withdraw.
关于知情同意中自愿性内容的共识尚缺乏。需要核心标准来确保自愿同意。本文概述了自愿性的多维性，并确定了哪些因素可能会降低自愿性，特别是在涉及细胞治疗的首次人体临床试验中。在这些试验中，真正的自愿同意尤为重要，因为：这些试验可能涉及严重伤害的风险，而在某些疾病的情况下，合格的患者通常有潜在有效的治疗替代方案；考虑参与高风险首次人体试验的患者可能感到更加绝望，一些患者可能依赖于他们的照顾者，包括那些在家庭中的照顾者；如果患者想要退出，植入的细胞不能从患者体内取出。
