College of Medicine, Central Michigan University, Mt. Pleasant, MI, USA.
Theor Med Bioeth. 2024 Dec;45(6):447-459. doi: 10.1007/s11017-024-09682-2. Epub 2024 Sep 11.
The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry significant foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk-benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research.
首次人体临床试验（FIH）的目的是收集有关药物或器械如何影响和与人体相互作用的信息：其安全性、副作用和（潜在）剂量。因此，FIH 试验的主要目标不是参与者的利益，而是获得药物或器械疗效的知识，即基本的人体安全知识。一些 FIH 临床试验对参与者具有重大可预见风险，几乎没有可预见的参与者受益。对于参与者来说，参与此类试验将是一个糟糕的选择，而且由于具有重大潜在社会效益的承诺，研究被认为是合理的。我认为，风险 FIH 研究中存在内在的伦理紧张关系，研究人员应该公平地补偿风险 FIH 试验参与者。这并没有使风险效益结果对参与者更加有利；相反，这相当于对研究中内在的伦理紧张关系进行集体清算。
