Department of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Toronto Centre for Liver Disease, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
Clin Infect Dis. 2023 Aug 14;77(Suppl 3):S216-S223. doi: 10.1093/cid/ciad382.
Global elimination of hepatitis C virus (HCV) will be difficult to attain without an effective HCV vaccine. Controlled human infection (CHI) studies with HCV were not considered until recently, when highly effective treatment became available. However, now that successful treatment of a deliberate HCV infection is feasible, it is imperative to evaluate the ethics of establishing a program of HCV CHI research. Here, we evaluate the ethics of studies to develop an HCV CHI model in light of 10 ethical considerations: sufficient social value, reasonable risk-benefit profile, suitable site selection, fair participant selection, robust informed consent, proportionate compensation or payment, context-specific stakeholder engagement, fair and open collaboration, independent review and oversight, and integrated ethics research. We conclude that it can be ethically acceptable to develop an HCV CHI model. Indeed, when done appropriately, developing a model should be a priority on the path toward global elimination of HCV.
如果没有有效的丙型肝炎病毒 (HCV) 疫苗，全球消灭 HCV 将难以实现。直到最近，当出现高效治疗方法时，才考虑进行 HCV 人体感染控制 (CHI) 研究。然而，既然成功治疗蓄意 HCV 感染是可行的，那么评估建立 HCV CHI 研究计划的伦理学就势在必行。在这里，我们根据以下 10 个伦理考虑因素评估研究 HCV CHI 模型开发的伦理学：充分的社会价值、合理的风险效益比、合适的选址、公平的参与者选择、强有力的知情同意、相称的补偿或报酬、特定背景的利益相关者参与、公平开放的合作、独立审查和监督，以及综合伦理学研究。我们得出结论，开发 HCV CHI 模型在伦理上是可以接受的。实际上，当恰当地进行时，开发模型应该是全球消除 HCV 的道路上的优先事项。
