1Day Sooner, Lewes, Delaware, USA.
Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, United Kingdom.
Clin Infect Dis. 2023 Aug 14;77(Suppl 3):S224-S230. doi: 10.1093/cid/ciad350.
Ethical human subjects research requires participants to be treated safely and respectfully, yet much bioethical debate takes place without participants. We aim to address this gap in the context of controlled human infection model (CHIM) research. Based upon our own experience as study participants, and bolstered by a survey of 117 potential hepatitis C virus CHIM participants, we present ideas to inform efficient, ethical, and scientifically useful study design. We advocate for full protocol transparency, higher compensation, commitment to the rapid dissemination of study results, and proactive efforts to detail risk-minimization efforts as early as possible in the recruitment process, among other measures. We encourage researchers to proactively partner with volunteer advocacy organizations that promote collective representation of volunteers to maximize their agency, and guard against ethical issues arising from healthy human subjects research.
伦理人体研究要求参与者得到安全和尊重的对待,但许多生物伦理辩论是在没有参与者的情况下进行的。我们旨在解决这一在受控人体感染模型(CHIM)研究中的差距。基于我们作为研究参与者的自身经验,并通过对 117 名潜在丙型肝炎病毒 CHIM 参与者的调查加以支持,我们提出了一些想法,以告知有效的、符合伦理的、科学有用的研究设计。我们主张全面的方案透明度、更高的补偿、承诺迅速传播研究结果、以及尽早在招募过程中积极努力详细说明降低风险的努力等措施。我们鼓励研究人员与志愿者倡导组织积极合作,促进志愿者的集体代表性,以最大限度地发挥他们的作用,并防止因健康人体研究而产生的伦理问题。