Associate professor of medicine at CPC Clinical Research at the University of Colorado Anschutz Medical Campus in the Department of Medicine at the University of Colorado Center for Bioethics and Humanities.
Professor of medicine and public health at the University of Colorado Anschutz Medical Campus in the Department of Medicine at the University of Colorado Center for Bioethics and Humanities.
Ethics Hum Res. 2021 Jan;43(1):32-36. doi: 10.1002/eahr.500077.
A research participant's right to withdraw from all research procedures is widely accepted, but there can be justifiable limits to a participant's exercise of autonomy to withdraw from some procedures. Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. Subjects' refusal to complete follow-up, even through passive medical record review, can cause failure to detect safety signals, inaccurate estimation of efficacy, or lack of acceptance of trial results, which alters the study's benefit-risk ratio. Allowing participant refusal of follow-up data collection therefore creates tension between respect for persons and beneficence. With minimal risk study procedures that can help preserve trial benefit, such as passive data collection, we argue that the importance of upholding the principle of beneficence outweighs individual autonomy concerns. Furthermore, a consent process that prospectively informs participants of mandatory passive follow-up is ethically justified and optimizes the balance between autonomy and beneficence.
研究参与者有权退出所有研究程序，这一权利得到广泛认可，但参与者在行使退出某些程序的自主权时可能会受到合理限制。临床结局试验依赖于对研究治疗的安全性和疗效进行准确评估的完整受试者随访。受试者拒绝完成随访，甚至通过被动病历审查，都可能导致无法发现安全信号、疗效估计不准确或试验结果不被接受，从而改变研究的获益-风险比。因此，允许参与者拒绝收集随访数据会在尊重人和行善之间产生紧张关系。对于可以帮助保留试验获益的风险极小的研究程序，例如被动数据收集，我们认为，坚持行善原则的重要性超过了对个人自主权的关注。此外，一个前瞻性地告知参与者强制性被动随访的同意过程在伦理上是合理的，并且优化了自主权和行善之间的平衡。
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