Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, Virginia.
Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.
Bioethics. 2019 Jan;33(1):4-12. doi: 10.1111/bioe.12532. Epub 2018 Nov 26.
This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to 'comparative effectiveness research' and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research.
本文评估了四项最近的随机临床试验，这些试验要么完全没有征求参与者的知情同意，要么在知情同意文件中遗漏了关键信息。随着这些研究的进行，一些关于无需同意或披露即可进行随机临床试验的提议开始出现在医学文献中。一些人提出的为什么可以绕过同意或披露要求的解释，似乎代表了对适用的政府法规甚至是研究企业的根本误解。其他的解释则是由于对传统研究伦理规范对“比较有效性研究”和现代研究环境的重要性和应用的概念性分歧。然而，这些解释的共同点是，未能理解研究干预措施（而不仅仅是数据的观察或审查）何时发生。审查委员会和研究人员未能看到或选择忽视研究对象生活中的干预措施。当这些研究被曝光时，具有监督权力的政府机构几乎没有采取行动或退缩了。有影响力的医学期刊发表了研究结果，明知没有获得所需的同意，或者即使在发现同意不充分后，他们仍然坚持发表这些研究。本文从理论和实践两方面批判性地审查了这种同意的侵蚀，并呼吁恢复知情同意的要求，使其成为人类受试者研究的首要任务。
