Tully Ian
Hecht-Levi Postdoctoral Fellow in the Berman Institute for Bioethics at Johns Hopkins University.
Ethics Hum Res. 2021 Jul;43(4):20-26. doi: 10.1002/eahr.500096.
Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulations. I focus my discussion on the newly created "benign behavioral interventions" category of exempt research, arguing that this exemption from the federal regulations governing research with human subjects should be more expansively interpreted by the Secretary's Advisory Committee on Human Research Protections (SACHRP) than is currently the case. Specifically, I argue against the restriction, advocated by SACHRP, that the exemption exclude "physical (bodily) tasks" unless they are "incidental to the behavioral intervention." This restriction, I argue, is problematically vague and does no significant moral work. Acceptance of my proposed reinterpretation of "benign behavioral interventions" would, I hope, result in a significant reduction in regulatory burden for minimal risk research.
最近对《共同规则》的修订有助于减轻从事最低风险研究的研究人员的监管负担。然而，在本文中，我提出了一种在现行法规的现有范围内进一步减轻负担的方法。我的讨论重点是新设立的豁免研究“良性行为干预”类别，认为负责保护人类研究对象的联邦法规给予的这一豁免，应由秘书人类研究保护咨询委员会（SACHRP）作出比目前更宽泛的解释。具体而言，我反对SACHRP所主张的限制，即该豁免应排除“身体（肉体）任务”，除非它们“附属于行为干预”。我认为，这一限制模糊得有问题，且没有起到重要的道德作用。我希望，接受我对“良性行为干预”的重新解释提议，将大幅减轻最低风险研究的监管负担。
