Clara L. West Professor of Ethics and Philosophy in the Department of Philosophy at Carnegie Mellon University.
Senior scientist in the clinical epidemiology program at the Ottawa Hospital Research Institute and an associate professor in the School of Epidemiology and Public Health at the University of Ottawa.
Ethics Hum Res. 2020 Nov;42(6):21-28. doi: 10.1002/eahr.500071.
Individual-cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as sufficient to grant a waiver of consent, then a loophole emerges in research oversight. Such loopholes are morally hazardous for study participants, the integrity of science, and public trust in the research enterprise. We conclude by articulating the standards that research ethics committees should use to evaluate requests for waivers of consent in individual-cluster trials.
个体集群试验对个体进行分组随机化，但直接向个体参与者提供研究干预措施。我们考察了三个论据，这些论据可能证明，在这种试验中，放弃同意的标准应该低于个体随机试验。我们认为，如果这些论据被视为足以豁免同意，那么研究监督就会出现一个漏洞。对于研究参与者、科学的完整性以及公众对研究事业的信任，这种漏洞是道德上有风险的。最后，我们阐述了研究伦理委员会在评估个体集群试验中豁免同意的请求时应使用的标准。
