Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania.
Bioethics. 2020 Nov;34(9):923-932. doi: 10.1111/bioe.12725. Epub 2020 Feb 24.
When research poses risks to non-participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be "minimal." Outside the research context, US tort law tolerates a more flexible "reasonable" risk threshold. This article advances a preliminary case that nonconsenting participants and nonconsenting bystanders exposed to similar research risks may be entitled to the same level of protection, but that risks generated by research may not be special in kind. Thus, limiting research risks to those that are "reasonable," rather than demanding that they be held to the "minimal" standard, may be the best approach for both nonconsenting participants and nonconsenting bystanders. Further work is needed to establish whether the descriptive standards used to support the analogies relied on here are normatively justifiable, as well as the extent to which the minimal risk standard and the reasonable risk standard would lead to meaningfully different outcomes in practice.
当研究对非参与的旁观者造成风险时，获得他们的同意并不总是可行的。评估可能对不同意的旁观者施加多少研究风险的一种方法是检查类似情况，包括为不同意的研究参与者和研究环境之外的非自愿风险设定的可接受的风险阈值。对于不同意的参与者，美国的研究法规通常将风险限制在被认为是“最小”的范围内。在研究环境之外，美国侵权法容忍更灵活的“合理”风险阈值。本文提出了一个初步的案例，即暴露于类似研究风险的不同意的参与者和不同意的旁观者可能有权获得相同水平的保护，但研究产生的风险在性质上不一定特殊。因此，将研究风险限制在“合理”范围内，而不是要求它们符合“最小”标准，可能是对不同意的参与者和不同意的旁观者的最佳方法。需要进一步的工作来确定这里所依赖的类比的描述性标准在规范上是否合理，以及最小风险标准和合理风险标准在实践中会导致有意义的不同结果的程度。
