Perspect Biol Med. 2020;63(2):327-345. doi: 10.1353/pbm.2020.0022.
Whether there is an upper limit of net risk that volunteers can consent to in research, and what that limit happens to be, has been the subject of persistent controversy in research ethics. This article defends the concept of an upper limit of risk in research against recent critics and supports the most promising approach for identifying this limit, that of finding comparator activities that are generally accepted in society and pose high levels of risk. However, high-risk activities that have been proposed as relevant comparators involve more certain benefits and confer considerable social esteem to those who take on the risks. This suggests that developing a robust approach to identifying social value, whether by developing a procedural safeguard or a systematic framework, could more effectively identify research with sufficient social value to justify high net risk. Additionally, the social status of research participants should be elevated to be more on par with others who laudably take on high risk for the benefit of others. By attending to the benefits necessary for the justification of high-risk research, the level of allowable risk will no longer be so controversial.
志愿者在研究中可以同意的净风险是否存在上限，以及这个上限是多少，这一直是研究伦理中的一个持续争议的问题。本文为研究中的风险上限概念辩护，反驳了最近的批评者，并支持了确定这一上限的最有希望的方法，即寻找在社会上普遍接受并存在高风险的对照活动。然而，被提议作为相关对照物的高风险活动涉及更确定的利益，并赋予承担风险的人相当大的社会尊重。这表明，无论是通过制定程序保障还是系统框架，发展一种强有力的方法来确定社会价值，都可以更有效地确定具有足够社会价值的研究，从而证明高净风险是合理的。此外，应该提高研究参与者的社会地位，使其与那些为了他人的利益而勇敢地承担高风险的人更加平等。通过关注高风险研究的合理性所需的利益，允许的风险水平将不再那么有争议。
