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Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics
Perspectives in Biology and Medicine ( IF 1 ) Pub Date : 2020-01-01 , DOI: 10.1353/pbm.2020.0022
Erin T Paquette , Seema K Shah

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.

中文翻译:

确定风险上限:研究伦理中一个持续存在争议的领域

志愿者在研究中可以同意的净风险是否存在上限,以及该上限恰好是多少,一直是研究伦理学中持续争论的主题。本文捍卫了研究中风险上限的概念,反对最近的批评,并支持最有前途的方法来确定这个极限,即寻找社会普遍接受并构成高风险的比较活动。然而,被提议作为相关参照物的高风险活动涉及更多特定的利益,并赋予承担风险者相当大的社会尊重。这表明,无论是通过制定程序保障措施还是系统框架,开发一种稳健的方法来识别社会价值,可以更有效地识别具有足够社会价值的研究,以证明高净风险是合理的。此外,研究参与者的社会地位应该提高,以与那些为了他人的利益而值得称赞地承担高风险的其他人更加平等。通过关注证明高风险研究的正当性所必需的利益,允许的风险水平将不再有争议。
更新日期:2020-01-01
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