Resnik David B
a National Institute of Environmental Health Sciences, National Institutes of Health , Research Triangle Park , North Carolina , USA.
Account Res. 2017;24(1):1-29. doi: 10.1080/08989621.2016.1198978. Epub 2016 Jun 13.
One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.
涉及人类受试者的伦理研究的关键原则之一是，相对于预期收益而言，研究的风险应该是可接受的。机构审查委员会（IRB）成员在对拟议的人体研究进行风险/收益决策时，常常依靠直觉。一些人反对使用直觉来做出这些决策，因为直觉不可靠、有偏见且缺乏透明度。在本文中，我审视了直觉在IRB风险/收益决策中的作用，并认为在这个过程中，我们减少对直觉依赖的能力存在实践和哲学上的局限。然而，IRB风险/收益决策涉及直觉这一事实并不意味着它必然是主观得无可救药或有偏见的，因为IRB可以采用一些策略来改进其决策，比如使用实证数据来估计潜在危害和收益的概率，开发分类系统以指导对危害和收益的评估，以及就风险的可接受性进行道德推理。
