US Food and Drug Administration, Silver Spring, MD 20993, USA.
Am J Bioeth. 2011 Aug;11(8):6-16. doi: 10.1080/15265161.2011.583318.
Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals' perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.
我们的主要关注点是对自愿性概念的分析，次要关注点是我们的分析对自愿同意概念和要求的影响。我们提出，一个行为要具有自愿性，必须满足两个必要且充分的条件：意向性和实质性地不受控制影响。我们拒绝将真实性作为自愿行为的必要条件，并指出约束性情境可能会或可能不会破坏自愿性，具体取决于情境和代理人的心理能力。我们比较和评估了几种自愿性的解释，并认为与生物伦理学中的其他处理方式不同，我们的观点不是一种带有价值倾向的理论。我们还讨论了对个体对非控制和自我控制程度的感知的实证评估。我们建议使用特定的决策控制工具。使用这种工具的实证研究可以提供有助于制定适当政策和程序以获得对研究的自愿同意的相关数据。
