Emory University, Atlanta, Georgia, USA.
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
J Med Ethics. 2019 Jan;45(1):18-21. doi: 10.1136/medethics-2017-104736. Epub 2018 Sep 15.
Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.
在紧急情况下进行临床试验会带来独特的挑战，因为它们涉及招募在急性疾病或损伤背景下缺乏同意能力的个体。美国卫生与公众服务部和食品药品监督管理局的法规允许在这些情况下进行知情同意豁免（EFIC），其中包含社区咨询、公开披露以及对研究风险和益处的限制的要求。在本文中，我们分析了法规中一个很少受到关注或分析但在伦理上很复杂的问题。这一挑战是何时征求并尊重对 EFIC 试验入组的反对意见，包括非法定代表的反对意见。我们涉及一些新的问题，包括应该尊重谁的反对意见、反对意见被认为有效的必要理解程度以及调查人员应该努力争取反对意见的程度。我们提出了一套标准，为概念和实践提供了指导。我们认为，如果反对意见破坏了允许 EFIC 试验许可的关键假设之一，即个人不太可能基于自己的价值观或偏好对入组提出反对，那么这些反对意见应该得到尊重。然后，我们通过审查 EFIC 研究中的三个拒绝案例来阐明这种方法的实际影响。
