Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA 30322, USA.
Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):251-7. doi: 10.1016/j.pcad.2012.10.001.
Clinical trials in acute myocardial infarction (AMI) and other urgent or emergent conditions present special challenges regarding informed consent. Available data suggest patients often poorly understand such research when they are offered enrollment, and unalterable factors such as time constraints and emotional and physical distress create barriers to informed consent on the part of patients and surrogates. We examine the challenges to informed consent in AMI trials in particular and suggest that full informed consent may not be a realistic goal. We propose instead a model of informed refusal, offering patients an informed opportunity to refuse participation rather than requesting a positive commitment to participate. Informed refusal may be both more achievable and more respectful of patients, and we describe how such a process might be implemented and evaluated. We also suggest a need for regulatory change in order to maximize effective patient participation in decisions for clinical research in AMI and other acute illnesses.
在急性心肌梗死（AMI）和其他紧急或突发情况下的临床试验中，知情同意方面存在特殊挑战。现有数据表明，当患者被招募时，他们往往对这类研究理解得很差，而且时间限制以及情绪和身体上的痛苦等不可改变的因素，给患者和代理人的知情同意造成了障碍。我们特别研究了 AMI 试验中知情同意的挑战，并提出充分知情同意可能不是一个现实的目标。相反，我们提出了一个知情拒绝的模式，为患者提供一个知情的拒绝参与的机会，而不是要求他们积极承诺参与。知情拒绝可能更具可操作性，也更尊重患者，我们还描述了如何实施和评估这样一个过程。我们还建议进行监管改革，以便在 AMI 和其他急性疾病的临床研究决策中最大限度地提高患者的有效参与度。
