急性心肌梗死临床试验中知情同意的伦理考虑。

IF 7.4 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Manasi Tannu, W Schuyler Jones, John H Alexander, Roxana Mehran, Adrian F Hernandez, Jennifer A Rymer
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引用次数: 0

摘要

由于患者的痛苦、镇静和治疗的紧迫性,获得参与急性心肌梗死临床试验的知情同意提出了独特的伦理和后勤挑战。传统的同意程序往往与狭窄的登记窗口相冲突,促使人们使用合法授权的代表以及短格式和长格式的同意模型。尽管这些方法能够加快试验入组,但它们可能会损害患者的自主权,引入选择偏差,或造成入组后的伦理困境。本综述探讨了急性心肌梗死研究中知情同意的复杂性,评估了现有策略的优势和局限性,包括合法授权代表同意、两步同意流程以及延迟同意和口头同意等替代方案。报告还审查了各国在监管监督方面的差异,并提出了一些新兴的解决方案,如事先同意、选择退出模式、电子平台和基于注册的试验,以简化登记过程,同时不延误护理。最终,应该重新评估同意规定,并可能放宽,以更好地支持及时的研究。在时间敏感的环境下,对同意框架进行深思熟虑的重新评估对于在道德上和有效地推进急性心肌梗死研究至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ethical Considerations for Informed Consent in Acute Myocardial Infarction Clinical Trials.

Obtaining informed consent for clinical trial participation in acute myocardial infarction presents unique ethical and logistical challenges because of the patient distress, sedation, and the urgency of treatment. Traditional consent procedures often conflict with the narrow enrollment windows, prompting the use of legally authorized representatives and short- and long-form consent models. Although these approaches enable faster trial enrollment, they may compromise patient autonomy, introduce selection bias, or create postenrollment ethical dilemmas. This review explores the complexities of informed consent in acute myocardial infarction research, evaluating the advantages and limitations of existing strategies, including legally authorized representative consent, 2-step consent processes, and alternatives such as deferred and verbal consent. It also examines international variations in regulatory oversight and presents emerging solutions, such as preemptive consent, opt-out models, electronic platforms, and registry-based trials, to streamline the enrollment without delaying care. Ultimately, consent regulations should be re-evaluated and potentially relaxed to better support timely research. A thoughtful reassessment of consent frameworks is essential to ethically and effectively advance acute myocardial infarction research in time-sensitive settings.

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来源期刊
Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
1.80%
发文量
221
审稿时长
6-12 weeks
期刊介绍: Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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