联合注册英国重症监护研究 - 2019年更新
Timothy Felton1, Natalie Pattison2, Simon Fletcher3
1Acute Intensive Care Unit, Wythenshawe Hospital, Manchester University Foundation Trust, Manchester, UK.
Journal of the Intensive Care Society
|August 18, 2023
概括
关于在重症监护试验中同时注册的指导意见于2013年制定. 由于对同意模式的经验和意识增加,这份指南正在被修订,以确保患者安全和研究质量.
科学领域:
- 关键护理研究研究 关键护理研究
- 临床试验的伦理学
- 研究中的患者安全.
背景情况:
- 2013年,由于缺乏现有协议,为参加多项重症监护试验 (联合注册) 的患者创建了指南.
- 最初的重点是确保重症监护机构的患者安全和高质量的研究成果.
- 这份指南是其他健康研究领域的典范.
研究的目的:
- 重新审视和更新现有的关于重症监护试验的联合注册指南.
- 在研究中纳入当前的经验和对同意模式不断变化的认识.
- 解决围绕同意共同入学的伦理考虑.
主要方法:
- 2013年,临床医生和ICU步骤的初步指导的制定.
- 基于在重症监护联合招生方面积累的经验,对指导的审查和修订.
- 考虑各种同意模式,包括推迟同意和咨询同意.
主要成果:
- 最初的指导制定了一个管理重症监护的联合入学的框架.
- 对同意模式的经验和认识增加,需要对最初的指导方针进行修订.
- 对共同入学同意的伦理考虑是更新指南的核心.
结论:
- 关于重症监护试验的同时注册的原始2013年指南需要更新.
- 推迟同意和咨询同意等同意模型的发展对于道德共同入学至关重要.
- 修订指南将确保持续的患者安全和在重症监护机构的强有力的研究.
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