Division of Critical Care, Department of Medicine, Faculty of Health Sciences, McMaster University; Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University; and Department of Critical Care, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Department of Physiotherapy, School of Rehabilitation Science, Faculty of Health Sciences, McMaster University; and Physiotherapy Department, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Crit Care Med. 2020 Oct;48(10):1403-1410. doi: 10.1097/CCM.0000000000004538.
To describe the importance of critical care clinical research that is not pandemic-focused during pandemic times; outline principles to assist in the prioritization of nonpandemic research during pandemic times; and propose a guiding framework for decisions about whether, when and how to continue nonpandemic research while still honoring the moral and scientific imperative to launch research that is pandemic-focused.
DESIGN/DATA SOURCES: Using in-person, email, and videoconference exchanges, we convened an interprofessional clinical research group, conducted a literature review of empirical studies, ethics documents and expert commentaries (2010 to present), and viewed traditional and social media posts (March 2020 to May 2020). Stakeholder consultation involved scientific, ethics, clinical, and administrative leaders.
Clinical research in the ICU.
Patients with and without coronavirus disease 2019.
None.
While clinical research should be prioritized to advantage patients with coronavirus disease 2019 in order to care for affected patients, it ideally would not unduly disadvantage patients without coronavirus disease 2019. Thus, timely, rigorous, relevant, and ethical clinical research is needed to improve the care and optimize outcomes for both patients with and without coronavirus disease 2019, acknowledging how many studies that are not exclusively focused on coronavirus disease 2019 remain relevant to patients with coronavirus disease 2019. Considerations to continue nonpandemic-focused research include the status of the pandemic, local jurisdictional guidance, capacity and safety of bedside and research personnel, disposition of patients already enrolled in nonpandemic studies, analyzing characteristics of each nonpandemic-focused study, research oversight, and final reporting requirements.
Deliberation about continuing nonpandemic research should use objective, transparent criteria considering several aspects of the research process such as bedside and research staff safety, infection control, the informed consent model, protocol complexity, data collection, and implementation integrity. Decisions to pause or pursue nonpandemic research should be proportionate, transparent, and revisited as the pandemic abates.
描述在大流行期间进行非大流行重点关注的重症监护临床研究的重要性；概述在大流行期间协助确定非大流行研究优先级的原则；并提出一个指导框架，用于决定是否、何时以及如何继续进行非大流行研究，同时仍尊重以大流行为重点开展研究的道德和科学必要性。
设计/数据来源：通过面对面、电子邮件和视频会议交流，我们召集了一个跨专业临床研究小组，对实证研究、伦理文件和专家评论（2010 年至今）进行了文献回顾，并查看了传统和社交媒体帖子（2020 年 3 月至 2020 年 5 月）。利益相关者咨询涉及科学、伦理、临床和行政领导。
重症监护病房内的临床研究。
患有和不患有 2019 年冠状病毒病的患者。
无。
虽然为了照顾受影响的患者，应优先考虑临床研究以有利于患有 2019 年冠状病毒病的患者，但这理想情况下不应使不患有 2019 年冠状病毒病的患者受到不利影响。因此，需要及时、严格、相关和符合伦理的临床研究，以改善对患有和不患有 2019 年冠状病毒病的患者的护理并优化其结果，同时认识到许多并非专门针对 2019 年冠状病毒病的研究对患有 2019 年冠状病毒病的患者仍然具有相关性。继续进行非大流行重点研究的考虑因素包括大流行的状况、地方司法管辖指导、床边和研究人员的能力和安全性、已入组非大流行研究的患者的处置、分析每个非大流行重点研究的特征、研究监督以及最终报告要求。
继续进行非大流行研究的审议应使用客观、透明的标准，考虑研究过程的几个方面，例如床边和研究人员的安全、感染控制、知情同意模式、方案复杂性、数据收集和实施完整性。暂停或继续进行非大流行研究的决定应是相称的、透明的，并随着大流行的缓解而重新审议。
