Glavinovic Tamara, Hingwala Jay, Harris Claire
Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, ON, Canada.
Division of Nephrology, Department of Medicine, Health Sciences Centre, University of Manitoba, Winnipeg, Canada.
Can J Kidney Health Dis. 2022 Feb 27;9:20543581221077504. doi: 10.1177/20543581221077504. eCollection 2022.
Quality improvement (QI) work is a cornerstone of health care, and a growing area within nephrology. With such growth comes the need to ensure that QI activities are implemented in an ethically responsible manner. The existing institutional research board (IRB) framework has largely focused on reviewing the ethical suitability of traditional research projects, and it can be challenging to know if QI initiatives require formal ethics oversight. Several tools have been developed to assist in distinguishing between the two, such as the "A pRoject Ethics Community Consensus Initiative" tool. Our objective was to demonstrate how QI is distinct from research, to outline how QI-focused IRB process is used across Canada, and to develop a practical aid for clinicians embarking on QI-related projects.
Publicly available institutional Web sites from academic and select nonacademic sites across Canada.
Institutional Web sites across all academic centers within Canada were examined to determine local QI-specific ethics review processes. We have provided examples of QI processes from select community sites. We have developed a tool to assist clinicians navigate the ethical challenges of QI projects and to determine whether their project may require ethics approval.
This overview of the considerations of the research ethics approval process helps clinicians to determine whether IRB approval is required for QI studies. Examples of the current ethical processes employed in both academic and community institutions across Canada demonstrate the variability between centers. We have included examples of fictional nephrology-oriented QI initiatives to illustrate when ethics approval may be considered, along with a flowchart. This summary highlights the opportunity for QI-specific IRB review processes to be standardized across Canada, along with the need for creation of a separate stream with dedicated expertise for QI project review.
We did not do a formal environmental scan of the QI IRB review process in all hospital institutions across Canada.
质量改进（QI）工作是医疗保健的基石，也是肾脏病学领域中一个不断发展的领域。随着其不断发展，需要确保QI活动以符合道德责任的方式实施。现有的机构研究委员会（IRB）框架主要侧重于审查传统研究项目的伦理适宜性，而要确定QI计划是否需要正式的伦理监督可能具有挑战性。已经开发了几种工具来协助区分两者，例如“A pRoject Ethics Community Consensus Initiative”工具。我们的目标是展示QI与研究的区别，概述加拿大各地如何使用以QI为重点的IRB流程，并为开展与QI相关项目的临床医生开发一种实用辅助工具。
加拿大各地学术机构和部分非学术机构的公开机构网站。
对加拿大所有学术中心的机构网站进行审查，以确定当地针对QI的伦理审查流程。我们提供了部分社区网站的QI流程示例。我们开发了一种工具，以协助临床医生应对QI项目的伦理挑战，并确定其项目是否可能需要伦理批准。
对研究伦理批准过程考量因素的概述有助于临床医生确定QI研究是否需要IRB批准。加拿大各地学术机构和社区机构目前采用的伦理流程示例展示了各中心之间的差异。我们纳入了以肾脏病学为导向的虚构QI计划示例，以说明何时可能需要伦理批准，并附上了流程图。本综述强调了在加拿大各地对针对QI的IRB审查流程进行标准化的机会，以及创建一个具有专门QI项目审查专业知识的单独流程的必要性。
我们未对加拿大所有医院机构的QI IRB审查流程进行正式的环境扫描。
