Ethics Quality Consulting, 814 Jones Street, Berkeley, CA, 94710, United States; Sigma Health Consulting LLC, 7918 Jones Branch Dr., Suite 240, McLean, VA, 22102, United States.
VA Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), 16111 Plummer Street, North Hills, CA, 91343, United States.
Healthc (Amst). 2020 Jun;8(2):100425. doi: 10.1016/j.hjdsi.2020.100425. Epub 2020 May 20.
Like all facets of healthcare practice, quality improvement (QI) should be conducted in an ethically responsible manner. For methodologically complex QI, accountability and thoughtful ethical monitoring might be particularly important. Yet, access to ethical guidance for QI, as opposed to research, is often limited. Available mechanisms tend to be ill-equipped to accommodate the rapid cycle nature of QI, and monitoring standards for QI are not well defined. Providing appropriate ethical guidance for complex, multi-site QI initiatives can be especially challenging, as the body providing guidance must be familiar with QI methods, recognize the competing interests of stakeholder groups, respond to numerous requests, and understand the initiative's design. This case report describes our solution-an initiative-specific QI Ethics Committee that provided ethical guidance and consultation to a Veterans Administration QI initiative employing local innovations and a centralized evaluation. Enhanced by multiple tables, we discuss structuring and staffing the committee, the committee's role, functions and activities, requests for ethics guidance, and our strategy applying initiative-specific ethical principles to guide recommendations. Supported by feedback obtained from stakeholder interviews, we share key insights regarding the value of: • Clarifying and marketing the committee's role to users. • Reconciling conflicting interests between site-based team members and cross-site evaluators. • Separating ethics guidance from regulatory oversight. • Addressing the ethics of evaluative design. • Adjusting the intensity of the committee's work over time. • Creating tangible products. Our approach shows promise in supporting the ethical practice of methodologically complex QI, especially in institutions that lack applicable ethics monitoring mechanisms. Building on this approach, other complex QI initiatives can develop effective and feasible methods to protect participants from unintentional ethical lapses.
与医疗实践的所有方面一样，质量改进（QI）应该以负责任的方式进行。对于方法复杂的 QI，问责制和深思熟虑的伦理监测可能尤为重要。然而，获得针对 QI 的伦理指导，而不是针对研究的指导，通常受到限制。现有的机制往往无法适应 QI 的快速循环性质，并且 QI 的监测标准也没有得到很好的定义。为复杂的多地点 QI 计划提供适当的伦理指导可能特别具有挑战性，因为提供指导的机构必须熟悉 QI 方法，认识到利益相关者群体的竞争利益，回应众多请求，并了解计划的设计。本案例报告描述了我们的解决方案-一个特定于 QI 的伦理委员会，该委员会为采用当地创新和集中评估的退伍军人事务部 QI 计划提供伦理指导和咨询。通过多个表格，我们讨论了委员会的结构和人员配置、委员会的角色、职能和活动、对伦理指导的请求以及我们应用特定于计划的伦理原则来指导建议的策略。我们分享了关键见解，这些见解得到了利益相关者访谈的反馈，这些见解涉及：
向用户阐明和宣传委员会的作用。
调和基于站点的团队成员和跨站点评估员之间的利益冲突。
将伦理指导与法规监督分开。
解决评估设计的伦理问题。
根据时间调整委员会工作的强度。
创造有形产品。
我们的方法在支持方法复杂的 QI 的道德实践方面显示出了前景，特别是在缺乏适用的伦理监测机制的机构中。在此基础上，其他复杂的 QI 计划可以开发有效的和可行的方法来保护参与者免受无意的道德失误。
