Facilitating ethical quality improvement initiatives: Design and implementation of an initiative-specific ethics committee.

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.