What's fair is… fair? Presenting JustEFAB, an ethical framework for operationalizing medical ethics and social justice in the integration of clinical machine learning: JustEFAB

The problem of algorithmic bias represents an ethical threat to the fair treatment of patients when their care involves machine learning (ML) models informing clinical decision-making. The design, development, testing, and integration of ML models therefore require a lifecycle approach to bias identification and mitigation efforts. Presently, most work focuses on the ML tool alone, neglecting the larger sociotechnical context in which these models operate. Moreover, the narrow focus on technical definitions of fairness must be integrated within the larger context of medical ethics in order to facilitate equitable care with ML. Drawing from principles of medical ethics, research ethics, feminist philosophy of science, and justice-based theories, we describe the Justice, Equity, Fairness, and Anti-Bias (JustEFAB) guideline intended to support the design, testing, validation, and clinical evaluation of ML models with respect to algorithmic fairness. This paper describes JustEFAB's development and vetting through multiple advisory groups and the lifecycle approach to addressing fairness in clinical ML tools. We present an ethical decision-making framework to support design and development, adjudication between ethical values as design choices, silent trial evaluation, and prospective clinical evaluation guided by medical ethics and social justice principles. We provide some preliminary considerations for oversight and safety to support ongoing attention to fairness issues. We envision this guideline as useful to many stakeholders, including ML developers, healthcare decision-makers, research ethics committees, regulators, and other parties who have interest in the fair and judicious use of clinical ML tools.