Facilitating Efficient and Ethical Trials at the Intersection of Research and Clinical Care

Research that is scientifically and ethically sound should gain institutional review board (IRB) approval without difficulty. Yet investigators seeking to address important questions through research conducted in the context of clinical care, including comparative effectiveness research and implementation science studies, often struggle with IRB review even when proposed research poses little risk. To facilitate approval, investigators sometimes feel compelled to make compromises that weaken the science (eg, pursuing “quality improvement” rather than “research”) or add complexity (eg, selecting cluster-randomized designs to avoid individual consent requirements). These work-arounds are not ethical improvements that reduce participant risk, meaningfully promote their autonomy, or otherwise change their experience of research. Instead, they reflect responses to regulatory interpretations that have become divorced from ethical goals.