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Human subjects protection in health care contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called “research on medical practice” (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. We conducted six semistructured, open-ended focus-group discussions with institutional review board (IRB) members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. Our …