Blurring Boundaries: Revisiting the distinction between research and care

Research ethics since the Belmont Report has rested on the assumption that there is an ethically important distinction between clinical research and clinical care. This distinction has provided the foundation for analyses of numerous bioethical concepts, including clinical equipoise, the researcher-participant relationship, and therapeutic misconception, among many others. However, the lines between research and care are increasingly blurred, due to such developments as embedded pragmatic trials, decentralized research designs, expanded access programs, and increased appreciation of the situations in which no standard of care options exist for patients. We will assess what this blurring means for the research/care distinction and whether it should prompt us to reconsider its import.

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