Blurred Lines: The Collapse of the Research/Clinical Care Divide and the Need for Context-Based Research Categories in the Revised Common Rule
Despite its recent update, the Common Rule governing research on human subjects remains fundamentally flawed. Research is still defined primarily in opposition to clinical care so that the Common Rule draws a line dividing the two, a mismatch that fails to appreciate modern developments in healthcare. The historical origins of the Common Rule imbue the regulations with an understanding that research usually involves greater risks than clinical care. This view is perhaps appropriate for old research models like the randomized control trial. However, as modern medicine shifts focus from infectious diseases with common pathways to chronic illness through personalized medicine, research and clinical care draw closer together in ways that defy the assumptions of the Common Rule. New frameworks of precision medicine and learning healthcare are reliant on and work best with data collected through both research and clinical care so useful information that can be used to personalize and improve standards of care is not lost. The same technological advances that enable these changes also make possible more serious abuses of healthcare data than previously imagined. Thus, research models now exist which are both no more risky than clinical care and which are far more dangerous. Conflating different uses of research means that Common Rule simultaneously impedes new frameworks while remaining unable to address new risks. Context-based research categories, each with regulations that appropriately match the set of risks and benefits inherent in each type of research would help to align the Common Rule with reality and better protect research participants.
Food and Drug Law Journal
Volume 73, Number 4