All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and development increasingly commingles clinical research and clinical care—as patients and physicians routinely reach into the drug development pipeline for treatment options. Given the vulnerabilities of those who confront end-of-life decision making, should the regulatory standard be raised to more effectively protect the terminally ill from additional suffering and the loss of quality time with family and friends, and to increase recognition of the opportunity to die with priority placed on comfort care and dignity? Alternatively, where death is the only existing option under standard of care, should the regulations be relaxed to promote access to experimental treatment alternatives? What importance should be placed on the overall advancement of biopharmaceutical research and development (R&D) in addressing these human health issues? This article proposes modifying the Common Rule to enhance human subject protection of the terminally ill, which the U.S. standard of care generally recognizes as a diagnosis of life expectancy of six months or less.


65 Hastings L. J. 615 (2014)


Common law -- United States, Patients -- Health, Medical care, Therapeutics, Drug development, Drug development -- Finance

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