Michael J. Malinowski

Volume 65, Issue 3, 615-660

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
comprehensively reevaluating the Common Rule, which designates specific groups as
“vulnerable populations”—pregnant women, fetuses, children, prisoners, and those
with serious cognitive challenges—and imposes heightened protections of them. Given
the vulnerabilities of those who confront end-of-life decisionmaking, 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? Alternatively,
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 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.

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