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Currents in Contemporary Ethics

Lawsuits Against IRBs: Accountability or Incongruity?

Published online by Cambridge University Press:  01 January 2021

Mary R. Anderlik  and
Nanette Elster
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Extract

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards (IREs) and their members may be pulled more and more into the legal fray.

On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency (OTC), a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 29 , Issue 2 , Summer 2001 , pp. 220 - 228
Copyright
Copyright © American Society of Law, Medicine and Ethics 2001

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Footnotes

Mark A. Rothstein serves as the section editor for “Currents in Contemporary Ethics.” Professor Rothstein is the Herbert F. Boehl Chair of Law and Medicine at the University of Louisville School of Medicine in Kentucky.

References

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