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IRBs, Conflict and Liability: Will We See IRBs in Court? Or is it when?

Whyte Hirschboeck Dudek SC, Madison, Wisconsin

REPRINT REQUESTS: Daniel L. Icenogle, MD, JD, Whyte Hirschboeck Dudek SC, One East Main St., Suite 300, Madison, WI 53703-3300, Telephone: 608-234-6115, Email: dicenogle{at}whdlaw.com

[See related article: 4]

Abstract

The entire human research infrastructure is under intense and increasing financial pressure. These pressures may have been responsible for several errors in judgment by those responsible for managing human research and protecting human subjects. The result of these errors has been some terrible accidents, some of which have cost the lives of human research volunteers. This, in turn, is producing both increased liability risk for those who manage the various aspects of human research and increasing scrutiny as to the capability of the human research protection structure as currently constituted. It is the author’s contention that the current structure is fully capable of offering sufficient protection for participants in human research–if Institutional Review Board (IRB) staff and members are given sufficient resources and perform their tasks with sufficient responsibility. The status quo alternative is that IRBs and their members will find themselves at great risk of becoming defendants in lawsuits seeking compensation for damages resulting from human experimentation gone awry.

Key Words: Ethics Committees • Research