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Article: Lawmakers Looking Into Clinical Trials, Want IRBs Accredited.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
WASHINGTON - Two highly publicized deaths of clinical trial participants have prompted lawmakers to look deeper into the rules that govern such research.
It all started about two years ago when Jesse Gelsinger, 18, a patient enrolled in a Phase I gene therapy trial at the University of Pennsylvania, unexpectedly died. And then last year, Ellen Roche, a 24-year-old healthy volunteer at Johns Hopkins University, died after inhaling a chemical as part of an asthma trial at the Baltimore university.
These are just two stories, but there are others.
Indeed, Sens. Edward Kennedy (D-Mass.) and Bill Frist (R-Tenn.) held a ...