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17 April 2014 12:48 pm ,
Vol. 344 ,
Officials last week revealed that the U.S. contribution to ITER could cost $3.9 billion by 2034—roughly four times the...
An experimental hepatitis B drug that looked safe in animal trials tragically killed five of 15 patients in 1993. Now,...
Using the two high-quality genomes that exist for Neandertals and Denisovans, researchers find clues to gene activity...
A new report from the Intergovernmental Panel on Climate Change (IPCC) concludes that humanity has done little to slow...
Astronomers have discovered an Earth-sized planet in the habitable zone of a red dwarf—a star cooler than the sun—500...
Three years ago, Jennifer Francis of Rutgers University proposed that a warming Arctic was altering the behavior of the...
- 17 April 2014 12:48 pm , Vol. 344 , #6181
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Company Nabbed in Sting With Bogus Study Stops Reviewing Trials
15 April 2009 1:33 pm
A company that gave ethics approval to a fake clinical trial has agreed to stop reviewing FDA-approved studies.
All studies of FDA-approved drugs and devices have to be approved by an institutional review board (IRB), a panel of experts that is supposed to make sure the people who volunteer for the study are protected. The company, Coast IRB in Colorado Springs, Colorado, is an example of a for-profit IRB.
Last month, the federal Government Accountability Office and a congressional committee revealed that Coast IRB had approved a fake study of a fictitious FDA-approved device. As part of an agreement with the FDA, up to 300 or so ongoing trials that the company had approved will stop enrolling new patients while the company improves its practices.