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.