(Originally posted by the Northwest Association for Biomedical Research)On Tuesday, April 14, officials at the Food and Drug Administration issued a warning letter to Coast IRB in response to their recent approval of a fake device study submitted by the Government Accountability Office. As a result Coast IRB has voluntarily agreed to review no new studies or enroll new subjects into ongoing protocols, both under 21 CFR Part 56.
- FDA warning letter: http://www.fda.gov/foi/warning_letters/s7157c.pdf
- FDA press release: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html
According to a Wall Street Journal article published on April 15, suspension of Coast IRB’s review functions represents the largest shutdown of an IRB to date by the FDA, impacting 300 trials and more than 3,000 researchers. Many other news agencies have picked up the story.