(Originally posted on the Wall Street Journal online)
Coast IRB said the disclosure of the sting and an April 14 warning letter from the Food and Drug Administration describing the company’s violations led several high-profile customers to pull their business. As a result, “Coast IRB’s owners decided, through counsel, to cease future company operations,” a company statement said.
The company had said earlier that it intended to temporarily halt accepting new business and to stop enrolling patients in studies that had begun while it made a thorough overhaul of its operations.
Nancy Walton has more details and commentary from a Research Ethics point of view, here:
http://www.researchethics.ca/blog/2009/04/update-on-coast-irb-sting.html
Hi Chris,
Thanks for sharing the link to Nancy's blog!
Anne Meade
PRIM&R
The Coast IRB has posted the PDF of a faxed letter received from FDA on June 4 at
http://www.coastirb.com/library/documents/forms/FDA-FAX-6-4-2009.PDF
Coast IRB will be closing it doors and ceasing operations as of June 30, 2009. Coast IRB will be conducting its last Board meeting on June 25, 2009.