Coast IRB, a for-profit institutional review board, oversees 300 human research trials, according to the FDA. The agency’s action stems from serious concerns about the institutional review board company's ability to protect human subjects participating in clinical trials.

 

More exactly, undercover investigators for the Government Accountability Office were able to get Coast IRB's approval for a fictitious testing protocol that supposedly involved pouring a liter of a product into a woman's stomach following surgery. Two other companies approached by GAO rejected the proposal.

 

This mistake brought harsh criticism to the company last month when a Congressional subcommittee was investigating the issue.

 

“The evidence suggests that Coast was more concerned with its bottom line than it was with patient safety,” said subcommittee Chairman Rep. Bart Stupak, D-Mich., during a hearing on the matter.

 

Coast released a statement saying it is cooperating with the FDA and is undertaking sweeping overhauls “to ensure maximum protection for human subjects.” It also plans to put in place a new board chair and new board members.