Company Caught in Clinical Trial Sting

Coast IRB, LLC is supposed to supervise and approve safety methods for clients in clinical trials involving human subjects. However, the Colorado based company was caught in a Congressional sting and ordered to cease work in the clinical trials. An FDA spokesperson cited the federal agency’s serious concern that Coast IRB was not doing enough to protect human subjects.
According to a report in the Wall St. Journal, the work stoppage could affect 300 clinical trials and over 3,000 researchers in such fields as pharmaceutical, biotech, and medical devices.
Coast IRB’s deficient practices were uncovered during a Congressional sting operation begun last year. The GAO and congressional staff created a phantom medical study of a phantom product. It was during this phantom study that Coast’s deficient measures to protect humans was discovered.