Coast IRB could have worked in the best way and earned reputation in the industry, but it had to close the doors due to the GAO sting on pharmaceutical investigations on them. The US FDA announced that there will be halt in the activities of Coast IRB, LLC of Colorado due to the serious concerns originated from their false clinical trials. This step was taken in the month of April 2009 for the protection of human subjects and concerns of mankind.
Company’s records revealed that there were investigating studies meant for these records and about 3000 clinical investigators made the report. However, it is a false statement as the reports had some false records. FDA had to issue warning letter to IRB with their concerns and immediately undertook the case for taking next actions. The restrictions came into effect after FDA finally found out the fakeness in the whole case and the negative impact for human research subjects.
There is approval of an IRB required for biological, medical devices and any new drugs. IRB constitutes a panel of doctors who make this research for the safety and rights of the subjects participating in the studies. There was undercover sting operation made by GAO in which fictitious research was involved. It was a matter of shock when FDA cleared the medical device without any actual implementation to any subjects. It was a successful sting operation by Government Accountability Office (GAO) of the United States and aimed at saving people from the hassles of fraud companies.
It was determined that Coast IRB committed violation of laws and rules intended for the rights of human research subjects. It failed to make the approval of the study and the actions were termed as precautionary. The research got an adequate review and progress reports were submitted by the officials acclaiming Coast IRB as non-trusted organization.