It is the matter of April 2009, when FDA announced that Coast IRB has voluntarily halted some of the clinical operations with the resultants of serious concerns about the ability of the company for protecting the subjects participating in the trials related to clinical aspects. The company’s records suggest that there were about three hundred active studies conducted by investigators for checking out the researches.
Coast IRB made agreement to terminate the review of FDA regulated studies. It focused on direct clinical investigators for on-going studies being approved by Coast IRB for keeping a check on the enrollment in new subject. There was warning letter issued to Coast IRB by FDA with the concerns related to quality check and it also made a decision for actively monitoring the company by undertaking necessary actions by their own. These restrictions were bound to get effected till the time Coast IRB would have been taken the corrective actions bringing the regulations on the right track.
FDA regulated products were required to get reviewed properly to get approval from IRB. The main constituents of IRB were a panel of doctors, researchers, scientists and experts to protect the welfare and rights of the people. US GAO submitted the Coast IRB for reviewing the fiction based research. FDA concerns were about the ability of Coast IRB to give the right report, but it was a fiction based approach. There were absolutely no human subjects involved and it was a negative aspect for the rights and welfare of human research subjects.
FDA determined that Coast IRB committed different violations for regulations and laws and it was aimed at protecting the rights of human research. The actions of FDA were absolutely right as there can be potential risk involved in the life of people by untested false reports and products.