Coast IRB halts operations amid concerns of subjects' safety in clinical trials

ROCKVILLE, Md. A company in Colorado that offers oversight services for clinical trials of drugs has agreed to voluntarily halt operations due to concerns that it has not adequately protected the safety of patient subjects in the trials.

The Food and Drug Administration announced Tuesday that it imposed restrictions on Colorado Springs, Colo.-based Coast IRB after an undercover investigation by the Government Accountability Office. The GAO submitted a fictitious research study to Coast IRB for review about a medical device that had purportedly received clearance from the FDA. The FDA said it evaluated information that the GAO provided and determined that Coast IRB committed several violations of laws and regulations intended to protect rights and welfare of human research subjects and failed to conduct an adequate review.

Under federal law, clinical research involving human subjects and FDA-regulated products must have the review and approval of an institutional review board, comprising doctors, scientists and non-scientists who review the research to protect the rights and welfare of human study subjects.