Fictitious research applications have been submitted to several institutional review boards (IRBs) for a fake clinical study of a cancer drug to treat recurrent or neoplastic polyps in patients with a history of colorectal adenomas. In a notice issued by the FDA, the agency notes that the fictitious research applications resemble the phony applications that were used in an undercover investigation conducted by the Government Accountability Office (GAO) two years ago.
The March 26, 2009 GAO study, available by clicking here, found that IRBs reviewing proposals for human subjects research are vulnerable to unethical manipulation. In that investigation, GAO succeeded in getting approval from one IRB to conduct human tests of a fictitious medical device.
FDA is investigating these new, fictitious research applications and requests that any information concerning the false submissions be reported to FDA. FDA is alerting IRBs of the phony applications “to remind them of their responsibilities under FDA regulations to protect the safety and welfare of research participants by conducting careful review of research.” FDA’s notice is available by clicking here.