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U.S. Department of Health and Human Services

Drugs

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Important Notice to IRBs Reviewing FDA-Regulated Research

Recently, it has come to FDA’s attention that fictitious applications for research have been submitted to several institutional review boards (IRBs).  The protocol submission is a multicenter, randomized, placebo-controlled study of a drug for the treatment of recurrent or neoplastic polyps in patients with a history of colorectal adenomas.  It appears that the name and address of the clinical investigator listed on the FDA Form 1572 are the same as that used in a previous Government Accountability Office (GAO) investigation1.  The current and previous investigator curricula vitae are very similar as is the investigator’s medical licensure information.  The name and address of the sponsor, while different, also appear to be fictitious.

FDA is conducting an investigation into this matter and requests that anyone with information relating to a false submission to an IRB report it to the FDA.  FDA is alerting institutional review boards and other stakeholders of these submissions to remind them of their responsibilities under FDA regulations to protect the safety and welfare of research participants by conducting careful review of research.

If you have any information that would be helpful to FDA or have questions regarding this notice, please contact Dr. Kevin Prohaska in the Division of Scientific Investigations, Center for Drug Evaluation and Research HSPTeamMailbox@fda.hhs.gov.


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1http://www.gao.gov/new.items/d09448t.pdf