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Bridget M. Kuehn

JAMA. 2009;302(16):1739-1741.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Researchers who flout regulations for the conduct of clinical trials or who commit crimes related to clinical research may face swifter repercussions as the US Food and Drug Administration (FDA) intensifies its efforts to identify and remove violators from the drug and device development process.

Clinical investigators who falsify data, hide adverse events, or fail to obtain proper patient consent face swift repercussions from the US Food and Drug Administration.

Since the 1960s, the FDA has had the authority to disqualify or remove from FDA-regulated trials any clinical investigators who have "repeatedly or deliberately" ignored regulations designed to protect human research participants or who have repeatedly or deliberately submitted false information to the agency or the sponsor of their research. But this process often took years to complete.

In 1992, Congress granted the FDA the additional authority to bar researchers who have been convicted of felonies related . . . [Full Text of this Article]

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