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Journal of the National Cancer Institute Advance Access originally published online on January 8, 2008
JNCI Journal of the National Cancer Institute 2008 100(2):90-91; doi:10.1093/jnci/djm314
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© Oxford University Press 2008.

NEWS

Federal Drug Agency Gets Flack About Human Subjects Protections in Clinical Trials

Mary Beckman

The first 10% of the full text of this article appears below.

The federal agency responsible for approving new drugs and medical devices is under fire for not doing enough to protect human subjects in research.

A recent federal report concludes that the U.S. Food and Drug Administration lacks ways to keep track of research on people and fails to conduct enough inspections. The FDA responded by saying that human subject protection is a complicated business. While it agreed with some of the report's findings, it also said that it conducts as many inspections as it can and that even the threat of inspections ensures safe treatment of patients. Clinical investigators, on the other hand, worry that the publicity the report generated could reduce the number of patients willing to participate in a clinical . . . [Full Text of this Article]

Role of IRBs

Negative Repercussions


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