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FDA Reexamines Patient Consent Rules

FDA is revisiting the 10-year old regulation that allows unapproved clinical emergency research in conditions when patient consent isn't possible. The Human Subject Protection and Bioresearch Monitoring Initiative is supposed to strengthen FDA's oversight and protection of patients in clinical trials involving medical devices, drugs, biologics, food, and veterinary medicine.

Recently, the agency has taken flack for two blood substitute studies--Northfield Laboratories' PolyHeme, a product used in trauma patients, and the U.S. Navy's request to use Biopure Corp.'s Hemopure without patient consent. FDA is drafting a guidance on emergency research and will hold a public hearing on the issue on October 11. The meeting will address the challenges of balancing emergency research with the protection of human subjects, along with providing suggestions for improving the process.  

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