FDA Reexamines Patient Consent Rules

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.