September 15, 2006
Draft Research Rules Are Released
The federal government has clarified its regulations for clinical research on patients who are unconscious or otherwise unable to give consent to be treated with unproven medical procedures or drugs. The new guidelines, which were released in draft form last month by the Food and Drug Administration, expand on regulations issued in 1996 for "exceptions to informed consent" in emergency situations.
The original guidelines had been updated in 2000, but the new draft guidance contains a
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