F.D.A. Proposes Rules on Experimental Emergency Treatment
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The Food and Drug Administration yesterday proposed rules to make it easier to carry out experiments on patients who are unable to give their consent because they are unconscious or undergoing emergency treatment. Dr. David A. Kessler, the Commissioner of Food and Drugs, said many experiments intended to be performed in an emergency setting had been stymied by “conflicting and confusing regulations” governing alternatives to prior informed consent from patients or their representatives. In practice, doctors deciding whether to use new or experimental therapies have made their choices on a case-by-case basis as they treat the emergency. But it has been difficult to carry out planned research on groups of emergency patients because different agencies have different rules about what is permitted and what protections for patients are necessary. The proposed rules, which will now be subject to a 45-day period of public comment and are expected to take effect soon afterward, would consolidate all such Federal regulations. They would permit more experiments on emergency patients but require that those experiments be announced ahead of time and then be approved by a local medical board, called an institutional review board, as well as by an independent doctor and the F.D.A. More : query.nytimes.com |