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THE REQUIREMENT for informed consent from subjects participating in some types of clinical experimental studies is in the process of being waived. The Food and Drug Administration (FDA) is proposing ways to make it easier for drugs and devices to be tested under life-threatening situations where the patient is unable to give consent to participate in research.
The action is prompted by growing concern that the current rules, as they are interpreted, are "making high quality acute care research difficult or impossible to carry out at a time when the need for such research is increasingly recognized," said the FDA in announcing the proposed rule.
The proposal is designed to amend the rule for drug and device testing in circumstances where the patient is unable to give informed consent. It provides that an independent physician and the institutional review board (IRB) granting approval of such research agree that the study
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