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Date: Thursday, September 26, 1996 FOR IMMEDIATE RELEASE Contact: Food and Drug Administration, Don McLearn (301) 443-1130
The FDA issued final rules to make it easier for promising experimental drugs and medical devices to be studied in persons who are in life-threatening situations and unable to give informed consent for their use. As a companion document, NIH has published "Emergency Research Consent Waiver" applicable to all agencies of the Department of Health and Human Services.
These policies establish narrow limits for allowing research without informed consent in certain studies of emergency medical procedures, and harmonize these standards throughout the Department of Health and Human Services.
"FDA and NIH have produced a coherent approach to protecting patients who may be helped by an experimental procedure, but who cannot give consent on their own," said HHS Secretary Donna E. Shalala. "These rules address a difficult ethical situation and they apply fair, common sense tests for allowing the use of experimental treatments in life-threatening emergencies."
HHS' new overall approach to emergency research situations may offer the best hope in cases when critically ill, unconscious, persons (with no readily available legal representative to give consent), cannot be successfully treated through conventional means, but might benefit from a promising experimental intervention.
FDA addressed this issue last September in a proposal that defined the main conditions under which patients could be enrolled in clinical trials without their consent, provided that an independent physician and an institutional review board (IRB) -- a committee of experts and lay persons established to review research -- agree that the clinical trial addresses a life-threatening situation and that other criteria are met.
The other criteria include:
The "Emergency Research Consent Waiver" authorized by the Secretary of HHS which was published as a companion document to the FDA final rules, applies to the basic HHS policy for protection of human research subjects. It contains the same criteria as the FDA rule for permitting this research to proceed.
These new policies were developed in response to growing concerns that the current regulations were making high quality research in emergency circumstances difficult or impossible to carry out at a time when the need for such research is increasingly recognized.
The FDA proposal, which was broadly supported by 19 leading medical, patient advocacy, and industrial groups, received more than 90 comments. Based on these comments, FDA expanded, in final regulations, the procedures to be followed by IRBs and investigators in attempting to obtain informed consent from the patient's legal representative, or to inform the patient's family about the research. FDA's final rule and the HHS Waiver Notice will be published in the Federal Register Oct. 2.
The regulations become effective 30 days after the date of publication.