U.S. Drops Barrier to Treatment of Comatose

Federal health officials announced new measures Thursday to allow the use of experimental drugs and devices in certain emergency and life-threatening situations where patients cannot be fully informed of the risks and possible benefits.

The policy is intended to ease the confusion and ethical concerns of medical personnel dealing with emergencies where patients may be unconscious or comatose, and where there is no one else available to provide informed consent.

“It makes no sense to take someone who is unconscious and say, ‘no one can do any research to try to save him,’ ” said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. Experimental treatments are generally administered as part of medical research to determine whether they are safe and effective enough to be approved for general use.

Current medical standards require patients to be fully informed of the dangers and potential benefits of an experimental drug, device or other treatment and to give consent for their use. Exceptions include children, in whose cases parents typically provide informed consent, and the mentally disabled, whose family members or other surrogates usually are involved in the process.

The new regulations would allow institutional review boards--panels of experts and lay persons established to review proposed research--to give prior approval for the use of experimental devices and drugs in certain circumstances where patients are not able to provide informed consent.

Under the regulations, released jointly by the Food and Drug Administration and the National Institutes of Health, the experimental treatments must pose “reasonable” risks and benefits, weighing them against the patient’s medical condition and the standard therapies available. And they may only be used in life-threatening situations, when there is no opportunity for informed consent from either the patient or a stand-in.