Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, September 22, 1995 TAG: 9509220092
SECTION: NATIONAL/INTERNATIONAL PAGE: A6 EDITION: METRO
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium
The rules proposed Thursday by the Food and Drug Administration tell hospitals how to determine in advance which trauma victims they can give potentially life-saving experiments without the patient's - or a relative's - permission.
Such patients often owe their lives to treatments given while they were unconscious. Doctors usually pick the best approved therapy and forge ahead.
But when a patient's only hope is an experimental treatment, the law requires that person first understand the risks and give consent - unless he or she is physically unable and thus needs a special emergency waiver.
The problem: Government regulations differ on when to allow that waiver. The FDA allowed it for anyone with no better option, while the National Institutes of Health permitted it only when the experiment posed minimal risk.
As a result, confused hospitals have sometimes ended formal research to see which emergency treatments actually work. Doctors sometimes abused the waivers, turning patients into unwitting guinea pigs when there were alternatives.
The FDA proposal would solve that problem by outlining specific steps for setting up emergency-room research so doctors know when it's proper to experiment on an unconscious patient - and the community knows what to expect.
``We are permitting clinical trials in very defined, life-threatening circumstances to go forward, but we are also increasing the patient's protections at the same time,'' said FDA Commissioner David Kessler.
The NIH helped the FDA write the rules, which are open for public comment for 45 days, and plans to adopt them as well. Hospitals could have one set of rules by early next year.
Every hospital has a special board that must approve any research its doctors do. Under the FDA plan, these boards and an independent physician not involved in the proposed emergency-room trial must conclude that it meets the following conditions:
Patients are in a life-threatening condition.
Available treatments are unproven or unsatisfactory.
Research is necessary to determine the best treatment.
The patient cannot physically consent and there is no time to track down family.
The risks of the experiment are reasonable in relation to the disease and other therapies.
by CNB