Informed Consent Waived in Public Crisis

By ANDREW BRIDGES
Associated Press Writer


WASHINGTON (AP) - In a public health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws.

Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration.

In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.

"To be candid, I hope it is a hypothetical problem. I hope we spent a lot of time creating a rule we never have to invoke," said Dr. Steve Gutman, director of the FDA's in-vitro diagnostics office.

Determining what constitutes a life-threatening public health emergency would be left up to the laboratories doing the testing. That creates the potential for conflicts of interest and other abuses, critics said.

"I don't like a rule like this because its most likely use is likely to be a form of abuse. The emergency exception it creates will be stretched to encompass non-emergency situations," said Jim Harper, director of information policy studies at the Cato Institute.