Consent not needed to test patients in emergency

WASHINGTON — 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 (FDA).

In all other cases, the use of an experimental test still requires the informed consent of a patient and 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 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 nonemergency situations," said Jim Harper, director of information policy studies at the Cato Institute, a libertarian think tank.

The FDA said it published the rule to ensure the ability to identify quickly whatever chemical, biological, radiological or nuclear agent is involved in a terrorist attack or outbreak of disease. Doing so could save lives, the FDA said.

Information

The rule: www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm

"Baloney," said Dr. Deborah Peel, chairwoman of the Patient Privacy Rights Foundation, a watchdog group. "This sounds like they're taking for themselves the right to test individuals every time they declare a public-health emergency."

The rule lays out a scenario where a laboratory discovers what appears to be an unusual bug in a sample taken from a patient before a public-health emergency is suspected. With the apparent bug in the lab but the patient gone, going back for permission to use a confirmatory but experimental test would introduce "unacceptable delays," the FDA said.

"They're basically overriding state informed-consent laws," said Sue Blevins, president of the Institute for Health Freedom. Blevins said informed consent could be sought after the fact.

The rule took effect Wednesday but remains subject to public comment until Aug. 7.