Sunday, June 11, 2006

Informed Consent Waived in Public Crisis

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.

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.


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