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Federal Rule Waives Informed Consent During Crisis

Global Security Newswire

A U.S. federal rule published yesterday allows health workers to run experimental tests on victims of a WMD attack or other crisis without their permission, the Associated Press reported (see GSN, Jan. 20).

The rule issued by the Food and Drug Administration allows for tests on blood and other samples from people sickened during a bioterrorist attack, radiological "dirty bomb" explosion or other potentially lethal public health emergencies.

The agency developed the rule to allow for quick detection of any chemical, biological, radiological or nuclear agent involved in a potential attack or disease outbreak, the agency said.

"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 Steve Gutman, director of the agency's in-vitro diagnostics office.

However, because the laboratories doing the testing would decide when to invoke the rule, conflicts of interest and other abuses could arise, critics said.

"This sounds like they're taking for themselves the right to test individuals every time they declare a public health emergency," said Deborah Peel, chairwoman of the Patient Privacy Rights Foundation. "There is no way getting consent would delay testing."

"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, information policy studies director at the Cato Institute.

The agency said obtaining informed consent in such cases could introduce "unacceptable delays."

The rule took effect yesterday but is open to public comment until Aug. 7, AP reported (Andrew Bridges, Associated Press/Yahoo!News, June 8).