FDA waives informed consent

New rule permits experimental in vitro diagnostic testing in emergencies

Ted Agres
Jun 14, 2006
The Food and Drug Administration (FDA) last week authorized US laboratories and clinics to perform investigational in vitro diagnostic testing without patients' informed consent in case of a declared or suspected public health emergency, such as a bioterrorist attack or avian flu pandemic. But some health policy experts say the provision could endanger patient privacy and is subject to abuse by devious medical device companies. The FDA's interim final rule, published in the June 7 Federal Register, allows health care and laboratory workers to use investigational in vitro diagnostic devices (IVDs) to identify chemical, biological, radiological, and nuclear agents without informed patient consent in case of a potential terrorism or other public health emergency. "I hope this rule is hypothetical, theoretical, and never used," said Steve Gutman, director of the FDA's Office of In Vitro Diagnostics. "But in some cases, it might be life saving," he told The...

Interested in reading more?

Become a Member of

Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!
Already a member?