FDA Rule Waives Informed Consent for Laboratory Tests in Emergencies

The Food and Drug Administration (FDA) on June 7 issued an interim final rule that would permit medical laboratory testing to be performed without informed consent in the event of a terrorist attack or other public health emergency. Public comments on the rule, which has officially already taken effect, may be submitted to the agency until August 7, 2006.

The Federal Register notice on the interim final rule, "Medical Devices; Exception From General Requirements for Informed Consent," is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-8790.htm.

The purpose of the rule is "to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances."

"The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject," the rule states. "In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational."

Send written comments on the rule to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments

For more information, contact Claudia M. Gaffey, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 109.