The FDA has published a new rule which would allow investigational testing on samples “left over” from the usual testing in the event of a public health emergency, such as a terrorist attack.
The Seattle Post-Intelligencer is reporting the new rule as though it is controversial. I do not believe that there is any ethical difficulty – the samples are “left over,” consent was already obtained to collect the samples and perform the usual tests. The new rule only concerns tests on these samples, using devices that are considered “investigational” or experimental.
The rule became effective June 7th and is published in the Federal Register:
“Guidance for Industry, Institutional Review Boards Clinical Investigators and Food and Drug Administration; Guidance on Informed Consent for In Vitro Diagnostic Device Studies using leftover Human Specimens;Availability.”
SUMMARY: The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, 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. 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.
Consider the following possible scenario in which a terrorist event
is not suspected until a public health laboratory cultures an unusual or rare organism. When a patient presents to a health care facility with symptoms suggesting a systemic microbial infection, blood and other specimens are typically collected to determine the identity of the causative organism. The clinical laboratory would determine that the specimens contain an unusual organism that cannot be identified by the tests available in that laboratory. Because many clinical laboratories do not have the capability or resources to identify unusual organisms or those to which humans are rarely exposed naturally, the organism (culture isolate) or collected specimen would be referred to a public health laboratory. The public health laboratory would use in vitro diagnostic devices, including those that are investigational, to try to identify the cultured organism or detect its presence directly in the specimen.
In this scenario, the referring laboratory would not have obtained informed consent when the specimen was collected because the person directing that the specimen be collected would not have known at the time that the infecting organism could be reliably identified only by using an investigational device.