FDA PROPOSES INFORMED CONSENT EXCEPTIONS FOR EMERGENCIES
The FDA may be making life easier for researchers conducting studies in emergency settings when patients are unable to give their informed consent, issuing a draft guidance on informed consent exceptions Aug. 29.
"Research is needed to address serious life-threatening events, many of which are poorly treated by interventions developed by trial and error and without research," FDA Deputy Commissioner for Operations Janet Woodcock said at a press conference to announce the draft guidance. Cardiac arrest, stroke and severe head trauma are examples, she said. The draft guidance is a successor to a document first released in 2001.
An emergency research situation occurs when an investigational device exemption or a new drug or biologics license application:
Involves subjects with life-threatening medical conditions for which available treatments are "unproven or unsatisfactory;"
Involves subjects who, because of their condition -- for example, unconsciousness -- cannot give informed consent; and
Involves an intervention that must be administered before it is possible to gain informed consent from the subject's legally authorized representative.
In these situations, patients have "no control over what happens to them and no capacity to consent," the FDA said. They "can neither give informed consent nor actively refuse enrollment."