FDA reviews clinical research consent rules
The US Food and Drug Administration has issued draft guidance and is organizing a public hearing on the topic of emergency clinical research when informed consent cannot be obtained. In particular, the agency is looking to review its 1996 regulation, 21 CFR 50.24, which provides for such research parameters.
The FDA described the project as part of its "ongoing effort to ensure the highest level of scientific and ethical rigor in clinical research and is one of many projects under its Human Subject Protection and Bioresearch Monitoring Program (HSP-BIMO Program)."
The "50.24" regulation is applied when a person in a life-threatening situation is enrolled in an emergency research study before arriving at a hospital and is unable to provide informed consent because of their medical condition.
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