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When can you receive exception from informed consent for planned emergency research?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The conduct of planned research in life-threatening emergent situations where obtaining prospective informed consent has been waived is provided by 21 CFR 50.24. The research plan must be approved in advance by FDA and the IRB, and publicly disclosed to the community in which the research will be conducted. Such studies are usually not eligible for the emergency approvals described above.

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