Frequently Asked Questions

When can you receive exception from informed consent for planned emergency research?

No items found.
IRB: General
CRO Consulting

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.