Exception from informed consent requirements for emergency research.

Researchers who plan to conduct research protocols in an emergency setting when they know that it will not be possible to obtain consent from the patient or legally authorized and the research involves an FDA regulated product are required to conduct the research in accordance with the FDA regulations 50.24 and DHHS regulations 45.CFR 46.101(i). The HHS and FDA regulations have been harmonized with just a few small differences noted below. Researchers are encouraged to consult with the Institutional Review Board staff and Chair in preparing their applications. The following is a short summary of the major points that will need to be considered carefully and discussed in depth in the protocol in order to conduct the research