HRPP Manual Section 6-9-E
Special Considerations: Emergency Research
Emergency research involves subjects without capacity to consent, in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject’s legally authorized representative. For this type of research, there is a narrow exception to the requirement that the investigator obtain informed consent from each subject, or the subject’s legally authorized representative, prior to enrollment in the research. This exception permits the study of potential treatments or improvements in the treatment of life-threatening conditions where current treatment is unproven or unsatisfactory.
For studies subject to United States (US) Food and Drug Administration (FDA) requirements, the regulations at 21 CFR 50.24 and the conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814 provide a narrow exception to consent requirements and provide additional protections for subjects enrolled in these studies.
For studies subject to US Department of Health and Human Services (HHS) requirements, pursuant to Section 46.101(i) of title 45 of the Code of Federal Regulations,
the Secretary of Health and Human Services (HHS) waived the general requirements for informed consent at 45 CFR 46.116 (a) and (b), and at 46.408, to be referred to as the ‘‘Emergency Research Consent Waiver,’’ for a class of research which have met the strictly limited conditions (Federal Register, Vol. 61, pp. 51531-51533). Because of special regulatory limitations relating to research involving prisoners (subpart C of 45 CFR
part 46), and research involving fetuses, pregnant women, and human in vitro fertilization (subpart B of 45 CFR part 46), this waiver is inapplicable to these categories of research under this exception.
The Institutional Review Board (IRB) responsible for the review, approval, and continuing review of the clinical investigation or research activity that involves emergency research may approve that activity without requiring that informed consent of all research subjects be obtained if the IRB finds and documents the requirements in 21 CFR 50.24 for studies subject to FDA requirements and/or the requirements in Federal Register, Vol. 61, pp. 51531-51533 for studies subject to HHS requirements are met. For studies subject to other federal agency human research protection requirements, additional consultation is required to determine whether a waiver of the relevant informed consent requirements pursuant to 101(i) has been granted.
Michigan State University (MSU) IRBs do not review exceptions from informed consent requirements for emergency research under 21 CFR 50.24 or the Federal Register, Vol. 61, pp. 51531-51533. However, MSU may rely upon an external (non-MSU) IRB that does review exceptions from informed consent requirements for emergency research.
For information on reliance processes, see HRPP Manual:
- 1-3, Use of Institutional Authorization Agreements
- 1-4, Reliance on External Independent (Commercial) Institutional Review Boards
- 1-7, Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements
- 8-11, External IRB Submissions
- 8-11-A, External Irb Submissions Involving Henry Ford Health Employed Principal Investigators
This section does not restrict the emergency use of investigational drugs or devices as described in the Human Research Protection Program Manual 7-3 “Emergency Use of Investigational Drugs and Devices.”
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 2-1-2006. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-22-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 11-18-2015. Revision 4 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 5 approved by Associate VP Research Regulatory Support on 11-8-2025.