MSU HRPP Manual Section 6-9-E

6-9-E, Special Considerations: Emergency Research

Emergency research is a planned clinical investigation of an intervention that may have direct benefit to human subjects in a life-threatening situation for which available treatments are either unproven or unsatisfactory, and the collection of valid scientific evidence is necessary to determine the safety and effectiveness of the intervention under study.

Emergency research is a special category of human subject research, because there is a high likelihood that the subjects may not be able to provide informed consent due to the nature of the emergency, i.e., they may not be conscious, they may be conscious but in a state of shock, or there is insufficient time for thoughtful consideration of potential risks and benefits. Further, there is a high likelihood that a legally authorized representative is not available to provide consent for subjects who are not able to consent for themselves.

The regulations governing the release from a requirement for informed consent for human subject research appear to conflict. The Common Rule permits a waiver of informed consent only if the research is minimal risk (e.g. 45 CFR 46.116(d)(1)). The U.S Food and Drug Administration (FDA) regulations permit an exception from the requirement of informed consent for emergency research if the intervention may benefit the subject and there is community consultation and disclosure, i.e., in essence the community “consents” (e.g. 21 CFR 50.24(a)). There is no FDA requirement for minimal risk for this exception.

Michigan State University does not permit emergency research involving human subjects unless informed consent is obtained from the subject or the legally authorized representative. This 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.

Related HRPP Manual Sections

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