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An Unanticipated Problem is defined as:
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; and
2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
For additional information on when an UP must be reported to the UCI IRB, please reference the HRP webpage on Reporting of Unanticipated Problems or contact Human Research Protections staff directly.
The Human Research Protections index page is a single portal to resources, expertise and best practices for researchers, participants, IRB members, IRB partners and affiliates.
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Contact us at IRB@research.uci.edu.
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