UW Research
unanticipated problem
A problem or event that meets all of the following criteria:
- Unexpected – The harm (or potential harm) is inconsistent with risk information previously reviewed and approved by the Institutional Review Board (IRB) in terms of nature, severity, or frequency as well as the characteristics of the study population.
- Related or probably related to participation in the research;
- Probably related: There is a reasonable probability (more likely than not) that the incident, experience or outcome may have been caused by the procedures involved in the research, or that it is associated with the use of any drug, biologic, or medical device that is part of the research.
- Suggests that the research places (or did place) one or more subjects or others at a greater risk of harm than was previously known or recognized. This includes physical, psychological, economic, educational advancement, or social harm.