Glossary Term
Unanticipated Problem (UP)
Glossary Term:
Unanticipated Problem (UP)
Definition
Unanticipated problems are defined as any incident, experience or outcome that occurs during the course of a study that meets all of the following criteria:
- Unforeseen (not expected by the researcher or the research participant) given the research procedures and the subject population being studied.
- Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
- 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.