Glossary Term

Unanticipated Problem (UP)

Glossary Term:

Unanticipated Problem (UP)


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.

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