Glossary | Human Research Protections

Unanticipated Event:

Problems, risks or events that occur during the conduct of the research, but were not expected and therefore are not cited in the written protocol, the consent form(s) or the Investigator's Brochure. Unanticipated events also include problems, risks or adverse events that were expected but occur with greater severity or frequency than originally anticipated.

Unanticipated Problem (UP):

Unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:

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;
Related or possibly related to participation in the research (in this guidance document, 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
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 (OHRP Guidance for Unanticipated Problems)

Undue Influence:

The inappropriate use of prestige, wealth, ability or position to directly or indirectly affect the potential participants' decision to participate.

Unmasking/Unblinding:

A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).