NOHSP Definitions - U

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

U

Unexpected adverse event: An event whose specificity and severity are not accurately reflected in the informed consent document, the protocol, or the current investigator’s brochure. For example, the parental permission form may state that mild headaches are a common adverse effect of the study drug. However, a report of a debilitating headache that required intervention would be ‘unexpected’. (HSP#067)

Unanticipated Problems: Unanticipated problem involving risks to participants or others. A problem that is:

unexpected, where unexpected means not described in the information provided to the IRB and
indicates that participants or others are at increased risk of harm. (HSP#058)

Unapproved device: A medical device that is used for a purpose or condition for which the device requires, but does not have, an approved application for pre-market approval or marketing clearance according to FDA regulations. (HSP-048)

Undue influence: The offer of something of value that could cause the recipient to engage in an activity they would not otherwise do.