DEFINITIONS
Unanticipated problems involving risks to subjects or others: Unanticipated problems involving risks to
subjects or others are defined as any incident, experience, or outcome that meets all of the following
criteria:
(a) 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;
(b) related or possibly related to participation in the research (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
(c) suggests that the research places subjects or others at a greater risk of harm (including physical,
psychological, health, economic, or social harm) than was previously known or recognized.
Adverse event (AE): Any undesirable and unintended (although not necessarily unexpected) event
experienced by a subject occurring as a result of interventions, interactions, or collection of identifiable
private information in research. An adverse event can be internal or external as it relates to the location
of the site.
Serious adverse event (SAE): Adverse events classified as serious include those resulting in death, lifethreatening injury, hospitalization or prolongation of hospitalization, persistent or significant disability,
or a congenital anomaly or birth defect. Events not meeting the above criteria but requiring
intervention to prevent one of these outcomes are also considered serious adverse events.
Unanticipated adverse event (UAE): An adverse event that is not consistent in nature, frequency, or
severity with the current IRB protocol, investigator's brochure, device manual/instructions for use,
consent form, or other available information.
Protocol deviation: Any deviations, whether intentional or unintentional, from the IRB-approved
protocol that are implemented without prior to IRB approval. Examples include, but are not limited to
accidental over-recruitment for a minimal risk study; a change implemented without prior Marquette
IRB approval to eliminate apparent immediate hazards to research subjects; and posting of a
recruitment flyer without prior Marquette IRB approval.
Follow-up to a previously submitted report: Previously submitted Reportable Event which the IRB
required a follow-up report, or additional or new information related to a previous report.
New information regarding risks or unanticipated problems: New information (e.g., investigator
finding, an interim analysis, safety monitoring report, or publication) indicates an increase in the
frequency or degree of previously known risk, or identification of new risk.
Complaint from participant: If a participant complaint is received by the investigator or study team, the
investigator must ensure that the complaint is addressed and resolved in a method that protects the
rights and welfare of the participant and is consistent with the IRB-approved study. The complaint must
also be submitted to the IRB for determination of possible non-compliance or misconduct.
FLOW CHART
Event occurs or is
discovered by the
PI
PI or Sponsor assess the event and determines
whether the event requires reporting per HR 98104. Any immediate risks or harm should be
minimized.
If the event meets the criteria under HR
Policy 98.104, PI submits the
Reportable Event Form to the ORC
within 10 working days.
ORC will issue an
acknowledgement letter to
the PI if the event does not
meet the criteria for HR
Policy 98.104.
ORC staff will review the form and
may request additional information.
If the event meets the criteria under
HR Policy 98.104, ORC staff will
present the report to the IRB Chair
and/or Vice Chair for review.
ORC will convey any required actions
needed by the PI or inform the PI if
Reportable Event will need to be
reviewed by the convened IRB.