IRB Unanticipated Problem and
Adverse Event Policy
During the conduct of research, various problems may
occur. The Principal Investigator (PI) is responsible for reporting these
problems for evaluation by the Seattle University IRB, according to federal
Adverse Event refers to any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign
(e.g., abnormal physical exam or laboratory finding), symptom, or disease, temporally
associated with the subject’s participation in the research (whether or not
considered related to the subject’s
participation in the research). Adverse events encompass physical and psychological harms. They occur
primarily in the context of biomedical research, although they may occur with social
and behavioral research. Unanticipated Problems encompass “other” events that
may arise during the course of research.
Circumstances for reporting
A PI must submit
an unanticipated problem report if all three
of the following criteria (in accordance with federal regulations) are met:
- An incident, experience, or
outcome is unexpected (in nature, severity, or frequency), given the
procedures described in the IRB-approved research protocol and informed
consent document; and given the characteristics of the research subject
- An incident, experience, or
outcome is related to or possibly caused by participation in the research.
- An incident, experience, or
outcome suggests that the research places subjects or others at a greater
risk of harm (including physical, psychological, economic, or social harm)
than previously realized or anticipated.
unanticipated problem may warrant corrective actions in the research protocol
or the informed consent process/document in order to ensure the safety,
welfare, or rights of participants. Some possible corrective actions may
- changes to the research
protocol initiated by the PI prior to obtaining IRB approval to eliminate
immediate hazards to subjects;
- modification of inclusion or
exclusion criteria to mitigate the newly identified risks;
- implementation of additional
procedures for monitoring subjects;
- suspension of enrollment of new
- suspension of research
procedures in currently enrolled subjects;
- modification of informed
consent documents to include a description of newly recognized risks; and
- provision of additional
information about newly recognized risks to previously enrolled subjects.
reporting Adverse Events
A PI must submit an unanticipated problem report if all three of the following criteria (in
accordance with federal regulations) are met, OR if it is a serious adverse event.
adverse event is unexpected because the nature, severity, or frequency
of the event is not consistent with either:
known or foreseeable risk of adverse events associated with research procedures
described in the IRB-approved research protocol or the current IRB-approved
informed consent form.
expected natural progression of any underlying disease, disorder, or condition
of the subject(s) experiencing the adverse event and the subject’s predisposing
risk factor profile for the adverse event.
adverse event is related to or possibly caused by participation in the
research. Adverse events may be caused by one or more of the following:
procedures involved in the research;
underlying disease, disorder, or condition of the subject; or
circumstances unrelated to either the research or any underlying disease,
disorder, or condition of the subject.
events determined to be at least partially caused by a) (above) would be considered related to participation in the
research, whereas adverse events determined to be solely caused by (b) or (c) would be considered unrelated to participation in the
adverse event suggests that the research places subjects or others at a greater
risk of harm than previously realized or anticipated. Any serious adverse event requires immediate reporting to the IRB, which
has the authority to suspend or terminate
approval of research associated with unexpected serious harm to subjects. An
adverse event is considered serious
life-threatening (places the subject at immediate risk of death from the event
as it occurred);
in inpatient hospitalization or prolongation of existing hospitalization;
in a persistent or significant disability/incapacity;
in a congenital anomaly/birth defect; or
upon appropriate medical judgment, may jeopardize the subject’s health and may
require medical intervention to prevent one of the outcomes listed above.
for reporting an Unanticipated Problem–Adverse Event
w Review the reporting timeframe below to ensure
w Complete the report form using MS Word or similar
word-processing software (no handwritten applications).
w Respond to all items as applicable, or the report may be
returned to you for additional information. Attach additional pages as
w Obtain all necessary signatures before submitting
your report: PI, Faculty Advisor (if not the PI), and Co-Investigators.
w Submit all forms in a sealed envelope to: IRB, Office
of Research Services & Sponsored Projects in the University Services
Building #203. After business hours, please place materials in
Timeframe for Reporting Unanticipated Problems–Adverse Events
Must Report the Following
of an unsafe research environment.
when it represents a significant departure from the approved protocol and/or
if it affects the welfare or safety of participants.
of harm to participants or others related to their participation in the
to the protocol made without prior IRB review to eliminate an apparent
immediate hazard to participants.
24 hours, if subject currently in protocol. Otherwise, within 60 days of
investigator’s notification of death.
instances should be reported to the IRB, key site personnel, and any other
authorities overseeing or involved in the research protocol.
3 days of discovery.
harm experienced by the participant, in the opinion of the investigator, that
is both unexpected and more likely than not caused by research procedures.
7 days of occurrence, or within 7 days of a reported occurrence to the PI by
other problem that the investigator considers to be unanticipated, and
indicates that participants or others are at increased risk of harm.
of a participant in a protocol not approved to enroll prisoners.
discovered information that indicates a change in the risk/benefit ratio.
10 days of discovery.
Please direct all questions to: firstname.lastname@example.org or (206) 296-2585