AMITA Health
INSTITUTIONAL REVIEW BOARD
Unanticipated Problems Reporting Instructions
Federal regulations require investigators to promptly report to the IRB all unanticipated problems
during the course of the research that involve risks to subjects or to others including adverse events
that should be considered unanticipated problems (§§56.108(b)(1), 312.53(c)(1)(vii), and 312.66).
Report unanticipated problems to the IRB within 10 working days of discovery, except as noted
below. These instructions and form apply only to this IRB; reporting requirements to your sponsor
may be different.
Unanticipated Problems Involving Risk to Subjects or Others (UPIRSOs) include any incident,
experience or outcome that meets all three of the following criteria:
 Unexpected (in terms of nature, severity, or frequency);
 Related or probably related to participation in the research (probably related means the event
was more likely than not caused by the research procedures);
 Suggests that the research places subjects or others at a different or greater risk of harm
(including physical, psychological, economic or social harm) than was previously known or
recognized.
Reportable AEs
An adverse event (AE) is considered a UPIRSO only if it is all three of: unexpected, serious, and
places subjects or others at a different or greater risk of harm than was previously known. While nonUPIRSO adverse events may still need to be reported to the Sponsor, they do not need to be
reported to the AMITA Health IRB and the AMITA Health IRB will not review them.
 If the adverse event appears in study documents such as the investigator brochure, and is of
the same nature, severity and frequency, it would not be unexpected and would not have to
be reported.
 If the adverse event is not related to the study procedures, it would not represent a risk to
other subjects in the research and would not have to be reported.
 For multicenter studies, the sponsor is in a better position to process and analyze adverse
event information for the entire study and to assess whether an individual AE occurrence is
unanticipated and represents a risk to other subjects in the research. If the unanticipated
problem occurs at a non-local site, respond to questions 3 and 4 on the UP Reporting Form by
explaining what the sponsor has done and recommends doing to alleviate the problem. If you
have also taken action or recommend action, include that.
o Adverse events that occur on studies in which your site is not participating do not need
to be reported to the AMITA Health IRB.
Deaths
All deaths of research subjects need to be reported to the IRB. Unanticipated deaths that are
related or probably related to the research should be reported on the Unanticipated Problems
Reporting Form. Investigators are required to report the unanticipated death of an AMITA Health
subject that is related to the research within 24 hours of learning about the death. The
unanticipated death of a non- AMITA Health subject that is related to the research should be reported
within 10 working days of investigator knowledge or notification.
Anticipated or unrelated deaths of subjects should not be reported on the Unanticipated Problems
Reporting Form. Instead, include those on your continuing review form.
Other Reportable Unanticipated Problems
Unanticipated problems that are not adverse events that meet all three of unexpected, serious, and
places subjects or others at a different or greater risk of harm than was previously known, should also
be reported on the UP Reporting Form. Some examples of these problems are breach of
confidentiality, including inappropriate disclosure, and lost or stolen confidential information; untimely
destruction of study records; unaccounted for study drug.
P&P Forms/Unanticipated Problems 3-3-15; 9-21-15
AMITA Health IRB
Unanticipated Problems Reporting Form
Including Reportable Adverse Events
(This form must be typewritten)
This Problem Is:
Location:
Report Stage:
IRB #/Protocol #:
Reportable AE
Local
Initial
Other UP
Non-Local
Follow-up # ____
Final
/
Protocol Title:
Principal Investigator:
Date of This Report:
Date PI Learned of Problem/Event Date:
/
PROBLEMS MUST BE REPORTED WITHIN 10 WORKING DAYS AFTER DISCOVERY.
Use this form only for problems/events that are all three of the following:



Unanticipated
Related to the research procedures
Place subjects or others at a greater risk of harm than was previously known
Attach reports to or from the sponsor, data and safety monitoring board (DSMB) or other relevant
information regarding the problem/event.
1. Summarize the problem and subject outcome:
(do not simply refer the IRB to another document)
2. In what way does this problem place subjects or others at greater risk of harm?
3. What actions have you (or the sponsor) taken to protect study subjects or others?
4. What actions do you (or the sponsor) recommend to protect study subjects or others in the
future and to prevent a reoccurrence of this problem?
Form Completed by (Name/Title):
Signature:
PI Signature (if different from line above):
Date:
P&P Forms/Unanticipated Problems 3-3-15; 9-21-15
Phone: