BIOMEDICAL INSTITUTIONAL REVIEW BOARD
American University of Beirut
Report of Unanticipated Problems Involving Risk to
Participants or Others
Unanticipated Problems: The AUB Biomedical IRB considers unanticipated problems,
in general, to include any incident, experience, or outcome that meets ALL of the
following criteria:
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research
procedures that are described in the protocol-related documents, such as the IRBapproved research protocol, investigator’s brochure, drug or device product information,
informed consent document, or the research materials; and (b) the characteristics of the
subject population being studies, including underlying diseases, behaviors, or traits;
2. Related or possibly related to participation in the research (possible related means that
that there is a reasonable possibility that the incident, experience, or outcome may have
been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at risk of unknown harm or
addition/increased frequency of harms (including physical, psychological, economic,
legal, or social harm) than was previously known or recognized.
Unanticipated problems may be adverse events, protocol deviations, noncompliance or
other types of problems, but MUST meet all of the criteria listed above.
Investigators should consult Guidance for AUB PIs for Reporting of Unanticipated
Problems involving Risks to Subjects and Others for definitions of events requiring prompt
reporting and time frames. https://cms.aub.edu.lb/irb/Documents/guidance.pdf
Several Key Definitions are cited below:
Adverse event (AE): Any undesirable and unintended (although not necessarily
unexpected) effect occurring as a result of interventions, interactions, or collection of
identifiable private information in research. In biomedical research, any untoward physical
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or psychological occurrence in research, including abnormal laboratory finding, symptom,
or disease temporally associated with the use (although not necessarily related to) a
medical treatment or procedure. Adverse events involving drugs are also referred to as
adverse drug experiences.
Serious adverse event (SAE):
An adverse event that is fatal or life threatening,
permanently disabling, requires or prolongs hospitalization, or results in significant
disability, congenital anomaly, or birth defect.
Timelines:

All Internal Serious Adverse Events (Fatal/Life-threatening unanticipated
problems under the jurisdiction of the AUB IRB; see list under definition of SAE
above) should be reported immediately (within 48 hours) to the IRB Chair.

Events, both Internal and External, resulting in temporary or permanent
interruption of study activities by the PI or sponsor to avoid potential harm to
participants should be reported to the IRB immediately (within 48 hours)
whenever possible.

All other Internal and External Unanticipated Problems requiring Prompt Reporting
(see Guidance) https://cms.aub.edu.lb/irb/Documents/guidance.pdf must be
reported to the IRB within 10 working days of investigator's knowledge of the
event. This includes adverse events, protocol major deviations, serious noncompliance, and other events that meet reporting criteria.
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I. GENERAL INFORMATION
Date:
BiomedIRB protocol number:
Title of Protocol:
Original Protocol approval:
[ ] Full Board
[ ] Expedited
[ ] Exempt
Principal Investigator:
Department:
Enrollment Site:
Phone:
[ ]AUBMC
Email:
[ ] External: specify: -----------------
This Report is an:
[ ] Initial report
[ ] Follow-up report (if so, please attach a copy to this form)
Date of event: _____________________
Date PI notified of event: __________________
List 4 keywords describing the event/problem (e.g., death, hospitalization, loss of
confidentiality, nausea and vomiting):
Subject information: (for reports involving single subjects only)
Do not provide subject personal identifiers.
Patient Number:
Patient Initial:
(if applicable)
Gender:
Case Number at AUBMC:
(if applicable)
Age:
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The study has a Data Safety Monitoring Committee/Board (DSMC/DSMB) or Data Safety Monitor
(DSM) .
If yes, choose one:
[ ] A copy of the DSMC, DSMB, or DSM’s review of the event/problem is attached
[ ] The DSMC, DSMB, or DSM has not reviewed the event/problem
[ ] The DSMC, DSMB, or DSM review is pending
[ ] Does not have a Data Safety Monitoring Committee/Board or Data Safety Monitor (DSM)
Enrollment/Research Procedure Status:
[ ] Participant recruitment ongoing
[ ] Participants are still receiving study treatment/intervention/procedures
[ ] Participants have completed study treatment/intervention/procedures; continue in follow-up
observation or long-term follow-up
[ ] Participant’s involvement completed but data-analysis is continuing.
[ ] Research activities suspended
II. DESCRIPTION OF THE EVENT
Event Category:
[ ] Serious Adverse Event
[ ] Not serious but Unanticipated/Unexpected Adverse Event, Major Deviation, Change to
Investigator Brochure, etc – i.e. event requiring Prompt Reporting
The event was:
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Life threatening
[ ] Fatal: (Date of death: ___________ )
Relationship to Research Intervention:
Based on your review of the information, what is the relationship of the event of the
research?
[ ] Causative (Highly probable that the research intervention caused the event/problem)
[ ] Probable (It is more likely than not that the research intervention caused the
event/problem)
[ ] Inconclusive (Research intervention is a plausible candidate for causing the
event/problem but there is not enough information to assign a greater than 50%-50%
(probability of 0.5) OR other equally or more plausible candidates exist)
[ ] Unlikely (There is a low probability that the research intervention caused the
event/problem OR a probable alternative candidate cause exists)
[ ] Negative (Another causative alternative exists to account for the event/problem OR
the research intervention is temporally ineligible to account for the event/problem (i.e., the
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timing of the event/problem is inconsistent with the administration of the research
intervention).
To the PI’s knowledge, has this or a related unanticipated problem been seen
previously in this or other research studies involving the same research intervention?
[ ] Yes (If Yes, kindly attach a summary of previous reports)
[ ] No
Was the event/problem caused by a major deviation from the protocol?
[ ] Yes
[ ] No (If no and no amendment to existing protocol required, report at Continuing
Review. Do not complete/submit this form)
Was the protocol discontinued for the subject?
[ ] Yes
[ ] No
Was any further treatment required?
[ ] Yes
[ ] No
If Yes, explain below:
Kindly provide a brief description of the event or problem, including the subject’s
demographic information. (Use separate sheets if need be).
Event outcome (check all that apply)
[ ] Death
[ ] Disability
[ ] Congenital abnormality/birth defect
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[
[
[
[
[
[
] Resolved
] Injury (Explain: --------------)
] Life threatening
] Hospitalization
] Required hospitalization to prevent permanent damage
] Discontinued from study
III. STUDY RELATED INFORMATION
How many subjects have been enrolled at this site? ------------------How many subjects are being followed at this site? ------------------If this is a multicenter trial, how many subjects (total) have been enrolled at all
centers? --------------------Has this unanticipated problem occurred with any other subject at this site?
[ ] Yes (number of subjects ------------)
[ ] No
Has this unanticipated problem occurred with any other subject at other sites?
[ ] Yes (number of subjects ------------)
[ ] No
The research involves (check the appropriate box(es):
[ ] Drug. Please provide name (s) of drug(s):
[ ] Device. Please provide name of device:
[ ] Procedure. Please provide list of procedures:
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IV. PROTOCOL DATA
Is this a 
[ ] Therapeutic protocol
[ ] Non-therapeutic protocol
Is reaction/risk listed in the investigator brochure?
[ ] Yes (if yes, is this problem change in severity or frequency of reaction/risk described
in brochure?) Explain:
[ ] No
Is reaction/risk listed in the protocol?
[ ] Yes (If yes, is this report a change in severity or frequency from anticipated
reaction/risk describe in protocol?) Explain:
[ ] No
Is reaction/risk listed in the informed consent document?
[ ] Yes (If yes, is this change in severity or frequency of reaction/risk described in consent
form?) Explain:
[ ] No
Has the sponsor provided any data on the frequency of this adverse event? If so,
please attach to this report. (Note: This refers to the sponsor’s data concerning adverse
events associated with the drug(s)/device(s)/procedure(s) irrespective of specific
protocols.)
[ ] Yes
[ ] No
V. CHANGES NECESSITATED BY EVENT/PROBLEM
Has the level of risk changed as a result of this event?
[ ] Yes
[ ] No
If “Yes”, please answer the following:
The level of risk has:
[ ] Increased
[ ] Decreased
Should the protocol be modified to describe this change of risk?
[ ] Yes (If yes, PI must submit an Amendment/Modification request for IRB review and approval
before modification can be implement, unless immediate change is necessary to safeguard health
and well-being of other subjects. Even if latter, formal Amendment to previously approved
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protocol is required for IRB review and approval.)
[ ] No
Are any changes required in the informed consent/assent document(s) to better
inform and protect the rights and welfare of subjects?
[ ] Yes ( If yes, attach copies of a proposed revised consent/assent form with changes
highlighted in one copy. IRB approval of revised consent form is required before it can be
used).
[ ] No (If Not, provide a brief rationale in the space below)
Is it necessary to inform subjects/legally authorized representatives who have already
consented to participation in the study of the event or problem?
[ ] Yes. It will be done and documented. (If a change has been made in the consent form,
the proposed new form must reviewed and approved by IRB before it can be presented to
subject/legally authorized representative to be signed)
[ ] No. (Provide a brief rationale in the space below)
Will you notify all other subjects currently enrolled in the research study?
[ ] Yes (Please describe the mechanism by which you plan to do so)
[ ] No (Please explain why)
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Are there steps that can be taken to minimize risk of a similar occurrence in the
future?
[ ] Yes, please describe _____________________________
[ ] No
Has this Event/Problem been reported to the Sponsor?
[ ] Yes
[ ] No (If No, please provide rationale for not reporting)
Sponsor’s response (if applicable):
VI. TREATMENT PROVIDED TO THE SUBJECT
Who is financially responsible for treatment of this adverse event?
[ ] Sponsor:________________________
[ ] Subject/subject’s insurer:___________
[ ] Other :___________
Date of Treatment: Subject’s recovery was:
[ ] Complete
[ ] Moderate
[ ] Minimal
[ ] None
Describe the treatment provided to the subject. (Use separate sheets as needed.)
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VII. ADDITIONAL COMMENTS
In the space below, feel free to add additional comments that you think are relevant to this report.
Attach a separate sheet as needed.
__________________________________
Signature of Principal Investigator
_______________
Date
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FOR IRB Chair or Designee USE ONLY
[ ] Doesn’t meet reporting criteria – RETURN to PI
[ ] Noted and no further action needs to be taken (existing approved protocol may continue)
[ ] Requires Modification of current Protocol
[ ] Halt study enrollment immediately
[ ] Continue of Data Analysis Only
[ ] Other (see comments below)
ACTIONS:
[ ] Send to IRB Meeting for Review
[ ] Expedite Review
Chairperson, Institutional Review Board
---------------------------------------------------------------
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References:
Vanderbilt University:
http://www.mc.vanderbilt.edu/irb/forms/Form1105_AdverseEvent.rtf
Georgetown University
http://ora.georgetown.edu/irb/pdf/GU-IRB_Policy_on_Adverse_Events.pdf
Oxford Radcliffe Hospital, UK http://www.oxfordradcliffe.nhs.uk/research/safety.asp
University of Florida IRB http://irb.ufl.edu/irb01/forms.htm
University of Nevada, Las Vegas http://research.unlv.edu/forms/unit.html
University of Kentucky http://www.research.uky.edu/ori/
The University of Georgia http://www.ovpr.uga.edu/docs/?toggle=hso
Northwestern University http://www.research.northwestern.edu/oprs/irb/forms/index.html
McGILL University http://www.mcgill.ca/medresearch/ethics/forms/
University of Vermont; University of Vermont Committee of Human Research
http://www.uvm.edu/irb/
University of Chicago Biomedical IRB http://humansubjects.uchicago.edu/
Ohio State University http://orrp.osu.edu/irb/forms/
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