Institutional Review Board
Office of Research Integrity | Oregon State University
B308 Kerr Administration Building, Corvallis, OR 97331-2140
Telephone (541) 737-8008
irb@oregonstate.edu | http://oregonstate.edu/irb/
Review Level and Type
Study Title
Principal Investigator
Pre-Reviewer
Primary Reviewer
STUDY ID
0000
IRB CHAIR WORKSHEET FOR PROBLEMS & EVENTS
Lisa Leventhal
Leslie Richards
Date of Pre-review
Date of Review
REVIEWER CONFLICT OF INTEREST
As a reviewer, are you an investigator, consultant, collaborator, or study personnel on the
proposed study; do you have a financial interest in the study; or do you have any other
conflict of interest related to this study which would prevent you from providing an
independent review or which may lend itself to the perception of a COI?
Yes
No
ADDITIONAL REVIEW
Yes
Forward to Biosafety Officer
Forward to Radiation Safety Officer
Forward to other:
Office Review Comments:
No
N/A
SECTION I: UNANTICIPATED PROBLEM
1. Unexpected: Is it 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?
2. Related or possibly related: Is there a reasonable possibility that the incident,
experience, or outcome may have been caused by the procedures involved in the
research?
3. Risk: Does the incident, experience, or outcome suggest that the research places
subjects or others at a greater risk of harm (including physical, psychological, economic,
and social harm) than was previously known or recognized?
4. Was the report submitted within 3 daysi of discovery?
Is there sufficient information to make a determination?
Determination: Is this an unanticipated problem (“yes” to 1-3)?
Yes
No
SECTION II: ADVERSE EVENT
5. Adverse event (AE): Was there an untoward or unfavorable occurrence in a human
subject that was temporally associated with the subject’s participation in the
research? If “no,” skip to next section.
Yes
No
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IRB Form | v. date August 2012
6. Attribution: Adverse event attribution will fall into one of the following categories:
a) Related or possibly related: Is there a reasonable possibility that the incident,
experience, or outcome may have been caused by the procedures involved in
the research? If “no,” skip to next section.
7. Severity: If there was an AE, was it mild, moderate, or severe?
a) Mild: Event results in transient discomfort; does not influence performance or
functioning; does not require intervention or treatment; does not limit or
interfere with daily activities; expected to resolve quickly with no physical,
psychological, social, or economic consequences. If mild severity, this is not a
reportable event.
b) Moderate: Of sufficient severity to make the patient uncomfortable; may
include worsening of conditions present at the onset of the study; treatment of
symptom(s) may be needed; expected to resolve but short term physical,
psychological, social, or economic consequences are possible.
c) Severe: Event results in significant symptoms that prevents normal daily
activities; may require hospitalization or invasive intervention. Long term
physical, psychological, social, or economic consequences are possible.
8. Was the report submitted within 30 days of discovery?
Is there sufficient information to make a determination?
Determination: Is this a reportable adverse event (“yes” to 5, 6a, and 7b or 7c)?
SECTION III: DEVIATION
9. Is the event or issue a deviation from the approved protocol that was unanticipated and
happened without any prior IRB approval? If “no,” skip to next section.
10. Does the deviation increase risk, have potential to recur, or was it undertaken to
eliminate an immediate hazard?
11. Does the type or number of deviations reported by this investigator (on this study or
others from this PI) warrant further action?
Is there sufficient information to make a determination?
Determination: Is this is an Unanticipated Problem (“yes” to 10)? Refer to Section I above?
Determination: Are there repetitive deviations for this study, or for this PI across multiple
studies, which may constitute non-compliance and require further review by the convened
Board (“yes” to 11)?
Yes
No
SECTION IV: EXCEPTION
12. Is this a circumstance in which the specific procedures called for in a protocol are not in
the best interests of a specific subject and the investigator is requesting permission for a
planned deviation from the approved protocol? If “no,” skip to next section.
13. Does the exception increase risk or decrease benefit, affect the participant’s rights,
safety, welfare, or affect the integrity of the resultant data?
Is there sufficient information to make a determination?
Determination: Can this request for an exception be approved (answer to 13 must be “no”)?
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IRB Form | v. date August 2012
SECTION V: NON-COMPLIANCE
14. Non-compliance is defined as failure to comply with any of the regulations and policies
governing the OSU IRB and/or failure to follow the determinations of the IRB. Noncompliance may be minor or sporadic, or it may be serious or continuing. Is this a
report of non-compliance? If “no,” skip to next section.
15. Serious non-compliance is defined as failure to follow any of the regulations and
policies governing the OSU IRB or failure to follow the determinations of the IRB and
which, in the judgment of either the IRB Chair or the convened IRB, increases risks to
participants, decreases potential benefits, or compromises the integrity of the human
research protection program. Examples of serious non-compliance include, but are not
limited to, (a) research being conducted without prior IRB approval, and (b)
participation of subjects in research activities without their prior consent (in studies
where consent was not specifically waived by the IRB). Is this a report of serious noncompliance?
16. Continuing non-compliance is defined as a pattern of non-compliance that, in the
judgment of the IRB Chair or convened IRB, suggests a likelihood that instances of noncompliance will continue without intervention. Continuing non-compliance also
includes failure to respond to a request to resolve an episode of non-compliance. Is this
a report of continuing non-compliance?
Is there sufficient information to make a determination?
Determination: Is this a report of non-compliance that is NOT serious or continuing?
Determination: Is this a report of serious and/or continuing non-compliance?
Determination: Do the allegations or findings of non-compliance warrant suspension or
termination of the research before completion of the review or investigation?
Yes
No
SECTION VI: COMPLAINT
17. Does this issue or event constitute a complaint? If “no,” skip to next section.
18. Does the complaint warrant suspension of the study?
19. Does the complaint involve non-compliance?
20. Does the complaint involve an unanticipated problem?
21. Does the complaint involve an adverse event?
Is there sufficient information to make a determination?
Yes
No
SECTION VII: PROJECT REVISION
22. Does the issue or event necessitate a project revision?
23. Was a project revision submitted with this report? If “yes,” complete an additional
reviewer sheet that is specific to project revisions. If “no,” skip to next section.
24. Was the revision sufficient?
25. Are additional revisions required?
Yes
No
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IRB Form | v. date August 2012
DETERMINATIONS AND NEXT STEPS
Are materials complete and sufficient to make a determination?
Yes
No
Is the event an unanticipated problem, serious or continuing noncompliance, or does it warrant suspension or termination?
Yes
No
Is the study exempt?
Yes
No
Is the risk to subjects or others greater than minimal?
Yes
Administrator requests
additional information
Full Board
Non-actionable
Send acknowledgement
Report to OHRP if HHS funded
Full Board
Actionable
Full Board
Non-actionable
Send Acknowledgement
No
Full Board
Actionable
REVISIONS or COMMENTS: Request the following additional information or revisions, or include
these comments in with the acknowledgement:
RESOLVED: No further action required as of <insert date>.
Send acknowledgement.
i
ii
Throughout this document, “days” refer to business days, not calendar days.
http://www.hhs.gov/ohrp/compliance/reports/index.html
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IRB Form | v. date August 2012