Human Research Protection Program
Institutional Review Board Office
Unanticipated Problem Involving Risks to Subjects or Others Reporting Form
Instructions and Contact Information
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
Use to report events that may constitute an unanticipated problem involving risks to subjects or others; for urgent situations, please
contact the HRPP office
See HRPP Manual 9-1, Unanticipated Problems Involving Risks to Subjects or Others for definitions such as an adverse event,
reporting requirements, etc.
Complete and submit to irbdocs@ora.msu.edu
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If you have questions about completing this form, please contact us.
Phone: 517-355-2180 / Email: irb@msu.edu / Visit hrpp.msu.edu for staff contact or additional information
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Form
1
Responsible Project Investigator Name: Click here to enter text.
2
Title of Project. Click here to enter text.
3
MSU IRB#: Click here to enter text.
4
When did the unanticipated problem occur? Click here to enter text.
5
Describe the unanticipated problem. Click here to enter text.
6
Please explain how the event may be unexpected (in terms of nature, severity or frequency) given the
research procedures that are described in the protocol-related documents, such as the IRB-approved
research protocol and informed consent document; and the characteristics of the subject population
being studied. Click here to enter text.
7
Please explain how the event may be related or possibly related to participation in the research. Possibly
related means there is a reasonable probability that the incident, experience, or outcome may have been
caused by the procedures involved in the research. Click here to enter text.
8
Please explain how the event may suggest that the research places subjects or others at a greater risk of
harm (including physical, psychological, social, legal, or economic) than was previously known or
recognized. Click here to enter text.
9
Could the unanticipated problem also be an adverse event?
☐ No
☐ Yes
If you answered yes, complete 9A, 9B, 9C, and 9D.
9A
The unanticipated problem was also an: adverse event serious adverse event
9B
What was the outcome?
☐ Death
☐ Life-Threatening
☐ Hospitalization – Initial or Prolonged
☐ Disability
☐ Required intervention to prevent permanent damage
☐Study drug withdrawn temporarily
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☐
☐
☐
☐
☐
Discontinued from study
Significant dosage or protocol error
Resolved
Outcome not yet determined
Other, Click here to enter text.
Human Research Protection Program
Institutional Review Board Office
9C
How related is the unanticipated problem to the following:
Subject’s underlying
disease process or
condition
☐Unrelated
☐Unlikely
☐Possible
☐Probable
☐Definite
☐ Unknown
☐Possible
☐ Probable
☐ Definite
☐ Unknown
☐Possible
☐ Probable
☐ Definite
☐ Unknown
Please explain your answer: Click here to enter text.
Study’s procedure
☐Unrelated
☐ Unlikely
Please explain your answer: Click here to enter text.
Study’s drug/device
☐Unrelated
☐ Unlikely
Please explain your answer: Click here to enter text.
9D
☐ No
Was a MedWatch Report submitted?
☐ Yes
If yes, attach a copy.
10
Does this unanticipated problem require a change in the consent form?
☐ No
☐ Yes
☐ No
☐ Yes
☐ No
☐ Yes
If yes, submit a “Revision” Application to request the change to the consent form and
submit this report as an attachment.
11
Will currently enrolled subjects be provided an informational letter or be asked to sign
a new consent form?
If yes, submit a “Revision” Application to request the change to the consent form and
submit this report as an attachment.
12
Does the information in these documents require that the research be suspended or
closed?
13
Describe any action or changes the investigators are making in response to this unanticipated problem. If
revisions to the project are needed, submit a “Revision” Application to request the change. Click here to
enter text.
14
Describe what will be done to prevent future occurrences (e.g. what corrective actions have been taken or
will be taken) or explain why correction actions are not needed. If revisions to the project are needed,
submit a “Revision” Application to request the change. Click here to enter text.
RESPONSIBLE PROJECT INVESTIGATOR
As the responsible investigator, my signature below indicates that the provided information is complete and accurate.
SIGN HERE:
Click here to enter text.
Print Full Name:
Click here to enter text.
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DATE:
Click here to enter text.