ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Abilene Christian University Institutional Review Board Committee &
Departmental Research Review Panel
Unanticipated Problem/Noncompliance Form
Complete the Report and send as an e-mail attachment to orsp@acu.edu. Include any appendix
materials, as applicable.
** Please see the HHS Guidance on Reviewing and Reporting Unanticipated Problems for
what qualifies as requiring prompt reporting.
Title of Project:
Protocol #:
Date of Report:
Principal Investigator:
Faculty Advisor (If PI is a student):
Investigator Assurances Form
Department / Affiliation:
Phone:
**Note: Faculty Advisor MUST read and sign the
Degree/Credentials:
Email:
Address or ACU Box:
Point of Contact, if other than PI (Name, phone, email):
Person Reporting the Problem:
Date the Problem Occurred:
Date the Research Team learned of the problem**:
Location where problem occurred:
Participant IDs of those affected by the problem:
** Unanticipated problems that are serious UPIRSOs (Unanticipated Problems Involving Risk to
Subjects or Others) should be reported within 7 days of this date, unless the UPIRSO is
potentially lethal, then it should be reported within 2 days. Other unanticipated problems should
be reported within 14 days of this date.
What is the Nature of the Event:
UPIRSOs [Complete Box 1]
Protocol Deviations/Noncompliance [Complete Box 2]
Other [Complete Box 3]
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ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Box 1: UPIRSOS
Please indicate the type of UPIRSO:
Unexpected problem, adverse event, injury, or reaction that is definitely or probably
related to the research and places participants at greater risk than previously recognized.
(“Unexpected” may refer to the nature, severity, or frequency of the event)
Breach of confidentiality involving private, identifiable information.
Complaint from a participant which suggests an increased risk, a violation of
participants’ rights or welfare, or that otherwise cannot be resolved by study staff.
Other: _________________________
If an adverse event occurred, was it serious and:
resulted in death
was life-threatening.
resulted in inpatient hospitalization or prolongation of hospitalization.
resulted in persistent or significant disability/incapacity
resulted in a congenital anomaly/birth defect
based upon appropriate medical judgment, may jeopardize the subject’s health and
may require medical or surgical intervention to prevent one of the other outcomes listed
above.
Box 2: Protocol Deviation or Noncompliance
Please indicate the type of Noncompliance:
Failure to conduct the study in accordance with all applicable regulations and policies.
Failure to conduct the study in accordance with the IRB-approved protocol and which
adversely affects participant safety, increases risks to participants, or violates
participants’ rights and welfare. (minor deviations that do not affect safety, increase risk,
or violate rights and welfare may be reported on the continuing review).
Other: _________________
Box 3: Other
Please indicate the type of Event:
Unapproved change made to eliminate an immediate hazard.
Other: ______________
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ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Did the problem involve any participants from a vulnerable population?
Yes
No
Children
Pregnant Women or Fetuses
Neonates
Decisionally Impaired
Prisoners
Students
Other: ____________
Please describe in detail the problem being reported, including what caused it; how it may have
adversely affected participant safety, increased risks to participants, or violated participants’
rights and welfare; how it was resolved; and what was the outcome:
Has this issue occurred before?
Yes
No If yes, please indicate whether it was
previously reported and provide the date of that report:
Please indicate the actions planned:
Action
Protocol amendment (must submit an
amendment form) including but not limited to
changes in methods/procedures, modification of
inclusion/exclusion criteria, changes to safety
monitoring plan
Revise Consent Form (must submit an
amendment form)
Notification of the problem to current and/or
past participants (must submit proposed
communications)
Study will be voluntarily placed on hold
pending resolution
Study will be voluntarily closed (must submit
an Inactivation Form)
Additional training of research team will be
provided
Other ____________
No action planned
####_PI_EventReport_########
Implemented
[X]
Planned but not
yet
implemented
[X]
ACU IRB # ____________
Date of Approval __/__/____
Date of Expiration __/__/____
Please summarize in further detail the actions that have been implemented or are planned:
Is this project being funded by an outside agency?
Yes
No
If yes, please specify which agency:
APPENDIX
Identify which items are included in the appendix
Signed Investigator assurance/signature form (required)
Amendment Form
Participant Communication
Inactivation Form
Other: ______________________
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