Unanticipated Events/Deviation/ Non-compliance Reporting Form
Directions: A form must be completed and submitted to the IRB via email (IRB@uccs.edu) for each
incident of an unanticipated event or deviation within 5 days of the P.I. becoming aware of the
occurrence (see comment below regarding reporting participant non-compliance.)
Filing of this form with the IRB does not release the Principal Investigator from any other reporting
requirements to the government, sponsor, or other regulatory agency. Please fill in all narratives on
the form electronically. Additional supporting documents may be sent as an attachment along with
this form to IRB@uccs.edu.
Examples of Reportable Events (not inclusive):
(a) An unplanned protocol deviation that harmed participants or others; that indicates participants or
others may be at increased risk of harm; that could adversely affect the safety or welfare of subjects; or
that compromises the integrity of the research data. (Note: A planned protocol deviation requires IRB
approval of a report of change prior to implementation.)
(b) Any change made to the research without prior IRB approval in order to eliminate apparent immediate
harm.
(c) Any unforeseen harmful or unfavorable occurrence to participants or others that is related or possibly
related to the research protocol (such as injuries, psychological events, or drug errors).
(d) Any unforeseen development related or possibly related to the research, that potentially increases the
likelihood of harm to participants or others in the future.
(e) Adverse events which, in the opinion of the PI, are both unexpected and related or possibly related to
the subject’s participation in the research.
(f) Information that indicates a change to the risks or potential benefits of the research.
(g) Breach of privacy or confidentiality.
(h) Incarceration of a participant in a protocol not approved to enroll prisoners.
(i) Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the
research team.
(j) Sponsor-imposed suspension for risk.
(k) Allegation of non-compliance with protocol requirements or IRB policies.
(l) Any safety reporting requirements specified by the IRB as a condition of approval.
(o) Any other problem or event that the investigator considers to be unanticipated and indicates that
subjects or others are at increased risk of harm.
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IRB Unanticipated Event /Deviation Reporting Form
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Definitions:
Unanticipated Event is 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 IRB-approved research protocol and
informed consent document; and (b) the characteristics of the subject population being studied;
2. related or possibly related to participation in the research (in this guidance document, possibly
related means 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 a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known or recognized
(http://www.hhs.gov/ohrp/policy/advevntguid.html)
Deviations are variances from the IRB approved protocol and protocol related materials that have not
been pre-approved.
IRB #:
example (12-000)
IS THIS A/AN:
Unanticipated Event
Deviation
PROTOCOL TITLE:
IF THIS IS A SPONSORED PROJECT, PROVIDE NAME OF SPONSOR:
TOTAL APPROVED NUMBER OF HUMAN SUBJECTS:
TOTAL NUMBER OF HUMAN SUBJECTS AFFECTED:
TODAY'S DATE:
1.
DATE OF OCCURRENCE:
Describe the adverse event/deviation/violation/ participant non-compliance:
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IRB Unanticipated Event /Deviation Reporting Form
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2.
Explain why this occurred.
3.
What steps were taken to resolve this particular occurrence?
4.
What is being done to prevent similar occurrences in the future?
5.
Did the occurrence result in an adverse event or a violation of the rights of a human subject (e.g. violation of
privacy, consent process not followed)?
Yes – Explain in Detail Below
6.
Will the participant continue with the research?
Yes
7.
No
No – List Date Stopped:
Will the research project itself continue?
Yes
No – List Date Stopped:
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IRB Unanticipated Event /Deviation Reporting Form
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By submitting this form to irb@uccs.edu, I
(type your name) acknowledge that the
information contained in the study is accurate to the best of my knowledge. I verify that I am the
Faculty Advisor or the Principal Investigator for this study and that I shall be responsible for the
oversight of the conduct of the research and adherence to all applicable University policies and
procedures.
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IRB Unanticipated Event /Deviation Reporting Form
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