Exceptions & Deviations

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Exceptions & Deviations
Purpose
The purpose of this policy is to outline the procedure for reporting and reviewing exceptions and
deviations.
Defined Terms
Deviation: Any change/alteration to the CRC IRB-approved protocol without prospective IRB
approval.
Major Deviation: Any change/alteration that has the potential to: 1) adversely affect the rights,
welfare or safety of the subjects, 2) adversely affect the integrity of the research data, or 3) affect
the subject’s willingness to participate.
Minor Deviation: Any change/alteration that has NOT or does NOT have the potential to: 1)
adversely affect the rights, welfare or safety of the subjects, 2) adversely affect the integrity of
the research data, or 3) affect the subject’s willingness to participate.
Exception: A one time, intentional change/alteration to the IRB-approved protocol that is
approved by the IRB prior to implementation.
Policy
Federal regulations require that the IRB reviews all changes to an approved research study and
ensures that these changes are not initiated without prior IRB review and approval except when
necessary to eliminate immediate hazards to the subject.
When an investigator anticipates a one time change/alteration to the IRB-approved protocol, a
protocol exception should be submitted to the IRB for review and approval prior to
implementation.
Any changes/alterations that are noted after they occur are considered to be
deviations. Deviations can be categorized as either major or minor.
Major deviations should be reported to the IRB within 5 working days. Minor deviations should
be reported to the IRB within 20 working days. The investigator is responsible for determining
if the deviation is major or minor.
The IRB will make a determination for all major deviations if the event constitutes serious and/or
continuing non-compliance.
Major Deviation Examples (this list is considered to be guidance and is not all-inclusive):
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Failure to obtain informed consent
Obtaining informed consent after study procedures are initiated
Performing study procedures not approved by the IRB
Enrolling a prisoner into the study if the study is not approved to enroll prisoners
Failure to report serious adverse events and unanticipated problems to the IRB, Sponsor,
and other agencies as applicable
Failure to follow the safety monitoring plan
Enrollment of a subject who did not meet the inclusion/exclusion criteria
Assent not obtained when required by the IRB
Verbal consent obtained when IRB requires written consent
Failure to perform a required study procedure that may affect subject safety or data
integrity
Minor Deviation Examples* (this list is considered to be guidance and is not all-inclusive):
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Over-enrollment
Use of an expired consent form that includes all the required information and elements of
informed consent
Study visits/procedures that are either omitted, conducted outside of the visit window or
in a different order than specified in the protocol that do NOT affect or have the potential
to affect subject safety or data integrity
Failure to submit continuing review to the IRB before study expiration
Inappropriate documentation of informed consent (e.g. missing signatures, missing dates,
copy not given to the subject)
*Similar minor violations that occur frequently may be considered to be a major violation
Procedures
Submission of Deviation or Exception:
1. The Principal Investigator is responsible for submitting the deviation/exception using the
Deviation/Exception Form. Major deviations should be reported within 5 working days
upon discovery. Minor deviations should be reported within 20 working days upon
discovery.
2. The Principal Investigator must submit all deviations/exceptions to the Sponsor and other
applicable agencies as required.
Screening of Submissions:
1. The Deviation/Exception is received by the IRB Coordinator and screened for
completeness. If information is missing, the IRB Coordinator will request the missing
information from the Principal Investigator.
Determining Review Type (Expedited vs. Full Board):
1. The IRB Coordinator forwards the Deviation/Exception form to the IRB Director for
review. The IRB Director confirms the completeness and accuracy of the form and then
forwards to the IRB Chair or Vice-Chair for review.
2. The IRB Chair/Vice-Chair and IRB Director makes a determination whether the
deviation/exception is major or minor and whether to review the event using full or
expedited review procedures.
3. If the deviation/exception is determined to be minor, the IRB Chair and IRB Director
conducts the review using expedited procedures.
4. Minor administrative deviations including, but not limited to, over-enrollment, lapsed
protocol, etc. may be reviewed by the IRB Director.
5. If the deviation/exception is determined to be major, it will be referred to the full board
for review.
6. If the IRB Chair/Vice-Chair and IRB Director are unable to determine if the event is
major or minor, it will be referred to the full board for review.
7. If additional expertise is needed, the IRB Director will contact the appropriate IRB
member for consultation.
Expedited Review Procedure for Minor Deviations/Exceptions:
1. If the Deviation/Exception is determined to be minor, the IRB Chair/Vice-Chair will
review the event using expedited procedures. The review will be documented by the use
of the appropriate reviewer checklist.
2. The IRB Chair/Vice-Chair will determine the appropriate corrective action plan.
3. The Principal Investigator will be notified of the determination and corrective action plan
via letter.
4. Minor administrative deviations will be reviewed by the IRB Director.
5. All deviations/exceptions will be reported to the full board at the next convened meeting.
Full Board Review Procedure for Major Deviations/Exceptions:
1. If the Deviation/Exception is determined to be major, the event will be reviewed by the
full board.
2. The IRB Chair/Vice-Chair and Director will assign the event to an IRB member(s) for
review. The review will be documented by the use of the appropriate reviewer checklist.
3. The assigned reviewer will present the event at the full board.
4. The full board will review the event and determine the appropriate corrective
action. Corrective actions may include:
o Education
o Modifications to the protocol
o Notification of current and/or past subjects
o More frequent IRB review
o Additional monitoring
o Prohibit use of study data
o Suspension
o Termination
5. For all major deviations, the IRB will determine if the event meets the definition of
serious and/or continuing non-compliance.
6. If the event meets the definition of serious and/or continuing non-compliance it will be
processed as outlined in the “Noncompliance Policy” and “Reporting Policy.”
7. The Principal Investigator will be notified of the determination and correction action plan
via letter.
Title
Author
Effective Date
Last Review/Update Date
Revision #
Approved
Exceptions and Deviations
Cynthia Monahan
10/01/2012
09/19/2012
Cynthia Monahan, IRB Director
Ara Tahmassian, PhD, Associate Vice President-Research
Compliance
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