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SOP #OIRB-058: Lapse of Approval Period
REV#1
EFFECTIVE DATE: 03/25/2015
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PURPOSE
1.1
This procedure establishes the process for determining circumstances and
implementing procedures where IRB study approval has lapsed.
REVISIONS FROM PREVIOUS VERSION
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Removed references to VA and HRRC; added scope; administrative updates
SCOPE
This SOP applies to IRB approval expirations which occur due to failure of the Principal
Investigator (PI) to provide a Progress Report (and all other required documents) to the Office
of the IRB (OIRB) and/or when the information is not submitted in sufficient time for the IRB to
review and approve a research study by the approval expiration date specified by the IRB.
POLICY
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The OIRB is responsible for maintaining records of the status of all approved studies.
A research study status is considered lapsed if the IRB has not reviewed and approved the
study by its expiration date.
The PI is either an individual who conducts a research investigation, is responsible leader of a
team of investigators, or is the mentor of a student led research study.
Non-compliance includes failure to comply with federal regulations and guidance if applicable,
or the requirements and determinations of the IRB. Failure to submit a continuation or closure
application prior to a study lapsing is considered non-compliance.
The OIRB is responsible for sending notification to the PI to inform the investigator that all
research activity must cease as of the IRB approval expiration date. Additionally, the OIRB will
instruct the PI to notify the Sponsor, if any, of the lapse immediately and copies of these
communications need to be submitted to the OIRB.
All research activities (including recruitment, enrollment, treatments, follow-up, and data
collection/analysis) must cease when a study approval period has lapsed. The PI must
immediately submit a written request to continue interventions for any research subjects for
whom discontinuation of the research would cause harm and continuation in the research
would be in the best interest of the individual participant. The IRB Chair or Vice Chair will
determine if the subject(s) may continue in the research and this determination may be
reviewed through an expedited process. Requests to allow continued participation should be
submitted via appropriate submission processes (containing the signature of the PI). The OIRB
will notify the PI and/or other key personal of the decision and will provide further instructions
as applicable.
If the PI does not submit all required documentation within 10 days of expiring, the OIRB will
assign the study for “Non-Compliance Review” to the IRB Chair (or Vice-Chair) and the study
status will be noted as lapsed and “closed-expired.” The IRB Chair or Vice-Chair has the right
to assign the study to a Full Board review if he or she decides it is necessary. The OIRB will
notify the PI of any decisions; a copy will be sent to the PI’s Department Chair.
For studies that are greater than minimal risk, the IRB may decide that additional reviews and
determinations are required.
OIRB Staff will make every reasonable attempt to contact the PI and/or study staff to obtain a
complete set of reactivation or closure documents. If the documentation is completed and there
are no contingencies that present more that minimal risk to the study participants, the study
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4.10
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may be reactivated. After 6 months of lapsed status, the study must be closed. If after 6
months, complete paperwork is not submitted, the study will be administratively closed.
For studies that are administratively closed, a new project submission will be required for
review and approval going forward.
If non-compliance issues have not been resolved, including but not limited to having a study
with lapsed status, the OIRB will not process submissions from that PI until those issues have
been resolved. Additionally, the IRB may rule that no new studies be accepted from the PI until
issues are resolved and official notification of study reactivation or documentation of study
closure is issued.
With a second occurrence of any study expiration under the PI, the PI will be notified in writing
that this is a second occurrence of non-compliance with regard to study expirations; the
department chair and others as applicable will also be notified.
With the third or greater occurrence of a study lapse under a PI, the PI, department chair, and
others will be notified in writing of the pattern of study lapses and a fully convened IRB review
will be conducted to determine if the non-compliance is actionable.
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REFERENCES
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5.1.1
45 CFR 46.109(e)
5.1.2
21 CFR 56.103(a)
FORMS
6.1
Continuing Review Application
6.2
Closure Application
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