Last Revised: 10.2015
Prior Version: 7.2007
Closures: Administrative Hold, Suspension, or Termination
of IRB-Approved Approvals
Introduction
The IRB conducts administrative holds, suspensions, and terminations in accordance with
45 CFR 46.113.
Definitions
Administrative Hold is a voluntary action by an investigator or departmental chair to
temporarily or permanently stop some or all research activities as a modification to approved
research. Examples when this would be appropriate include the following: unanticipated
problem, investigator going on a sabbatical leave or leave of absence. Although the investigator
may discuss this action beforehand with the IRB chair, Director of the Human Research
Protection Program or Vice President for Research, the hold must be initiated voluntarily by the
investigator and must not be used to avoid IRB mandated suspension or termination or reporting
requirements. During administrative hold, the research remains subject to continuing review and
requirements for reporting non-compliance and unanticipated problems involving risks to
subjects or others. Administrative holds must not be used to avoid reporting deficiencies or
circumstances that otherwise require reporting by federal agencies. Administrative holds are not
considered suspensions or terminations, and do not meet reporting requirements to OHRP, FDA
and other federal agencies.
Administrative Termination of non-approved protocol/protocol submission is an action by
the IRB on research which has been reviewed and given contingent approval (minor
modification required to secure approval), and the investigator does not respond.
Continuing Review Reminder Notices are correspondences sent by the IRB to an investigator
and/or study staff, as a reminder of the upcoming expiration of IRB approval of a protocol.
Closure or Termination of approved protocol is an action taken by an investigator to
permanently discontinue research activities for a study that has current IRB approval.
Expiration Date is the last day that a protocol maintains its IRB approval. For example, an IRB
approval letter that indicates that a protocol expires on “2/1/2015” is active until 11:59 on
2/1/2015 and no longer has IRB approval on 2/2/2015 if continuing review has not been
obtained. If the study is not renewed via continuing review, then all research activities must
cease after the expiration date.
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Expired Study is when continuing review of the research does not occur prior to the end of the
approval period specified by the IRB, IRB approval expires automatically. No activities may
occur after the expiration date.
Research Misconduct means fabrication, falsification, plagiarism in proposing, performing, or
reviewing research, or in reporting research results.
Suspension is when research on an approved protocol is partially or completely stopped pending
future action by the IRB. Examples include: an unanticipated problem in research involving
greater than minimal risks to subjects or others; unexpected serious harm to subjects; or when the
IRB is investigating a research protocol for possible issues of human subject non-compliance or
continuing non-compliance with federal regulations, or with the determinations of the IRB.
Suspended protocols remain open and require continuing review.
Termination of IRB approval is defined as permanent halt in IRB approval of all research
activities.
Policy
The IRB has the authority and responsibility to suspend or terminate approval of research that is
not being conducted in accordance with the IRB policies and procedures, or that has been
associated with unexpected harm to participants or others. The IRB has the ability to temporarily
or permanently suspend or terminate approval for some or all research activities. Depending on
the circumstances surrounding the suspension or termination action, the investigator may be
required to submit a report to the IRB, detailing any adverse events and/or study outcomes that
were previously unreported to the IRB for consideration. Any letter of suspension or termination
of approval to an investigator must include a statement of the reasons for the action by the IRB
(45 CFR 46.113 and 21 CFR 56.113).
The IRB Chair, Vice-Chair, or the Vice President for Research is authorized to suspend or
terminate the enrollment of subjects; and the ongoing involvement of subjects in research, as it
deems necessary to protect the rights and welfare of participants. This also includes compelling
and urgent instances when subject safety is of concern. The IRB will review such suspensions
and terminations at a subsequent convened meeting. A plan will be developed that takes into
account the rights and welfare of currently enrolled subjects and those subjects who may need to
be withdrawn from the study. If the agreed upon plan of action involves withdrawal of enrolled
participants, the IRB will take into account their rights and welfare (e.g., transfer to another
researcher, and continuation in the research under independent monitoring). If the IRB
determines that a suspension or termination of the research will place subjects at risk of harm,
the investigator will be requested to submit a proposed script or letter for participants for IRB
review and approval. The IRB determines the information that is to be provided to participants
and the method of their notification e.g., in writing or by telephone. This includes appropriate
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participant follow-up and notification of the reasons for the action. All protocol suspensions or
terminations are reviewed at a subsequent IRB meeting.
When study approval is suspended or terminated, the IRB or the person ordering the suspension
or termination:
 Considers actions to protect the rights and welfare of currently enrolled subjects.
 Considers informing current subjects of the termination or suspension.
 Has any adverse events or outcomes reported to the IRB.
Investigators’ Responsibilities
Investigators have the responsibility to formally close a study with current IRB approval once it
is completed or discontinued. When investigators have completed or discontinued recruitment
of/re-contact with study participants, and the investigators are no longer working with
individually identifiable data, they must formally close out or terminate the research study.
Destruction of individually identifiable data includes:


Master lists
If data has been coded, all linkable information
Notification must be sent to the IRB office by completing the electronic Continuing
Review/Termination Form in iRIS, which must include the following information:
 A summary of findings
 Final subject statistics
 Any previously unreported adverse events
Once a protocol is permanently closed or terminated, all research activities must cease, including
data analysis (unless the data are de-identified). Once the data has been de-identified, it can be
retained indefinitely. A protocol that has been closed cannot be reopened. To resume research
activities a new protocol must be submitted and approved by the IRB via iRIS.
If the investigator continues to conduct the research after the study has expired (without prior
approval from the IRB that it is in the best interest of the current subjects to continue activity),
this becomes an issue of non-compliance and will be reported to the IRB. The matter may also
be reportable to the CWRU Compliance Officer, and to applicable regulatory or funding
agencies.
Expiration of IRB Approval
The federal Regulations (45 CFR 46.109(e)) and the CWRU IRB do not allow for the conduct of
research beyond the protocol expiration date. The investigator is responsible for ensuring that
the research is submitted to the IRB for continuing review in an appropriate time frame, in order
to avoid a lapse of IRB approval. The continuing review deadline and the protocol expiration
dates are listed on the protocol approval letter and in iRIS. In order to avoid a lapse in IRB
approval, the investigator is encouraged to plan ahead to meet the deadline specified by the IRB.
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The iRIS system will indicate when a protocol is ready to expire and will automatically send
courtesy notices at 90-day, 60-day, 30-day, and 14-day intervals alerting the investigator to
submit a continuing review. If no continuing review is received before the expiration date and
the protocol expires, iRIS will send a Notice of Expired Study to investigators on the protocol’s
expiration date. The Notice of Expired Study informs the investigator that all research activities
must cease and, if federally funded, the Office of Sponsored Projects will be notified and asked
to cease all federal funding activities (i.e., reimbursement) related to the study. Further,
investigators must inform the IRB if any research activities have occurred after the expiration
date (a non-compliance issue, which will be processed as described in the CWRU IRB NonCompliance policy).
Research activities include but are not limited to the following:
●
recruitment;
●
enrollment;
●
study interventions and subject interactions (i.e. any involvement of current participants
including the scheduling of study visits); and
●
identifiable data analysis, this also includes looking at new subject information
If a protocol has been placed on Notice of Expired Study, the investigator has thirty (30) days
from the protocol expiration date to submit a continuing review form. Within the Notice of
Expired Study period, no research activity, including data analysis may occur. If a continuing
review submission is not received for review within the 30-day Notice of Expired Study period,
the protocol will be terminated. If an investigator wishes to resume his or her research protocol,
the investigator must submit a termination form to properly close out the terminated protocol and
submit a new protocol application to resume the research. On a case by case basis, the IRB
Manager in consultation with the IRB Chair or Vice-Chair may extend the 30-day period in
appropriate circumstances.
If a response is not received in the IRB Office by thirty (30) days after study expiration, the IRB
Office will issue a letter to the investigator to inform them that the study IRB approval lapsed, no
application for renewal was received and that the research cannot be re-opened without a new
protocol submission. If the investigator continues to conduct the research after the study has
expired, this becomes an issue of non-compliance and will be processed as described in the
CWRU IRB Non-Compliance policy.
The IRB has the authority to allow the continued participation of subjects in research for which
IRB approval has lapsed while the continuing review process occurs, only if there are overriding
safety concerns or ethical issues that indicate it is in the best interest of the participants to
continue, for example when the research interventions have the prospect of direct benefit to
subjects or when withholding the study interventions poses an increased risk to subjects. In such
cases, the study will be closed to new enrollment and all data analysis must stop until the IRB
completes the review process.
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If an investigator makes a determination that immediately stopping all or some of the research
activities would not be in a subject’s best interest, the investigator must inform the IRB via iRIS.
This formal request should be made as an Amendment Form and must include the rationale and
justification as to why the research activities should be allowed to continue. It should also
include a confidential list of the research participants (identified by study number or initials only)
for whom suspension of the research interventions would potentially increase risk or deny
benefits. The determination by the IRB may be made by the IRB chairperson, by another IRB
member or group of IRB members designated by the IRB chairperson, or at a convened meeting
of the IRB. Furthermore, this determination may be made for all enrolled subjects as a group or
for each individual subject. If the investigator or IRB determines that it is not in the best
interests of already enrolled subjects to continue to participate, investigators must stop all human
subjects research activities, including intervening or interacting with subjects and obtaining or
analyzing identifiable private information about human subjects (45 CFR 46.109(a) and (e)).
The IRB will acknowledge the closure of a study by sending a letter via iRIS. After a protocol
has been closed, the IRB does not accept reports of adverse events unless they impact the rights
and welfare of participants enrolled or the integrity of the data. The investigator should keep all
non-reported adverse events on file for review by regulatory agencies as required.
After a study has been permanently closed, signed consent forms should be available for IRB
inspection for three years. In the event the principal investigator departs from CWRU, copies of
signed consent forms should be given to a CWRU co-investigator or archived in accordance with
the Records SOP. Closures/Terminations are included in the Notice of Committee Report to the
IRB and those reports will maintained by the CWRU IRB office.
Reporting to Regulatory Agencies, Department Heads and Institutional Officials
The IRB will report all suspensions or terminations of IRB approval to Regulatory Agencies,
Department Heads and Institutional Officials as required.
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