IRB approval may be suspended or terminated if research is not being conducted in accordance with IRB or regulatory requirements or has been associated with unexpected problems or serious harm to subjects.
(See SOP 029: Suspensions, Administrative Holds, Early Terminations for more guidance)
Suspension
Suspension of IRB approval is a directive of the convened IRB or IRB Chair to temporarily stop some or all previously approved research activities. Short of permanently stopping all previously approved research activities. Suspension directives made by the IRB Chair must be reported to a meeting of the convened IRB. Suspended protocols remain open and require continuing review.
Termination
Termination of IRB approval is a directive of the convened IRB to stop permanently all activities in a previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review. Terminations of protocols approved under expedited review must be made by the convened IRB.The IRB shall notify the PI in writing of such suspensions or terminations and shall include a statement of the reasons for the IRB's actions. The terms and conditions of the suspension must be explicit. The PI shall be provided with an opportunity to respond in person or in writing.
When study approval is suspended or terminated by the convened IRB or an authorized individual, in addition to stopping all research activities, the convened IRB or individual ordering the suspension or termination will notify any subjects currently participating that the study has been suspended or terminated. The convened IRB or individual ordering the suspension or termination will consider whether procedures for withdrawal of enrolled subjects are necessary to protect their rights and welfare of subjects, such as: transferring participants to another investigator; making arrangements for care or follow- up outside the research; allowing continuation of some research activities under the supervision of an independent monitor; or requiring or permitting follow-up of participants for safety reasons.
If follow-up of subjects for safety reasons is permitted/required by the convened IRB or individual ordering the suspension or termination, the convened IRB or individual ordering the suspension or termination will require that the subjects should be so informed and that any adverse events/outcomes be reported to the IRB and the sponsor.
The PI MUST continue to provide reports on adverse events and unanticipated problems to both the IRB and sponsor just as if there had never been a suspension (i.e., all events that need to be reported during a study need to continue to be reported during the suspension period).
NOTE: Suspension or termination of protocols approved by the IRB can also be issued by WVU officials acting outside of and unrelated to the HRPP (i.e., not necessarily related to protecting the rights and welfare of study participants). Such University actions can be made by the University President, Provost, and Deans. Such University actions may be made for any reason in furtherance of the Institution’s interest provided, however, that the aggrieved PI is entitled to all rights and procedures afforded to him/her under the Grievance Policy.The PI must report any suspension or termination of the conduct of research by organization officials to the IRB. The IRB will then determine if suspension or termination of IRB approval is warranted.
Administrative Hold
An investigator, Institutional Official, or sponsor may request an administrative hold on a protocol when one of the individuals wishes to temporarily or permanently stop some or all approved research activities. An administrative hold is initiated by an investigator, Institutional Official, or sponsor. Administrative holds are not suspensions or terminations.
Procedures
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The investigator must notify the IRB in writing that:
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They are voluntarily placing a study on administrative hold.
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A description of the research activities that will be stopped.
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Proposed actions to be taken to protect current participants.
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Actions that will be taken prior to IRB approval of proposed changes in order to eliminate apparent immediate harm.
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Upon receipt of the written notification from the investigator, an IRB Manager places the research on the agenda for review.
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The IRB Chair and/or Director, in consultation with the investigators, determine whether any additional procedures need to be followed to protect the rights and welfare of current participants as described in “Protection of currently enrolled participants” below.
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The IRB Chair and/or Director, in consultation with the investigators, determine how and when currently enrolled participants will be notified of the administrative hold.
- Investigators may request a modification of the administrative hold by submitting a request for a modification to previously approved research.
Protection of Currently Enrolled Participants
Before an administrative hold, termination, or suspension, is put into effect, the convened IRB or IRB designee considers whether any additional procedures need to be followed to protect the rights and welfare of current participants. Such procedures might include:
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Transferring participants to another investigator
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Making arrangements for clinical care outside the research
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Allowing continuation of some research activities under the supervision of an independent monitor
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Requiring or permitting follow-up of participants for safety reasons
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Requiring adverse events or outcomes to be reported to the IRB and the sponsor
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Notification of current participants
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Notification of former participants