740. Suspensions or Terminations of IRB Approval

Updated July 14, 2021

The University IRB has the authority to suspend or terminate IRB approval of research that is not being conducted in accordance with IRB requirements or that may pose unexpected, serious harm to participants. The authority to suspend or terminate IRB approval is retained regardless of whether the research was approved by the convened IRB, through the expedited procedure, through limited IRB review, or is exempt. The IRB retains the ability to suspend or terminate research even when continuing IRB review is not required.

The IRB considers the best interests of research participants in deciding whether to temporality or permanently halt a research study. The IRB will require that procedures for withdrawal of enrolled participants consider their rights and welfare (e.g., planning for medical care off a research study, transfer to another researcher, and continuation in the research under independent monitoring).

IRB-Initiated suspension of approval: A determination made by the University IRB to temporarily withdraw University IRB approval for some or all activities of a currently approved research study.

IRB-Initiated termination of approval: A determination made by the University IRB to permanently withdraw University IRB approval for some or all activities of a currently approved research study.

During suspension or following termination of IRB approval, no new participants may be enrolled; no research drugs, devices, or treatments or procedures may be administered (unless necessary for the safety of enrolled participants); and no data to which a participant identifier is attached may be collected or analyzed. Exceptions include partial suspension and temporary continuation of research activities for safety reasons. NOTE: The terms “suspension” and “termination” do not apply to interruptions in research resulting solely from expiration of a protocol approval period. For more information, see IRB policy for determining dates for IRB review, following lapse of IRB approval.

Suspensions by the IRB

The convened IRB (for imminent harm the IRB Chair) may suspend approval for some or all activities for a research project. The research may be suspended immediately following a report of a problem, during an investigation of noncompliance or unanticipated problem involving risks to participants or others (Unanticipated Problem) or following review of noncompliance or an Unanticipated Problem by the convened IRB. Suspensions by the IRB Chair are reported to and reviewed by the convened IRB.

IRB Chair or his/her/their designee has the authority to suspend some or all research activities if exceptional participant safety issues are identified. This authority is only exercised if an action is required prior to a convened meeting and it is not feasible to assemble an emergency meeting. When this authority if exercised, it will be reported at the next convened University IRB meeting. Correspondence is sent to the Principal Investigator as well as to all listed co-investigators and research staff. The study moves to a “suspended” state.

Suspended protocols are active studies and require continuing review by the IRB. The IRB may approve keeping a suspended research project open but with no research activities (or only specified activities) until the suspension is lifted or the IRB approval for the research is terminated.

Terminations by the IRB

A fully convened IRB may terminate a research project when it determines that cessation of all research activities is in best interest of participants. Studies may be terminated during IRB review of noncompliance or an Unanticipated Problem. Correspondence is sent to the Principal Investigator as well as to all listed co-investigators and research staff. The study moves to a “terminated” state.

Suspensions or Terminations by the Investigator, Sponsor or Other Oversight Body

Sponsors, Principal Investigators (PI) and other oversight bodies have the authority to suspend their own research any time suspension or termination may be necessary to protect the safety and welfare of research participants or others, or the integrity of a research project.

PIs or sponsors may voluntarily suspend or terminate a research project after reviewing or monitoring study data; upon recommendation from a Data and Safety Monitoring Board or Committee; or prior to or during an investigation of noncompliance or an Unanticipated Problem.

When a PI, sponsor or other oversight body determines that it is in the best interest of research participants to suspend or terminate a protocol, the PI must submit a problem report to the IRB within five days of the PI planning for or learning of suspension or termination.

The termination report information should include:

the primary reason for the termination;
the number of participants enrolled to date;
the plan for notifying currently enrolled participants, if necessary;
the procedures that will be undertaken to ensure the orderly and safe withdrawal of currently enrolled participants, if necessary;
whether there were any unanticipated problems involving risks to participants or others that were not previously reported;
whether participants will be notified of the study results;
whether the study had been monitored/reviewed/audited by an outside monitor, sponsor, or agency;
whether the report has been sent to other agencies.

The suspension report information should include:

the primary reason for the suspension;
the type of suspension (intervention only; all research activities);
the number of participants currently enrolled in the study;
the procedure that will be undertaken to ensure the safe withdrawal of currently enrolled research participants, if necessary;
whether permission is being requested to continue research activities during the suspension period for the safety of currently enrolled participants;
whether participants will be notified of the study suspension;
whether the report has been sent to other agencies;
a description of what must occur for a request for re-initiation of study activities can be submitted.

If the PI has a contractual relationship with the sponsor, contract requirements should include notification of the sponsor of investigator initiated suspension or termination of research. In circumstances where the IRB is notified that the investigator cannot contact the sponsor, the IRB will inform the sponsor of the suspension or termination of research.

Partial Suspension of Research Activities

If only some of the research activities will be suspended (e.g., suspension of enrollment), the PI must:

specify which activities are to be suspended, and which will continue;
justify the continuation of research activities during the suspension;
include a timeline for eventual discontinuation of all research activities (unless the suspension is lifted); and
describe procedures to ensure adequate oversight of research activities that will continue.

Temporary Continuation of Research Activities for Suspended or Terminated Research

When IRB approval for a research project is suspended or terminated, all research activities must stop immediately unless the project involves therapeutic treatment or intervention, and cessation of the treatment, or discontinuation of an investigational drug or device may be detrimental to the research participants. Under these circumstances, the PI may ask for a temporary continuation of the essential components of the treatment or intervention.

When it is necessary to temporarily continue some research activities to ensure participant safety during suspension or following termination of a research project, the PI must submit a discontinuation plan. The plan must:

specify which research activities will temporarily continue,
justify the continuation of research activities during the suspension or following termination of a research study,
include procedures and materials for notifying participants of effects of the suspension or termination on their treatment or the intervention, and
describe the process for eventual discontinuation of treatment, tapering dosages for investigational drugs, or removing investigational devices.

For safety reasons, the discontinuation plan may suggest, or the IRB may require follow-up of participants after the cessation of research activities. The PI must tell participants about the follow-up procedures and may not use information from the follow-up procedures for research purposes. During the follow-up period, the PI must report unexpected adverse events, outcomes, or problems to the IRB and the sponsor (as required in sponsor correspondence or contract) as per IRB requirements for reporting problems.

The convened IRB will review the proposed plan and recommend amendments to the plan or approve it. For situations in which a timelier decision is necessary, the IRB Chair may assess the plan, propose essential amendments, and temporarily approve the original or amended plan until the matter is reviewed at a convened IRB meeting.

Notification of Participants

When study approval is suspended or terminated, the IRB or IRB Chair/designee will:

Consider actions to protect the rights and welfare of currently enrolled participants.
Consider whether procedures for withdrawal of enrolled participants consider their rights and welfare (e.g., planning for medical care outside of a research study, transfer to another researcher, and continuation in the research under independent monitoring).
Consider informing current participants of the termination or suspension.
Have any adverse events or outcomes reported to the IRB.

Upon review, the IRB will decide whether individuals currently participating in a research study may need to be notified of its termination or suspension as well as the best mechanism for the research team to utilize to make the notification. The discontinuation plan must include a script or letter to notify enrolled participants who are affected by the suspension or termination. Affected participants should be told about changes to their treatment that are being implemented as the result of the suspension/termination and the related risks. When possible, affected participants should be informed of alternative therapies that may be available to them.

Actions Following Suspension or Termination of IRB Approval

The IRB may allow the current PI to oversee participants during the continuation of the research until the suspension is lifted or until all participants have been safely withdrawn. However, if warranted, the IRB may require changes in the oversight of the research project to ensure orderly and compliant implementation of the suspension or termination procedures. The IRB may:

transfer the responsibility for overseeing the remaining research activities to another investigator,
require independent monitoring for participants, or
transition participants to standard clinical care.

During the suspension period and after termination of the research project, the PI must report situations or events to the IRB and the sponsor (if applicable) that would have required reporting had the former participants continued to be enrolled in the research.

The PI will be notified in writing of the suspension or termination, and additional required actions or agreement with the proposed discontinuation plan.

Removal of Suspension

Following IRB confirmation that corrective actions have been satisfactorily addressed, the PI may ask for reinstatement of a suspended research project. The PI must submit a project amendment in which the study design and procedures have been revised to mitigate or correct the problem that resulted in suspension.

The convened IRB will review the amendment and may require minor changes to reinstate IRB approval, require substantive changes (to be reviewed at a subsequent IRB meeting), or reinstate IRB approval. The IRB may require more frequent continuing review (i.e., IRB approval period of less than one year; to be stated in IRB meeting minutes). The project anniversary date would be updated to reflect the approval period as determined by the IRB, beginning with the date the IRB approved the reinstatement of IRB approval.