740. Suspensions or Terminations of IRB Approval
Updated Oct. 4, 2019
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 IRB considers the best interests of research participants in deciding whether or not to temporality or permanently halt a 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 subject 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.
Suspended protocols are considered to be 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.
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 making a decision for or learning of suspension or termination. In addition to the required content, problem reports involving suspension or termination must include the reasons for the suspension or termination. (For more information, see IRB policy for reporting problems to the IRB.)
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 time line 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 more timely 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
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.