740. Suspensions or Terminations of IRB Approval

Updated June 10, 2024

The University IRB has the authority to suspend or terminate IRB approval of w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting even when continuing IRB review is not required.

The IRB considers the best interests of w88 online sports betting participants in deciding whether to temporality or permanently halt a w88 online sports betting 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 w88 online sports betting study, transfer to another researcher, and continuation in the w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting study.

During suspension or following termination of IRB approval, no new participants may be enrolled; no w88 online sports betting 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 w88 online sports betting activities for safety reasons. NOTE: The terms “suspension” and “termination” do not apply to interruptions in w88 online sports betting 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 w88 online sports betting project. The w88 online sports betting 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.

The IRB Chair or their designee has the authority to suspend some or all w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting project open but with no w88 online sports betting activities (or only specified activities) until the suspension is lifted or the IRB approval for the w88 online sports betting is terminated.

Terminations by the IRB

A fully convened IRB may terminate a w88 online sports betting project when it determines that cessation of all w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting any time suspension or termination may be necessary to protect the safety and welfare of w88 online sports betting participants or others, or the integrity of a w88 online sports betting project.

PIs or sponsors may voluntarily suspend or terminate a w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting activities);
• the number of participants currently enrolled in the study;
• the procedure that will be undertaken to ensure the safe withdrawal of currently enrolled w88 online sports betting participants, if necessary;
• whether permission is being requested to continue w88 online sports betting 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 w88 online sports betting. 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 w88 online sports betting.

Partial Suspension of w88 online sports betting Activities

If only some of the w88 online sports betting 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 w88 online sports betting activities during the suspension;
• include a timeline for eventual discontinuation of all w88 online sports betting activities (unless the suspension is lifted); and
• describe procedures to ensure adequate oversight of w88 online sports betting activities that will continue.

Temporary Continuation of w88 online sports betting Activities for Suspended or Terminated w88 online sports betting

When IRB approval for a w88 online sports betting project is suspended or terminated, all w88 online sports betting activities must stop immediately unless the project involves therapeutic treatment or intervention,andcessation of the treatment, or discontinuation of an investigational drug or device may be detrimental to the w88 online sports betting 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 w88 online sports betting activities to ensure participant safety during suspension or following termination of a w88 online sports betting project, the PI must submit a discontinuation plan. The plan must:

• specify which w88 online sports betting activities will temporarily continue,
• justify the continuation of w88 online sports betting activities during the suspension or following termination of a w88 online sports betting 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 w88 online sports betting activities. The PI must tell participants about the follow-up procedures and may not use information from the follow-up procedures for w88 online sports betting 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 w88 online sports betting study, transfer to another researcher, and continuation in the w88 online sports betting 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 w88 online sports betting study may need to be notified of its termination or suspension as well as the best mechanism for the w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting project to ensure orderly and compliant implementation of the suspension or termination procedures. The IRB may:

• transfer the responsibility for overseeing the remaining w88 online sports betting 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 w88 online sports betting 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 w88 online sports betting.

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 w88 online sports betting 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.