740. Suspensions or Terminations of IRB w88 online game

Updated June 10, 2024

The University IRB has the authority to suspend or terminate IRB w88 online game 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 w88 online game 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 w88 online game considers the best interests of research participants in deciding whether to temporality or permanently halt a research study. The w88 online game 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 w88 online game: A determination made by the University IRB to temporarily withdraw University IRB w88 online game for some or all activities of a currently approved research study.

IRB-Initiated termination of w88 online game: A determination made by the University IRB to permanently withdraw University IRB w88 online game for some or all activities of a currently approved research study.

During suspension or following termination of IRB w88 online game, 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 w88 online game period. For more information, see IRB policy for determining dates for IRB review, following lapse of IRB w88 online game.

Suspensions by the w88 online game

The convened IRB (for imminent harm the IRB Chair) may suspend w88 online game 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.

The w88 online game Chair or 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 w88 online game 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 w88 online game for the research is terminated.

Terminations by the w88 online game

A fully convened w88 online game 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 w88 online game 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 w88 online game Investigator, Sponsor or Other Oversight Body

Sponsors, Principal Investigators (PI) and other oversight bodies have the authority to suspend their own w88 online game any time suspension or termination may be necessary to protect the safety and welfare of w88 online game participants or others, or the integrity of a w88 online game project.

PIs or sponsors may voluntarily suspend or terminate a w88 online game 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 w88 online game within five days of the PI planning for or learning of suspension or termination.

The w88 online game report information should include:

• the primary reason for the w88 online game;
• the number of w88 online game enrolled to date;
• the plan for notifying currently enrolled w88 online game, if necessary;
• the procedures that will be undertaken to ensure the orderly and safe withdrawal of currently enrolled w88 online game, if necessary;
• whether there were any unanticipated problems involving risks to w88 online game or others that were not previously reported;
• whether w88 online game will be notified of the study results;
• whether the w88 online game had been monitored/reviewed/audited by an outside monitor, sponsor, or agency;
• w88 online game has been sent to other agencies.

The w88 online game report information should include:

• the primary reason for the w88 online game;
• the type of suspension (intervention only; all w88 online game activities);
• the number of w88 online game currently enrolled in the study;
• the procedure that will be undertaken to ensure the safe withdrawal of currently enrolled w88 online game participants, if necessary;
• whether permission is being requested to continue w88 online game activities during the suspension period for the safety of currently enrolled participants;
• whether w88 online game will be notified of the study suspension;
• w88 online game has been sent to other agencies;
• a description of what must occur for a request for re-initiation of study w88 online game 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 w88 online game is notified that the investigator cannot contact the sponsor, the w88 online game will inform the sponsor of the suspension or termination of research.

Partial Suspension of w88 online game Activities

If only some of the w88 online game activities will be suspended (e.g., suspension of enrollment), the PI must:

• specify which w88 online game are to be suspended, and which will continue;
• justify the continuation of w88 online game activities during the suspension;
• include a timeline for eventual discontinuation of all w88 online game activities (unless the suspension is lifted); and
• describe procedures to ensure adequate oversight of w88 online game activities that will continue.

Temporary Continuation of w88 online game Activities for Suspended or Terminated w88 online game

When IRB w88 online game 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 w88 online game 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 game activities to ensure participant safety during suspension or following termination of a w88 online game project, the PI must submit a discontinuation plan. The plan must:

• specify which w88 online game activities will temporarily continue,
• justify the continuation of w88 online game activities during the suspension or following termination of a w88 online game study,
• include procedures and materials for notifying w88 online game of effects of the suspension or termination on their treatment or the intervention, and
• describe the process for eventual w88 online game treatment, tapering dosages for investigational drugs, or removing investigational devices.

For safety reasons, the discontinuation plan may suggest, or the w88 online game 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 w88 online game and the sponsor (as required in sponsor correspondence or contract) as per w88 online game requirements for reporting problems.

The convened w88 online game will review the proposed plan and recommend amendments to the plan or approve it. For situations in which a timelier decision is necessary, the w88 online game Chair may assess the plan, propose essential amendments, and temporarily approve the original or amended plan until the matter is reviewed at a convened w88 online game meeting.

Notification of w88 online game

When study w88 online game is suspended or terminated, the IRB or IRB Chair/designee will:

• Consider actions to protect the rights and welfare of currently enrolled w88 online game.
• Consider whether procedures for withdrawal of enrolled participants consider their rights and welfare (e.g., planning for medical care outside of a w88 online game study, transfer to another researcher, and continuation in the w88 online game under independent monitoring).
• Consider informing current w88 online game of the termination or suspension.
• Have any adverse events or outcomes reported to the w88 online game.

Upon review, the w88 online game 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 w88 online game

The w88 online game 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 w88 online game may require changes in the oversight of the research project to ensure orderly and compliant implementation of the suspension or termination procedures. The w88 online game may:

• transfer the responsibility for overseeing the remaining w88 online game activities to another investigator,
• require independent monitoring for w88 online game, or
• transition w88 online game to standard clinical care.

During the suspension period and after termination of the research project, the PI must report situations or events to the w88 online game 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 w88 online game or termination, and additional required actions or agreement with the proposed discontinuation plan.

Removal of w88 online game

Following w88 online game 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 w88 online game, require substantive changes (to be reviewed at a subsequent IRB meeting), or reinstate IRB w88 online game. The IRB may require more frequent continuing review (i.e., IRB w88 online game period of less than one year; to be stated in IRB meeting minutes). The project anniversary date would be updated to reflect the w88 online game period as determined by the IRB, beginning with the date the IRB approved the reinstatement of IRB w88 online game.