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IRB: Suspension or Termination

Suspension or Termination

 

Purpose

The purpose is to outline the policies and procedures for suspension or termination of human research approval.

Definitions

Continuing Noncompliance is any noncompliance that occurs in a persistent or repeated manner.

Noncompliance is failure to comply with the regulations, institutional policies, laws or the requirements or determinations of the IRB or Exempt Review Committee (ERC).

Serious Noncompliance is any noncompliance that adversely affects the rights and welfare of the subjects, increases risks to subjects or others, alters the risk/benefit ratio, compromises the integrity or validity, or results from intentional misconduct on the part of the investigator or research team.

Suspension of research approval is an action performed by administrators of the Office of Research and Sponsored Programs, the convened IRB, or the Institutional Official, whereby approval is placed on hold until a determination is made that research may resume. Suspension may include some research activities, temporarily or permanently, or all research activities temporarily, short of terminating all activities. Note: Similar actions initiated by investigators or sponsors to stop research activities are not considered to be suspensions as described in this policy.

Termination of research approval is an action performed by administrators of the Office of Research and Sponsored Programs, the convened IRB, or the Institutional Official whereby approval for a project is permanently revoked (except for follow-up procedures that may be necessary to protect the health and/or welfare of participants). Note: Similar actions initiated by investigators or sponsors to stop research activities are not considered to be terminations as described in this policy.

Policy

The Institutional Review Board (IRB) has authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

In urgent situations, either the Institutional Official or administrators of the Office of Research and Sponsored Programs (ORSP), which manages both the IRB and Exempt Review Committee, has authority to suspend or terminate research between meetings. In these cases, the suspension or termination is reported to the full board when it next meets.

Administrators of the ORSP also have authority to suspend or terminate research for failure to submit mandatory reports (e.g., status reports).

Research may be suspended or terminated based on information received during continuing review, from findings of a quality improvement visit, from an investigator’s self-report of an unanticipated problem or adverse event, from an investigator’s self-report of a deviation or violation, or from complaints made to the IRB by participants or others.

Any suspension or termination of approval shall include a statement of the reasons for the action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head (if applicable).

See also our Mandatory Reporting Policy for information about unanticipated problems, adverse events, deviations or violations.

Procedures

  1. Noncompliance information is discovered or received by the Office of Research and Sponsored Programs, which manages the IRB and ERC, in the following ways:
    • During continuing review (including 6 month status reporting)
    • Findings of a quality improvement visit
    • An investigator's self-report of an unanticipated problem or adverse event
    • An investigator's self-report of a deviation or violation
    • Complaints made to the office by research participants or others
  2. The convened IRB, or in certain cases, an administrator from the Office of Research and Sponsored Programs, the IRB Chairperson, and/or the Institutional Official, reviews the information and considers the appropriate action, based on the rights and welfare of the participants, the integrity and validity of the research, and policies and procedures.
  3. If the project is suspended, the reason(s) are communicated to the Principal Investigator (PI) via an official letter, along with any actions required to protect the rights and welfare of current or past research participants. Appropriate actions may include, but are not limited to:
    • Notification of current and/or former participants
    • Transfer of responsibility for the project and participants to another investigator
    • Continuation of participants in the project with and independent monitor
    • Withdrawal of current participants from the research
    • Requiring or permitting follow-up of participants (e.g., for safety reasons)
  4. Suspension may be lifted by the convened IRB, the Office of Research and Sponsored Programs, or the Institutional Official once there are no longer concerns about the following. Once the suspension is lifted, it will be communicated to the PI via an official letter.
    • Potential harm(s) to research participants
    • Research noncompliance
  5. If the project is terminated, the reason(s) are communicated to the PI via an official letter, which will include any actions required to protect the rights and welfare of current or past research participants. Appropriate actions may include, but are not limited to:
    • Notification of current and/or former participants
    • Transfer of responsibility for the project and participants to another investigator
    • Withdrawal of current participants from the research
    • Requiring or permitting follow-up of participants (e.g., for safety reasons)
  6. Suspensions or terminations are also promptly reported to the appropriate institutional officials and the department or agency head (if applicable).
  7. Investigator Responsibilities: Upon notification that research has been suspended or terminated by the IRB, the PI is responsible for the following:
    • Closing enrollment and research activities as communicated to the PI
    • Cooperating with any investigation about the issue
    • Assisting with and/or carrying out actions required to protect the rights and welfare of participants (e.g., notification, withdrawal, follow-up, etc.)
    • Reporting to the IRB or ERC any adverse events or outcomes encountered during suspension or termination of the research

 


Related Policies & Procedures

  • Approval of Research
  • Closure or Withdrawal
  • Mandatory Reporting
  • Misconduct
  • Procedures for Failure to Report a Deviation/Violation
  • Procedures for Failure to Report a Status Report

History

07/19/2013 - Created

 


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