Boston University
Charles River Campus IRB
Policies and Procedures
Title: Suspension or Termination of Research by the IRB
Date: October 30, 2014

Purpose

The purpose of this policy is to outline the procedure for suspending or terminating research approved by the IRB.

Defined Terms

Continuing Noncompliance: Any noncompliance that occurs in a persistent or repeated manner.

Investigator-Initiated Suspension or Termination: The investigator voluntarily suspends or terminates an IRB-approved research study.

Noncompliance: Failure to comply with the regulations, institutional policies, laws, or the requirements or determinations of the IRB

Serious Noncompliance: Any noncompliance that: 1) adversely affect the rights and welfare of the subjects, 2) increases risks to subjects or others or alter the risk/benefit ratio, 3) compromises the integrity or validity, or 4) results from the willful, knowing, or intentional misconduct on the part of the investigator or research staff.

Suspension: IRB-approved research or some of the activities in the research are temporarily stopped in order to protect human subjects pending completion of an investigation. Once the investigation is complete, a determination is made as to: 1) lift the suspension and allow protocol activities to resume or 2) terminate the study or some activities of the protocol.

Termination: IRB-approved research is permanently stopped. No further work may be done on this research.

Unanticipated Problem Involving Risks to Subjects or Others: Any incident, experience or outcome that is: 1) unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and the informed consent document, and the characteristics of the subject population being studied, 2) related or possibly* related to participation in the research, AND 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

*Possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research

Policy

The IRB may suspend or terminate any research that involves: 1) serious or continuing noncompliance or 2) unanticipated problems involving risks to subjects or others. In addition, the Institutional Official, the IRB Chair or Vice-Chair, or IRB Director may suspend or terminate research on an urgent basis in between meetings. In this case, the suspension or termination will be reported to the full board at the next meeting.

Procedures

  1. The full board will determine and document the reason(s) for suspending or terminating the research.
  2. If the research was previously suspended or terminated by the Institutional Official, the IRB Chair or Vice-Chair, or IRB Director, the full board will review the suspension or termination.
  3. When suspension or termination involves the withdrawal of current subjects, the IRB will consider the following:
    • Actions to protect the rights and welfare of currently enrolled subjects
    • Whether procedures for withdrawal of enrolled subjects take into account their rights and welfare (e.g. making arrangements for medical care, transferring to another Investigator, continuation in the research under independent monitoring, etc.)
    • Informing current subjects of the suspension or termination
    • Have any adverse events or outcomes been reported to the IRB
  4. The IRB will notify the Principal Investigator in writing of the suspension or termination. The notification will include:
    • The reason for the suspension or termination
    • An explanation of the suspension or termination including any terms and requirements (e.g. notification of subjects, transfer of subjects, independent monitoring, follow-up data to be reported to the IRB, etc.)
  5. The IRB will determine which institutional officials and external agencies should be notified of the suspension or termination in accordance with the “Reporting Incidents to Institutional Officials and Regulatory Agencies” policy.
  6. Investigator-initiated suspensions or terminations are not considered to be reportable events unless the IRB determines that serious and/or continuing noncompliance or unanticipated problems involving risks to subjects or others have occurred in the research.

Appeals

If an investigator wishes to appeal a suspension or termination that has been issued by the IRB, they may appeal to the Institutional Official. The appeal request must be sent in writing to the Institutional Official and must include justification for the request. The Institutional Official will launch an inquiry into the request. The Institutional Official may solicit internal or external consultation during the inquiry. After completing the inquiry, the Institutional Official will issue an opinion on the determination made by the IRB. The opinion and recommendations of the Institutional Official will be brought back to the full board for review as necessary.

Title: Suspension or Termination of Research by the IRB

Author: Cynthia Monahan

Effective Date: April 1, 2013

Last Review/Update Date: October 30, 2014

Revision #: 1

Approved:
Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance

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