Closing an IRB Approved Study

SUBJECT:

Closing an IRB Approved Study

 Policy Number:
10.3.9 		Effective Date:
January 10, 2026
Supersedes:
November 20, 2015
October 21, 2011
September 10, 2010 		Pages 4
Responsible Authorities:
Vice President for Research
Associate Vice President, Research Integrity
Human Research Protection Program Staff
Institutional Review Board

  1. Background

    Continuing Institutional Review Board (IRB) review and approval is required for non-exempt research as long as study activity is ongoing, including intervention or interaction with subjects, continued use of a drug or device, and/or data analysis of identifiable data. When all study activity has ceased an investigator should close a research study.

  2. Purpose

    The purpose of this policy is to set forth when and how a study may be closed or terminated by the Principal Investigator (PI) or the IRB.

  3. General Statement

    A process for closing studies shall be required due to potential risks to human subjects that may arise when study activities are completed without final review.

    The Florida Atlantic (FAU) IRB will notify the research team that an IRB approval has expired or that a project has been administratively closed for lack of response from the research team. The IRB and/ or Institutional Official (IO) may also suspend or terminate an IRB approval if the project poses an increased or unacceptable risk to participants. IRB approved projects may be closed for any of the following reasons:

    • Request initiated by the PI;
    • Non-response from PI to IRB requests for revisions;
    • Non-enrollment of subjects for three years;
    • Lapse of approval due to PI's non-response to requests for continuing review (see Policy 10.3.14, "Continuing Review of IRB Approved Studies").

  4. Definitions

    Closed to Enrollment: Enrollment of new subjects is stopped either permanently or temporarily.

    Temporary Closure to Enrollment: A study may be temporarily closed or closed to enrollment when there is a pause in the conduct of research or recruitment.

    Permanent Closure to Enrollment: A study is closed permanently when no further enrollment will occur and individually-identifiable follow-up data are no longer being collected on subjects.

    Suspension: An action taken by the IRB or other body with such authority. It is a temporary or permanent halt to some or all research procedures short of a termination until the IRB (or other body with such authority) determines whether the research may re-commence or must be terminated.

    Termination: An action to permanently end a study with the guarantee that no further contact with human subjects or their individually identifiable information is planned; no subjects are or will be treated or followed; all data are gathered and analyzed; and any final reports or publications, if applicable, are complete. A PI may request to terminate a study when it no longer constitutes human subject research, which can be done by de-identifying the data. The IRB may also terminate a study, therefore halting further research.

  5. Policy

    A study should be terminated by the PI when no further contact with human subjects or their individually identifiable information is planned, no subjects are or will be treated or followed, and all identifiable data are gathered and analyzed. Investigators are expected to continue to honor confidentiality protections for data after studies are officially closed. Multi-site studies, such as clinical investigations, may be closed when the sponsor has completed all data queries on the FAU site's study records, has "locked" the site data, and remaining data analysis will not be completed by FAU.

    1. Closure by PI

      Studies may be closed by PI if all the following conditions are met:

      • All subject enrollment is complete;
      • All data (including study follow-up data) pertaining to human subjects have been collected;
      • No further human subject interaction is planned for the purpose of research;
      • No further analysis of identifiable private information is to be conducted.

      Under some circumstances, PIs must fulfill stated commitments to the participant, such as communicating research results or following through on compensation to subjects, even if the study is closed. These can be done with permission of the IRB Chair.

    2. Closure by IRB or IO

      Studies may be closed by the IRB without PI approval in the following circumstances:

      • If it is determined that the investigator is no longer affiliated with FAU.
      • If the study expires because the PI has not provided a continuing review.
      • In response to unanticipated problems involving risk to subjects or others, serious or continuing non-compliance, findings presented during an IRB review, or problems identified in a monitoring process.
      • If the investigator has not responded to the IRB's requests for revisions and/or clarifications within the timeframe determined by the IRB, based upon the vulnerability of the subject population and the risk of the research.
      • If a study is not accruing participants.
        • If a study has been open for a period of three or more years and the PI has not enrolled subjects in the study, the IRB may require study closure unless there are extenuating circumstances for keeping the project open.

      The FAU IRB shall have 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. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, IO, and if funded, the department or agency head (45CFR46.113)

  6. Accountability

    The Principal Investigator (PI) will be responsible for submitting a project closure when:

    • All research activities including data analysis and reporting are complete;
    • The PI never initiated the study;
    • Subject accrual is finished, all data collection is complete and the only remaining activity is analysis of the data, the data are de-identified, and there are no identifying links or codes to the de-identified data;
    • The PI plans to leave the University and intends to continue the research activities at another institution. When a PI terminates employment or other association with FAU, they are obligated to either:
      • Submit the continuing review / final report form with request to close the study or;
      • Submit a project amendment to transfer the study to another FAU PI. (Note: change of key personnel in federally funded or FDA-regulated research requires prior approval of the funding agency and/or FDA.)
    • The study has been open for a period of three or more years and no subjects have enrolled.
      • In the event that a PI wishes to keep a study open and there is a lack of enrollment activity, the PI must justify the rationale for keeping the study open as part of the continuing review process. The IRB will make a determination and notify the PI of its decision.

    The PI will also be responsible for retaining all records relating to an IRB approved research study for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by persons authorized through the appropriate university, state or federal agency requesting such documents, at reasonable times and in a reasonable manner.

    HRPP Staff will be responsible for:

    • Automated expiration alerts through electronic protocol management system at multiple intervals prior to expiration.
    • Administratively closing the study if a PI fails to respond to IRB requests within the given timeframe, and the study expires.
    • Providing for administrative final review and closure of submission unless concerns warrant Chair involvement.
    • Reviewing and acknowledging the request for closure.
    • Ensuring the rationale presented by the PI for closure is acceptable for the protection of human subjects.
    • Providing principal investigators with written notice detailing the IRB's action regarding the closure.

  7. Policy Renewal:

    N/A

  8. References

    21CFR56.109
    21FCR56.113
    21CFR56.115
    45CFR46.109
    45CFR46.113
    45CFR46.115

POLICY APPROVAL

Initiating Authority

Gregg Fields, Ph.D., Vice President for Research

Executed signature pages are available in the Initiating Authority Office(s)