HRPP Manual Section 8-9

Closure

Principal investigators (PI) or PI proxy must request closure when non-exempt research and/or clinical investigation activities with human subjects are complete. Please see HRPP Manual 4-3 “Determination of Human Subject Research,” for relevant definitions. However, if the study is sponsored and requires a close-out visit, the study typically cannot be closed with the IRB until the close-out visit and process with the sponsor is complete. Study closure may occur before a sponsor required close-out visit in limited circumstances, for example, when no subjects have been enrolled and no identifiable private information is maintained.

When renewed approval is required, a continuing review submission for renewed approval or closure must be submitted to the Institutional Review Board (IRB) prior to the expiration of IRB approval for non-exempt research. After expiration of IRB approval, all human research activities must stop. See HRPP Manual 8-7 “Renewed Approval” for more information.

The PI or PI Proxy must also request closure for an exempt study that requires limited IRB review. See HRPP Manual 8-1 “Exemptions” for more information.

Closure Review Process

The PI or PI proxy is required to submit through the MSU IRB online system a continuing review submission with the HRP-528 – Template – Closure Report to close the study when research and/or clinical investigation activities involving human subjects is complete. When requesting closure of a study regulated by the U.S. Food and Drug Administration and conducted under an IND or IDE, the HRP-555 - Template - Appendix to the Closure-Final Report Form for FDA Regulated Studies Conducted Under an IND or IDE is also required.

An IRB member reviews the submission. A letter confirming that the study has been closed is made available through the MSU IRB online system and notification of the letter is sent to the researchers. If the study is externally funded, notification of the closure is sent to the MSU Office of Sponsored Programs.

The PI will be informed if the study still involves human subject research activities and cannot be closed.

Closure Based on Failure to Apply for Renewed Approval or Failure to Respond

The study will be administratively closed:

  • After expiration of IRB approval and upon failure of the PI to submit a continuing review submission.
  • For studies that do not require continuing review, upon failure of the PI to respond to requests regarding the study status.

To reactivate the research after this time, a new initial study submission will be required.

If a study is administratively closed, the IRB may need to determine the status of the study. Typically, a Closure Report will still be required through the MSU IRB online system. This may also require additional attempts to contact the PI or their chair, director, or dean to obtain needed information, or may require conducting a site visit of the study. “When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. Such expiration of IRB approval does not need to be reported to OHRP as a suspension of IRB approval under HHS regulations.” OHRP Guidance on Continuing Review

Record Storage

Data resulting from the study should be stored and protected in a manner to maintain the confidentiality of the subjects and that is consistent with the IRB approved protocol and any relevant information in the consent document, when appropriate. In general, identifiers should be removed once analyses of the identifiable data are complete, unless such information is essential or must be maintained as required by law or other requirements (e.g. FDA, funding agency, contract).

For guidance on data storage, see Michigan State University Guidelines on Research Data: Management, Control and Access.

Record Retention

See HRPP Manual 4-7-A, “Recordkeeping for Investigators” for investigator recordkeeping and retention requirements. Investigators should be aware that other laws and requirements (e.g., FDA, funding agency, contract with industry sponsor) may require a longer record retention periods and/or may require retention of specific records. For example, if the research is being conducted under an IND or IDE, investigators must also retain additional specific records (e.g. case histories) for a period typically longer than three years. See HRPP Manual 4-7-A, “Recordkeeping for Investigators” for specific retention requirements.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research & Graduate Studies on 3-9-2008. Revision 1 approved by VP Research & Graduate Studies on 8-22-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 8-1-2017. Revision 4 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 5 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 6 approved by Assistant VP Regulatory Affairs on 3-18-2021.

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