When to Close Your Study at Harvard

What To Do When You Have Completed Your Study

Closing A Study At Harvard

By submitting a Study Closure, a researcher confirms that the study is finished and that there will be no further interaction with subjects or their data. 

If your study was approved under the Convened IRB or Expedited review category, requesting closure is appropriate under the following circumstances:

  • The research is permanently closed to enrollment;
  • All participants have completed all research-related interventions/interactions;
  • Collection of private identifiable information is completed, and
  • Analyses of private identifiable information is completed. 

These study closure instructions will walk you through this follow-on submission (see page 56). Note that if you wish to enroll new subjects for the study, or otherwise engage human subjects in research after the study has been closed, a new application must be submitted.

Exempt studies need not be closed in ESTR.

IRB Tip! After closure, analyses of de-identified data/specimens and manuscript preparation can occur indefinitely.

What To Do If You Are Leaving Harvard

When leaving Harvard, PLEASE PLAN AHEAD and TAKE ACTION PRIOR TO YOUR DEPARTURE

If you will no longer have a formal affiliation at Harvard, your Harvard IRB approval will no longer be active. The Harvard University Area IRB will not be able to provide IRB review for you. You will no longer be able to access ESTR to make any changes. Follow these steps.

PLEASE NOTE:  ESTR requires creating a Continuing Review in order to close your study.  You will be answering “no” to four questions about your study at Harvard, even if you will be transferring your research to another institution.  If your study is Exempt it does not need to be closed in ESTR.

  • If you are moving to a new institution and will continue your research

    • Contact your new institution’s IRB office for instructions on how to open the study(ies) there.
    • Close your study(ies) here using these study closure instructions from the ESTR Study Submission Guide.

  • If you plan to transfer your research to another Harvard PI

    • Determine if the identified individual is “PI eligible.” If not, you will need to also identify a Faculty Sponsor for this individual.
    • Submit a Modification using these modification instructions from the ESTR support site.

  • If you no longer plan to conduct the research

 

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Researcher Responsibilities After Review

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