#  When to Close Your Study at Harvard 

 



 What To Do When You Have Completed Your Study What To Do If You Are Leaving 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](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=58) 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](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=58) 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.](/am-I-PI-eligible)” If not, you will need to also identify a Faculty Sponsor for this individual.
    - ##### Submit a Modification using [these modification instructions](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=52) from the ESTR support site.
- #### **If you no longer plan to conduct the research**
    
    
    - Close your study(ies) here using [these study closure instructions](https://estrsupport.fss.harvard.edu/sites/g/files/omnuum886/files/estr/files/irb_study_submission_guide.pdf#page=58) from the ESTR Study Submission Guide.



 



 

 

 

 

 

   ![Left directional arrow](/sites/g/files/omnuum921/files/styles/hwp_1_1__100x100_scale/public/cuhs/files/left_directional_arrow_lifecycle_widget_cropped.jpg?itok=lAqHwNuj) 

 

#### [**Researcher Responsibilities After Review**](/researcher-responsibilities-after-review?admin_panel=1)