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IRB-HSR > Managing Protocol After Initial Approval > Closing a Protocol

 

 

 

 

 

 

Closing a Protocol

Principal investigators have the responsibility of informing the IRB when a study has been completed.

A study is considered to be open and active until the investigator has submitted a Closure Form to the IRB.

Investigators will be notified by the IRB at least annually following the initial approval of the research. At these notification intervals, investigators are to submit either a continuation request or a Closure Form.

Faculty advisors for student research have the obligation to ensure that the Closure Form is filed with the IRB in a timely fashion.

When a principal investigator terminates employment or other association with UVA, he or she is obligated to submit a Closure Form to the IRB or formally transfer the protocol to another principal investigator via a modification which is reviewed and approved by the IRB. In very rare cases, the IRB may grant special permission for the departing individual to remain as principal investigator on the project. Cases are reviewed on a case by case basis.

A study may be closed when all of the following apply:

  • All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
  • All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
  • No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
  • Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors.

Please complete the Study Closure Form and submit it to the IRB within 30 days of closure of the study. For studies classified Exempt", notification by e-mail from the PI that the study has been closed is sufficient.

In order to close your IRB protocol officially, submission of Closure Form is required.

IRB-HSR Protocol Closure Form

*Taken from UVa IRB-HSR Research Guidance