Chapter 12 - Study closures (routine)

See other sections in this manual for information related to study termination by the IRB or early study closure.

Overview

Key points

• You must submit all required study closure materials via NIH electronic IRB system using the Modification/Continuing Review (CR) form.
  
  
• Unless a new Principal Investigator (PI) is named, a study must be closed if the current PI is leaving the NIH.
  
  
• Once the protocol is closed, all research activities will cease.
  
  
• Once the study is closed, any analyses using the identifiable private information or identifiable biospecimens from the study, will require prospective IRB review and approval.

What is Study Closure?

Study closure refers to closure of a non-exempt human subjects research protocol for which all human subjects activities are complete, and for which access to identifiable private information or identifiable biospecimens, consistent with the purposes described in the IRB-approved protocol, has ceased.

When can my non-exempt human subjects research study be closed?

Unless the study is being prematurely closed or is being terminated by the IRB, for non-exempt human subjects research, the research study will be closed when all subjects have completed research interactions, and interventions and primary data analysis are complete. This includes analysis of identifiable private information or identifiable biospecimens, consistent with the analyses described in your protocol. 

What happens when studies are closed because all study activities are complete?

Once all study activities are complete, they may be closed as follows:

• Studies for which CR is required: Submit the Modification/CR Form no later than the expiration date of the study.
  
  
• Studies for which CR is not a requirement: Submit the Modification/CR Form when all human subjects research activities are complete.