After research has begun, research studies must undergo continuing review by the IRB to ensure IRB guidelines are constantly followed. Any modifications to the study need to be submitted to CyberIRB and may require further IRB review as well.

• Submit Continuing Review through CyberIRB by completing the Study Renewal/Closure

• For Expedited and Full Board studies, approval is granted for a maximum of 365 days

• A study must be renewed annually even if the data collection phase has ended

• It is the Investigator’s responsibility to ensure there is no lapse in study approval

• All study activities must stop if a study expires

• Community Medical Centers IRB will administratively retire studies that expire

• Repeated instances of administrative study retirements may result in Continuing Non-Compliance

• Office for Human Research Protections (OHRP) has regulations regarding reporting requirements for Continuing Non-Compliance

Study Modifications

• Use the Post Approval Form in CyberIRB to make changes to IRB-approved studies. Examples:

  • Add study staff

  • Increase the sample size

  • Change study time period

  • Change study visit window

  • Add materials (study diary, patient info sheet, recruitment material) 

  • Changes to the informed consent or protocol

• Be sure to include all supporting materials, as applicable (CVs and CITI completion certificate, new protocol highlighting changes, etc.)

• Minor modifications will be reviewed by the IRB chairperson or his/her designee

• Major modifications require full board review and approval

• You must receive an IRB approval letter before changes can be implemented

For more information refer to CyberIRB.