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 OneAegis and may require further IRB review as well.
Submit Continuing Review through OneAegis by completing the Study Renewal/Closure xForm.
For Expedited and Full Board studies, approval is granted for a maximum of 364 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 Health System 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 xForm in OneAegis 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
