The Office of Human Research Ethics (OHRE) and the Institutional Review Board (IRB) will no longer verify CITI Training for the PI or research team members at the time of Continuing Review or Administrative Review. The intent of this change is to improve the timely review and approval of Continuing Renewals and Administrative Reviews and to reduce the administrative burden caused by study expiration due to expired CITI Training.
The PI and the research team member continue to be responsible for ensuring applicable and current CITI Training for all team members during the life of the research study.
As of 7/17/2023, CITI training completion will only be verified by OHRE at the time of:
- initial IRB submissions and
- new study personnel being added through personnel modification
SOP 0301: Education and Training has been Revised with this New Information
As a reminder, per the Office of Human Research Ethics SOP 1501: Investigator Responsibilities, the PI and research team members are still responsible for completing applicable CITI training every 3 years and monitoring expiration of CITI training.
Failure to maintain current and applicable training by team members and/or the PI during involvement in conducting human subjects research is considered to be noncompliance. Repeated failure to ensure all team members have current training may be considered to be serious and/or continuing noncompliance, which may result in required corrective actions and/or restriction of research privileges.
Please do not submit an Initial IRB submission or Personnel Modification until a member of the research team has verified that every team member has completed the applicable CITI training. If a stipulation is returned due to incomplete CITI training, please do not resubmit until all training has been completed.
Thank you for your continued dedication to the protection of human participants and compliance with institutional research requirements and policies.
Questions about this update in procedure can be sent to UNC IRB Questions: email@example.com.