Office of Research Compliance
         Frequently Asked Questions About CITI

What is CITI?
How does CITI work?
Why do I need to take CITI?
How often do I need to take human subjects education?
How long will it take to complete the course?
Do I need CITI certification to have my IRB application approved?
Who needs to take CITI?
Who are “key personnel”?
Who are NOT considered "key personnel"?
Do I need to take CITI if a project is "exempt"?
Do I need to take CITI if a project was determined to be "not human subjects research"?
Do I need to take CITI for amendments to a previously approved IRB application?

What is CITI?
CITI (Collaborative IRB Training Initiative) is the premiere online human subjects education program. It is currently used at more than 800 institutions. It was created, developed, and is maintained by experts from the human subjects research community.

How does CITI work?
The CITI program provides key personnel the opportunity to complete education modules and quizzes relevant to their research and discipline. A pool of modules is offered from which key personnel elect which ones to complete. At the University of Southern Maine, researchers and key personnel are expected to complete, at minimum, the Social & Behavioral Research - Basic/Refresher course. A cumulative score of at least 80% is required for a completion certificate to be issued. The certificate is automatically sent to the Office of Research Compliance (ORC), so there are no additional steps needed once you complete the program.

Why do I need to take CITI?
Mandatory CITI education fulfills USM's commitment to promote ethical conduct towards human subjects in all research projects, funded or unfunded. An IRB application, with key personnel listed who do not receive CITI certification, will not be approved by the IRB.

How often do I need to take human subjects education?
Key personnel listed on IRB applications are required to complete the CITI program or equivalent every three (3) years. Confirmation of educational certification will be required prior to the approval of research projects submitted to the IRB.

How long will it take to complete the course?
Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hrs in the Basic Course site and uses approximately 5 logins to complete the course.

Do I need CITI certification to have my IRB application approved?
YES!! And so do all key personnel listed on the IRB application. However, if you completed a human subjects education program at another institution, please consult with a staff member at the ORC. You can reach us at: 207-780-4268 or usmirb@usm.maine.edu.

Who needs to take CITI?
All “key personnel” listed on the IRB application will be required to complete human subjects education before a study is approved by the IRB.

Who are “key personnel”?
“Key Personnel” are any individuals responsible for the protocol development or design, conduct, or reporting of research. These include but are not limited to: Principal Investigators (PIs), Co-PIs, faculty advisors, study coordinators, recruitment staff, and anyone else performing study procedures or interventions. If you are unsure whether or not you or someone on your study team needs to take CITI, please contact the the ORC at 207-780-4268 or usmirb@usm.maine.edu.

Who are NOT considered "key personnel"?
Individuals who are not considered “key personnel” includes technical staff such as: coders, statisticians, data entry personnel, IT support, and others. Administrative staff including secretarial support, and logistics coordinators, and others types of administrative staff are also not considered “key personnel”.

Do I need to take CITI if a project is "exempt"?
Yes, even if a projects is exempt all key personnel are still required to take CITI.

Do I need to take CITI if a project was determined to be "not human subjects research"?
NO, if a project was determined to be "not human subjects research" key personnel do not need to take the CITI course.

Do I need to take CITI for amendments to a previously approved IRB application?
Amendments for adding "key personnel" on a study require that the added individual(s) complete CITI before the amendment is approved.