CITI (Collaborative IRB Training Initiative) was founded as a collaboration between the University of Miami and Fred Hutchinson Cancer Research Center to develop a web based training program in human subjects protection. Consult the information below before visiting www.citiprogram.org.
|Human Subjects Protections “Basic Course” for Health Science Campus (HSC)||There are two courses that fulfill the Human Subjects requirement for the Health Science Campus based on your research role:1) “Health Sciences Campus: Medical Students and those conducting Exempt Research”Must complete any 4 of 17 available modules with a passing score of 80%.OR2) Health Sciences Campus: Investigators, Key Personnel and HSIRB Members/Staff”.Must complete any 8 of 17 available modules with a passing score of 80%.“Refresher” training must be repeated every 3 years.||Complete if you are conducting biomedical research with human subjects. Learning objectives pertain to ethics and principles, laws and regulations, informed consent, vulnerable populations, and more.|
|Human Subjects Protections “Basic Course” for University Park Campus (UPC)||There are two courses that fulfill the Human Subjects requirement for the University Park Campus based on your research role:1) “University Park Campus: Students, faculty advisors, and those conducting Exempt Research”Must complete any 4 of 17 available modules with a passing score of 80%.OR2) University Park Campus: Faculty/Staff Investigators, Key Personnel and UPIRB Members/Staff”.Must complete any 8 of 17 available modules with a passing score of 80%.“Refresher” training must be repeated every 3 years.||Complete if you are conducting social-behavioral research with human subjects. Learning objectives pertain to ethics and principles, laws and regulations, informed consent, vulnerable populations, and more.|
|Good Clinical Practice (GCP)||Good Clinical Practice (GCP) training is required for USC PIs and personnel conducting Expedited and Full Board clinical trials. Training is primarily intended for study staff who have interaction, conduct intervention, or have access to subject identifiable information. A study will NOT be approved until the training requirement is met. All 15 modules must be completed with a passing score of 80%, no refresher course is necessary.||Pertains to the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.|
|Responsible Conduct of Research (RCR)||Mandatory for all investigators on NSF grants, as well as some NIH training awards, and PHS traineeships. Cannot be substituted for Human Subjects Protections training.Must complete all 9 required modules with a passing score of 80%, no refresher course is necessary.||Pertains to ethics, data integrity, collaborative research, and more.The USC Office of Compliance will provide the certificate of completion.|
|Conflict of Interest||Mandatory for all USC Investigators supported by HHS funding. This course does not qualify for the Human Subjects Requirement.Must complete all 3 required modules with a passing score of 80%, and must complete a refresher course every 4 years.||For more information visit the Conflict of Interest page.|
|Generic Classroom||Mandated at the discretion of the instructor, this course is sometimes used as an assignment for research methods courses.||Consists of 4 modules; two modules from the Human Subjects Protections course and two from the Responsible Conduct of Research course.|
|HIPAANOTE: the USC HIPAA course is not hosted by CITI||HIPAA training is required for all investigators who have access to Protected Health Information such as patient health records.Visit the USC Office of Compliance website to access the HIPAA course.||ooc.usc.edu/hipaa-privacy-education-program|
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.
Please refer to the Instructions for CITI and ISTAR manual for course registration, completion instructions, and printing your certificate. In addition, CITI and iStar are separate systems: while you can use the same log-in information for both you will need to register for each separately.
Previously Completed/Expiring Human Subjects Certificates
Human subjects certifications completed within the past 3 years may be accepted at USC’s discretion, but a copy must first be emailed to firstname.lastname@example.org make that determination.
If you received a notice from iStar indicating your certificate is about to expire, you must re-certify. The human subjects education policy is that investigators/key personnel must complete training every 3 years. Please refer to “Signing Up For A Refresher Course” in the Instructions for CITI and ISTAR manual.
No. Investigators/key personnel that complete GCP training DON’T need to complete the human subjects “refresher course” (course offered in CITI after initial three year certificate expires). The GCP course will fulfill the “refresher” human subjects training requirement for three years from the date it is completed. However, the human subjects “refresher course” does not fulfill the GCP training requirement. GCP training is a one time requirement while human subjects education is required every three years.
Human Subjects Training
Yes, even if a project is exempt, study personnel are still required to take Human Subjects Protections Training.
If a project was determined to be “not human subjects research”, do I need to take Human Subjects Protections Training?
No. If a project was determined to be “not human subjects research” (NHSR) (e.g., this applies whether coded specimen/data or not meeting the federal definition) study personnel do not need to take the Human Subjects training on CITI.
Yes, you must complete Human Subjects Protections Training even if you completed HIPAA Training.
Do I need to take Human Subjects Protections Training 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.
Questions or Comments
USC CITI Help Desk