Education in Human Research Protection Programs - IRB
|Mandatory Investigator Education for Human Research Protection|
|IRB Education Requirements, Courses, & Certificates|
Mandatory Investigator Education for Human Research Protection
The USF HRPP requires all individuals who engage in human subjects research to obtain USF IRB-approved human subjects protection education prior to receiving IRB approval for new and continuing research. Recertification must take place every three years from the date of initial certification through the CITI Refresher Course or another USF IRB-approved program listed on the IRB website. In lieu of a CITI course, USF Undergraduate and Graduate students can choose to participate in one of the USF IRB's bi-annual Student Researcher Workshops, offered in the fall and spring semesters. This live workshop provides training and information regarding human subjects research, and fulfills the education requirement for three years.
It is the responsibility of investigators and their staff to maintain current certification in human research protection education while engaged in human subjects research. Education in human research protection is required for all faculty, staff and students directly involved in the conduct of research. This includes:
- Individuals who collect or enter data
- Individuals who conduct study procedures (including informed consent) or interventions with human subjects
- Individuals who use or have access to private information that can be linked to research subjects
This policy applies to all research involving human participants regardless of funding or sponsorship.
Failure to Comply
The IRB has the authority to suspend or withhold approval from any project that involves study personnel who fail to meet these education requirements.
For More Information
See section 7.2 of the HRPP Policy and Procedure Manual (HRPP Policy Manual ) or contact (813) 974-5638.
IRB Educational Requirements
To meet the USF IRB educational requirement, please complete the required readings and the appropriate CITI course. The Principal Investigator (PI) must keep his/her original Certificates of Completion on file, as well as the certificates for everyone directly involved in the conduct of the study.
Required Readings (read and review all):
- Federalwide Assurance - Terms
- Code of Federal Regulations:
- Title 21 CFR - FDA Regulations
- Title 21 CFR Part 50 - FDA Policy on Informed Consent
- Title 21 CFR Part 50D - FDA: Additional Safeguards for Children
- Title 21 CFR Part 56 - FDA Policy on IRBs
- Title 45 CFR Part 46 - DHHS Policy on IRBs
CITI Course in the Protection of Human Research Subjects:
This course presents a comprehensive overview of human subject protections. It has separate tracks for Biomedical or Social/Behavioral researchers. In many instances, the CITI Program courses are transferrable between institutions.
Instructions for CITI Program Registration Process
CITI Courses Currently Offered by DRIC (Please note, only those courses denoted with an (*) will satisfy the Human Subjects Protection Education Requirement.)
Choose the appropriate CITI course, which typically takes approximately 2-3 hours for completion. You can re-enter the site as often as you like. After you complete the course, you can look up and print your certificate in the Certificates section below. If you register through the VA or an institution other than USF, you must send a copy of your certificate to the IRB office.
Please call 813-974-5638 if you would like additional information.
Veterans Administration (VA) Course #RSRCH-EES-J425
For VA employees and non-VA employees working on a VA project.
Web-Based Course - 2 hours. From a non-VA computer. Complete the course on the site on which you began. Please forward a copy of your certificate of completion to the IRB office.
Find & Print Your Certificates - Certificates are posted within two business days after completion.
- OHRP Educational Videos on Conducting Research
- USF IRB Step-by-Step: Guidance for New Researchers Navigating Through the USF IRB Process
- IRB 101
- Navigating The IRB Application
- The Categories: When It Is Not So Obvious
- UPIRHSOs, AEs, SAEs: Understanding the difference and knowing when and whom to report &
Common Audit Findings
For USF Health
HIPAA education is mandatory for USF Health faculty, staff, students, residents, and fellows who are in the USF Covered Health Care Component.
If you are required to complete HIPAA education for USF Health, you must go to their website to complete it: USF Health HIPAA Education.
If you have any questions or problems with the USF Health HIPAA training, please contact their Helpdesk at (813) 974-6288.
Note: The USF Health HIPAA course does not meet the USF IRB requirement for education in human subject protections.
USF is dedicated to providing a safe, secure, and ethical workplace. This hotline provides an easy, anonymous way to discreetly and confidentially report activities that may involve improper conduct or violations of USF policies.