Education in Human Research Protection Programs - IRB
| Mandatory Investigator Education for Human Research Protection |
| IRB Education Requirements, Courses, & Certificates |
| Additional Resources |
| HIPAA Education |
Mandatory Investigator Education for Human Research Protection
Effective January 1, 2010, the USF IRB changed the requirement for human subjects training to allow for renewal every two years. This change in policy requires researchers and their staff to participate in more comprehensive training, which can be found in the IRB Education Requirements, Courses & Certificates section of this page.
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 the use of human participants regardless of funding or sponsorship. The policy also applies to both currently active and future research submitted to the USF IRB. All study team members must have current training in order to receive full approval from the USF IRB.
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 the Policy on Requirements for Human Subjects Protection Education 
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):
- Belmont Report
- 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 USF IRB Policies and Procedures
- USF IRB-HRPP Policies and Procedures
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.
CITI Program
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 need 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.
Certificates
Find & Print Your Certificates - Certificates are posted within two business days after completion.
Additional Resources
Presentations:
- IRB 101 – Biomedical Research
- IRB 101 – Social Behavioral Research
- A Deeper look at IRB – Social Behavioral Research
- Certificates of Confidentiality
- Continuing Review
- Genome Wide Association Studies
- How to Identify Noncompliance in Human Subjects Research
- Investigational New Drug Regulations
- IRB Determinations for Approval (111 Criteria)
- Reporting Unanticipated Problems to the USF IRB
The Return of The Good, The Bad, and The Ugly… We Feel Your Pain! Presentations:
- Ethical Considerations of the Past and Present
- A Review of the Intricacies of the IRB Application
- The Categories: When It Is Not So Obvious
- Will You Do Me a Favor? A look into the consent process
- UPIRHSOs, AEs, SAEs: Understanding the difference and knowing when and whom to report
- A Practical Guide on Applying USF HRPP P&Ps in the Clinical Setting
HIPAA Education
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 Web Site 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.
For All Others
If you are not within USF Health, we recommend that you complete this Research Integrity & Compliance Web-based course: HIPAA in Research: An Introduction.
Note: This 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.
» USF EthicsPoint Hotline
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.
