All persons submitting an application for review to the USD IRB must complete human subjects protection training. This is required of ALL members of a research team, including principal investigators (PIs), co-PIs, faculty advisors, researchers who will or will not have contact with human subjects, student research assistants, etc.
USD-affiliated faculty, administrators, staff, and students are required to complete this training through the Collaborative Institutional Training Initiative (CITI) Program. Cayuse IRB and CITI systems are linked. When a researcher’s name is entered in a Cayuse IRB application as a PI, co-PI, Primary Contact, or Secondary Contact, their USD-affiliated CITI training record can be viewed directly by IRB reviewers, so there is no need to attach the actual training certificates for these individuals. Please make sure that USD email address used for Cayuse matches exactly with the CITI account. However, a valid CITI training certificate (in PDF format) must be attached to the IRB application for all individuals listed under the “Other Research Team Member(s)” category (including USD-affiliated).
Completed certifications for USD-affiliated researchers under “Other Research Team Member(s)” must meet the following requirements:
- Matching the first and last name of the researcher as indicated in the IRB application.
- Current (expiration date in future, preferably at least one year from the start date of the study)
- Showing “University of San Diego” as the affiliated institution on the certificate for USD-affiliated researchers.
- For a Human Subjects Research course (in either Social & Behavioral Research OR Biomedical Research, depending on the scope of the proposed study)
Non-USD affiliated members of the research team who do not have access to an institutional subscription to the CITI Program may satisfy the requirement for human subjects protection training by completing training offered by the federal Office for Human Research Protections (OHRP). The individual must satisfactorily complete all 5 OHRP lessons (see list here) and attach certificates of completion for each lesson (in PDF format) to meet USD IRB training requirements.
- Lesson 1: When HHS Regulations Apply
- Lesson 2: What is Human Subjects Research
- Lesson 3: What are IRBs
- Lesson 4: IRB Review of Research
- Lesson 5: Institutional Oversight of Human Research
Obtaining CITI Training
Register as a University of San Diego affiliate - your @sandiego.edu email address gives you access, free of charge. Step-by-step instructions for CITI training registration and course enrollment.
When adding a new course in CITI, you are only required to answer questions three and six. In question three, you will choose ONE training based on the nature of your research and role. For IRB approval, all members are required to choose either Social & Behavioral Research Investigators and/or Biomedical Research Investigators. In question six, if you are registering for the first time, you will answer NO.
List of required modules/lessons for human subjects protection training: (note that the required modules for a refresher course may be slightly different from a basic/initial course)
- Belmont Report and Its Principles
- Conflicts of Interest in Human Subjects Research
- Students in Research
- History and Ethics of Human Subjects Research
- Defining Research with Human Subjects
- Informed Consent
- Privacy and Confidentiality - SBE
- Belmont Report and Its Principles
- History and Ethics of Human Subjects Research
- Basic Institutional Review Board (IRB) Regulations and Review Process
- Informed Consent
- Records-Based Research
For questions about human subjects protection training or CITI training, please refer to the IRB’s FAQs page or contact irb@sandiego.edu.
Frequently Asked Questions
- Note that only research team members listed under “Other Investigators’ category in the IRB application are required to download their certificate and attach to their IRB application.
- Watch this video on how to download CITI training certificate
CITI training offers a refresher course and upon completion new certificates must be uploaded to the Cayuse IRB application for corresponding study/studies.
- The USD IRB will accept other human subjects training certificates only for non-USD affiliated researchers. Please see details above on how to complete modules for the Office of Human Research Protections.
- USD-affiliated researchers must show proof of human subjects research training under USD requirements.
- If you are a USD-affiliated researcher with CITI training under a different institution, you must add an institutional affiliation with USD to transfer your training credits from another institution. Watch this video to complete this process.