For human subjects research (HSR) training, UC Santa Cruz uses modules within the CITI Program. The training addresses a broad range of human subjects issues, from logistical to ethical, and promotes compliance with federal guidelines. The modules required will vary based on the activities being conducted. Completing the training before completing an Initial Submission will help ensure timely processing of your submission.
Who must complete training
Individuals involved in any of these activities are considered “engaged” in human subjects research and must be listed in the Human Ethics submission as study personnel and must complete training:
- Recruiting subjects (beyond just distributing a recruitment message for the UC Santa Cruz study investigators).
- Obtaining subject consent.
- Interacting or intervening with subjects for research purposes.
- Accessing private identifiable information about subjects for research purposes.
- Using UC Santa Cruz facilities for conducting research (beyond just posting a recruitment message or conducting observations).
- Faculty advisors who supervise students engaged in human subjects research.
Course requirement information
Each CITI Program course consists of modules with passages to review and related quiz questions. You need an aggregate score of 80% or higher on all modules to complete a course. You may repeat courses to improve your quiz scores.
All required CITI training must be completed before a study receives a determination, and before any HSR activities begin. CITI refresher courses must be completed every five years to ensure investigators maintain knowledge of ethical considerations and regulations regarding HSR protections. Refresher courses become available 60 days prior to course expiration and CITI automatically sends reminders both before and after a course expires.
Some CITI courses may take a few hours to complete. You can complete a course over multiple sessions, and the CITI system will save your progress. Training requires renewal every 5 years.
Required HSR training
| Who | Required course |
| Most study investigators involved in social, behavioral and Economic Research (SBER) studies | Group 1: Human Subjects Researchers-Social, Behavioral, and Economic (ID: 96465) |
| Most study investigators involved in biomedical procedures | Group 2: Human Subjects Researchers – Biomedical (ID: 96466) |
| All faculty advisors who are not engaged in HSR, but supervise UC Santa Cruz students who are engaged in HSR on behalf of UC Santa Cruz | Group 3: Faculty Advisors Not Engaged in Human Subjects Research Activities (ID: 207497) |
| All student-interns engaged in human subjects research activities on a UC Santa Cruz study | Students in Research (ID: 1321) |
| Research activity – all investigators who: | Required course |
| Access or receive Protected Health Information (PHI) from a HIPAA covered entity | Health Privacy Issues for Researchers (ID: 215959) |
| Are involved in research related to subjects’ illegal activities or documentation status | Illegal Activities or Undocumented Status in Human Research (ID: 16656) |
| Conduct international research | International Research – SBE (ID: 509) |
| Are involved in internet-based research | Internet-Based Research – SBE (ID: 510) |
| Are involved in research with decisionally impaired subjects | Research with Decisionally Impaired Subjects (ID: 16610) |
| Are involved in research in which pregnant women, fetuses, or neonates are subjects or in which placental or fetal materials are involved | Research Involving Pregnant Women, Fetuses, and Neonates (ID: 10) |
| Are involved in research in which prisoners are subjects | – Research with Prisoners – SBE (ID: 506) or – Research Involving Prisoners (ID: 8) |
| Will handle, as part of study activities, subject education records where FERPA applies | Research involving Family Educational Rights and Privacy Act (FERPA), which includes the following modules: – FERPA: An Introduction (ID: 17407) – FERPA for Researchers (ID: 17410) |
| Conduct research in a public elementary or secondary school | Research in Public Elementary and Secondary Schools – SBE (ID: 508) |
| Are involved in research with child subjects | – Research with Children – SBE (ID: 507) or – Research Involving Children (ID: 9) |
| Conduct a NIH-sponsored clinical trial or FDA-regulated clinical trial | One of the following Good Clinical Practices (GCP) courses, corresponding to the type of research being conducted, is required: – GCP – Social and Behavioral Research Best Practices for Clinical Research (ID: 146855) – Good Clinical Practice Course (US FDA focus) (ID: 75054) – GCP Course for Clinical Trials Involving Investigational Medical Devices (international focus) (ID: 75053) – GCP Course for Clinical Trials Involving Investigational Drugs (international / ICH focus) (ID: 75052) |
| Conduct, review, approve, oversee, support, or manage Department of Defense (DOD) human subject research | DOD requirements for research ethics training, as outlined in the UCSC IRB Policy on Department of Defense Funded Research |
Training for community partners
CIRTification is a training developed at University of Illinois – Chicago and is tailored to the unique roles of community research partners. Due to federal and institutional policies, researchers are required to complete human subjects protection training. However, most research ethics training programs are geared towards academic researchers and do not address the unique context of community-engaged research. CIRTification provides human research protection training that shares relevant, meaningful information to help community partners translate their unique knowledge and skills to research collaborations.
The training is interactive and covers some history of research abuses, has informed current ethical principles, standards for recruitment and informed consent, best practices for collecting and protecting data, handling challenges that may arise during participant interactions, the role of the IRB in protecting the rights and welfare of participants, and a dictionary of research terms and a toolbox with resources related to human research protections. The training is available in English and Spanish.
The IRB will accept this training instead of CITI for anyone who is a community partner and the training will be valid for five (5) years. This training will not replace human subjects research training required for UCSC personnel.
The following steps can be used to access the training:
- Go to https://training.ccts.uic.edu/
- Click “Register” in the top right
- Select “I am not from UIC”.
- Complete the registration form
- For the site, select “University of California, Santa Cruz”
- Click “Register” to finish
- To access the CIRTification course, visit the course catalog and scroll down
- Select “Learn more” and then “Enroll”
Learners complete a knowledge quiz at the end of the program and receive a certificate of completion. The program takes on average 2-3 hours and can be completed in multiple sessions.
Training language options
- Spanish language equivalents to the Group 1 and Group 2 courses are offered by CITI.
- ORCA offers two options for foreign engaged investigators for whom CITI training is not available in their language. Both forms can be found on Human Subjects Research Forms and Templates, but investigators should discuss use of either form with ORCA in advance.
- If the investigators are affiliated with an institution that has its own HSR training, the Human Subjects Research Ethics Training Equivalency Letter may be used to fulfill the training requirement.
- If the investigators are not affiliated with an institution, or are affiliated with an institution that does not have its own HSR training, the Local Community Research Assistant Field Training Pamphlet may be used to fulfill the training requirement.
Completing CITI Program courses
- Log in to the CITI Program. Detailed instructions can be found on CITI Program Training.
- Select “View Courses” next to “University of California, Santa Cruz.”
- Select “Add a Course.”
- Please note that questions are displayed based on the answers provided to previous questions (e.g., not everyone gets Question 4, 5, or 6).
- Click Start Now for any course in your personal list of courses to begin.
- You must complete the Assurance Statement before beginning the course. Check the I agree… checkbox and select Submit to proceed.
- Complete the required course modules and associated quizzes.
- Once completed, a copy of the report is automatically available to ORCA. To print a completion report or certificate for your own records, first click on “My Records” at the top of the page, then click the “View-Print-Share” link in the “Completion Report” column for the appropriate course and a printable PDF will open.
If you have questions, contact orca@ucsc.edu.
Completion reports/certificates
ORCA automatically receives CITI Program HSR training completion reports for study investigators affiliated with UC Santa Cruz. Study investigators affiliated with another institution that uses the CITI Program can “affiliate” with UC Santa Cruz in CITI and, once affiliated, ORCA will receive their course completion reports. It is not necessary to submit a completion report unless you are instructed to do so.