Human Subjects Research Training

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. 

Required HSR training
WhoRequired course
Most study investigators involved in social, behavioral and Economic Research (SBER) studiesGroup 1: Human Subjects Researchers-Social, Behavioral, and Economic (ID: 96465)
Most study investigators involved in biomedical proceduresGroup 2: Human Subjects Researchers – Biomedical (ID: 96466)
All student-interns engaged in human subjects research activities on a UC Santa Cruz studyStudents in Research (ID: 1321)
Optional HSR training
Research activity – all investigators who:Optional course
Access or receive Protected Health Information (PHI) from a HIPAA covered entityHealth Privacy Issues for Researchers (ID: 215959)
Are involved in research related to subjects’ illegal activities or documentation statusIllegal Activities or Undocumented Status in Human Research (ID: 16656)
Conduct international researchInternational Research – SBE (ID: 509)
Are involved in internet-based researchInternet-Based Research – SBE (ID: 510)
Are involved in research with decisionally impaired subjectsResearch 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 involvedResearch 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 appliesResearch 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 schoolResearch 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 trialOne 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 researchDOD 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”
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.  
Accessing CITI Program courses
  • Detailed instructions for creating an account and accessing CITI can be found at CITI Program Training.
  • Log in to the CITI Program.
  • Select “My Courses” in the top left,
  • Select “View Courses” in the middle of the screen
  • Scroll down to the very bottom of the page and select “Add a course”
  • Select “No”, then “Next” for Question 1
  • Select “Human Subjects Research” then “Next” for Question 2
  • Select “Group 1” for the Group 1 training
  • If desired, select “Optional Human Subjects Research (HSR) Courses”
  • Select “Next” for Question 3
  • Select any desired optional courses from the list that populates, then select “Next”
  • Scroll down to find and begin the necessary course(s)/module(s).

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.

Last modified: Feb 06, 2025