HSR Training Requirements
- Human Research Protections Program
- What to Consider Before Completing an IRB Application
- Training Requirements
- Accessing the CITI Program
- Forms
- Exempt Categories
- Procedures and Policies
- Regulations and Guidance
- Collaborative Research
- NIH Funded Research
- UCSC European Union General Data Protection Regulation (GDPR) Statement of Privacy
- FAQ
Training Requirement Fulfillment
Accessing CITI Program Training
Completing CITI Program Courses
Completion Reports/Certificates
Who Must Complete Training
Human subjects research (HSR) training is required for all UCSC investigators (faculty, staff, and students) who will be engaged in research activities involving human subjects. It is also required for all UCSC investigators who are engaged in collaborative HSR activities for which UCSC has entered into a reliance agreement.
Activities that engage a study investigator in HSR include:
- enrolling individuals
- obtaining subjects' informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the study investigators
- intervening or interacting with subjects by performing invasive or non-invasive procedures on them
- collecting data directly from or follow-up directly with subjects,
- collecting identifiable private information from subjects
- having access to information that links subjects’ names or other identifiers with their data
All non-UCSC study team members engaged in HSR activities reviewed by the UCSC IRB/ORCA must either complete an appropriate UCSC required CITI Program course, or complete their own institution’s training requirements.
Modified HSR training is required for all faculty advisors who supervise students engaged in HSR activities on behalf of UCSC.
Training Requirement Fulfillment
The training requirement can be fulfilled by selecting and completing appropriate online CITI Program HSR training courses based upon the study procedures being conducted. Each CITI course consists of various modules that contain passages to review and related quiz questions. An aggregate score of 80% or higher on all modules is required for course completion. A running tally for each course selected is compiled in a grade book. Courses may be repeated to improve quiz scores. See Required HSR Training Courses for additional detail on the required courses.
All required CITI training must be completed before a study receives IRB approval or an exempt 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.
Please note that some CITI courses may take a few hours to complete. Courses can be completed over multiple sessions, and the CITI system will save user progress.
* As the NIH no longer offers its course Protecting Human Research Participants (PHRP), UCSC ORCA now requires all UCSC investigators who will be engaged in research activities involving human subjects to complete appropriate CITI Program HSR training courses.
Required HSR Training Courses
- For most study investigators involved in social, behavioral and Economic Research (SBER) studies, completion of the course Group 1: Human Subjects Researchers-Social, Behavioral, and Economic (ID: 96465) is required.
- For most study investigators involved in research studies involving biomedical procedures, completion of the course, Group 2: Human Subjects Researchers – Biomedical (ID: 96466) is required.
- For all faculty advisors who are not engaged in HSR, but supervise UCSC students who are engaged in HSR on behalf of UCSC, completion of the course Group 3: Faculty Advisors Not Engaged in Human Subjects Research Activities (ID: 207497) is required.
- For all student-interns engaged in human subjects research activities on a UCSC study, ORCA requires completion of the online CITI Program course Students in Research (ID: 1321). UCSC defines “student intern” as a non-UCSC student performing a supervised research internship offered by an organization (not only UCSC) for a limited period of time. For example, the UCSC Science Internship Program (SIP) or a non-UCSC undergraduate or graduate visiting for a short, defined period to work on an already established research study.
- Research Activity Specific Training:
- For all study investigators accessing or receiving Protected Health Information (PHI) from a HIPAA covered entity, the course Health Privacy Issues for Researchers (ID: 215959) course is required.
- For all study investigators involved in research related to subjects’ illegal activities or undocumented status, ORCA requires completion of the course Illegal Activities or Undocumented Status in Human Research (ID: 16656) is required.
- For all study investigators conducting international research, the course International Research - SBE (ID: 509) is required.
- For all study investigators involved in internet-based research, the course Internet-Based Research - SBE (ID: 510) is required.
- For all study investigators involved in research with decisionally impaired subjects, the course Research with Decisionally Impaired Subjects (ID: 16610) is required.
- For all study investigators involved in research in which pregnant women, fetuses, or neonates are subjects or in which placental or fetal materials are involved, the course Research Involving Pregnant Women, Fetuses, and Neonates (ID: 10) is required.
- For all study investigators involved in research in which prisoners are subjects, the course Research with Prisoners - SBE (ID: 506) or the course Research Involving Prisoners (ID: 8) is required.
- For all study investigators who will handle, as part of study activities, subject education records where FERPA applies, completion of the course Research involving Family Educational Rights and Privacy Act (FERPA), which includes the following modules, is required:
- FERPA: An Introduction (ID: 17407), and
- FERPA for Researchers (ID: 17410).
- All UC Santa Cruz-affiliated study investigators conducting research in a public elementary or secondary school are required to take the CITI Program online optional course Research in Public Elementary and Secondary Schools - SBE (ID: 508).
- For all study investigators involved in research with child subjects, the course Research with Children - SBE (ID: 507) or the course Research Involving Children (ID: 9) is required.
- For any investigators conducting a NIH-sponsored clinical trial or FDA-regulated clinical trial, completion of 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).
This training is required in addition to the SBER or Biomedical human subjects training requirement.
- For any investigators who conduct, review, approve, oversee, support, or manage Department of Defense (DoD) human subject research, the DoD requirements for research ethics training, as outlined in the UCSC IRB Policy on Studies Involving the Department of Defense, must also be met.
Spanish language equivalents to the Group 1 and Group 2 courses are offered by CITI. Also, the Office of Research Compliance Administration (ORCA) offers two options for foreign engaged investigators for whom CITI training is not available in their language:
- If the investigators are affiliated with an institution that has its own HSR training, the Human Subjects Research Ethics Training Equivalency Letter may be utilized 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 utilized to fulfill the training requirement.
Both forms can be found on the IRB Forms page. However, investigators should discuss use of either form with ORCA prior to its use.
Accessing CITI Program Training
Log in to the CITI Program Online.
More detailed instructions can be found on Accessing CITI Program.
Completing CITI Program Courses
- Log in to the CITI Program.
- Select “View Courses” next to "University of California, Santa Cruz".
- Select "Add a Course".
- Answer the questions you are presented with. 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 the Office of Research Compliance Administration. 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 UCSC. Study investigators affiliated with another institution that utilizes the CITI Program can “affiliate” with UCSC in CITI and, once affiliated, ORCA will receive their course completion reports. Thus, it is not necessary to submit a completion report/certificate unless instructed to do so as part of an Initial or Modification Submission in which a study investigator is added to a study.
