Education and Training

Note: Please keep certificates and dates of completion as you will need this information for your CPHS application.

CITI Training: Required Human Subjects Research Training for UC Berkeley Faculty, Staff, and Students

UC Berkeley faculty (with some exceptions), staff, and students engaged in human subjects research must complete either the biomedical or social-behavioral human research course, depending upon which is most germane to the research, through the online Collaborative Institutional Training Initiative (CITI). All study personnel must successfully complete the required CITI course(s) before CPHS will grant research approval or determination of exemption.

To get started with CITI, please review our CITI Login Instructions and then proceed to the CITI Online Course.

UC Berkeley offers many CITI elective/optional modules and courses as well. You are welcome to take any of these courses to enhance your human subjects research knowledge in such areas as public health, records based research, FDA-regulated research, FERPA, HIPAA, Good Clinical Practice, Conflicts of Interest, Export Compliance, undocumented status in human research, and international issues. For faculty who wish to incorporate a short human subjects research overview into their courses or seminars, OPHS has designed a group titled, “Essentials of Human Subjects Research.” Please note: this course does not fulfill the policy requirements referred to above.

For those who completed a CITI Human Research course at another institution

The user should contact CITI Program to transfer modules in common. The user will need to complete the UC Berkeley course by completing any outstanding modules as applicable.

Guidance

UC System IRB Memorandum of Understanding (MOU) Training Requirements

All UC Berkeley faculty, staff, and students who want to use the UC System Memorandum of Understanding to rely on another UC System institution’s IRB review must complete and pass the Collaborative Institutional Training Initiative (CITI) online training program module sequence most germane to their area of study. The exception to this rule is when the study is NIH-funded: legacy Principal Investigators may substitute the NIH online training created in 2008 (if taken before 1/1/2021) or the Human Research Protection Training offered by the HHS Office for Protection of Human Subjects (OHRP) (see below) for the CITI online training.

Human Subjects Research Training for Non-Affiliates of UC Berkeley

Collaborating researchers who are not UC Berkeley affiliates must also complete training in human subjects research, but there is some flexibility in what program(s) may be used. If CITI or a comparable human subjects training program is offered through the collaborator’s local institution or organization, then the protocol (section 3) should describe the collaborator’s training and confirm that it has been completed. Another option is the Human Research Protection Foundational Training offered by the US HHS Office for Human Research Protections (OHRP). All online lessons must be completed in order to fulfill the training requirement. If needed, the UC Berkeley researchers can provide training directly to collaborators using the PowerPoint “Working with Research Study Participants: An Overview.” The protocol should indicate how the training was/will be provided, and by whom.

Additional training requirements may apply, depending on the nature of the research. See below for training requirements related to specific categories of research.

NIH-Funded Principal Investigators and Key Personnel

Principal Investigators and Key Personnel of NIH-funded research with human subjects are required by the NIH to complete training in the protection of human research participants. This requirement may be satisfied by completing the online CITI course, or legacy Principal Investigators have the option of completing the Human Research Protection Training offered by the HHS Office for Protection of Human Subjects (OHRP). All lessons must be completed in order to fulfill the training requirement. Users should be careful to save a copy of their completion record as OHRP does not maintain a database of completion records. The 2008 online NIH course: NIH Online Course - Protecting Human Research Participants (PHRP) is no longer updated or maintained. If this course was completed before 1/1/2021, it may fulfill NIH’s training requirement.

NIH Clinical Trials

Effective January 1, 2017, NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.

This requirement must be satisfied by completing one of the following online CITI courses for Good Clinical Practice (GCP), most germane to the research in question:

  • Group 1: Clinical Trials - FDA Focus - Investigators and/or Team Members
  • Group 2: Clinical Trials - ICH Focus - Investigators and/or Team Members
  • Group 3: Clinical Investigations of Devices - Investigators and/or Team Members
  • GCP – Social and Behavioral Research Best Practices for Clinical Research

NSF Training Requirements

Responsible Conduct of Research (RCR) course completion is required for ALL students, postdocs, faculty and other senior personnel supported by NSF funds. The RCR training course must be completed before any funding can be awarded. RCR requirements are satisfied via the CITI Responsible Conduct of Research (RCR) course in addition to the CITI human research course (i.e., Group 2 social behavioral or Group 1 biomedical human research course). The RCR human subjects research course does NOT substitute for the CITI human subjects research course and vice versa. The RCR course certificate should be retained for the grant Principal Investigator’s records and should not be attached to the eProtocol application. See Responsible Conduct of Research (RCR) Training for additional information.

U.S. Department of Education (ED) Grant Applicants, Grantees, and Subgrantees

The following online course provides an overview of the key issues surrounding the protection of human subjects in ED-funded research as required in 34 CFR Part 97.

Training for Investigators Using Protected Health Information (PHI)

Investigators using protected health information (e.g. individually identifiable health information from the Tang Center, Human Resources Health Plan, Athletics and Recreational Sports, Optometry Clinic, or other covered entities outside of UC Berkeley) are subject to the requirements of the Health Insurance Portability and Accountability Act (HIPAA), and must complete Health Privacy (HIPAA) Training through CITI before their CPHS protocol will be approved.

For general information on HIPAA and research, refer to the CPHS Guidelines on HIPAA and Human Subjects Research.

Department of Defense (DoD)-Supported Research

The DoD requires initial and continuing research ethics and human participant protection training for “all personnel involved in reviewing, approving, supporting, conducting, managing, or overseeing” human participant research [see also: SECNAV Instruction 3900.39D, DoD Instruction 3216.02]. Principal Investigators (PIs) and all research personnel engaged in DoD-supported human subjects research are required to complete one of the following online CITI courses, depending upon which is most germane to the research:

  • DoD course for Social and Behavioral Research Investigators
  • DoD course for Biomedical Research Investigators

Researchers must complete one of the above courses before CPHS/OPHS will grant research approval or determination of exemption. The DoD requires that training be refreshed every three years; PIs and study personnel are responsible for complying with this three-year requirement. Failure to complete initial and/or continuing education training while DoD funding is active will be considered a noncompliance by CPHS and may result in loss of funding.

OPHS Outreach Presentations

The Director of Research Subject Protection and/or OPHS staff make educational presentations at classes, seminars, and other venues throughout the year. The presentations cover the fundamentals of human subjects research requirements and the CPHS application process, but can be geared to the specific interests and needs of your group. If you are interested in scheduling OPHS staff to speak to your class or group, please send your request to OPHS at ophs@berkeley.edu. (Note: Fulfillment of such requests depends on OPHS workload/staff availability and other factors at the time.)

UC Learning Center Course

As part of the Research Administration Professional Development Program (RAPDP), a specialty eCourse on human subjects research is available:

While this course is geared towards Research Administrators (RA), others may find it helpful.

Synopsis: A 1-hour specialty online specialty workshop that explores the policies and procedures related to research on Human Subjects.

Learning Objectives:

  • Identify human subjects research
  • Recall the rationale for human subjects research regulatory compliance
  • Recognize human subjects research regulations
  • Plan and prepare for grant proposals involving human subjects research activities
  • Identify training requirements for investigators planning to conduct human subjects research
  • Recall who to contact for human subjects research questions

 

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