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1.23 HRPP Training Requirements

Last Revised: 8/13/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements and opportunities for training personnel conducting human subject research.

2.0 Policy

It is the policy of the Organization that all personnel involved in the conduct of human subject research under the oversight of the UNMC IRB will be qualified through initial and continuing education to fulfill their responsibility to protect the rights and welfare of human subjects.

3.0 Definitions

  • 3.1. Biomedical Research and Social Science and Behavioral Research are defined in HRPP 1.8 (Investigational Activities Requiring IRB Review and Approval). Briefly:
    • 3.1.1. Biomedical Research is research about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods
    • 3.1.2. Social Science and Behavioral Research is research performed with intent to study behaviors, attitudes and interactions and social processes among and between individuals, groups, and cultures

4.0 Required Training

  • 4.1. Protection of Human Subjects of Research
    • 4.1.1. Training in the protection of human subjects is primarily accomplished through completion of the Collaborative Institutional Training Initiative (CITI) web-based training program. CITI training is required for:
      • 4.1.1.1. All investigators and research staff conducting non-exempt research who (a) participate in the process of consent, (b) have contact with subjects, or (c) have access to identifiable private information or identifiable biospecimens.
      • 4.1.1.2. Faculty Advisors of student investigators.
    • 4.1.2. The Biomedical and the Behavioral and Social Science courses consist of a series of Basic (core) modules which must be completed by users, and additional modules (primarily related to specific types of research or research subject populations).
    • 4.1.3. The Good Clinical Practice (GCP) course consists of a series of required modules.
    • 4.1.4. CITI training course requirements

      • 4.1.4.1. The Biomedical course must be completed by personnel who conduct non-exempt biomedical research (including medical records and human biological material research within the Organization or at external sites under the jurisdiction of the UNMC IRB where the UNMC IRB serves as the IRB of record.

        Note: This does not include personnel at sites under the jurisdiction of another IRB but for which the UNMC IRB is acting as the IRB of record.

      • 4.1.4.2. The Behavioral and Social Science course must be completed by personnel who conduct non-exempt Behavioral and Social Science research within the Organization or at external sites where the UNMC IRB serves as the IRB of record.

        Note: This does not include personnel at sites under the jurisdiction of another IRB but for which the UNMC IRB is acting as the IRB of record.

      • 4.1.4.3. The GCP course must be completed by (a) personnel who conduct a clinical trial funded by NIH, and (b) personnel who conduct research utilizing an FDA regulated drug, device or biologic.

    • 4.1.5. All personnel conducting non-exempt research (excluding personnel listed solely as Research Point of Contact) must successfully complete CITI training prior to release of the protocol by the Office of Regulatory Affairs.
      • 4.1.5.1. Personnel must complete all Basic (core modules) appropriate for the type of research.
      • 4.1.5.2. Personnel who are conducting research where the additional modules are relevant must attest that they have completed those additional modules before final release of the protocol by ORA.
    • 4.1.6. New research personnel added to IRB-approved research via a Request for Change must complete CITI training as described above prior to involvement in the research.
    • 4.1.7. The Organization will accept CITI Training records from other institutions, provided those institutions have substantively similar CITI required modules. A copy of any training record must be provided to the ORA.
    • 4.1.8. On a case by case basis, the Organization may accept other forms of Human Subject protection, or GCP training, instead of CITI, provided such training is (a) substantively similar to UNMC requirements, (b) was completed at a site that did not participate in the CITI Program, and (c) has been completed in the previous three years.
    • 4.1.9. For research conducted at external sites where the UNMC IRB is the IRB of record, the participating site PI is responsible for assuring personnel at that site have satisfied training requirements dictated by that site.
    • 4.1.10. CITI training (including GCP Training) must be renewed every three years from the original date of completion. Training must be up to date for the individual to be listed on new IRB applications or added to existing IRB-approved applications.
    • 4.1.11. Community Research Partners may be trained through CITI or through the use of the CIRTification Online program at University of Illinois Chicago (link available on IRB website). Training is required prior to involvement of the partner in the research and must be renewed every three years.
    • 4.1.12. For personnel, including Community Partners, already listed on an active protocol, training is considered valid for the duration of that study. If a person’s training expires after they are added to the protocol, they may remain on the study without renewing the training.
    • 4.1.12. Neither CITI Training nor CIRTification-based training is required for personnel who conduct Exempt research.
  • 4.2. Conflict of Interest Training Conflict of Interest Training is required in accordance with UNMC Conflict of Interest policy #8010 and HRPP policy 1.25 (Financial Conflicts of Interest).

5.0 Optional Training

  • 5.1. UNMC Websites

    • 5.1.1. The HRPP Policy Manual is posted on the UNMC Guides website (https://guides.unmc.edu/). When policies are updated, a Summary of Changes will be included with the HRPP Policy Manual.
    • 5.1.2. The IRB website contains links to OHRP, FDA, Office of Civil Rights and other websites where research personnel can access the federal regulations, guidance documents and other information pertinent to human subject research.
    • 5.1.3. The ORA will periodically post access to relevant presentations and other educational materials on the IRB website.

  • 5.2. Individual Training

    • The ORA will provide individualized training to any faculty, staff or student associated with the Organization as requested.

  • 5.3. Topic Specific Presentations

    • The ORA regularly provides education on various topics related to protection of human subjects and to IRB/ORA policies and procedures.

  • 5.4. Student Education

    • Classroom presentations are offered to UNMC and UNO students on topics pertaining to human subject protection by request.

  • 5.5. Webinars

    • The ORA facilitates access to webinars sponsored by external organizations on topics relevant to Human Subject Research.

  • 5.6. UNMC Protection of Human Subject Conference

    • This annual regional conference, produced in collaboration with the Great Plains Health Research Consortium, and partially funded by the Great Plains IDeA-CTR Network, brings together national and local speakers to explore topics in research ethics and IRB management and function. The conference has occurred annually since 2010, though postponed in 2020 due to the Coronavirus pandemic. The target audience is IRB analysts and staff, IRB members, investigators and research coordinators.

6.0 Procedures for Assessing Training Requirements

  • 6.1. At regular intervals, the Assistant Vice-Chancellor for Regulatory Affairs, the Executive Chair, the IO and the ORA will re-evaluate the content, specific requirements, and effectiveness of training for research personnel associated with the Organization. This assessment will take into consideration current literature and evolving federal guidance regarding various aspects of research ethics and human subject protection, feedback from research personnel regarding their training needs, assessment of the quality and completeness of IRB submissions by IRB members and the IRB Analysts.

7.0 Procedures for Maintaining Training Records

The ORA maintains all training records for CITI Training and maintains copies of educational materials sent by to the research community.

DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 6/28/2018 - revision not documented

 Revised: 8/31/2021 - Described basic vs additional modules for CITI courses; described requirement to complete additional modules based on type or research and subject population; clarified location of UNMC HRPP Policies manual; correction of references to sections within this and other policies; delineated required vs optional training; deleted training no longer offered; minor stylistic changes and clarification.

 Revised: 6/30/2022 - clarification or requirements for CITI biomedical course (section 4.1.4.1).

 Revised: 8/17/2022 - clarification regarding expiration of CITI training for personnel on an active protocol (section 4.1.10).

 Revised 08/13/2025 - Simplified definitions of Biomed research and SBS research (referred to HRPP 1.8); clarified training requirements apply to UNMC research personnel and for research personnel at external sites under the jurisdiction of the UNMC IRB; clarified that research personnel at sites under the jurisdiction of another IRB but for which the UNMC IRB is acting as the IRB of record are subject to training requirements dictated by those sites; clarified that CITI is not required for exempt research; clarified that CITI training must be successfully completed prior to ORA release of non-exempt research; clarified that CITI Training completed at a prior institution need only be substantively similar to UNMC requirements; deleted requirement for EC or IO approval of non-CITI training; added requirements for training of Community Partners; simplified descriptions of Optional Training; stylistic changes; corrected typographic errors.

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