Skip to main content

1.23 HRPP Training Requirements

Last Revised: 8/17/202213/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements and opportunities for training for all personnel involved in 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 in order to fulfill their responsibility to protect the rights and welfare of human subjects.

3.0 Definitions

  • 3.1. Biomedical Research isand Social Science and Behavioral Research are defined (as perin HRPP policy 1.8 (Investigational Activities Requiring IRB Review &and Approval,Approval). sectionBriefly: 4.1)
      as
    • 3.1.1. Biomedical Research is research performed with intent to develop or contribute to generalizable knowledge (i.e., test a hypothesis and draw conclusions) about human biological systems and processes, including efficacy and safety of preventative, diagnostic or therapeutic methods. Biomedical research includes:
      • 3.1.1. Clinical trial using a drug, medical device, technique or other intervention or strategy (including non-physical means, like diet, cognitive therapy, etc.) to diagnose, treat or otherwise study a particular condition or diseasemethods
      • 3.1.2. Non-clinical biomedical research to study normal or abnormal physical or physiologic processes (for example, gait and balance testing, biomechanical assessments).For the purpose of this policy “Biomedical Research” includes Human Biological Material Research and Medical Records Research (per HRPP policy 1.8 Investigational Activities Requiring IRB Review & Approval, sections 4.2 and 4.3 respectively)
    • 3.2. Social Science and Behavioral Research is defined (as per HRPP policy 1.8 Investigational Activities Requiring IRB Review & Approval, section 4.4) as research performed with intent to study behaviors, attitudes and interactions and social processes among and between individuals, groups, and cultures.cultures
      • Generally
    this category of research has no intent of producing a diagnostic, preventive, or therapeutic benefit to the subject who is not seeking nor expecting a health benefit from the research.

4.0 Required Training

  • 4.1. CollaborativeProtection Institutionalof TrainingHuman InitiativeSubjects (CITI)

    of Research
    • 4.1.1. Training in the protection of human subjects is primarily accomplished through completion of thisthe 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 CITI Training Program is accessible via http://www.citiprogram.org, or through a link on the UNMC IRB website.
    • 4.1.3. 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 GCPGood 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 described in section 4.1.1 who conduct non-exempt biomedical research (including medical records and human biological material {HBM})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 described in section 4.1.1 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 (Good Clinical Practice) course must be completed by:by

          (a)
        • 4.1.4.3.1. Personnel described in section 4.1.1personnel who conduct a clinical trial funded by NIH.NIH, For the purpose of this policy, “clinical trial” is defined as “a research study in which one or more human participants are prospectively assigned to one or more interventionsand (whichb) may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (per NIH Policy NOT-OD-15-015)
        • 4.1.4.3.2. Personnel described in section 4.1.1personnel 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 besuccessfully complete CITI trainedtraining prior to IRB approvalrelease of initialthe researchprotocol applications.by the Office of Regulatory Affairs.
      • 4.1.5.1. Personnel described in section 4.1.1 must complete all Basic (core modules) appropriate for the type of research (as per 4.1.3.1 thru 4.1.3.3)research.
      • 4.1.5.2. Personnel described in section 4.1.1 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 or Application for Continuing Review 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 ifhave thesubstantively other institution utilized thesimilar CITI trainingrequired courses specified above.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,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. The Executive Chair, in consultation with the IO as needed, will have the sole authority to accept such training.
    • 4.1.9. The Organization will accept other certificates of training from external organizations for externalFor research personnel conducting non-exempt biomedical researchconducted at external sites where the UNMC IRB is the IRB of record.record, Thethe participating site PI mustis certifyresponsible for assuring personnel at that all external research personnelsite have completedsatisfied appropriatetraining 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,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 rolesresearch definedand inmust Sectionbe renewed every three years.
    • 4.1.1.12. However,For personnelpersonnel, including Community Partners, already listed on an active protocolprotocol, whosetraining CITIis considered valid for the duration of that study. If a person’s training expires after they are added to the protocol, they may continueremain associatedon withthe thatstudy protocol.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 Additional (Optional)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 the 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 Staff will periodically post access to relevant presentations and other educational materials on the IRB website.website.

  • 5.2. Individual Training

    • 5.2.1. The IRBORA Administratorswill provide individualized training to any researchfaculty, personnel on request. This training may be conducted in the ORAstaff or atstudent anyassociated requested location within the Organization.
    • 5.2.2. Supervisors of new employees ofwith the Organization may request IRB Introduction and Overview as mandatory training. This training is generally provided by an IRB Administrator.requested.

  • 5.3. UNMCTopic IRBSpecific Workshops:Presentations

    Workshops
      are
    • The scheduledORA regularly provides education on various topics,topics suchrelated asto theprotection IRBof onlinehuman submission system, informed consentsubjects and how to workIRB/ORA morepolicies effectivelyand withprocedures.
      • the
    IRB. Research personnel within the Organization are notified in advance.

  • 5.4. Student Education:

    Didactic
      classroom
    • 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. HRPP Regional Conference (“Hot Topics in theUNMC Protection of Human Subjects”):Subject TheConference

    • 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 cutting edge topics in human research subjectethics protection.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 administratorsanalysts 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 Administrators.Analysts.

7.0 Procedures for Maintaining Training Records

The ORA maintains all training records for CITI Training and didactic activities described above, and maintains copies of educational materials sent by mail or email or posted onto the website.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.

Back to top