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1.23 HRPP Training Requirements and Opportunities for Research Personnel

1.0 Purpose

The purpose of this policy and procedure 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 is defined (as per HRPP policy 1.8: Investigational Activities Requiring IRB Review & Approval, section 4.1) as 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 disease
    • 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. 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 Procedures

The Organization utilizes the following education and training methods for research personnel:

  • 4.1. Collaborative Institutional Training Initiative (CITI)

    • 4.1.1. Training in the protection of human subjects is primarily accomplished through completion of this web-based training program. CITI training is required for 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. In addition, Faculty Advisors of student investigators are required to be CITI trained.
    • 4.1.2. The CITI Training Program is accessible via http://www.citiprogram.org, or through a link on the UNMC IRB website (http://www.unmc.edu/irb).
    • 4.1.3. CITI training course requirements
      • 4.1.3.1. The Biomedical course must be completed by:
        • 4.1.3.1.1. UNMC, CHMC, Nebraska Medicine, BMC and UNO personnel listed in section 3.1.1 who conduct non-exempt biomedical research within the Organization or at external sites where the UNMC IRB serves as the IRB of record.
        • 4.1.3.1.2. Research personnel not associated with the Organization listed in section 3.1.1 who conduct non-exempt biomedical research within the Organization at external sites where the UNMC IRB is the IRB of record.
      • 4.1.3.2. The Behavioral and Social Science course must be completed by:
        • 4.1.3.2.1. UNMC, CHMC, Nebraska Medicine, BMC and UNO personnel listed in section 3.2 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.
        • 4.1.3.2.2. Research personnel not associated with the Organization listed in section 3.2 who conduct non-exempt Behavioral and Social Science research within the Organization at external sites where the UNMC IRB is the IRB of record.
      • 4.1.3.3. The GCP (Good Clinical Practice) course must be completed by:
        • 4.1.3.3.1. UNMC, CHMC, Nebraska Medicine, BMC and UNO personnel listed in section 3.1.1 who conduct a clinical trial funded by 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 interventions (which 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)
        • 4.1.3.3.2. UNMC, CHMC, Nebraska Medicine, BMC and UNO personnel listed in section 3.1.1 who conduct research utilizing an FDA regulated drug, device or biologic.
    • 4.1.4. All research personnel must be CITI trained prior to IRB approval of initial research applications.
    • 4.1.5. New research personnel listed in Section 3.0 added to IRB-approved research via a Request for Change or Application for Continuing Review must complete CITI training prior involvement in the research
    • 4.1.6. The Organization will accept CITI Training records from other institutions if the other institution utilized the CITI training courses specified in Section 4.1.3 above. A copy of any training record must be provided to the ORA.
    • 4.1.7. 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 substantively similar, was completed at a site that did not participate in the CITI Program, and had 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.
    • 4.1.8. The Organization will accept other certificates of training from external organizations for external research personnel conducting non-exempt biomedical research at external sites where the UNMC IRB is the IRB of record. The PI must certify that all external research personnel have completed appropriate training.
    • 4.1.9. The Organization requires a passing score of 75% to receive credit for CITI training.
    • 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, in the roles defined in Section 4.1.3.

  • 4.2. UNMC IRB Website

    • 4.2.1. Research personnel can access the IRB website at http://www.unmc.edu/irb.
    • 4.2.2. The HRPP Policy Manual is posted on the IRB website. When policies are updated, a Summary of Changes will be included with the HRPP Policy Manual.
    • 4.2.3. 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.
    • 4.2.4. IRB Staff will periodically post access to relevant presentations and other educational materials on the IRB website.

  • 4.3. IRB Education Series

    The IRB Education Series is scheduled on a regular basis, and research personnel within the Organization are notified in advance. The series consists of didactic presentations relevant to the protection of human subjects of research. Some presentations will subsequently be made available on the IRB or other Organization websites.

  • 4.4. “HRPP: Working Together” Bulletins The bulletins are issued electronically on regular intervals and contain practical information from HRPP policies, often in a question and answer format.

  • 4.5. UNMC IRB Workshops Workshops are scheduled on various topics, such as the IRB online submission system, informed consent and how to work more effectively with the IRB. Research personnel within the Organization are notified in advance.

  • 4.6. Student Education Didactic classroom presentations are offered to UNMC and UNO students on topics pertaining to human subject protection by request.

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

  • 4.8. Individual Training upon Hire Upon hiring a new employee, the new hire’s supervisor can select an IRB Introduction and Overview as mandatory training. This training is generally provided by the IRB Administrator/ Education Coordinator.

  • 4.9. Individual Training upon Request The IRB Administrators provide individualize training to any research personnel on request. This training may be conducted in the ORA or at any requested location within the Organization.

  • 4.10. 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).

  • 4.11. Annual Regional Conference (“Hot Topics in the Protection of Human Subjects”) The 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 for a day-long conference exploring cutting edge topics in human research subject protection. The conference has been occurred annually since 2010. The target audience is IRB administrators and staff, IRB members, investigators and research coordinators.

5.0 Procedures for Assessing Training Requirements and Opportunities

  • 5.1. At regular intervals, the Assistant Vice-Chancellor for Regulatory Affairs, the Executive Chair, the IO and the ORA will re-evaluate the specific training and requirements for research personnel associated with the Organization. This assessment will include and consider:
    • 5.1.1. Review of the current literature and evolving federal guidance regarding various aspects of research ethics and human subject protection.
    • 5.1.2. Feedback from research personnel regarding their training needs.
    • 5.1.3. Assessment of the quality and completeness of IRB submissions by IRB members and the IRB Administrators
    • 5.1.4. Implementation of new IRB requirements, which require training.

6.0 Procedures for Maintaining Training Records The ORA maintains all training records for CITI Training and didactic activities described above, and maintains copies of materials sent by mail or email or posted on the website.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JUNE 28, 2018

 INITIAL DECEMBER 28, 2015

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