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1.27 Research Personnel Qualifications and Responsibilities

Last Revised: 11/26/2025

1.0 Purpose

The purpose of this policy is to describe the qualifications and responsibilities of personnel conducting research within the Organization and at external sites under the jurisdiction of the UNMC IRB. Specific responsibilities of the Principal Investigator (PI) are described in HRPP policy 1.26 (PI Qualifications & Responsibilities).

2.0 Policy

It is the policy of the Organization that

  • 2.1. Personnel involved in the conduct of research must possess the required experience, skill, education and (as appropriate) licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).

3.0 General Requirements

  • 3.1. Research personnel who are Responsible Personnel per HRPP policy 1.25 (Financial Conflicts of Interest) must comply with that policy.
  • 3.2. Investigators and research staff, including faculty advisors, conducting non-exempt research are required to comply with HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel).

4.0. Categories of Research Personnel and Specific Requirements

  • 4.1. Secondary Investigator(s) (SI):

    • 4.1.1. The SI shares responsibility with the PI for assure safe conduct of the research in full compliance with the protocol, HRPP policies, IRB requirements, Federal regulations, and state law.
    • 4.1.2. Secondary Investigator(s) responsibilities may include (but are not limited to):
      • 4.1.2.1. Development of the research plan (in conjunction with the PI and other investigators)
      • 4.1.2.2. Obtainment of legally effective informed consent/assent from prospective subjects.
      • 4.1.2.3. Performance of research interventions or tests
      • 4.1.2.4. Analysis of data or biospecimens
      • 4..1.2.5. Presentation or publication of the data (in conjunction with the PI and other investigators).
    • 4.1.3. More than one SI may be named on the IRB application.
    • 4.1.4. The SI is not required to be associated with the Organization; however an unaffiliated investigator must sign a Collaborating Institutional Investigator Agreement or Collaborating Individual Investigator Agreement unless they do not have access to subjects or to identifiable private information or identifiable biospecimens
    • 4.1.5. The SI must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

  • 4.2. Faculty Advisor (FA)

    • 4.2.1. The FA shares responsibility with the student PI for assure safe conduct of the research in full compliance with the protocol, HRPP policies, IRB requirements, Federal regulations, and state law.
    • 4.2.2. FA responsibilities include (but are not limited to):
      • 4.2.2.1. Development of the research plan (in conjunction with the student PI and other investigators)
      • 4.2.2.2. Assisting the student PI with completion and submission of the IRB application, and applications to any other ancillary committees
      • 4.2.2.3. With the student PI, monitoring and responding to communications with the IRB/ORA, or from any other ancillary committees
      • 4.2.2.4. Obtainment of legally effective informed consent/assent from prospective subjects.
      • 4.2.2.5. Performance of research interventions or tests
      • 4.2.2.6. Analysis of data or biospecimens
      • 4.2.2.7. Presentation or publication of the data (in conjunction with the student PI and other investigators).
    • 4.2.3. The FA must be prepared to assume the role of PI of the project upon departure of the student from the organization, including all responsibilities described in HRPP policy 1.26 (PI Qualifications and Responsibilities)
    • 4.2.4. The FA must be qualified as per the requirements of HRPP policy 1.26 (PI Qualifications and Responsibilities), and must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

  • 4.3. Participating Personnel:

    • 4.3.1. Participating Personnel responsibilities may include (but are not limited to):
      • 4.3.1.1. Obtainment of legally effective informed consent/assent from prospective subjects, if authorized by the PI in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
      • 4.3.1.2. Performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject
      • 4.3.1.3. Analysis of data or biospecimens
      • 4.3.1.4. Presentation or publication of the data (in conjunction with the PI and other investigators).
    • 4.3.2. Participating Personnel are generally not involved in the development or the research plan.
    • 4.3.3. More than one PP may be named on the IRB application.
    • 4.3.4. Participating personnel are not required to be associated with the Organization; however unaffiliated personnel must sign a Collaborating Institutional Investigator Agreement or Collaborating Individual Investigator Agreement unless they do not have access to subjects or to identifiable private information or identifiable biospecimens
    • 4.3.5. Participating personnel must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

  • 4.4. Research Point of Contact (formerly Lead Coordinator):

    Note: some IRB applications may be still request “Lead Coordinator” rather than “Point of Contact”. In all cases, the characteristics of this position are described in this section.

    • 4.4.1. The Research Point of Contact (POC) is the primary regulatory contact point for the IRB/ORA. All correspondence from the IRB/ORA will be directed to both the PI and the POC.
    • 4.4.2. Research POC may also serve a role as SI, PP, coordinator or data personnel in addition to serving as POC or may serve no other role on the research team.
    • 4.4.3. Only one Research POC may be named in a study.
    • 4.4.4. A Research POC is not required for all research. The PI will serve as the single contact when a Research POC is not identified.

  • 4.5. Coordinator

    • 4.5.1. Coordinator responsibilities may include (but are not limited to):
      • 4.5.1.1. Obtainment of legally effective informed consent/assent from prospective subjects, if authorized by the PI in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
      • 4.5.1.2. Performance of research interventions or tests, either as research procedures, or in the course of providing clinical care or routine services to the patient/subject
      • 4.5.1.3. Analysis of data or biospecimens
    • 4.5.2. More than one coordinator may be named on the IRB application.
    • 4.5.3. Coordinators must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

  • 4.6. Data/Administrative Personnel:

    • 4.6.1. Data/Administrative Personnel may be responsible for management of data collected during the course of the research.
    • 4.6.2. Data/Administrative Personnel may be involved in preparation of IRB applications and in submission of reports and/or forms to the IRB/ORA or to other ancillary committees within the institution, and to the sponsor as applicable, under the direction of the PI.
    • 4.6.3. Data/Administrative Personnel do not have direct subject contact, but may have access to subject's identifiable private information, or protected health information (PHI).

DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded

 Revised: 2/18/2019 - revision not documented

 Revised 5/28/2025 – Revised section 3.2 regarding training requirements for investigators and research staff, including faculty advisors, to harmonize with policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel); deleted section 4.1 (PI) (redundant to policy 1.26); specified qualifications and responsibilities of faculty advisors (section 4.2); revised section 4.4 to describe qualifications and responsibilities of Research Point of Contact (formerly Lead Coordinator) (section 4.4); clarified responsibilities of coordinators (section 4.5); revised title of Administrative personnel to Data/Administrative personnel (section 4.6)

 Revised 11/26/2025 – added note to section 4.0 regarding transition from “Lead Coordinator” title to “Point of Contact”

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