1.27 Research Personnel Qualifications and Responsibilities

4.00. DefinitionsCategories of Research Personnel and Specific Requirements

• 4.1. Principal Investigator (PI):

  • 4.1.1. The PI assumes overall responsibility for the conduct of the research. Specific responsibilities are described in HRPP policy 1.26 (PI Qualifications & Responsibilities).
  • 4.1.2. Only one PI can be named on the IRB application. Co-PIs (for example, on NIH grants) must be listed as Secondary Investigators.
  • 4.1.3. The PI must be an employee, faculty, or student associated with the Organization.
  • 4.1.4. The PI must be qualified by education, training, experience and licensure (as applicable) to assume overall responsibility for the safe and proper conduct of the research in full compliance with all applicable regulations and UNMC HRPP policies.
  • 4.1.5. If the PI is a student, resident, or house officer, a faculty advisor or program director must be identified on the IRB application. The faculty advisor/program director assumes responsibility for overall supervision of the student’s research and must sign off on the IRB application before submission to the IRB.
• 4.2. Secondary Investigator(s) (SI):
  • 4.2.1. Secondary Investigator(s) responsibilities may include (but are not limited to):
    • 4.2.1.1. Development of the research plan (in conjunction with the PI and other investigators)
    • 4.2.1.2. Obtainment of legally effective informed consent/assent from prospective subjects.
    • 4.2.1.3. Performance of research interventions or tests, or analysis of data or biospecimens
    • 4.2.1.4. Presentation or publication of the data (in conjunction with the PI and other investigators).
  • 4.2.2. The SI shares responsibility with the PI for assure safe conduct of the research in full compliance with the protocol, HRPP policies, IRB requirements, HHS or other Federal regulations, applicable FDA 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.
  • 4.2.1.4. The SI is not required to be associated with the Organization; however an unaffiliated investigator must sign ana externalCollaborating investigatorInstitutional agreementInvestigator Agreement or Collaborating Individual Investigator Agreement unless he/shethey doesdo not have access to subjects or to identifiable private information or identifiable biospecimens
  • 4.2.1.5. The SI must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

• 4.3.2. ParticipatingFaculty Personnel: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.
  • 4.3.1.2.2. ParticipatingFA Personnelresponsibilities include (but are not involvedlimited into):
    • 4.2.2.1. Development of the developmentresearch plan (in conjunction with the student PI and other investigators)
    • 4.2.2.2. Assisting the student PI with completion and submission of the ApplicationIRB application, and applications to any other ancillary committees
    • 4.2.2.3. With the IRB.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.

• 4.3.2. Participating Personnel:

  • 4.3.1. Participating Personnel responsibilities may include (but are not limited to):
    • 4.3.2.1.1. 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).
    • 4.3.1.2.2. Performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject,subject
    or
    • 4.3.1.3. analysisAnalysis of data or biospecimens
    • 4.3.2.3.1.4. 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 ana ExternalCollaborating 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: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 LeadResearch Coordinator is directly involved with working with the PI in the submissionPoint of allContact applications(POC) and reports to the IRB.
  • 4.4.2. The Lead Coordinator serves asis the primary regulatory contact point for the IRB/ORA. All correspondence from the IRBIRB/ORA will be directed to both the PI and Leadthe Coordinator.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. The Lead Coordinator may be authorized by the IRB to obtain informed consent/assent in accordance with HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
  • 4.4.4. Performance of research interventions or tests in the course of providing clinical care or routine services to the patient/subject, or analysis of data or biospecimens.
  • 4.4.5. Only one LeadResearch CoordinatorPOC may be named in a study.
  • 4.4.6.4. A LeadResearch CoordinatorPOC is not required for all research. The PI will serve as the single contact when a LeadResearch CoordinatorPOC is not identified.

• 4.5. Coordinator

  • 4.5.1. CoordinatorsCoordinator responsibilities may beinclude authorized(but toare obtainnot 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. Coordinators may be involved with performancePerformance of research interventions or teststests, either as research procedures, or in the course of providing clinical care or routine services to the patient/subject,subject
    or
    • 4.5.1.3. analysisAnalysis of data or biospecimens.biospecimens
  • 4.5.3.2. More than one coordinator may be named on the IRB application.
  • 4.5.4.3. Coordinators must be qualified by education, training, experience and licensure (as applicable) to perform the specific responsibilities described above.

• 4.6. Data/Administrative and Data Management Personnel:

  • 4.6.1. Data/Administrative and Data Management Personnel generallymay handlebe theresponsible for management of data collected during the course of the research.
  • 4.6.2. Data/Administrative and Data Management Personnel may be involved in preparation of IRB applications and requiredin paperworksubmission 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 Lead Coordinator and PI.
  • 4.6.3. Data/Administrative and Data Management Personnel do not have direct subject contact, but may have access to subject's identifiable private information, or protected health information (PHI).