Section IX:

Principal Investigator Requirements

WPP #: IX-3

Title 3:

Personnel Qualifications

Effective Date:

07-30-14

Revision History:

10-1-13; 10-22-13

Policy Statement

All research personnel involved in the conduct of human subject research must be qualified by training, experience and be current in IRB required research subject protection training. Personnel involved in clinical research must be appropriately licensed and credentialed. Students and trainees engaged in the conduct of research as learning activities must receive adequate oversight to ensure responsible conduct and research subject protection.

Description

  1. Principal Investigator:

    Principal Investigators (PI) must be appropriately qualified by education, training, experience, and background and eligibility to competently manage research in accordance with procedures outlined in the protocol. See WPP IX-1: Principal Investigator Eligibility and Statement of Responsibilities for further information.

  2. Medically Responsible Investigator:

    If research procedures involve clinical elements and the PI is not qualified in the appropriate clinical area, does not hold an applicable license, or does not have privileges to practice where the research will occur, a licensed and institutionally credentialed clinician appropriately qualified by education, training, experience, and background and appropriate privileges must be designated as the Medically Responsible Investigator. The Medically Responsible Investigator must manage or delegate (see C below) all clinical elements of the research such as physical examinations, conducting any drug administrations, follow-up examinations, evaluating lab values, test results and reviewing all adverse events. Clinical elements of a study are considered any event, procedure, test or intervention that would require performance by a licensed/credentialed professional in a non-research setting.

  3. Sub-Investigators and Other Personnel:

    The Principal Investigator or the Medically Responsible Investigator (if required for the study) is responsible for ensuring that all personnel engaged in conducting human research are adequately qualified and are provided with appropriate oversight to perform study responsibilities. When personnel will conduct clinical elements, the PI or Medically Responsible Investigator is responsible for ensuring personnel hold appropriate, current credentials. It is advised that the VCUHS credentialing system be utilized to verify credentials and privileges for VCU/VCUHS employees. For non-VCU employees performing clinical elements outside VCU/VCUHS facilities verification can include but is not limited to, checking current license, certifications, or credentialing through other organizations. For FDA regulated research, all personnel engaged in the research should have active (non-disbarred) status with the FDA.

  4. Department/Division Chairperson or Dean Verification:

    The Principal Investigator’s Department Chairperson, Division Chairperson or Dean or their respective designee must sign off on each new expedited or full board study submission to the VCU IRB to verify: 1) the PI is appropriately eligible and qualified to serve as a principal investigator; 2) adequate personnel including a Medically Responsible Investigator if required are included in the study 3) adequate resources are available for the conduct of the study; and 4) the proposed research has scholarly or scientific merit, ensuring study design is sufficient for answering the research questions; statistical power and sample size (if applicable) are adequate; literature review is current; and research questions, goals, or hypotheses are relevant. Departmental reviewers may return a submission to an investigator for revision for any reason. This sign-off occurs electronically and is documented in the history of the electronic submission system.

Procedures

  1. Verifying Principal Investigator and Medically Responsible Investigator Eligibility

    1. For Principal / Medically Responsible Investigators engaged in clinical research:
      1. IRB staff will verify that VCU / VCUHS investigators have been credentialed through the VCUHS credentialing system and, if applicable, are not debarred from conducting FDA regulated research.
      2. IRB staff will verify that the Principal Investigator and Medically Responsible Investigator (as applicable) have submitted curriculum vitae for review by the IRB.
    2. Principal Investigators Engaged in Non-Clinical Research:
      1. IRB staff will verify that the principal investigator has submitted a curriculum vitae for review by the IRB.
  2. IRB Review of Investigator Qualifications

    The IRB is responsible for assessing the investigator’s training and experience specifically related to the proposed research. This determination may include a review of the investigator’s previous research experience as demonstrated by recent presentations or publications, and prior clinical experience with a test article or study-related procedures.

References

FDA Guidance for Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
WPP IX-1: Principal Investigator Eligibility and Statement of Responsibilities for further information