Section IX:

Principal Investigator Requirements

WPP #: IX-1

Title 1:

Principal Investigator Eligibility and Statement of Responsibilities

Effective Date:

09-24-14

Revision History:

06-07-04; 09-30-05; 04-28-06; 06-21-06; 12-01-07; 01-15-08; 1-1-12, 10-1-13; 10-22-13

Policy Statement

Permanent, full time or part-time employees of Virginia Commonwealth University or the Virginia Commonwealth University Health System Authority and non-employees holding a VCU faculty appointment may serve as principal investigator on a human research protocol. Human research conducted by student investigators must designate a non-student who meets the above criteria as principal investigator. Principal investigators are ultimately responsible for the conduct of the study and for protecting the rights and welfare of research subjects.

Description

  1. Principal Investigator Eligibility:

    By definition, the principal investigator of a human research protocol is the individual with ultimate responsibility for the conduct of the activities described in the protocol and for protecting the rights and welfare of human participants involved in the research. The principal investigator must be available to devote adequate time and attention to the study to ensure its responsible conduct. In light of these responsibilities, the VCU IRB requires that the individual holding the title of principal investigator for a human research protocol be:

    1. a permanent, full-time or part-time employee of Virginia Commonwealth University or the Virginia Commonwealth University Health System Authority; OR
    2. a non-employee with a VCU faculty appointment who will conduct research within the scope of his/her appointment and provides the following to the IRB:
      1. a copy of the appointment letter and
      2. the PI Eligibility Request form completed and signed by both the appropriate Department Chair and Dean.

    For clarity, those ineligible to serve as PI include:

    • employees who are also students and are submitting their student projects
    • undergraduate and graduate students
    • post-doctoral students
    • fellows, residents
    • house staff
    • hourly and PRN staff
    • volunteers

    The VCU IRB recognizes that a key component in the educational mission of VCU includes research experience for all students. While students/trainees may not serve as principal investigators on human subject research protocols, they are encouraged to submit to the VCU IRB with qualified faculty or staff supervision. The supervisory faculty or staff must be clearly identified as the principal investigator on any VCU IRB submission and agree to keep the student informed about all decisions/actions of the IRB. The ORSP will also assist students with information regarding the actions of the IRB pertaining to a research protocol (if they are identified on the application).

  2. PI Signed Statement of Responsibilities:

    The Principal Investigator, as part of the application process, must agree to follow and abide by all policies and procedures, as well as by all federal, state and local laws concerning the protection of human subjects in research, including but not limited to:

    • Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
    • Conducting the research as described in and required by the Research Plan.
    • Implementing no changes in an expedited or full board approved research plan or approved documents without prior approval of the Institutional Review Board (IRB), unless such changes are necessary to project the safety of human participants.
    • Conducting the research using only the qualified and trained personnel only, and ensuring that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials and, when relevant, privileges) to perform procedures assigned to them during the study.
    • Obtaining informed consent from all subjects without coercion or undue influence, and provide the potential subject sufficient opportunity to consider whether or not to participate (unless Waiver of Consent is specifically approved or research is exempt).
    • Submitting a timely continuing report as requested by the IRB (unless research is exempt).
    • Notifying the IRB of any unanticipated problems involving risks to participants or others within 5 business days.
    • Promptly reporting and/or respond to all inquiries by the VCU IRB concerning the conduct of the approved research when so requested..Immediately notifying the IRB upon termination of the study or prior to the departure of the Principal Investigator from this Institution. Determine which personnel are COI investigators and designate in the personnel section of the smartform RAMS-IRB.
    • The Principal Investigator assumes full responsibility for the conduct of the study and for the protection of the rights and welfare of human subjects involved in the research. The PI is ultimately responsible for all activities related to the research protocol including the quality and timeliness of submission to the VCU IRB.
  3. Department Chair/Division Head Responsibilities:

    The Department/Division Chairperson or other appropriate supervising administrator is responsible for ensuring compliance with IRB requirements should the PI depart VCU and is required to maintain all research-related documents upon departure of the PI, if departure is less than six years since the completion of the research project or longer if applicable.

Responsibility

It is the responsibility of the investigator to determine if he or she is eligible to serve as the principal investigator for the VCU IRB and to represent themselves as PI only in accordance with this policy. When a PI departs the university, the Department/Division Chair assumes responsibility for study conduct and record keeping, unless a change in PI has been previously approved by the IRB.

References

None listed