Section IV:

VCU IRB Organization, Composition, and Responsibilities

WPP #: IV-1

Title 1:

Panel System Organization

Effective Date:

8-27-13

Revision History:

06-20-00; 09-20-01; 06-07-04; 04-28-06; 08-27-13

Policy Statement

The VCU IRB system is composed of multiple independent Federalwide Assurance registered panels. Each Panel operates independently but follows the same policies, procedures, and regulations. The Panels are connected through the IRB Leadership and Enhancement Committee (ILEC) and the support of the Office of Research Subject Protection (ORSP) and the Office of Research Integrity and Ethics (ORIE).

Key Points

  • VCU IRB is a single IRB, comprised of four local panels, Western IRB and NCI Central IRB.
  • Each of the four local VCU panels has its own chairperson and operates under the oversight of the Senior Chairperson.
  • All research that is industry sponsored is eligible for review by Western IRB.
  • All research that is sponsored by the NCI Cooperative Groups is eligible for review by the NCI Central IRB

Procedures and Guidance

The VCU IRB is a single IRB, comprised of four Panels, each with its own chairperson. Additionally VCU utilizes the Western IRB (central IRB) and the NCI Central IRB when appropriate. The four local panels operate under the oversight of a Senior Chairperson, who is selected by the Vice President for Research. The Senior Chairperson chairs the IRB Leadership and Enhancement Committee (ILEC) and has a direct line of reporting to the VCU President and VCU Vice President for Research (Institutional Official).

Each panel meets all requirements of a fully functioning and independent IRB. Investigator selection of a specific IRB panel for protocol review is not permitted, however an IRB Chairperson (or the ORSP Director), at his/her discretion, may refer the review of a research project to a specific IRB panel within the institution.

Once a panel has approved a protocol, all additional oversight and actions will typically be performed by that same panel [i.e., continuing review, amendment, and evaluation of reportable events that may represent unanticipated problems involving risks to participants or others. However, should the need arise to reassign a review to another panel the IRB Chairperson (or the ORSP Director) may do so at his/her discretion. Each panel is distinct and functions independently from the other panels. If an issue affects more than one panel (e.g., an investigator with studies open under more than one panel is failing to comply with regulations), each panel addresses the issue pertaining to individual studies separately and reports to the Office of Research Subject Protections. The Director and the Senior Chair will coordinate a comprehensive response which may include referral to ILEC for discussion.

  1. Panel Organization:

    • Panel A (IRB Registration Number IRB00000410)
    • Panel B (IRB Registration Number IRB00000411)
    • Panel C (IRB Registration Number IRB00001127)
    • Panel D (IRB Registration Number IRB00002338)

    VCU IRB Panels A, B, C, and D are registered with the federal Office of Human Research Protections and fully qualified to act on any research project involving human subjects. Panel A, C and D are registered to review studies that are funded by the Food and Drug Administration. All panels make every effort to meet at least once per month and conduct full, expedited, and exempt reviews.

    Western IRB

    Western IRB is an independent central IRB located in Olympia, Washington. Western IRB is registered with the Office of Human Research Protections and fully qualified to act on any research project involving human subjects, regardless of source of funding. VCU has determined that all industry sponsored research is eligible for review by Western IRB. Other non-industry sponsored research may be reviewed by WIRB as appropriate and needed.

    National Cancer Institute Central IRB

    The NCI Central IRB (CIRB) provides centralized IRB oversight for institutions that conduct certain multi-site oncology trials. VCU has formed a relationship with NCI CIRB based on a signed Authorization Agreement and Division of Responsibilities, describing VCU’s reliance on NCI CIRB for IRB oversight of applicable studies.

  2. Evaluation of the Panel System:

    In accordance with the responsibilities outlined within the VCU Terms of Assurance (Federalwide Assurance) and in accordance with VCU IRB WPP II-1, the Vice President for Research will monitor the progress of the IRB as each panel carries they carry out the activities outlined within these written policies and procedures.

References

VCU IRB WPP II-1