Section III:

VCU IRB Relationships

WPP #: III-2

Title 2:

External Relationships (non-VCU): VCU Health System Authority, Other IRBs, and Inspection by Outside Agencies

Effective Date:

12-20-16

Revision History:

06-20-00; 09-20-01; 06-07-04; 12-06-04; 04-28-06; 06-21-06; 02-05-14; 08-06-14

Policy Statement

VCU establishes relationships with external institutions and organizations to provide oversight to research involving human subjects.

Description

  1. VCU Health System

    VCU is an institution of higher education encompassing an academic medical center referred to as VCU Medical Center. VCU Medical Center, along with its inpatient and outpatient clinics, comprise Virginia Commonwealth University Health System Authority (“VCU Health System”), a separate legal entity. VCU Health System is closely linked to its affiliates: MCV Associated Physicians, the Health System’s physician practice plan; Community Memorial Hospital in South Hill, Virginia; Crippled Children’s Hospital on Brook Road; and Virginia Premier Health Plan, Inc. The VCU Health Sciences Schools – Allied Health Professions, Dentistry, Medicine, Nursing, and Pharmacy – utilize VCU Health System facilities to conduct patient care, education, and research. All research sponsorship is awarded to Virginia Commonwealth University. Accordingly, VCU maintains an active Federalwide Assurance (FWA) for the protection of human subjects with the U.S. Department of Health and Human Services. All research oversight responsibility rests with VCU under the leadership of the Vice President for Research and Innovation.

    All human subject research activities are conducted under the auspices of VCU, including all activities utilizing the VCU Health System facilities as research sites. All investigators and research personnel conducting human subject research act as agents of VCU.

    IRB review of all VCU research is conducted by the VCU IRB, unless the Office of Research Subjects Protection and the Institutional Official authorize reliance on an external IRB.

  2. Other IRBs

    Only the VCU Institutional Official (or delegate) may defer the responsibilities of the VCU IRB to another IRB (to act as the IRB of record for studies to be conducted by, or with the assistance of VCU personnel). Likewise, only the VCU Institutional Official (or delegate) may agree for the IRB to function as the IRB of record for another investigator and/or institution if the project involves the material collaboration from VCU personnel.

    1. Western IRB (WIRB):

      WIRB, an independent IRB, is identified on the VCU FWA as a panel relied upon to conduct IRB reviews on behalf of VCU. The current relationship between VCU and the Western IRB is detailed within a written agreement. WIRB is primarily utilized for the review of industry-sponsored human research, but may be utilized for other research at the discretion of the ORSP.

    2. National Cancer Institute Central IRB (NCI CIRB)

      The NCI CIRB pediatric and adult panels are identified on the VCU FWA as panels relied upon to conduct IRB reviews on behalf of VCU. This relationship is detailed within a written authorization agreement. NCI CIRB may be utilized for review of NCI cooperative group research studies.

    3. Hunter Holmes McGuire VA Medical Center (McGuire VAMC)

      When VCU faculty and staff conduct McGuire VA or McGuire Research Institute directed research, and no human research activities are being conducted at VCU, they are acting as agents of the Hunter Holmes McGuire VA Medical Center. As such, they are fully accountable to the McGuire VAMC and McGuire IRB while the study remains open with McGuire IRB. In such situations, the McGuire IRB is the sole IRB reviewing, approving, and overseeing the VA/MRI directed research. This relationship is described in a memorandum of understanding, “Agreement for VCU Faculty and Staff to Function as Agents of Hunter Holmes McGuire VAMC for the Purpose of Conducting VA-Directed Research.”

      When VCU faculty and staff conduct research at both VCU and the McGuire VAMC, the VCU IRB is responsible for reviewing and approving procedures taking place at VCU. The McGuire IRB is responsible for reviewing and approving procedures taking place at the McGuire VAMC.

  3. Inspection by Outside Agencies and Regulatory Agencies

    The Board is subject to regulation by federal oversight agencies, including the FDA and DHHS/OHRP and all other applicable federal, state and local agencies with oversight of any aspect of the research. If access to IRB records is required by any outside agency for inspection, other than the DHHS and FDA, notice must be provided to the Director of the ORSP and permission granted.

References

Agreement for VCU Faculty and Staff to Function as Agents of Hunter Holmes McGuire VAMC for the Purpose of Conducting VA-Directed Research