OPRR approves establishment of VCU-based IRB panel

By Erin Lucero
Office of Development, School of Medicine

RICHMOND, Va. — On June 1, the federal Office for Protection from Research Risks (OPRR) approved Virginia Commonwealth University’s plan for establishing its own university-based panel to review new and previously approved research studies involving human subjects. The new Institutional Review Board (IRB) panel is on schedule to review its first protocols as early as the end of June. It will review studies in addition to those being reviewed by Western IRB, an independent review board based in Olympia, Wash., that has reviewed VCU studies since January.

Working separately, Western IRB and the new VCU-based review panel will have responsibility for re-reviewing previously approved studies and approving or disapproving proposed studies involving human subjects at VCU. The addition of the VCU-based panel is expected to accelerate the review rate of VCU protocols.

"I am proud of VCU’s response to OPRR’s concerns," said Dr. Eugene P. Trani, president of VCU. "We’ve made good progress in creating the administrative infrastructure to assist us in reaching our goals, and that progress is reflected in OPRR’s approval of our first university-based panel."

Since January, VCU’s IRB Task Force has overseen a number of initiatives, including the submission of VCU’s initial Quarterly Progress Report to OPRR. A new executive chairman of VCU’s IRB system has been named as well as a new chairman of the first IRB panel. VCU also has implemented an education and training program for IRB members as well as all investigators involved in human subjects research.

VCU’s IRB Task Force will continue to oversee the re-building of a VCU-based IRB system. Current plans call for four VCU-based IRB panels in addition to VCU’s current Exempt Research Committee, which determines whether studies are exempt from review by an IRB panel.

On Jan. 11, OPRR suspended all human subjects research at VCU in response to administrative deficiencies with the university’s Institutional Review Board, which monitors all research involving human subjects. OPRR did not identify any cases in which research study participants were harmed.

On Jan. 31, OPRR lifted the suspension on VCU human subjects research and approved Western IRB as the university’s board of record. OPRR also directed that all previously approved protocols be re-reviewed by the Western IRB before investigators could resume research projects involving human subjects. To date, Western IRB has approved 325 VCU research protocols.