VCU officials work around the clock to reinstate research

By Melissa Jones

Virginia Commonwealth University is working to reverse a federal mandate suspending research involving human subjects. VCU officials have made the issue a top priority.

The suspension was in response to administrative deficiencies with the university’s Institutional Review Board and was not due to improper care of research participants or the exposure of subjects to a specific risk.

As part of the effort to reverse the suspension, VCU President Eugene P. Trani, Ph.D., is serving as the signatory official for all of VCU’s IRB activities. In addition, Roy Pickens, Ph.D., associate vice president for research, has assumed administrative responsibility for VCU’s IRB and will work with the federal Office for Protection from Research Risks (OPRR) to reinstate the university’s Multiple Projects Assurance, which was suspended by the OPRR on Jan. 11. An IRB Task Force has been formed to determine immediate actions as well as develop a long-term plan for addressing the issues concerning the university’s IRB. The Task Force is made up of senior university administrators and researchers and chaired by Dr. Trani.

"Throughout this process, the primary goals of the university have been to notify investigators of the status of the university’s initiatives to resolve the issue and to ensure the protection of protocol subjects," said Dr. Trani.

"The Task Force has taken this issue and is working to do whatever it requires to reach a resolution as quickly as possible."

The Task Force will meet every two days until the situation is resolved. The Task Force’s immediate priorities are to secure approval by the OPRR for the revised MPA as well as the university’s plan for education and training for IRB members and university investigators. The MPA is the formal, written, binding agreement that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects. Approval of the MPA, which is granted by the OPRR, is necessary before investigators at an institution can conduct research with human subjects.

The university’s plan for education and training will involve re-training the VCU IRB with expanded facilities and technical support and implementing a required educational program in regulatory issues and IRB procedures for all faculty. Successful completion of training will be required before investigators can submit new grant applications to the IRB.

The university’s actions are in response to mandates from the OPRR and the U.S. Food and Drug Administration. Both organizations are part of the U.S. Department of Health and Human Services. The FDA required VCU to revise its IRB policies and procedures and to hire an outside IRB to review protocols involving human subjects until the matter is resolved.

The OPRR suspended VCU’s MPA, which effectively suspends enrollment of all new human subjects in VCU research protocols, including federally or non-federally funded projects as well as non-funded projects. Currently, there are about 1,500 protocols involving human subjects approved at the university. Protocols involving previously enrolled subjects may continue only if it can be shown to be in the best interest of the individual subjects. This suspension will be in effect until the protocols can be re-reviewed by an OPRR-approved independent IRB to be hired by the university.

The OPRR cited administrative deficiencies in the functioning of the university's IRB, which monitors all research involving human subjects. Based on a review of VCU reports submitted to the OPRR, the committee found and cited the following concerns regarding VCU's review process as contributors to the temporary suspension: changes in the IRB membership were not promptly reported to the OPRR; IRB procedures for conducting continuing review do not appear to comply with the OPRR requirements; and lack of documentation of continuing review of any research protocol in the IRB meeting minutes prior to September 1999.

"We take the concerns very seriously, and are modifying all of our procedures and reporting mechanisms to be in complete compliance with all federal, state and local regulations," Dr. Trani said. "We are working closely with both organizations to ensure that their issues are addressed completely and expeditiously."