OHRP lifts restrictions on human subjects research at VCU

By Melissa Jones

RICHMOND, Va. – The federal Office for Human Research Protections has lifted its restrictions on human subjects research at Virginia Commonwealth University.

In a letter dated Dec. 15 from OHRP, formerly the Office for Protection from Research Risks (OPRR), university officials learned that OHRP has closed its compliance evaluation of the university’s human-subject research. As a result, the university is no longer required to submit quarterly progress reports to OHRP.

Michael A. Carome, M.D., director of the Division of Compliance Oversight at OHRP, credited VCU President Eugene P. Trani, Ph.D., and Roy Pickens, Ph.D., associate vice president for research, for their leadership in VCU’s "markedly enhanced research system."

"VCU’s research program is stronger than ever," said Dr. Trani, who established and guided an IRB Task Force to oversee the re-building of the university’s IRB system. "VCU administrators, faculty and staff have worked efficiently and effectively to meet our research goals, and we are very proud of the outcome."

Pickens and Lisa Ballance, administrative director of the VCU Clinical Trials Institute, have led VCU’s effort to respond to OHRP concerns over the university’s Institutional Review Board system and to re-build the university’s system for human subjects research.

Carome also credited VCU for its:

• efforts regarding a multifaceted, ongoing education program for research investigators as well as IRB members and staff;

• expanded number of IRB panels, from one to three;

• expanded professional and administrative staff that support the VCU IRBs; and

• improved minutes of IRB meetings that "now clearly document high-quality, detailed and substantive reviews of research protocols that reflect the IRBs’ understanding of important ethical issues and regulatory requirements related to the protection of human subjects."

OHRP’s action fully restores VCU’s Multiple Project Assurance, which is the formal, binding agreement in which an institution promises to comply with applicable regulations governing research with human subjects. Approval of the MPA, which is granted by OHRP, is necessary for an institution’s investigators to conduct research with human subjects.

"I am pleased that OHRP has lifted its restrictions less than a year after they were initially imposed. The process took less time than we had estimated and that is evidence of the tremendous research team we have at VCU, " said Dr. Trani. "Now we will continue to move forward with our mission. Under the leadership of Marsha Torr, Ph.D., our vice president for research, and with the strength of our faculty, we are poised to secure new research funding and focus on the important scientific work for which we are known."

On Jan. 11, OPRR suspended all human-subjects research at VCU in response to administrative deficiencies with the university’s IRB, 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, directing that all previously approved protocols be re-reviewed by the Western IRB before investigators could resume research projects involving human subjects. In the following months, VCU was permitted to establish two additional VCU-based IRB panels.

To date, approximately 1,100 clinical research protocols have been approved after either a re-review or an initial review. Only about 100 protocols remain in the re-review queue.

VCU is a Carnegie Research-Extensive University, the top category for U.S. research universities. VCU ranks among the top 100 universities in sponsored research, with more than $120 million in annual funding.