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MCG Presents Enhanced Oversight Plans to Regents Audit Committee

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Atlanta — October 7, 1997

Prompted by calls from members of the Board of Regents to further outline planned measures to tighten oversight of medical research conducted at the institution, Medical College of Georgia officials today (October 7) expanded its response to an audit of its research control procedures first presented to the board last month.

The Board of Regents Internal Audit Division, guided by an external review team of leading administrators from three nationally recognized research universities, conducted an audit of research-related grants and contracts at the Medical College of Georgia and reported findings and recommendations to the Board of Regents Audit Committee at its September meeting. The audit, requested by University System of Georgia Chancellor Stephen R. Portch, was aimed at identifying potential weaknesses in the grants and contracts controls process at MCG, with particular emphasis placed on clinical trials research. It resulted from board members’ inquiries into the alleged medical research fraud uncovered by institutional officials at last year.

Members of the external review team who participated in the MCG audit included: Mr. Anthony J. Dowgiewicz, director of the Office of Audits and Management Services at Johns Hopkins University; Mr. Michael Barone, director of the Internal Audit Department at Harvard University; and Ms. Nancy L. Wilkinson, assistant vice president for research and director of Sponsored Programs at Emory University.

Medical College of Georgia officials presented a preliminary response to the report at last month’s board meeting, during which they were instructed to further outline newly implemented procedures for tracking industry-sponsored medical research being conducted at the institution. MCG’s response was presented by MCG President Dr. Francis J. Tedesco.

“MCG has been responsive to the need for tighter control measures, and has sought to identify some of the best practices in the field to improve the institution’s operations,” said Dr. Lindsay Desrochers, senior vice chancellor for capital resources with the Board of Regents. “The external review process provided the regents as well as the campus with insight gained from some of the top research programs in the nation, and we are extremely appreciative of the team’s contributions. Now MCG officials are integrating these recommendations into their operations, along with other proactive steps already being taken to ensure the integrity of fiscal controls.”

The external report contained findings and recommendations categorized into three areas of emphasis: Management Oversight of Sponsored Research, Office of Grants and Contract Operations, and Financial Considerations. In all, 10 recommendations for improvement were offered in the report, with high emphasis placed on the need to ensure that all clinical trials and other research projects are adequately monitored. At today’s presentation, MCG officials detailed their formal written response to each of the 10 recommendations and findings included in the audit, many of which currently are being addressed, while others have proposed resolutions with specific deadlines established for completion. Several key concerns are being addressed by MCG’s recently established Office of Clinical Trials Compliance, which was operational as of July 1, 1997.

The responsibilities of the compliance operation were described in detail to the regents, along with a flow chart outlining the academic/research reviews and fiscal cycles through which industry-sponsored grants will be tracked at the institution. Since opening in July, the office has been responsible for monitoring all industry-sponsored clinical studies at the institution, including post-award compliance. Specific responsibilities include auditing budget reports of clinical trials to monitor balances of individual research projects and reviewing clinical trial agreements to assure that the financial and intellectual property interests of the University are protected. The office also is responsible for conducting periodic audits of research records to assure that contractual requirements of the University are being met.

Another key recommendation emphasized the need for closer evaluation of the relationship between MCG and the Medical College of Georgia Research Institute. MCGRI is a separate corporate entity which serves as the fiscal agent through which contracts with MCG researchers and sponsors are executed. Institutional officials have reviewed the Memorandum of Understanding that currently exists between the two entities and recommended improvements that will enhance and clarify that agreement. Approval of that revised agreement will be finalized by October 31, 1997. The audit team also determined that MCG officials should explore alternatives to the database currently employed by the Office of Grants and Contracts, in order to enhance monitoring of projects from inception to closure. A commitment has been made by institutional officials to complete database and information management enhancements currently underway by December 31, 1997.

“Our perspective on this audit is that it provides us with valuable insights that we might not otherwise have sought had it not been for events that occurred earlier this year,” Dr. Tedesco stated. “We are confident that the steps we have taken to improve our research monitoring and fiscal controls will serve this institution well, and we will continually evaluate these measures to insure their integrity and effectiveness.”

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