The University and the Medical Center are planning several changes to bring the campus Institutional Review Board and the five medical center IRBs into closer collaboration.
Currently, Duke has two IRB systems, which are responsible for reviewing any research conducted on human subjects for its scientific merit and ethical validity. Both systems solely review the proposals conducted within their geographical jurisdiction, although each system has varying expertise--the campus IRB specializes in non-clinical research primarily consisting of behavioral and social science investigations, while the medical center IRBs concentrate on clinical studies.
The new synergy will allow all behavioral and social science research from both the University and the Medical Center to be cleared through the campus IRB and all clinical research to pass through the medical center IRBs.
"[This is] so we use the expertise of the University efficiently," said Linda George, chair of the campus IRB and a professor of sociology. She added that the primary motivating factor for the coordination was to take better advantage of each system's resources.
George said this restructuring has been her goal since she assumed her position five years ago.
Officials in the medical center emphasized the introduction of efficiency-increasing software as the main motivation for the cooperation.
The medical center received a government grant for software that would permit the electronic submission of protocols and would expedite the review process by greatly increasing the speed of information interchange.
Dr. John Falletta, chair of the principal IRB in the medical center, said the move also promises a more balanced workload between the campus and the medical center.
Early discussions of this coalition--which both chairs emphasize is not a merger--addressed campus concerns that its IRB would lose its autonomy by being overwhelmed by the much-larger medical center system IRB.
One of the primary issues stems from a 1999 incident in which clinical research involving humans at the medical center was halted for five days because it was ill-managed. The Office of Human Research Protection found that DUMC needed to upgrade its method of record-keeping and documentation of reviews.
"OHRP was probably right," said Dr. Ross McKinney, vice-dean of research for the School of Medicine. "We weren't giving adequate attention to any one study."
As a result of this research stoppage, four new IRBs were established and the IRB budget expanded from $200,000 to over $1.5 million, McKinney said.
During this incident, the campus IRB was not at all affected because of its autonomous status, and some campus officials worry that losing autonomy would remove the buffer that protected non-clinical research from being affected.
"A lot of people say, 'What if it happens to the Medical Center again?'" said George, who personally does not foresee a clinical research stoppage occurring at Duke again.
McKinney said that the new association should not pose a threat to the campus IRB. "We've been trying to make sure they understand that we respect their need for autonomy," said McKinney, who is also an associate professor of pediatrics. "[We have] no intention of making them dysfunctional."
The new arrangements will likely increase the workload of the campus IRB as all the medical center's non-clinical cases will be sent to it, but it is still unclear exactly how many protocols this will affect.
McKinney said the collaboration was just a matter of time and would certainty be implemented by spring 2004, when a new federal accreditation organization surveys Duke's IRB capabilities as part of a standard review.
Officials are optimistic about the changes. "It should make it easier for everyone, frankly," George said. "It's just an administrative change."
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