Conflict of Interest Office Helps Balance Innovation, Disclosure
Paul K. Mueller | June 6, 2011
Valerie Dixon, director of UC San Diego's Conflict of Interest Office
“Conflict of interest,” says Valerie Dixon, director of the university’s Conflict of Interest Office, correcting a common misconception, “is not a statement of wrongdoing.”
Rather, she says, the term refers to situations in which financial or other considerations may compromise — or have the appearance of compromising — an employee’s professional judgment. And that applies to administration, management, teaching, and other professional activities, not just research.
Her office helps identify potentially inappropriate conflicts, and finds ways to eliminate, reduce or otherwise manage those conflicts. “We balance the desire to encourage innovation through research and commercialization with the emerging best practices in disclosure, assessment and management of conflicts,” she says.
Dixon must know what she’s talking about, because her office, part of the Office of Research Affairs under the Vice Chancellor for Research, is considered so effective that it’s become a model for managing conflict-of-interest issues for the entire University of California system.
The Conflict of Interest Office (COI) is a central resource for faculty, administrators and staff, and serves the general campus, Scripps Institution of Oceanography, the Medical Center, and the Veterans Affairs facilities associated with the campus. The office “assists employees in assessing circumstances under which their outside activities or interests may inappropriately conflict with their responsibilities to the university.”
Research activities subject to conflict-of-interest disclosure include both sponsored research and other research-related activities. Sponsored research may be federal, such as NSF and NIH awards and sub-awards, or non-governmental, such as gifts, research agreements, or clinical-trial agreements. Research-related activities might include lab-service agreements, incoming purchase orders, or material-transfer agreements.
Dixon and her staff do not assess conflict-of-interest situations on their own. A campus Independent Review Committee (IRC) for conflict-of-interest issues, required by state law, is composed of full-time tenured faculty members from all areas of campus, and representatives from the Office of Research Affairs and the Technology Transfer Office.
“Collaboration of academic researchers and educators with entrepreneurial ventures and industries helps discoveries improve lives and boost economic growth,” Dixon says. “But those ties also bring increased risk of potential or actual conflict between individuals and the public interest that federal investments should serve. The IRC works to mitigate those risks, and eliminate or manage any conflicts.”
To help do so, the committee ensures public disclosure of significant financial interests; uses independent reviewers to monitor research; modifies research plans as needed; disqualifies researchers from participation if necessary; ensures divestiture of financial interests if appropriate; or severs relationships that create potential or actual conflicts.
Some of the areas where scrutiny is common include faculty start-ups, subcontracts, human-subject research, and consulting activities — and life is going to get tougher for universities and their conflict-on-interest offices, Dixon says.
The National Institutes of Health — one of the principal sources of funding for UC San Diego and other research universities — have proposed new rules that require that all financial interests related to institutional responsibilities must be disclosed and assessed. The proposal would also require electronic reporting of both conflicts of interest and conflicts of commitment by universities.
“No UC campus currently has an integrated electronic COI and COC reporting solution,” says Dixon, who adds that upcoming challenge to others that her office faces — most notably overlapping and inconsistent disclosure mechanisms from different parts of campus. “Processes are redundant and laborious right now,” she says, “but we’re engaged in a robust evaluation of those processes that should lead to an agile, convenient system that collects all relevant information, shares that information as needed, and issues all required reports.”
The technological tool that Dixon and her colleagues are counting on — and which other UC campuses may adopt — is the Kuali-Coeus COI eSolution. Affordable and highly configurable, the module was designed by UC San Diego staff to be quickly compatible and to reduce administrative burdens for faculty and staff across the campus. IT specialists in the Office of Research Affairs are fine-tuning the high-tech tool right now.
Looking ahead, Dixon sees self-regulation of university-industry relationships threatened by increasing government regulations and oversight — all of which add complexity and un-funded costs to university projects.
“To try to stay ahead of the process, we’re asking ourselves some tough questions,” she says. “How do we implement an integrated system to capture information, disseminate it as required, and monitor compliance? How can we reduce the administrative burden on researchers? Do all participants in the research enterprise understand their obligations? How do we secure adequate resources to implement best practices?”
It’s not surprising that the questions are tough, she says, because competently managing conflict-of-interest issues is vitally important to the university’s missions of education, outreach and research.