Outside financial interests are not necessarily conflicts of interests in research. The University recognizes that outside financial interests can facilitate opportunities for innovation, collaboration, and support. Federal, state, and university regulations and policies requiring financial disclosure and review were implemented to address those instances when the outside financial interests may bias or appear to bias the research. In addition to promoting transparency and accountability, financial disclosures also protect the researcher’s interests by (1) meeting the requirements set by sponsors and the University; (2) having the COIOC, an objective third party, review the financial interests and the research; and (3) demonstrating a commitment to scientific integrity.
The Conflict of Interest Oversight Committee (COIOC), a committee comprised of faculty members, works with researchers to minimize the potential bias or appearance of bias, protect the researcher and the University’s interests through the disclosure and review process, and support research. The COIOC’s goal is to help researchers successfully conduct their work while remaining compliant with the conflict of interest policies and regulations. The COIOC meets once a month and is supported by staff who work with the Committee and investigators to ensure proper compliance.
As new opportunities arise and relationships with outside entities become more complex, the COIOC strives to continue providing guidance ad recommendations to facilitate research at the University.
The Conflict of Interest Oversight Committee (COIOC) serves the campus community by reviewing disclosures of financial interest related to research. The COIOC is charged with ensuring that a researcher's personal interest in, or commitment to, entities outside the University's purview does not compromise or appear to compromise his/her objectivity in performing a research project, in mentoring students involved in a research project, or in reporting the results of a research project conducted under the aegis of the University of California.
In assessing research projects for potential conflicts of interest, the COIOC is guided by policies established by the State of California, the Public Health Service (PHS), the National Science Foundation (NSF), and UCI related to conflicts of interest in human subjects research. The COIOC operates within a University policy that seeks to achieve a balance between industry/university collaborations and obligations to maintain the public trust. The COIOC reviews research projects sponsored by PHS, NSF, private industry/business and other non-governmental agencies, as well as projects sponsored by the UC Discovery Grant and human subjects research referred by UCI's Institutional Review Board (IRB).
The COIOC is not a punitive body. Its purpose is to protect the integrity of the research related to outside interests such as industry/university partnerships, personal investments, or consulting. The COIOC’s recommendations guide the Vice Chancellor for Research's decisions regarding the acceptability of gifts, contracts, or grants funded by PHS, NSF, or non-governmental sponsors.
Factors for Evaluating Conflict of Interest
Once a financial or managerial interest has been disclosed, the Oversight Committee considers a number of factors to determine the seriousness of the conflict, and whether and how the conflict can be managed. Examples of factors that may be seen to increase the severity of the conflict include the following.
1. Restrictions on Dissemination:
Limitations on publication or presentation of research results are excessive. Restrictions are overly broad or provide for delays that exceed the short periods specified under current University policy.
2. Student Involvement:
Students are inappropriately involved in research activities or are provided additional financial support from the sponsor. Students are required to sign confidentiality agreements. Students are bound by publication and/or presentation restrictions, especially those that exceed the University standard.
3. Separation of Interests:
Investigator holds a significant management, equity or advisory position, which might allow undue influence on Sponsor's research decision-making process, including funding of the investigator. Investigator is testing her/his own invention.
4. Past and Current Research Funding:
Investigator has limited or no other source of research funding. Investigator has previously received substantial awards from the sponsor. Sponsor's component of investigator's salary is disproportional to time commitments.
5. Research and/or Development Facilities:
Amount of research conducted for the Sponsor at the University is high in comparison to the Sponsor's total research effort. Sponsoring entity lacks facilities to pursue independently its research and development objectives. Mechanisms for separating the sponsored research from other activities within University facilities are not well defined. Provisions for recovery of direct and indirect costs in the use of University facilities are inadequate or are not clearly defined.
6. Clinical Trials:
Clinical trial is single-site as opposed to multi-center; lacks well developed blind, randomized or prospective protocols.
7. Educational Impact:
Commitment of faculty time is substantial and may impact availability for teaching, educational and other scholarly activities. Potential exists for an imbalance in overall time commitment to the missions/goals of the University.