Frequently Asked Questions
General Information
A conflict of interest (in research) is a situation where an investigator's outside financial interests (e.g., salaries; consulting income; equity interests; honoraria; gifts; loans; or travel payments) or paid or unpaid obligations (e.g., director, officer, partner, consultant or manager of an entity) bias or have the potential to bias a research project.
When the COI concerns and risks have not been sufficiently addressed, the COIOC will determine those financial interests pose a potential conflict of interest and will work with the disclosing individual to develop a management plan before the disclosure can be approved.
A “positive disclosure” or "disclosable financial interest" is when an Investigator is required by State, Federal, and/or IRB policies to disclose their specific financial interests because they surpass the maximum thresholds indicated in the policies. Please note State, Federal, and IRB policies require Investigators to disclose not only their financial interests but also the financial interests of their spouses/registered domestic partners and dependent children. Investigators may be required to submit additional forms to be reviewed by the Conflict of Interest Oversight Committee (COIOC).
The University and the Conflict of Interest Oversight Committee (COIOC) recognize that developing relationships with outside entities (including founding a company) are important and can result in new opportunities that support the University's mission. The COIOC and the COI Team supports these entrepreneurial efforts, relationships with industry, and UCI research by reviewing these financial interests (as required by regulations and policies) and working with researchers to appropriately address the COI concerns raised by these financial interests so that their UCI research can continue.
Not necessarily. Each policy defines what types of financial interests require disclosure and possibly COIOC review. Please refer to the Forms & Policies page for the different thresholds.
In addition, many studies with related disclosable financial interests have sufficient mitigating factors protecting the research from bias that the studies do not require any further action to reduce, eliminate or manage the possible conflict of interest. In such cases, the COIOC will determine there is no harmful conflict of interest and will recommend that the disclosable financial interest be recommended for approval. In cases where there is insufficient mitigating factors, the COIOC may recommend or require additional steps to address the potential conflict of interest before recommending it for approval.
Investigators/researchers who do NOT have financial or management interests in outside entities that surpass the maximum thresholds for themselves, their spouses/registered domestic partners, and their dependent children are still required to report their negative status under State, Federal, and/or UCI policies. This is considered a "negative disclosure." The investigator/researcher does NOT need to submit a COI Addendum and will not need to be reviewed by the COIOC.
You do not need to disclose the following financial interests:
- values below thresholds defined as "significant" or "disclosable" based on which COI policy applies
- income, other remuneration, and reimbursement from the UC Regents
- investments where the Investigator has no direct control over the investment decisions, such as mutual funds and retirement accounts
- income from investment vehicles over which the Investigator has no direct control.
Types of Financial Interests
No, a financial conflict of interest refers to financial interests outside of the current UCI research project. Therefore, if you receive no other forms of compensation, do not hold any equity interests or management positions with the entity in addition to what is included in the research grant, then you submit a negative disclosure by indicating “No” and do NOT need to submit a COI Addendum.
No. The COIOC has reviewed multiple cases over the years where a researcher has financial interest in the sponsor of their study. Please review our Addressing Potential Conflicts of Interest Risks Guidance and we recommend contacting the COI Team, coioc@research.uci.edu, to discuss the details of your plans and help prepare for the pending COIOC review.
Yes, within the allowable limits set by the Academic Personnel Manual (APM). UCOP’s APM-025 and APM-671 set forth the University policy on conflict of commitment and outside activities of faculty members.
With regards to conflict of interest in research, this consulting agreement could result in additional disclosure and conflict of interest review requirements. The COIOC is concerned about the degree of overlap of the consulting activity and UCI research. The consulting activities should be as separate from the research as possible, so that these activities are not seen as an extension of the sponsored research. The COIOC requests submission of the consulting agreement in cases where consulting income exceeds $10,000 per year. Prior to signing consulting agreements with an outside entity, we advise you reach out to the Research Translation Group at Beall Applied Innovation to ensure that there are no clauses in the agreement that conflicts with UCI employment obligations. For more information, visit the Outside Consulting section.
Yes, the UCI's conflict of interest policy does not prohibit investigators/researchers from engaging in these types of outside activities but it could result in additional disclosure requirements and reviews.
However, each different type of relationship or activity comes with a different set of disclosure and review requirements from multiple compliance areas, including conflict of interest in research, conflict of commitment, etc. To make an informed decision, we recommend you review the Startup Guide and contact the COI Team at coioc@research.uci.edu to discuss your unique opportunity.
Most likely but with some restrictions to address COI concerns. We highly recommend you consult the Conflict of Interest Administrator.
Please note that the Principal Investigator for the small business and the Principal Investigator for the UCI subcontract must be different individuals to avoid an inherent conflict of interest. Researchers should only be involved in either the small business portion of the project or the UCI subaward not both.
Your financial interests in the company will likely need to be reviewed by the COIOC. Please see here for additional guidance on SBIR/STTR grants.
Special concerns arise when human subjects are involved, as the subjects may be placed at additional risk because of an investigator’s financial interests. If the investigator is conducting an industry sponsored clinical trial and has any financial interest in the sponsor, the Committee would consider the following:
- The investigator’s role in the project (especially, with regards to data collection, analysis and reporting)
- Whether the investigator is involved in recruiting or consenting human subjects.
- The structure of the clinical study – whether it is a single-site, investigator-initiated study or a multi center study with other oversight mechanisms.
- The size of the industry sponsor.
- The diversity of the industry sponsor’s products portfolio.
Disclosures
The California disclosure (Statement of Economic Interests- Form 700U) is filed:
- at the proposal submission stage;
- when additional funding is requested.
- when a research gift is earmarked for a specific individual or a specific research project
National Science Foundation requires disclosure (KR COI Annual Disclosure):
- at the time of proposal submission;
- new investigators are added to the project; and
- when the investigator's financial interests change.
Public Health Service and Department of Energy (starting June 18, 2022) require disclosure (KR COI Annual Disclosure) for the duration of the award:
- at the time of proposal submission;
- annually with non-competing continuation funding;
- at renewals;
- at no-cost time extensions;
- when new investigators are added to the project; and
- when the investigator's financial interests change.
The IRB policy requires disclosure (Application for IRB Review):
- when submitting the KR Protocols Application;
- when changing the Lead Researcher or adding Co-Researchers or other research personnel; and
- with any change in the financial interest.
Non-governmental Sponsors, excluding the entities listed here:
- State of California law requires the principal and co-principal investigators to disclose the financial or management interests in the non-governmental sponsor of a research project for themselves, their spouses/registered domestic partners and their dependent children.
PHS (including NIH), Department of Energy (starting June 18, 2022), NSF, and several non-governmental agencies adopting the federal requirements:
- Investigators: All individuals with responsibility for the purpose (DOE only), design, conduct or reporting of the research must disclose the “significant” and “related” financial or management interests to the research described in the proposal for themselves, their spouses/registered domestic partners, and their dependent children.
Human Subjects:
- All individuals listed on protocol are required to disclose the financial or management interests of themselves, their spouses/registered domestic partners and their dependent children if the research involves human subjects.
Research Gifts:
- California policy requires recipients of research gifts earmarked for a specific individual or a specific research project to disclose the financial or management interests in the non-governmental donor for themselves, their spouses/registered domestic partners, and their dependent children.
- Compromise of Scientific Integrity
- Misuse of University Facilities
- Improper Direction of Student's or University Employee's Work
- Unbalanced Allocation of Faculty Member's Time and Effort
- Failure to Recognize the University's Intellectual Property and Related Financial Interests
- Improper Channeling of Research Funds
- Inappropriate Delay or Restriction on Publications
- Appearance of Impropriety
For more information, please visit Addressing Potential COI Risks.
Review and Management of a Conflict of Interest
The Conflict of Interest Oversight Committee (COIOC) consists of faculty from the campus and the UCI Medical Center and is advisory to the Vice Chancellor for Research (VCR). The COIOC considers a number of factors to determine the seriousness of the conflict, and whether and how the conflict can be managed. There are also ex oficio members from Office of Research, Academic Personnel, Beall Applied Innovation, Office of Equal Opportunity and Diversity, and Health Sciences- Academic Affairs and Compliance.
The COIOC meets once a month and is supported by Office of Research staff who work with the Committee and investigators to ensure proper compliance.
Review times largely depend on how long it takes for a researcher to respond to a request for a COI disclosure form or question.
At a minimum, full committee reviews take about a month since the COIOC meets once a month. Disclosures that qualify for administrative review and expedited review usually take less than two days after we have received all the necessary documents.
The COIOC advises the Vice Chancellor for Research (VCR) whether a disclosure can be approved or needs additional management. Sometimes the COIOC recommends that certain actions be taken to manage the conflict of interest in order to preserve objectivity in the design, conduct or reporting of research by creating a management plan because the existing mitigating factors do not address all of the COI concerns.
The investigator will receive an approval memo via email from the COI Team. If the award or research project is approved with conditions by which to manage the potential conflict of interest, they will be noted in the memo from the COI Staff. The approval email will also briefly highlight the main mitigating factors on which the COIOC based their approval recommendation. This approval email will also be sent to the Disclosing Individual's department chair, PI/LR (if not the Disclosing Individual), and COI Point Person/COI Liaison to promote transparency.