Conflict of Interest (in Research) Frequently Asked Questions
A conflict of interest 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 a financial interest constitutes a financial conflict of interest, the COIOC 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).
Not necessarily. First, the threshold for reporting excludes financial interests that are of such minimal value that they do not meet the definition of disclosable financial interests. Please refer to the Disclosure Chart for the different thresholds.
Second, some disclosable interests are so minimal or have sufficient mitigating factors protecting the research from bias that they 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 research support be accepted with no further action.
Finally, almost all disclosed financial interests and any potential resulting harmful conflict of interest can be either reduced, eliminated or managed so that the research support can be accepted. To date, there have been very few exceptions to this. The exceptions represent very unusual and complex situations in which the disclosing individuals played multiple roles.
Investigators 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 does NOT need to submit an Addendum.
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 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 an Addendum.
No. However, any positive financial interests should be disclosed and reviewed.
The first principle is the avoidance of situations in which investigators may have the opportunity to influence the design, conduct or reporting of the research in ways that could lead to personal financial gain or give advantage to the outside entity in which they have a financial interest. Other important principles include appropriateness of the research, open research and teaching environment and freedom to publish. For more details on the UC guidelines, please see UCOP APM - 028: Guidelines for Disclosure and Review of Financial Interest in Private Sponsors of Research.
Yes, within the allowable limits set by the Academic Personnel Manual (APM). UCOP’s APM-025 sets forth the University policy on conflict of commitment and outside activities of faculty members.
A limited amount of consulting is permitted. The COIOC is concerned about the degree of overlap of the consulting activity and proposed 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. The COIOC may review the consulting agreements to check for any language that makes the consulting income contingent on the outcome of the research. Prior to signing consulting agreements with an outside entity, we would advise that you reach out to Dave Gibbons at UCI’s Applied Innovation office to ensure that there are no clauses in the agreement that conflicts with UCI employment obligations.
Certain activities such as assuming an executive or managerial position in an outside entity or establishing a relationship as a salaried employee outside the University will likely raise conflict of commitment issues and is generally not allowed without the Chancellor or Chancellor's designee's written approval.
In regards to the equity interest, the Committee is interested in the value of the stock or stock options. The more significant the equity is financially, or the more likely the research may benefit the company (and thus the equity, particularly in the case of stock options), the greater the risk of compromising the research objectivity. The Committee would also consider the size of the outside entity (outstanding share of stock) in which the equity interest is held, whether it is a publicly traded or a privately held start up company, and the diversity of the company’s interests. Usually, the larger the company and the lower the relative investigator equity, there is less concern that the investigator would be in a position to affect the stock value. Similarly, a larger and more successful company with diverse products would diminish concerns for the influence of one research project at UCI.
Yes, the UCI's conflict of interest policy does not prohibit investigators from starting their own company.
However, where such outside activities are related to the investigator's research, the investigator must report his or her interests to the COIOC. As a founder, it is assumed that the investigator has both an intellectual and financial commitment to the outside entity; however, the investigator’s primary commitment is to the University and his/her commitment should not conflict with that obligation. Per the Conflict of Commitment policy, the investigator would need to request prior approval from the University before serving in a management capacity for the outside entity while a University employee.
If the COIOC determines that these interests may conflict with the research, the Committee will require the investigator to take steps to manage, reduce or eliminate the conflict before the research can proceed. Investigators who are contemplating starting a new company can contact the Conflict of Interest Office to discuss possible conflict of interest issues. Please see here for UCI’s Start Up Guide.
Yes, the UCI's conflict of interest policy does not prohibit investigators from serving on a board of directors. Service on a board of directors carries with it legal fiduciary responsibility but generally not management responsibility and hence, is generally permissible. However, the investigator’s primary commitment is to the University and service on a board of directors should not interfere with their primary obligations as a faculty member or university employee. The investigator must avoid any conflict of commitment between their university responsibilities and their relationship with the outside entity.
However, where such outside activities are related to the investigator's research, the investigator must report their interests to the COIOC. If the COIOC determines that these interests may conflict with the research, the Committee will require the investigator to take steps to manage, reduce or eliminate the conflict before the research can proceed. Investigators who are contemplating serving on a board can contact the Conflict of Interest Office to discuss possible conflict of interest issues.
It depends, so we highly recommend you consult the Conflict of Interest Administrator. If you would like to receive a subcontract from the company as part of the SBIR/STTR grant, please keep in mind that the Principal Investigator for the small business and the Principal Investigator for the UCI subcontract must be different individuals. In addition, your financial interests in the company will likely need to be reviewed by the COIOC. If you would like to conduct research as part of the company's SBIR/STTR prime award, there may be conflict of commitment concerns in addition to conflict of interest. Please see here for additional guidance on SBIR/STTR grants.
The Committee has serious reservations about investigators conducting early phase clinical trials testing technologies that they have invented. When investigators have wanted to conduct later phase trials using technologies they have invested, the Committee will ask whether the investigator has access to the human subjects or study data. It is recommended that recruitment and enrollment of human subjects and any data collection or analysis be done by other investigators who have no financial conflict of interest.
Yes, serving on a SAB is permitted because such positions do not carry, nor are they perceived to carry, management responsibility. The investigator, however, should recuse themselves from any discussion or decision to fund their own research.
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.
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 requires 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 Application for IRB Review;
- When changing the Lead Researcher or adding Co-Researchers or other research personnel; and
- with any Continuing IRB Application.
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), NSF, and several non-governmental agencies adopting the federal requirements:
- All individuals "with responsibility for the 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.
- 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.
- 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.
UC Discovery Program (University of California Industry-University Cooperative Research Program: BioSTAR, DiMi, CoRe, LSI, and UC-SMART):
- Principal investigators and co-principal investigators are required to disclose the financial or management interests of themselves, their spouses/registered domestic partners and their dependent children under both the state and federal policies.
- All other investigators are only required to disclose according to the federal requirements.
- 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 Potential Risks.
Review and Management of a Conflict of Interest
The Conflict of Interest Oversight Committee (COIOC) is composed of faculty from throughout 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. It can recommend approval of a disclosure, which means an award can be accepted. It can also recommend the reduction or elimination of a financial or other interest when one or more potential risks exist. And, it can recommend that certain actions be taken to manage the conflict of interest.
The COIOC meets once a month and is supported by staff who work with the Committee and investigators to ensure proper compliance.
Please note the submission deadlines to ensure the disclosure is reviewed in time for other deadlines, especially if submitting a new proposal or if previously disclosed financial interests have changed.
The information provided in a disclosure is confidential and is only used for the purposes of administering the policy by the Conflict of Interest Oversight Committee and the Office of Research Staff.
However, per federal and state regulations and laws, some information may be disclosed to the public if requested.
For financial disclosures for new protocols or proposals and for financial disclosures that reflect a significant change in financial interests (i.e. an increase in financial interests of at least $5000, an increase in financial involvement), you must submit the required paperwork by the COI Deadline (usually the 1st of the month) to be reviewed at the next COIOC meeting (usually the 3rd Thursday of the month). If no additional information is required, then approvals should be processed within the next following week. If the COIOC determines additional information is required, then the approval process will take longer.
For financial disclosures that have not experienced a significant change in financial interests from the previous year’s review, the disclosure qualifies for an expedited review and takes no more than a week from the time all the required paperwork are submitted to COI.
The COIOC advises the Vice Chancellor for Research (VCR) on the seriousness of the potential conflict and, when necessary, whether and how the conflict can be managed. 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.
The investigator will receive an approval memo via e-mail from the COI Staff. If the award is approved with conditions by which to manage the potential conflict of interest, they will be noted in the memo from the COI Staff.