- What is a conflict of interest?
- What is a “positive disclosure” or "disclosable financial interest"?
- Is a financial interest automatically a conflict of interest? Are all conflicts of interest harmful?
- What does NOT have to be disclosed?
- What if an investigator does not have any disclosable financial interests?
Types of Financial Interests
- If the research grant/contract includes financial compensation for my work in the research project and I have no other financial interests with the entity, do I need to disclose those financial interests?
- Can I start a company?
- Can I serve on a board of directors?
- I have a financial interest in a company that wants to apply for an SBIR or STTR grant; can I participate?
- Can I participate in clinical trial research that involves testing a technology that I invented?
- Can I serve on a Scientific Advisory Board?
- I have a financial interest in an outside entity. Does that mean that the outside entity cannot sponsor my research project at UCI?
- Can I perform corporate consulting or be employed by an outside company while I am on the faculty at UCI?
- Can I conduct an industry sponsored clinical trial while having a financial interest in the sponsor?
- When is reporting required?
- Who discloses and what is reported?
- What are the potential risks of a Conflict of Interest?
Review and Management of a Conflict of Interest
- Who reviews the positive disclosures?
- Who gets to see the information I provide in my disclosure?
- How long does the review process take?
- How are Conflicts of Interest managed?
- How are investigators notified of the outcome of the review?
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 his/her specific financial interests because they surpass the maximum thresholds indicated in the policies. These individuals 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 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/resgistered 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
- investments over which the Investigator has no direct control,
- income, other remuneration and reimbursement from the UC Regents and income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles
Types of Financial Interests
1. If the research grant/contract includes financial compensation for my work in the research project and I have no other financial interests with the entity, do I need to disclose those 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 research in ways that could lead to personal financial gain or give advantage to 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 visit http://www.ucop.edu/academic-personnel/_files/apm/apm-028.pdf.
Yes, within the allowable limits set by the Academic Personnel Manual (APM). APM-025 chapter (http://www.ucop.edu/academic-personnel/_files/apm/apm-025-07-01.pdf) 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 need to 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 can also review the consulting agreements to check for any language that makes the consulting income contingent on the outcome of the research.
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 risk of compromising objectivity in research. 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 company or a start up company, and the diversity of the company’s interests. Usually, the larger the company and the lower the relative investigator equity, the less the 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. The investigator should not serve 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.
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 his/her primary obligations as a faculty member or university employee. The investigator must avoid any conflict of commitment between his/her 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 his or her 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.
Yes, but the Principal Investigator for the small business and the Principal Investigator for the subcontracted work to UCI must be different individuals. If a UCI Principal Investigator has a significant financial interest in a small business entity, that individual may not bring research into his/her own laboratory under a SBIR or STTR subcontract from that same small business.
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 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.
8. Can I serve on a Scientific Advisory Board?
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 himself/herself from any discussion or decision to fund his/her 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 (Disclosure Form for NSF Conflict of Interest Policy- Form 900):
- at the time of proposal submission;
- new investigators are added to the project; and
- when investigator's financial interests change.
Public Health Service requires disclosure (Financial Disclosure for PHS-Funded Research- Form 800) 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 investigator's financial interests change.
The IRB policy requires disclosure (Application for IRB Review):
- when submitting the Application for IRB Review; and
- with any Continuing IRB Application.
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/resgistered 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 comprised 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 maybe 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 (i.e. change of less than $5000, reduction in financial involvement), the review process is expedited and can take about 3 weeks 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 a memo from the COI Staff. A copy of the memo will be sent to the department administrator. If the investigator under review is not the principal investigator (PI), then the PI will also receive copies of the memoranda.