Conflict of Interest FAQ

For all employees at UC San Diego, the basic definition of a conflict of interest refers to a situation in which outside financial interests or other personal considerations may compromise or have the appearance of compromising an employee's actions or judgments in the administration, management, or performance of their professional activities.

For researchers at UC San Diego, the definition is more specific as it refers to a situation in which outside financial interests may compromise, or have the appearance of compromising, a researcher's professional actions or judgments in the design, conduct, or reporting of their research results.

A financial interest is anything of monetary value, including a fiduciary relationship with an outside entity. Financial interests are the most important component or components of a conflict of interest for researchers. Some examples include, but are not limited to:

• Salaried or unsalaried positions with the sponsor or entity
• Scientific advisory board memberships
• Vested or non-vested stock or stock options
• Gifts
• Loans
• Travel payments/reimbursements
• Income received through honoraria or consulting

When an opportunity arises to influence UC San Diego’s business decisions, which produces personal financial gain for an employee, thus potentially compromising the integrity of decisions they may make as researchers, teachers, and providers of patient care in consideration of personal financial interests.

• When an employee has a significant financial interest in a company that is providing funding for the employee's research or other UC San Diego activity.
• When research directly and significantly affects the financial interest of an employee who has the responsibility for the design, conduct, and reporting of their research results.

Yes, but generally not in both the research being conducted by the company and research to be conducted at UC San Diego, as the academic collaborator. The Principal Investigator for the small business and the Principal Investigator for the subcontracted work to UC San Diego must be different individuals. 

University resources should not be used for a private or personal purposes. Per BFB-BUS-20, University employees shall not use University property or property in the care and custody of the University for personal purposes. Equipment procured through the federal government under a grant or contract must only be used for the authorized purposes of the project during the period of performance, or until the property is no longer needed for the purposes of the project. Once the equipment is no longer needed for the project, the University can use the equipment for other projects, but in this order of priority:

1. Research funded by the agency that funded the purchase of the equipment;
2. Research funded by other federal awarding agencies;
3. Non-federally funded projects.

Special concerns arise when human subjects are involved, as the research subjects may be placed at additional risk because of an Investigator's financial interests. Situations that warrant additional consideration by the IRC include those where an Investigator has a financial interest in the sponsor or manufacturer of a product being tested in human subjects, or in which the Investigator is the inventor of the product.

In such situations, the Independent Review Committee (IRC) maintains that any research involving human subjects must be free of conflict of interest and recommends that individuals who have independent roles in projects and who are responsible for the design, analysis, conduct or reporting of the research performed (or to be performed) under a human subjects protocol shall not concurrently receive any compensation from the sponsor or other entity supplying materials, drugs or devices for the project, including honoraria and consulting fees, during the course of the study.

However, the Independent Review Committee(IRC) will also consider:

• The Investigator's role in the project.
• Whether the Investigator is involved in subject selection, including prescreening for inclusion/exclusion criteria.
• Participation of the Investigator in the consent process.
  Investigator participation in clinical treatment of subjects, separate from the research interventions or procedures.
• The design of the clinical study; whether it is a single-site, investigator-initiated study or a multicenter study with oversight provided by a sponsor or other third party.

University employees are expected to devote primary professional allegiance to the University. Outside or financial interests must not interfere with University duties. Outside professional activities, personal financial interests, or acceptance of benefits from third parties can create actual or perceived conflicts between the University's mission and an employee's private interests. Learn more about all of the Conflict of Interest and Integrity Policies.

A University employee has a personal financial interest in a decision if it is reasonably foreseeable that the decision will have a material financial effect on the employee or his/her immediate family. If so, the University employee is prohibited from participating in the University decisions. Learn more about the conflict of interest guidance for UCSD employees. 

All University employees are required to disqualify themselves from making, participating in making or influencing University decisions in which they have a disqualifying conflict of interest. For example, if you are involved in a University RFP, and you have a financial interest with an entity that plans to bid, you may have to disqualify yourself from participating. Learn more about the disqualification rule.

All University employees are expected to act with integrity and good judgment and to recognize that the acceptance of personal gifts from those doing business or seeking to do business with the University, even when lawful, may give rise to legitimate concerns about favoritism depending on the circumstances. Learn more about the UC Policy and Guidelines Regarding Acceptance of Gifts and Gratuities by Employees.

For PHS Sponsored Research

All PHS-funded Investigators (i.e., the Project Director/Principal Investigator, any other person identified as Senior/Key personnel in a grant application, progress report, or other report submitted to the PHS, and others who direct or can materially influence the research, or who are responsible for the design, conduct, and reporting of such research) will be required to disclose any Significant Financial Interests (SFI) related to their institutional responsibilities.

Note: Financial interests must be reported for the disclosing individual(s) and their spouse or registered domestic partner and dependent children.

For Federal (Non-PHS) Sponsored Research

The Investigators (i.e., Principal Investigator, Co-Principal Investigators) and any other individuals who have responsibility for the design, conduct, or reporting of research results for the sponsored project must disclose their financial interests.

Note: Financial interests must be reported for the disclosing individual(s) and their spouse or registered domestic partner and dependent children.

For Non-Federal Sponsored Research

The Principal Investigator must disclose their financial interests.

Note: Financial interests must be reported for the disclosing individual(s) and their spouse or registered domestic partner and dependent children.

For Research Involving Human Subjects

The Principal Investigator must disclose their financial interests and all University employees on the list of research personnel (Section 7 on FaceSheet) must disclose as well.

Note: Financial interests must be reported for the disclosing individual(s) and their spouse or registered domestic partner and dependent children.

For Federal Sponsored Research

Failure to file or update economic interests forms or to comply with any conditions or restrictions imposed on the conduct of the project will be grounds for discipline under the University Policy on Faculty Conduct and the Administration of Discipline and/or other applicable employee discipline policies. Furthermore, federal sponsors may suspend or terminate the award and/or debar an Investigator from receiving future awards.

For Non-Federal Sponsored Research

Failure to file the required Statement of Economic Interests or failure to report a financial interest may subject the individual to civil liability, including fines, as well as University discipline (Government Code sections 81000-91014).

For PHS Sponsored Research (and other agencies adopting the PHS requirements)

All PHS-funded Investigators planning to participate on a proposed PHS Research Activity will be required to disclose any Significant Financial Interest (SFI) related to their Institutional Responsibilities at the following times:

• At the time of the initial proposal submission, continuation, renewal or supplemental funding, and at least annually.
• Whenever new personnel are added.
• Within 30 days if there is any new or change in SFIs occurring prior to or during the period of an award.
• When a project is awarded through a subaward and the awarding agency is PHS or another agency who has adopted the PHS financial disclosure requirements.
• When the University is the prime contractor and subawards a portion of the research with another entity. The receiving entity is required to supply assurances that will allow the University to comply with the PHS regulations.

For Federal (Non-PHS) Sponsored Research

The researcher and all other individuals who have responsibility for the design, conduct, or reporting of research results for the sponsored project must disclose financial interests related to the proposed research:

• At the time of the initial proposal submission and renewal.
• Whenever new personnel are added.
• If there is a change in reported financial interests occurring prior to or during the period of an award.
• When a project is awarded through a subaward and the awarding agency is NSF, NASA, UC Discovery Grant Program, and UC Programs BCRP, TRDRP, and UARP.

For Non-Federal Sponsored Research

The PI must disclose financial interests in the research sponsor or donor:

• At the time of initial proposal or solicitation, renewal or additional funding.
• Whenever there is a change in PI.
• If the PI has a change in reportable financial interests during the term of an award for which disclosure is required.

For Research Involving Human Subjects:

The Principal Investigator (PI) and all University employees on the list of research personnel (Section 7 on FaceSheet) must disclose:

• At the time of protocol submission.
• With any modification request that changes the PI.
• If the PI or any Investigators listed as research personnel has a change in reportable financial interests during the course of the study.
• Upon protocol resubmission (not continuing review).

Note: All positive disclosures must be reviewed and approved before final IRB approval of the protocol and the Informed Consent document.

For PHS Sponsored Research

All Significant Financial Interests (SFI) related to the Investigator’s Institutional Responsibilities. Institutional Responsibilities include the teaching/education, research, outreach, clinical services, training and University and public service performed on behalf of the University and directly related to those credentials, expertise and achievements upon which your UC San Diego appointment/employment is based.

SFI means a financial interest consisting of one or more of the following interests of the Investigator or the Investigator's spouse or registered domestic partner and dependent children that reasonably appears to be related to the Investigator’s Institutional Responsibilities. Note: Travel SFI applies only to the Investigator.

• Publicly-Traded Entity: Any income received from an entity during the 12 months prior to disclosure which, when combined with the value of any equity interest you hold in the entity, exceeds $5,000 from a single entity, which is any for-profit entity or non-profit organization.

This may include salary, consultant payments, honoraria, royalty payments, dividend, loan, or any other payments or consideration with value, including payments made to the University of California Health Sciences Compensation Plans during the prior twelve months. These activities include providing consulting services, serving on a board of directors, scientific advisory board, committee, panel or commission sponsored by a for-profit or non-profit organization, including professional or scholarly societies; acting in an editorial capacity for a professional journal; reviewing journal manuscripts, book manuscripts, or grant or contract proposals for a non-profit or for-profit organization. Equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

Investigators are not required to disclose significant financial interests in mutual funds or other investment vehicles such as retirement funds as long as the Investigator does not directly control the investment decisions made these investment vehicles.

• Non-Publicly Traded Entity: Any compensation received from an entity during the 12 months prior to disclosure that exceeds $5,000 OR an equity interest of any amount you hold in that entity.

This may include stock or stock options in a company that is developing, manufacturing or selling products or providing services used in your clinical practice, teaching, research, administrative or committee responsibilities.

Excluded is income from seminars, lectures, or teaching engagements sponsored by a Federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001 (a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

• Intellectual property rights and interests: Income (e.g. royalties or licensing fees) received from an entity, other than UC, during the 12 months prior to disclosure that exceeds $5,000.

This may include receipt of income such as royalties or licensing fees from an organization other than The UC Regents for use or sale of patented or copyrighted intellectual property (e.g. software, textbooks, or other scholarly works).

• Travel: The occurrence of any sponsored or reimbursed travel must be disclosed whether payment is made to the Investigator directly or expenses are paid on behalf of the Investigator by a for-profit or non-profit organization. This includes travel paid for or reimbursed by a professional society, a company for which you are consulting, or any other for-profit or non-profit organization.

Investigators are not required to disclose travel that is reimbursement or sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with an institution of higher education.

For Federal (Non-PHS) Sponsored Research

The significant financial interests that must be disclosed include:

• Income received from the entity of $10,000 or more from a single for-profit company or non-profit foundation, for services that can include; salaries, consulting income, honoraria from speeches or other services that were performed, royalty payments, and stock dividends and/or interest earned, or the proceeds from any stock sales. In addition, income also includes compensation received by the University of California Health Sciences Compensation Plans.
• Investments in the entity can include stocks, bonds, warrants, stock options, including margin or brokerage accounts, loans, or any other investments or ownership interest exceeding either $10,000 market value if publicly traded; otherwise the amount of the investment, or 5% ownership interest in the entity.
• Positions with the entity as founder, partner, director, manager, officer, trustee, employee or any other position of management with the entity.
• Intellectual property associated with any invention, discovery, or work of authorship, in a patent, patent application or a copyright assigned or licensed to a party other than The Regents of the University of California.

The four financial interest categories above, each use a 12 month threshold for financial disclosure, but it is applied in different ways. For example:

• Income uses the 12 month threshold in 2-ways; for activities that took place 12 months prior to the time of financial disclosure, as well as for 12 months of future or anticipated financial interest.
• Investments, Positions, and Intellectual property applies only to current, as well as for 12 months of future or anticipated financial interest.

For Non-Federal Sponsored Research

A financial interest refers to the direct financial relationship between the Principal Investigator and the non-federal sponsor, or indirectly through their spouse, their registered domestic partner, or their dependent child. These include:

• Positions with the sponsor as founder, partner, director, manager, officer, trustee, employee or any other position of management with the sponsor.
• Investments in the sponsor can include stocks, bonds, warrants, and stock options, including margin or brokerage accounts that have a value totaling $2000 or more.
• Income from the sponsor can include consulting income, honoraria from speeches or other services that were performed, royalty payments, and stock dividends and/or interest earned, or the proceeds from any stock sales. In addition, income also includes compensation received by the University of California Health Sciences Compensation Plans.
• Gifts from the sponsor or personal gifts from the sponsor, which includes the gift or the promise of a gift received from the sponsor of $50 or more, or multiple gifts from a single sponsor totaling $50 or more. Keep in mind that it is the acceptance of the gift, not the ultimate use of the gift, which imposes your obligation to disclose. Therefore, you must disclose the personal gift even if you never use it or even if you give it away to another person. If the exact amount of the gift is not known, you must make a good faith estimate of the item’s fair market value. Some common examples of disclosable gifts include; tickets or passes to sporting or entertainment events, or amusement parks, parking passes, transportation and lodging, and forgiveness of a loan received by you from the sponsor.
• Loans from the sponsor require disclosure if the outstanding balance has exceeded $500. This also includes community property interest in loans received by the spouse or registered domestic partner.
• Travel reimbursements from the sponsor can includes per diem, payments for transportation, travel advances, lodging, and meals that were received from the sponsor.

For Research Involving Human Subjects

A financial interest "in" the sponsor or "in" another entity that would reasonably appear to be affected by the research, such as a Contract Research Organization or the manufacturer of the test article.

• Positions such as Founder, Partner, Director, Manager, Officer, Employee or any position of management.
• Investments including Stocks, Bonds, Stock Options, valued at $2,000 or more held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months.
• Income including Salaries, or any other payment for services in excess of $500 including consulting fees, honoraria, dividends or travel reimbursement, including payments made to the University of California Health Sciences Compensation Plans. Income also includes royalty or other income on a patent, patent application or copyright that is related to the proposed study. This applies to income received 12 months prior to the time of financial disclosure, as well as future or anticipated income in the next 12 months.
• Gifts or promised gifts or multiple gifts received in excess of $50.
• Loans received or outstanding loans in excess of $500.
• Intellectual Property interest on a patent, patent application, or copyright assigned or licensed to any party including The Regents of the University of California. This applies to current as well as anticipated intellectual property interests in the next 12 months.

The disclosure form is routed to the Conflict of Interest (COI) Office. If no financial interest exists, then it is approved. This is referred to as a Negative Disclosure. The COI Office informs the proposal review office to release funds upon receipt of the award.

If a financial interest exists, this is referred to as a Positive Disclosure. Positive disclosures are forwarded to the Independent Review Committee (IRC) on Conflict of Interest for further review. The IRC is a panel of faculty members from disciplines across the campus, which functions as the principal advisory committee to the Chancellor for conflict of interest related to research. The IRC meets monthly to review disclosures of financial interests to determine whether these interests constitute significant conflicts of interest that must be eliminated, reduced, or managed before research support can be accepted. If the IRC determines that the research support may be accepted, they then also recommend to the Chancellor appropriate strategies for the management of any significant conflict.

The Independent Review Committee (IRC) reviews each financial disclosure in accordance with the University of California Policy on Disclosure of Financial Interests in Private Sponsors of Research, the University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects, and the UC Policy on Disclosure of Financial Interests and Management of Conflict of Interest Related to Public Health Services Sponsored Awards for Research.

The IRC then determines whether the financial interest represents a real or perceived conflict of interest, and if so, whether any action should be undertaken to eliminate, reduce, or manage the conflict of interest. The IRC applies standards that have evolved over time, based on their prior experience, the appearance of new types of conflicts, and input from the local and national research community.

If the Independent Review Committee (IRC) determines that the disclosed financial interests constitute a real or perceived conflict of interest, they will recommend actions designed to eliminate, reduce or manage the conflict of interest. In some instances, the IRC may simply recommend disclosing the interest in all presentations, abstracts and publications.

Depending on the facts, the IRC may also recommend other measures such as divestiture of all equity interest in the sponsor or elimination of any consulting arrangement with the sponsor or other entity. In some cases, the IRC may attempt to mediate the conflict of interest situation by recommending changes in financial arrangements to protect the interests of UC San Diego or implementing some form of faculty accountability for research by monitoring and oversight.

If the Investigator does not agree with the IRC’s recommendations:

• The Investigator will contact the IRC.
• The Investigator will be asked to discuss this matter with their Dean and/or Vice Chancellor to implement the IRC’s requests, recommendations or to suggest an acceptable alternative to manage the conflict of interest.
• The IRC will meet with the Dean and/or Vice Chancellor to discuss the matter.
• If all attempts to mediate the conflict of interest situation have not been successful, and the PI or Researcher is still not in agreement with the recommendations made by the IRC, the IRC will then recommend that funding for the project not be accepted and forward this recommendation to the Chancellor for concurrence.
• If the PI does not concur with the IRC's recommended management strategies even after this process, the PI can appeal the decision to the Chancellor for review.

Collaborators from other institutions who share responsibility for the design, conduct or reporting of research results, and who will be conducting research under a sub-grant or subcontract from the University are expected to comply with the policies and procedures for disclosure and review of Significant Financial Interests at the institution at which they are employed. If their institution does not have a conflict of interest policy that complies with the PHS regulations, they must comply with the University’s policies and procedures for disclosure and review of Significant Financial Interests related to PHS sponsored awards.

Subawards issued by the University will ask the subrecipient institution to certify that its policy is in compliance with PHS conflict of interest regulations and, unless the subrecipient does not have a PHS-compliant policy, will indicate that the recipient organization is responsible for reviewing the disclosures submitted by its Investigators. If a Financial Conflict of Interest is identified, the subrecipient organization is responsible for sending the University notification of the conflict and of the subrecipient institution’s plan to manage, reduce or eliminate the identified conflicts, in accordance with PHS reporting requirements.

The FCOI regulations also include requirements for mandatory and ongoing education and training.

All PHS Investigators, as defined by the rule, must complete this training prior to beginning work on a PHS-funded project with a Notice of Award issue date after August 24, 2012.

See the UC Conflict of Interest Training for Public Health Service Investigators.