Frequently Asked Questions
FAQs at a Glance:
- What is a conflict of interest?
- What is a financial interest?
- Who must disclose?
- When do I need to disclose?
- What financial interests must be disclosed?
- Why are there separate procedures for disclosing financial interests for non-federal and federal sponsors?
- What is the difference between non-federal and federal financial interest disclosure requirements?
- Is a financial interest automatically a conflict of interest?
- Who reviews financial disclosures to determine if a conflict of interest exists?
- Are there set rules or general guidelines as to what may or may not be acceptable financial interests?
- What happens if the IRC determines that a conflict of interest exists?
- What is the Conflict of Interest Management Subcommittee (COIMS)?
- Can I start a company or serve on a board of directors?
- I have a financial interest in an outside company; can they sponsor my research project at UCSD?
- I have a financial interest in a company that wants to apply for an SBIR or STTR grant; can I participate?
- What if my project involves human subjects?
- Are there special considerations for involving students in research if I have a financial interest?
- Are my financial disclosures treated confidentially?
Want to learn more? Take the Conflict of Interest for Researchers narrated online class.
1. What is a conflict of interest?
For all employees at UCSD, 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 UCSD, 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 designing, conducting, or reporting of their research results.
2. What is a financial interest?
A financial interest is anything of economic 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 certainly 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 reimbursements
- Income received through honoraria or consulting
Financial interests do not include monies derived from licensing fees or royalty income paid to UC by the research sponsor. A sponsor's support for a research project, such as salary support paid by UCSD from the grant or the reimbursement of study-specific travel costs, is not considered a financial interest.
3. Who must disclose?
For Non-Federal Sponsored Research:
The principal investigator at UCSD must disclose their financial interests; as well as the financial interests of their spouse or registered domestic partner, and/or their dependent children.
For Federal Sponsored Research:
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The researcher at UCSD is not the only individual who must disclose their significant financial interests; all other individuals who have responsibility for the design, conduct, or reporting of research results for the sponsored project must also disclose their financial interests as well. These individuals can include co-principal investigators, other investigators, and other individuals participating in the project.
4. When do I need to dislcose?
For Non-Federal Sponsored Research:
- Disclosure is required with the initial proposal, renewal or additional funding and whenever there is a change in PI or if the PI has a change in reportable financial interests during the term of an award for which disclosure is required. The PI must disclose prior to final acceptance of a contract, grant, or gift.
For Federal 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 their financial interests at the time of the initial proposal submission, continuation, renewal or supplemental funding and whenever new personnel are added. Researchers must disclose if there is a change in reported financial interests occurring prior to or during the period of an award.
5. What financial interests must be disclosed?
For Non-Federal Sponsored Research:
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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. Some examples of what must be disclosed includes:
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Equity holdings in the sponsor
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Management positions with the sponsor
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Consulting income received from the sponsor
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Honoraria received from the sponsor
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Principal investigator's spouse or registered domestic partner being an employee of or having a financial interest in the non-federal sponsor
For Federal Sponsored Research:
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A financial interest refers to the direct financial relationship between the researcher and an entity other than the federal sponsor. This is also referred to as a related financial interest and only applies to entities that could benefit from the results of the federal sponsored project. Some examples of what must be disclosed includes:
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Equity holdings in the entity
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Management position with the entity
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Consulting income received from the entity
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Honoraria received from the entity
6. When can a conflict of interest occur?
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When an opportunity arises to influence UCSD'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.
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When an employee has a significant financial interest in a company that is providing funding for the employee's research or other UCSD activity.
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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.
7. How do I know which conflict of interest form(s) to submit?
For Non-Federal Sponsored Research:
Submit the 700-U form - Statement of Economic Interests for Principal Investigators for projects that are being sponsored by:
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Gifts
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Contracts and Grants:
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Non-Profit Foundations or For-Profit Companies:
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Research Agreements
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Material Transfer Agreements
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Clinical Trial Agreements
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Service Agreements
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UC Discovery Grant Program:
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MICRO - Microelectronics
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bio - Biotechnology
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com - Communications and Networking
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dig - Digital Media
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ele - Electronics Manufacturing and New Materials
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itls - Information Technology for Life Sciences
For more detailed information and requirements regarding the 700-U form, click here.
For Federal Sponsored Research:
Submit the 9510 form - Disclosure of Financial Interests Related to Federal and Other Sponsored Projects Adopting the Federal Requirements for projects being sponsored by:
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National Institutes of Health (NIH), as well as other DHHS sponsors
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National Science Foundation (NSF)
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American Cancer Society (ACS)
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American Heart Association (AHA)
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California Institute for Regenerative Medicine (CIRM)
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UCOP Special Research Programs:
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Breast Cancer Research Program (BCRP)
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California HIV/AIDS Research Program (CHRP)
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Tobacco-Related Disease Research Program (TRDRP)
For more detailed information and requirements regarding the 9510 form, click here.
Please Note: If a financial interest exists as a result of filing the 700-U or the 9510, the Addendum to Investigator's Statement of Economic Interests must also be submitted. For more detailed information regarding the Addendum, click here.
8. Why are there separate procedures for disclosing financial interests for non-federal and federal sponsors?
This is because the State of California and the Federal government each have their own laws, requirements for disclosure and review, and reporting thresholds.
For Non-Federal Sponsored Research:
- The State of California's Fair Political Practices Commission requires disclosure of the financial interests by using the State of California's Statement of Economic Interest for Principal Investigators, or the 700-U form. The 700-U form is required for non-federal sponsored projects that are being funded by gifts, contracts or grants from a non-profit foundation or from a for-profit company, which may include, but are not limited to; research agreements, Material Transfer Agreements, and Clinical Trial Agreements.
For Federal Sponsored Research:
- UCSD requires disclosure of significant financial interests by using the Disclosure of Financial Interests Related to Federal and Other Sponsored Projects Adopting the Federal Requirements, or the 9510 form. Unlike the State of California issued 700-U disclosure form, the 9510 disclosure form was created by UCSD to comply with federal regulations, as well as with University of California policy. The 9510 form must be completed by the Principal Investigator who has primary responsibility for the scientific and technical conduct, reporting, fiscal, and programmatic administration of a sponsored project, and any other individual(s) responsible for the design, conduct, or reporting of research results for a sponsored project.
9. What is the difference between non-federal and federal financial interest disclosure requirements?
Financial interest disclosure requirements for non-federal and federal sponsoring agencies can differ in several ways. The most significant difference refers to who the financial interest relationship is with.
For a Non-Federal sponsor:
- 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. Some examples of this include; equity holdings in the sponsor, a management position with the sponsor, consulting income received from the sponsor, honoraria received from the sponsor, and/or the principal investigator's spouse or registered domestic partner being an employee of or having a financial interest in the non-federal sponsor.
For a Federal sponsor:
- A financial interest refers to the direct financial relationship between the researcher and an entity other than the federal sponsor. This is also referred to as a related financial interest and only applies to entities that could benefit from the results of the federal sponsored project. Some examples of this include; equity holdings in the entity, a management position with the entity, consulting income received from the entity, and/or honoraria received from the entity.
In addition to these relationships mentioned, and the various types of financial interests, the equity and dollar thresholds that must be disclosed also differ depending upon whether the researcher is requesting funding from a non-federal or a federal sponsor.
10. Is a financial interest automatically a conflict of interest?
Having an outside financial interest is not automatically a conflict of interest. It is also important to remember that some financial interests are of such low value and/or limited duration that they do not meet the definition or threshold of disclosable financial interests, or are so small or inconsequential that the research support from the sponsor can be accepted with no further action. And, almost all disclosed financial interests and resulting conflicts of interest can be reduced, eliminated, or managed so that the research project can be accepted and funded by the proposed sponsor.
11. Who reviews financial disclosures to determine if a conflict of interest exists?
The Independent Review Committee (IRC) on Conflict of Interest is a panel of faculty members from disciplines across the campus, that 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.
12. Are there set rules or general guidelines as to what may or may not be acceptable financial interests?
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 and the University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects. In general, the IRC asks:
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Are the research interests and the private interests kept separate?
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Is the research appropriate to the University?
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Is the teaching and research environment open?
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Is there freedom to publish?
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Have licensing agreements been appropriately reviewed?
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Are UCSD facilities used appropriately?
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.
13. What happens if the IRC determines that a conflict of interest exists?
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 UCSD, or implementing some form of faculty accountability for research by monitoring and oversight.
14. What is the Conflict of Interest Management Subcommittee (COIMS)?
The COIMS was established by the Independent Review Committee (IRC) to review those Principal Investigators/Researchers with complex financial relationships that need closer monitoring. It is comprised of a panel of faculty members from disciplines across the campus and meets monthly with an investigator to review documentation related to the project and discuss the progress of the research throughout the funding period of a specific project and provide reports of such reviews to the IRC.
15. Can I start a company or serve on a board of directors?
Yes, the UCSD's conflict of interest policy does not prohibit investigators from starting their own company or serving on a board of directors. However, where such outside activities are related to the investigator's research, the investigator must report his or her interests to the IRC. If the IRC 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 or serving on a board can contact the Conflict of Interest Office to discuss possible conflict of interest issues.
16. I have a financial interest in an outside company; can they sponsor my research project at UCSD?
Yes, but financial interest(s) must be disclosed using the proper form(s), and the Independent Review Committee (IRC) must review the disclosure to determine whether the interest(s) constitute significant conflicts of interest that must be eliminated, reduced, or managed before research support can be accepted.
17. I have a financial interest in a company that wants to apply for an SBIR or STTR grant; can I participate?
Yes, but generally
not in both the research being conducted by the company and research to
be conducted at UCSD, as the academic collaborator.
The Principal Investigator for the small business and the Principal Investigator
for the subcontracted work to UCSD must be different individuals. If a
UCSD Principal Investigator has 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.
18. What if my project involves human subjects?
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 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 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.
19. Are there special considerations for involving students in research if I have a financial interest?
Yes, UCSD graduate students and postdocs may not be involved in a company in which their dissertation adviser or faculty mentor has a significant financial interest. Involvement means they may not be employed in the company, undertake training in the company, or do their dissertation research in the company. Students and postdocs may undertake educationally-related research activities at companies as long as the following conditions are met:
- The faculty adviser does not have a significant financial interest in the company.
- The company places no confidentiality or non-disclosure restrictions on the student and permits the student to freely discuss and publish the results of his work without delays.
- Any company patent agreement the student is required to sign be reviewed and approved by the University.
The Office of Graduate Studies can provide additional information on the responsibilities of faculty members to students as teachers, mentors, or supervisors of research.
20. Are my financial disclosures treated confidentially?
Yes, the details of personal financial interests reported to the campus are treated sensitively and confidentially and are shared only on a need to know basis within UCSD. The decision of the IRC may be shared with UCSD officials as deemed necessary. In cases relating to projects involving human subjects, the recommendation will be shared with the IRB. It may also be shared with the research sponsor if requested. Other than these mandated disclosures or limited internal disclosures, the information is treated as confidential. However, under California law, information disclosed to the University must be made available to the public upon request.
