COI Financial Interest Reporting Requirements Quick Reference

• Gifts
• Contracts and Grants:
  • Non-Profit Foundations or For-Profit Companies:
    • Research Agreements
    • Material Transfer Agreements
    • Clinical Trial Agreements
    • Service Agreements
• UCOP Special Research Programs:
  • MICRO – Microelectronics
  • bio – Biotechnology
  • com – Communications and Networking
  • dig – Digital Media
  • ele – Electronics Manufacturing and New Materials
  • itls – Information Technology for Life Sciences
• Exempt Sponsors (all non-profit tax exempt educational institutions and foreign governmental entities are also exempt)

The 2012 implementation of the PHS regulation applies to all research activities supported by a PHS agency, including:

• Research grants, cooperative agreements and contracts
• Career development awards
• Center grants
• Individual fellowship awards
• Infrastructure awards
• Institutional training grants
• Program projects
• Research resources awards
• Conference grants

To determine if a project requires disclosures, see the Activity Codes (e.g., R01, T32, S10) and description of funding found here.

• Disclosure is required for projects with a D, F, K, L, M, P, R, S, or T prefix
• Disclosure is required for U research projects
• Disclosure is probably not required for a C, G, H, I, V, or X prefix, unless UCSD is a subrecipient conducting a research component
• Contact COI for help at info-coi@ucsd.edu if you are unable to determine if disclosure is required

List of Sponsors that Follow Public Health Services (PHS) Conflict of Interest Disclosure Requirements

Effective June 18, 2022, Department of Energy (DOE) follows the PHS FCOI regulations.

If the agency you are interested in is not on this list and you are unsure if it is a PHS agency, contact the Conflict of Interest Office.

• National Science Foundation (NSF)  contract/grant for research and/or educational activity
• National Aeronautics and Space Administration (NASA)
• Other federal research contract/grant (except PHS)
• Non-governmental entity that flows down federal funds (excluding PHS funds and SBIR/STTR Phase I awards)
• California Institute for Regenerative Medicine (CIRM)
• UC Special Research Programs: Breast Cancer Research Program (BCRP) & California HIV/AIDS Research Program (CHRP) & Tobacco-Related Disease Research Program (TRDRP) & Drug Discovery Consortium (UC DDC)
• Exempt sponsors 

Potential Conflict of Interest means:

Any Researcher including their spouse or registered domestic partner, and/or their dependent children, participating in human subject research and have a potential conflict of interest, which refers to a situation in which outside interest(s) 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 must disclose a conflict of interest in Kuali COI.  Interest(s) also includes being an inventor of a UC San Diego intellectual property being used in the human subjects study.

Depending on funding source, type of activity and role of an individual on a project, please refer to COI for Kuali IRB.

• Principal Investigator (PI) 

• Principal Investigator
• 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 SFIs related to their institutional responsibilities. 

• Principal Investigator
• All other Individuals who have the responsibility for the design, conduct, or reporting of research results.

• Principal Investigator
• All study team members are listed in Study Personnel in Kuali IRB application. Those Researcher’s with a potential conflict of interest* will need to mark “yes” under the conflict of interest question within Kuali IRB.

  Potential Conflict of Interest Definition:

  Any Researcher including their spouse or registered domestic partner, and/or their dependent children, participating in human subject research and have a potential conflict of interest, which refers to a situation in which outside interest(s) 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 must disclose a conflict of interest in Kuali COI.  Interest(s) also includes being an inventor of a UC San Diego intellectual property being used in the human subjects study. 
  
  
  Depending on funding source, type of activity and role of an individual on a project, please refer to COI for Kuali IRB.

A financial interest "in" the sponsor:

• Positions:
  • Founder, Partner, Director, Manager, Officer, Employee, or any position of management
• Investments:
  • Stocks, Bonds, Stock Options, etc. greater than $2,000 held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months
• Income:
  • Salaries, Consulting Income, Honoraria, etc. greater than $500 including consulting fees, honoraria, or dividends including payments made to the University of California Health Sciences Compensation Plans.  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:
  • Gift, Promise of a Gift, or Multiple Gifts greater than $50
• Loans:
  • Loans received or outstanding greater than $500
• Travel Reimbursement:
  • Per Diem, Transportation, Travel Advances, Lodging and Meals
• Travel Payments:
  • Advances and reimbursements for travel and related expenses, including lodging and meals. See 700U Instructions for additional reporting requirements

Please Note: Financial interests must be reported for the Principal Investigator and their spouse or registered domestic partner, and dependent children.

A summary matrix of the Non-Federal State COI Reporing Requirements is available for reference and download.

Read more on financial interest reporting requirements for non-federal sponsored research.

Significant Financial Interests related to the investigator’s Institutional Responsibilities. Institutional Responsibilities include the teaching/education, research, outreach, clinical services, and University and public service you perform in the course and scope of the Investigator’s UC appointment/employment.

Significant Financial Interest 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 for the following categories, except travel:

• Income received from a publicly-traded 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.

This may include income or honoraria received for outside activities arising from your professional credentials, expertise and achievements upon which your University position is based, such as 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.

• Income received from a non-publicly traded entity during the 12 months prior to disclosure that exceeds $5,000 AND/OR any equity interest you hold in that entity even if the value is zero or unknown.

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.

Investigators, including subrecipient Investigators, must disclose financial interests received from a foreign Institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).

• Any Income received from an entity, other than UC, for intellectual property rights and interests during the 12 months prior to disclosure. 

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

• Sponsored travel or reimbursement exceeding $5,000 during the twelve months preceding disclosure, from professional organizations, for-profit and foreign entities.

This includes travel paid directly for or reimbursed by a professional society, a company for which you are consulting, or any other for-profit or non-profit organization (for the Investigator only)

A summary matrix of the two Federal COI Disclosure Reporting Requirements is available for reference and download.

Read more on financial interest reporting requirements for PHS Sponsored Research.

The term “significant financial interest” means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options, private equity, or other ownership interests); venture or other capital financing, and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

A related significant financial interest in an entity "other" than the Federal sponsor that would reasonable appear to be affected by the research (or educational activities) funded or proposed for funding or are in entities who financial interests would reasonably appear to be affected by such activities:

• Positions:
  • Founder, Partner, Director, Manager, Officer, Employee, Trustee, or any position of management (paid or unpaid)
• Investments:
  • Stocks, Bonds, Stock Options, etc. greater than $10,000 Market Value or 5% ownership interest held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months
• Income:
  • Salaries, or any other payment for services greater than $10,000 including Consulting Fees, Honoraria, Dividends, or travel reimbursement, including payments made to the University of California Health Sciences Compensation Plans. This applies to income received 12 months prior to the time of financial disclosure, as well as future or anticipated. 
•  
• Intellectual Property:
  • Intellectual property interest on a patent, patent application, or copyright assigned or licensed to a party other than The Regents of the University of California. This applies to current as well as anticipated intellectual property interests in the next 12 months.

Please Note: Financial interests must be reported for the disclosing individual(s) and their spouse or registered domestic partner¹ and dependent children.  

A summary matrix of the two Federal COI Disclosure Reporting Requirements is available for reference and download.

Read more on financial interest reporting requirements for federal (non-PHS) sponsored research.

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:
  • Founder, Partner, Director, Manager, Officer, Employee, or any position of management
• Investments:
  • Stocks, Bonds, Stock Options, etc.  greater than $2,000 held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months.
• Income:
  • Salaries or any other payment for services greater than $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:
  • Gift, Promise of a Gift, or Multiple Gifts greater than $50
• Loans:
  • Loans received or outstanding greater than $500
• Intellectual Property:
  • 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.

• With the initial proposal
• With additional funding
• With any change with the PI’s financial interest(s)

Please Note: All positive disclosures must be reviewed and approved prior to acceptance of the award or additional funding.

• With the initial new proposal
• With Renewal proposals
• With progress reports
• With Supplemental funding proposals
• When new personnel are added
• Within 30 days of any change to an Investigator’s significant financial interests
• At least annually through the life of a PHS-supported research grant/contract.

Effective June 18, 2022, Department of Energy (DOE) follows the PHS FCOI regulations.

Please Note: All positive disclosures must be reviewed and approved prior to acceptance of the award, requests for no cost time extensions or additional funding and before a new investigator joins an ongoing project.

For projects funded by the NSF and other sponsors who have adopted the NSF policy such as the California Institute for Regenerative Medicine:

• With initial proposals
• With renewal proposals
• Annually or with any change in the investigator's financial interest(s)

For Federal projects that are not NSF or PHS:

• With initial proposal
• With continuation proposals (if required)
• With renewal proposals
• With supplemental proposals
• When new personnel are added
• With any change with the PI’s financial interest(s)

Please Note: All positive disclosures must be reviewed and approved prior to acceptance of the award or additional funding and before a new investigator joins an ongoing project.

• With the initial proposal
• With any continuing IRB application
• With any modification request that changes the Lead Researcher or adds Co-Researchers or other research personnel

Please Note: All positive disclosures must be reviewed and approved prior to IRB approval of the protocol and informed consent.