Disclosing Individuals must disclose their financial interests received within the 12 months prior to the disclosure submission including the financial interests of their spouse/registered domestic partner, and/or dependent child(ren). All positive disclosures must be approved prior to the acceptance of the award/expenditure of funds and/or to the IRB approval of the protocol.  Depending on the nature of the study and the sponsor(s), more than one conflict of interest disclosure policy may apply.  Please check with the COI Team if you have questions.

Note: Non-UCI Researchers have different COI forms.

State Law

Update: DocuSign is approved form of electronic signature on the Form 700U by the California Fair Political Practices Commission requirements as long as the signer accesses DocuSign through their UCI email account.  To access the UCI DocuSign, click this link.

  • Starting 1/24/22- DocuSign will be the only form of electronic signature accepted; paper form still accepted
  • Starting 3/1/22, all Form 700Us must be signed through DocuSign; paper form no longer accepted

Reporting Triggers:

  • Research contract/grant from a non‐governmental entity
  • Research gifts earmarked for a specific individual or a specific research project
  • Material Transfer Agreement

Note: Exclude all exempt sponsors on FPPC approved list and all non-profit, tax-exempt educational institutions. However, researchers must disclose for the prime sponsor if the educational institution received its funds from a non-governmental entity.

Who:

  • UCI Principal Investigator and co-Principal Investigator, if applicable

What to Disclose:

Principal Investigators and Co-Principal Investigators must disclose the following financial interests in themselves, their spouse/registered domestic partner, and dependent child(ren).

A financial interest in the non‐governmental sponsor of the research including:

  • Income ≥ $500 over the past 12 months
  • Investments ≥ $2,000
  • Director, Officer, Employee, Partner, Trustee, Consultant or Management position
  • Loan Balances ≥$500 over the past 12 months
  • Personal Gifts Valued at ≥ $50 over the past 12 months (given directly to you not UCI on your behalf)
  • Travel Reimbursements over the past 12 months

When to Disclose:

  • With the initial award
  • With renewal award (additional funding intended to extend or results in the extension of a project beyond the originally approved project period)

Forms:

Policies/Regulations:

Resources:

National Science Foundation

Reporting Triggers:

  • NSF research contract/grant
  • Non‐governmental entity which flows down NSF funds
  • California Institute for Regenerative Medicine (CIRM) Grant
  • Juvenile Diabetes Research Foundation (JDRF)
  • UC Special Research Programs (HIV/AIDS, breast cancer and tobacco related disease)

Note: Exclude Phase 1 SBIR or STTR grants

Who:

  • Investigator(s), who are the individuals responsible for the design, conduct, or reporting of the funded research project, must disclose their significant financial interests. The Principal Investigator is responsible for accurately classifying the individuals on their project based on their roles, and collecting financial disclosures from all project participants that meet the definition of "Investigator."
    • NSF Definitions of Categories of Personnel are based on titles - not responsibilities in the funded project. However, the NSF COI Policy requires Principal Investigators/Project Directors to identify individuals as Investigators based on their responsibilities on the project. All UCI Investigators, which may include senior personnel and other personnel, are required to submit the KR COI Annual Disclosure.
    • For any non-UCI Investigators on the UCI proposal/award and any subrecipients following UCI's NSF COI policy, all individuals who meet the definition of an Investigator must complete the Subrecipient/Non-UCI Investigator Disclosure- Form 900SR.

What to Disclose: 

Investigators must disclose the  following financial interests in themselves, their spouse/registered domestic partner, and dependent child(ren).

A significant financial interest related to the NSF compliant research project including:

  • Income > $10,000 (excluding income from seminars, lectures, teaching engagements, or service on advisory committees or review panels for public or nonprofit entities) received in the last 12 months
  • Equity interest (including stock, stock options, and other ownership interests) > $10,000 or 5%
  • Intellectual Property interest in a patent, patent application, or copyright of a software (excluding intellectual property owned by the UC)

Note: The KR COI Annual Disclosure has a lower disclosure threshold (for example, income > $5000 rather than NSF's income > $10,000).  Please answer the KR COI Annual Disclosure questions carefully.  When your NSF compliant project is awarded, the COI Team will email the Disclosing Individual to confirm that the financial interest meets the NSF disclosure requirements requiring a COIOC review.

When to Disclose:

  • With the initial proposal
  • When a new Investigator(s) is added
  • With any change in an investigator’s financial interest

Definitions:

  • Related: Work to be performed under the sponsored project and results therefore that would reasonably appear to affect the Significant Financial Interest of the Investigator or the financial interests of the entity in which the Investigator has a financial interest. Consistent with federal regulations, the following examples are financial interests that are considered "related" to a sponsored project:
    • The Investigator is conducting a project where the results could be relevant to the development, manufacturing, or improvement of the products or services of the entity in which the investigator has a financial interest;
    • The Investigator has consulting income in his/her professional field that exceeded $10,000 from a single entity during the prior twelve months, where the financial interest of the entity or the Investigator would reasonably appear to be affected by the federally-sponsored research;
    • The Investigator has a financial interest in an entity and the sponsored project proposes to subcontract a portion of the work, or lease property, or make referral of participants to, or make purchases from the entity; or
    • The Investigator has a financial interest in an entity that is part of a consortium or that will otherwise participate in the sponsored project.

Forms:

Policies/Regulations:

Public Health Service and Department of Energy

Reporting Triggers:

  • PHS grant, cooperative agreement and contracts/DOE financial assistance awards (e.g., grant, cooperative agreement, or technology investment agreement)
  • Non-governmental entity which flows down PHS/DOE funds
  • Research Funding from organizations that follow PHS disclosure requirements (i.e., American Cancer Society, American Heart Association). See the complete list below.

Note: Exclude Phase 1 SBIR or STTR and Office of Indian Energy grants

  1. Administration on Aging (AoA)
  2. Administration for Community Living (ACL)
  3. Agency for Healthcare Research & Quality (AHRQ)
  4. Agency for Toxic Substances & Disease Registry (ATSDR)
  5. Alliance for Lupus Research (ALR)
  6. Alpha-1 Foundation
  7. American Asthma Foundation
  8. American Cancer Society (ACS)
  9. American Foundation for Suicide Prevention
  10. American Heart Association (AHA)
  11. American Lung Association (ALA)
  12. Arthritis Foundation (AF)
  13. Centers for Disease Control & Prevention (CDC)
  14. Centers for Medicare and Medicaid Services (CMS) [formerly HCFA]
  15. CurePSP Foundation for PSP/CBD and Related Brain Diseases
  16. Food and Drug Administration (FDA)
  17. Harrington Discovery Institute
  18. Health Resources & Services Administration (HRSA)
  19. Indian Health Service (IHS)
  20. Lupus Foundation of America (LFA)
  21. National Institutes of Health (NIH)
  22. Office of Global Affairs (OGA)
  23. Office of the Assistant Secretary for Health (OASH)
    1. Office of the Assistant Secretary for Preparedness and Response (ASPR)
      1. Biomedical Advanced Research and Development Authority (BARDA)
    2. Office of the Assistant Secretary for Planning and Evaluation (ASPE)
    3. Office of Minority Health Resources Center (OMH)
    4. Office of Population Affairs (OPA)
    5. Office of Public Health and Science (OPHS)
    6. Office of Research Integrity (ORI)
    7. Office of Research on Women’s Health (OWH)
  24. Patient-Centered Outcomes Research Institute (PCORI)
  25. Substance Abuse & Mental Health Services Administration (SAMHSA)
  26. Susan G. Komen for the Cure

Public Health Service

Who:

  • Investigator(s) (individuals responsible for the design, conduct, or reporting of the funded research project). Principal Investigators should carefully consider how they classify the individuals involved in their study based on the PHS definitions, due to the different requirements and implications. The Principal Investigator is responsible for accurately and appropriately classifying the individuals on their project based on their responsibilities, and collecting financial disclosures from all project participants that meet the definition of Investigator.
    • Identifying PHS Investigators
      • Based on the PHS/NIH definitions, all individuals listed as “senior/key personnel” on a PHS funded proposal, award, or a project sponsored by an entity following PHS regulations are considered Investigators. Therefore, all senior/key personnel must submit KR COI Annual Disclosures and complete COI training as required by the PHS regulations.
      • Please note the definition of Investigator is broader than the definition of senior/key personnel so there may be investigators on the project who are not senior/key personnel.
      • The PHS/NIH Application Guide allows PIs to also include Other Significant Contributors in their senior/key personnel section.  Based on the definition of an Other Significant Contributor, these individuals (when appropriately classified) do not meet the definition of an Investigator.  Therefore, they are not required to submit financial disclosures or complete the COI training.
      • For any non-UCI Investigators on the UCI proposal/award and any subrecipients following UCI's PHS COI policy, all individuals who meet the definition of an Investigator must complete the Subrecipient/Non-UCI Investigator Disclosure Form 800SR.

What to Disclose:

Investigators must disclose the following financial interests in themselves, their spouse/registered domestic partner, and dependent child(ren).

A significant financial interest related to the investigator’s institutional responsibilities including:

  • If publicly traded entity, total value of compensation and equity interest (including stock, stock options, and other ownership interests) > $5,000 over the past 12 months
  • If non-publicly traded entity, total value of compensation > $5,000 or any equity interest (including stock, stock options, and other ownership interests) over the past 12 months
  • Income received over the past 12 months related to intellectual property > $5,000 (excluding intellectual property owned by the UC)
  • Any reimbursed or sponsored travel (excluding (1) travel that is reimbursed or sponsored by a US Federal, state, local government agency, an Institution of higher education as defined by 20 U.S.C. 1001(a) within US, an academic teaching hospital, a medical center, or a research institute affiliated with an Institution of higher education within US; and (2) sponsored or reimbursed travel for the Investigator’s spouse/registered domestic partner and/or dependent children)- see Travel Disclosure Process below

A significant financial interest does not include: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for- profit organization; 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; 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; or income from service on advisory committees or review panels for 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.

Travel Disclosure Process

All reimbursed or sponsored travel related to Investigator’s Institutional Responsibilities must be disclosed in the PHS/DOE Travel Log in KR COI (excluding travel that is reimbursed or sponsored by a US federal, state, local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a) within the US, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education).  All significant financial interests from a foreign entity (governmental, non-profit, for-profit, etc.) must be disclosed.

Policies/Regulations:

Resources:

Department of Energy

Who:

Investigator: Any individual responsible for the purpose, design, conduct, or reporting of research performed or to be performed with DOE funding or a subaward from a pass-through entity to carry out part of a DOE award (subrecipient), regardless of whether the Investigator receives compensation from the DOE funding.  Investigators may include collaborators, consultants, non-UCI personnel, postdoctoral fellows and students depending on their responsibilities for the funded research. For example, reporting includes authorship on publications resulting from the research; thus, graduate and undergraduate students may be required to disclose as Investigators.   

  • Note: DOE program offices have the discretion to expand this definition to include also any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. Such expansion will be specified in the applicable funding opportunity announcement and/or terms and conditions of the financial assistance award. 

What to Disclose:

Investigators must disclose the following financial interests in themselves, their spouse/registered domestic partner, and dependent child(ren).

A significant financial interest related to the investigator’s institutional responsibilities including:

  • If publicly traded entity, total value of remuneration and equity interest (including stock, stock options, and other ownership interests) > $5,000 over the past 12 months
  • If non-publicly traded entity, total value of remuneration > $5,000 or any equity interest (including stock, stock options, and other ownership interests) over the past 12 months
  • Income received over the past 12 months related to intellectual property (excluding intellectual property owned by the UC)
  • Any reimbursed or sponsored travel (excluding (1) travel that is reimbursed or sponsored by a US Federal, state, local government agency, a domestic Institution of higher education or a domestic research institute affiliated with an Institution of higher education; and (2) sponsored or reimbursed travel for the Investigator’s spouse/registered domestic partner and/or dependent children)- see Travel Disclosure Process below

SFIs do not include: 

  1. Financial interests in mutual funds or other investment vehicles such as retirement funds where the Investigator or the Investigator’s spouse/registered domestic partner or dependent children does not directly control the investment decisions made for these investment vehicles.   
  2. Payments made by The Regents, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from the University of California.
  3. Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a US federal, state or local government agency; a domestic institution of higher education; or a domestic research institute affiliated with a domestic institution of higher education. 

Travel Disclosure Process

All reimbursed or sponsored travel related to Investigator’s Institutional Responsibilities must be disclosed in the PHS/DOE Travel Log in KR COI (excluding travel that is reimbursed or sponsored by a US federal, state, local government agency, a domestic institution of higher education or a domestic research institute affiliated with an institution of higher education).  All significant financial interests from a foreign entity (governmental, non-profit, for-profit, etc.) must be disclosed.

Policies/Regulations:

 

When to Disclose:

  • With the initial and renewal proposals
  • With supplemental funding proposal
  • With non‐competing continuation
  • With no cost time extension
  • When a new Investigator(s) is added
  • At least annually for duration of project
  • With any new significant financial interest (New significant financial interests must be reported within 30 days of acquiring or discovering the new SFI.)

Definitions:

  • Institutional Responsibilities: Teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California which are in the course and scope of the Investigator’s University of California appointment/employment.
  • Related: (Note: Determined by COI Team) Related financial interests occur when the researcher, their spouse/registered domestic partner or dependent children have a disclosable financial interest that would reasonably appear to be affected by the research or when the entity in which the financial interests are held would reasonably appear to be affected by the research. To assist in the disclosure process, the following examples are provided:
    • The project results could be relevant to the development, manufacturing, or improvement of products or services of the entity in which the researcher has a financial interest;
    • The researcher has a financial interest in an entity that might manufacture, commercialize or license a drug, device, procedure or any other product used in the project or that will predictably result from the project;
    • The researcher received compensation from activities in his/her professional field during the prior twelve months, where the financial interest of the entity or the investigator would reasonably appear to be affected by the project;
    • The research involves a product, services, method, etc. that competes or is an alternative to the entity's product, services, method, etc.;
    • The researcher has a financial interest in an entity and the project proposes to subcontract a portion of the work, or lease property, or make referral of participants to, or make purchases from the entity; or
    • The researcher has a financial interest in an entity that is part of a consortium or that will otherwise participate in the project.

Forms:

Training

All UCI Investigators are required to complete the Ethics and Compliance Briefing for Researchers (ECBR) training found on UCLC every two years to satisfy the UC Ethics and Compliance and PHS/DOE training requirements.

Non-UCI Investigators' training requirements are satisfied by the completion of the Form 800SR and review of the ECBR Slides.

New Significant Financial Interest (30 day update requirement)

Each Investigator is required to disclose within 30 days of acquiring or discovering a new significant financial interest (SFI).  A "new SFI" is a different type of SFI (e.g., royalty payment versus income) than what had previously been disclosed from the same source/entity that meets or exceeds the threshold.  In addition, a "new SFI" is also considered to be the same type or nature of SFI (e.g. royalty payment) from a different source/entity (e.g., company A versus company B).

  • Travel Only Significant Financial Interests: If the new significant financial interest only includes sponsored or reimbursed travel, then the Investigator enters the travel information in the PHS/DOE Travel Log in KR COI
  • Non-Travel Significant Financial Interests: For all other types of significant financial interests (excluding travel), the Investigator updates their financial interest by submitting an updated Annual Form 810 to coioc@research.uci.edu.

Public Accessibility

Certain information concerning identified FCOIs of senior/key personnel will be available upon written request to any requestor within 5 business days.  Please contact the Public Records Office.

Retrospective Review

In cases of non-compliance, UCI is required to conduct a retrospective review for later determined financial conflicts of interest but not required to report the review to the federal agency unless bias is found.

Human Subjects

Update: Revised IRB COI Policy effective April 1, 2022.  Webpages have been updated accordingly.

Reporting Triggers:

  • All studies involving human subjects research

Who:

  • All individuals listed in the protocol application as research personnel ("engaged in human subjects research")

What to Disclose:

Research Personnel must disclose the following financial interests in themselves, their spouse/registered domestic partner, and dependent child(ren).

A disclosable financial interest related to the research including:

  • Income ≥ $10,000 received over the past 12 months
  • Equity interest (including stock, stock options, and other ownership interests) ≥ $10,000 or 5% in a publicly traded company
  • Any equity interest (including stock, stock options, and other ownership interests) in a privately held company, regardless of the value
  • Board of Directors, director, officer, partner, trustee or management position
  • Intellectual Property interest in a patent, patent application, or copyright of a software (excluding intellectual property owned by the UC)

When to Disclose:

  • With the KR Protocol application
  • With any amendment that changes the Lead Researcher or adds Co‐Researchers or other research personnel
  • With any new related disclosable financial interest

For IRB Reliance studies:  COIOC clearance or approval required before IRB Staff's administrative review to issue formal "Clearance to cede" to a non-UCI IRB.

Definitions:

  • New disclosable financial interest: A newly discovered or acquired and not previously reviewed by the Conflict of Interest Oversight Committee disclosable financial interest related to an active IRB protocol. This also includes acquiring or discovering a new type of disclosable financial interest (income, equity, management position, or intellectual property rights) in an entity that was previously disclosed and approved for the related IRB protocol.  For example, a Researcher receiving equity interests in a company after having previously disclosed receiving income from that company is considered a new disclosable financial interest that needs to be reviewed if it relates to an active IRB protocol.
  • Related: Related financial interests occur when the researcher, their spouse/registered domestic partner or dependent children have a disclosable financial interest that would reasonably appear to be affected by the research or when the entity in which the financial interests are held would reasonably appear to be affected by the research. To assist in the disclosure process, the following examples are provided:
    • The project results could be relevant to the development, manufacturing, or improvement of products or services of the entity in which the researcher has a financial interest;
    • The researcher has a financial interest in an entity that might manufacture, commercialize or license a drug, device, procedure or any other product used in the project or that will predictably result from the project;
    • The researcher received compensation from activities in his/her professional field during the prior twelve months, where the financial interest of the entity or the investigator would reasonably appear to be affected by the project;
    • The research involves a product, services, method, etc. that competes or is an alternative to the entity's product, services, method, etc.;
    • The researcher has a financial interest in an entity and the project proposes to subcontract a portion of the work, or lease property, or make referral of participants to, or make purchases from the entity; or
    • The researcher has a financial interest in an entity that is part of a consortium or that will otherwise participate in the project.

Forms:

Policies/Regulations:

Resources: