Forms & Policies

Printable COI Disclosure Chart

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: Two new fillable DocuSign versions of the Form 700U available.

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:

  • Form 700U
    • Principal Investigator Only Form 700U (for cases when the PI completes the entire form)
      • In the DocuSign PowerForm Signer Information page, enter the PI's name and UCI email address in the first two text boxes.
        • (Optional) Enter a Department Administrator name and UCI email address in the last two text boxes if they should also receive a copy of the completed Form 700U
    • Department Administrator/Delegate and PI Form 700U (for cases when a department administrator or other delegate will complete the first sections of the form before sending it to the PI to complete the financial interest section and sign)
      • In the DocuSign PowerForm Signer Information page, enter the Department Administrator’s name and UCI email address in the first two text boxes and enter the PI’s name and UCI email address in the last two text boxes. 
      • After the Department Administrator completes the top portion and sections 1 & 2, the form will route to the PI to complete and sign the Form 700U.
    • Form 700U PDF- still needs DocuSign signature
  • COI Addendum (COI-1CA) - updated
  • COI Gift Addendum (COI-2) - updated
  • COI Liaison Acknowledgement Form

Policies/Regulations:

Resources:

National Science Foundation, National Aeronautics and Space Administration

Update: NASA published its final conflict of interest policy to be implemented by December 1, 2023 for grants and cooperative agreements. UCI webpages are being updated accordingly.

Reporting Triggers:

  • NSF research contracts and grants
  • NASA grants and cooperative agreements
  • Non‐governmental entity which flows down from NSF/NASA funds (including SBIR/STTR subawards)
  • California Institute for Regenerative Medicine (CIRM) Grant
  • Juvenile Diabetes Research Foundation (JDRF)
  • UC Special Research Programs (HIV/AIDS, breast cancer and tobacco related disease)

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."
    • All UCI Investigators, which may include senior personnel and other personnel, are required to submit the KR COI Annual Disclosure. Principal Investigators are responsible for determining who meets the definition of an "Investigator" and is required to disclose.
      • 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.
    • For any non-UCI Investigators on the UCI proposal/award and any subrecipients following UCI's NSF/NASA 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/NASA compliant research project including:

  • Income (including salary, consulting payments, honoraria, royalty payments, dividends, loans from the entity, or any other payments or consideration with value) > $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, private equity, real estate, or other investment or ownership interests) > $10,000 or 5% ownership interest in entity (Note: Additional questions regarding venture or other capital financing may be asked in cases of 5% or greater equity/ownership interest in private entity); OR
  • 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 > $5,000 rather than NSF/NASA's income > $10,000).  Please answer the KR COI Annual Disclosure questions carefully.  When your NSF/NASA compliant project is awarded, the COI Team will email the Disclosing Individual to confirm that the financial interest meets the NSF/NASA 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, 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

 

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: