Forms & Policies

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 Federal Disclosure and Certification. 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 Federal Disclosure and Certification 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:

• KR Federal Disclosure and Certification
• Federal Supplemental Disclosure
• COI Addendum (COI-1) - updated
• COI Liaison Acknowledgement Form
• Non-UCI Investigators
  • Subrecipient/Non-UCI Investigator Disclosure- Form 900SR
  • Non-UCI COI Addendum (COI-3) - updated

Policies/Regulations:

• UC Disclosure of Financial Interests & Management of Conflicts of Interest, National Science Foundation Awards- updated
• NSF Conflict of Interest Policy
• NASA Conflict of Interest Policy- effective 12/1/23

Reporting Triggers:

• PHS or Department of Energy research contract/grant
• Non-governmental entity which flows down PHS/DOE funds
• Research Funding from organizations that follow PHS/DOE disclosure requirements (i.e., American Cancer Society, American Heart Association). See the complete list below.

Note: Exclude Phase 1 SBIR or STTR grants

Who:

• UCI Investigator(s) (individuals responsible for the design, conduct, or reporting of the funded research project)

What to Disclose:

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
• If non-publicly traded entity, total value of compensation > $5,000 or any equity interest (including stock, stock options, and other ownership interests)
• Income received 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)

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.)

Policies/Regulations:

• UCI Disclosure of Financial Interests Related to Public Health Service Sponsored Projects for Promoting Objectivity in Research
• UC Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service Research Awards
• PHS Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought

Forms:

• KR Federal Disclosure and Certification (Effective 10/31/24)
• Annual Form 810
• PHS/DOE Travel Log
• Form 820
• Subrecipient/Non-UCI Investigator Disclosure- Form 800SR
• Non-UCI COI Addendum (COI-3)

List of Organizations that require compliance with PHS regulations:

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 Heart Association (AHA)
10. American Lung Association (ALA)
11. Arthritis Foundation (AF)
12. Centers for Disease Control & Prevention (CDC)
13. Centers for Medicare and Medicaid Services (CMS) [formerly HCFA]
14. CurePSP Foundation for PSP/CBD and Related Brain Diseases
15. Food and Drug Administration (FDA)
16. Harrington Discovery Institute
17. Health Resources & Services Administration (HRSA)
18. Indian Health Service (IHS)
19. Lupus Foundation of America (LFA)
20. National Institutes of Health (NIH)
21. Office of Global Affairs (OGA)
22. Office of the Assistant Secretary for Health (ASH)
    1. Office of the Assistant Secretary for Preparedness and Response (ASPR)
       1. Biomedical Advanced Research and Development Authority (BARDA)
    2. Office of Minority Health Resources Center (OMH)
    3. Office of Population Affairs (OPA)
    4. Office of Research Integrity (ORI)
    5. Office of Research on Women’s Health (OWH)
23. Patient-Centered Outcomes Research Institute (PCORI)
24. Substance Abuse & Mental Health Services Administration (SAMHSA)
25. Susan G. Komen for the Cure

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:

• COI Addendum (COI-1) - updated
• COI Liaison Acknowledgement Form
• Non-UCI Researchers
  • Non-UCI COI Addendum (COI-3) - updated

Policies/Regulations:

• UCI Policy Disclosure & Review of Financial Interest in Human Subjects Research

Resources:

• Clinical Trials Procedure