Conflict of Interest (COI) Committee


About COI

Investigators at UC Riverside are subject to UC system-wide policies, as well as specific State of California laws and federal regulations. Reporting to the Vice Chancellor for Research and Economic Development, the faculty Conflict of Interest committee, is responsible for the review and assessment of all financial disclosures related to research projects at UC Riverside, as well as determining any actions required to ensure that real or perceived financial conflicts of interest are managed, reduced or eliminated. The COI committee’s primary goal is to promote research objectivity by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under relevant grants, cooperative agreements and contracts will be free from bias resulting from investigator financial conflicts of interest.

The ORC research staff provides support for UCR investigators and the COI committee to facilitate and promote compliance with University, state, and federal policies and regulations regarding financial conflicts of interests related to the objective conduct of research, including Public Health Service (PHS) and National Science Foundation (NSF).
 

What is a Conflict of Interest?

A Conflict of Interest (COI) is a situation where an investigator's outside financial interests (e.g., salaries; consulting income; receipt of income from intellectual property rights; equity interests; ownership of equity in publicly or privately held businesses; honoraria; gifts; loans; or travel payments) or paid or unpaid obligations (e.g., director, officer, partner, consultant or manager of an entity) bias or have the potential to bias a research project. This also applies to the immediate family members of that investigator. When a financial interest constitutes a Financial Conflict of Interest (FCOI), COI will work with the disclosing individual to develop a management plan, if applicable, before the disclosure can be approved.

Please note a conflict of interest is not 1) research misconduct, 2) evidence of wrongdoing, 3) indication of moral weakness, or 4) prohibited by law, regulation, or policy.

Be aware that not all outside financial interests are necessarily conflicts of interests in research. The University recognizes outside financial interests can facilitate opportunities for innovation, collaboration, and support. Federal, state, and university regulations and policies requiring financial disclosure and review were implemented to address those instances when the outside financial interests may bias or appear to bias the research. In addition to promoting transparency and accountability, financial disclosures also protect the researcher’s interests by 1) meeting the requirements set by sponsors and the University, 2) having the COI committee, an objective third party, review the financial interests and the research, and 3) demonstrating a commitment to scientific integrity.

Depending on the nature of the study and the sponsor(s), more than one conflict of interest disclosure policy may apply.  Please check with COI if you have questions.
 

Levels of Reporting

In terms of financial interest and disclosures, there are five different levels of reporting and each has different reporting requirements:

  • Non-governmental Sponsor (State Law)
  • Public Health Service & Organizations following PHS Regulations
  • National Science Foundation & Organizations following NSF Policy and
  • Department of Energy (All DOE information is located on this page)
  • National Aeronautics and Space Administration (All NASA information is located on this page)

 

When to Disclose

  • For Research Funded by Non-governmental Sponsors (State Law)

    For Research Funded by Non-governmental Sponsors (State Law)

    State 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 Discloses
    • All persons employed by UC who have principal responsibility for a research project if the project is to be funded or supported, in whole or in part, by a contract or grant (or other funds earmarked by the donor for a specific researcher) from a non-governmental entity.
    • All persons employed by UC who have principal responsibility for a research project if the project is to be funded or supported, in whole or in part, by a gift (earmarked by the donor for a specific researcher) from a non-governmental entity.
    When to Disclose
    • With the initial proposal submitted to the Sponsored Programs Office.
    • What to Disclose:
      • Income ≥ $500
      • Investments ≥ $2,000
      • Director, Officer, Employee, Partner, Trustee, Consultant or Management position
      • Loan Balances ≥ $500
      • Personal Gifts Valued at ≥ $50
      • Travel Reimbursements
  • For Research Funded by the Public Health Service or Organizations Following PHS Regulations

    For Research Funded by the Public Health Service or Organizations Following PHS Regulations

    PHS Reporting Triggers
    • PHS research contract/grant
    • Non-governmental entity which flows down PHS 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
    Who Discloses
    • All individuals "with responsibility for the design, conduct or reporting of the research" must disclose the “significant” and “related” financial or management interests to the research described in the proposal for themselves, their spouses/registered domestic partners, and their 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 new personnel are added
    • At least annually for duration of project
    • With any new significant financial interest (SFI - new significant financial interests must be reported within 30 days of acquiring or discovering the new SFI)
    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 > $5,000
    • If non-publicly traded entity, total value of compensation > $5,000 or any equity interest
    • 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 Federal, state, local government agency, an Institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a 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.)
  • For Research Funded by the National Science Foundation & Organizations Following NSF Policy

    For Research Funded by the National Science Foundation & Organizations Following NSF Policy

    NSF 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 Discloses

    This policy also applies to any proposal submitted to California Institute for Regenerative Medicine (CIRM), UC Discovery Grant Programs, UCOP Special Research Programs: CBCRP, CHRP, TRDRP, or any other institutions whose proposal to any of the above sponsors includes a subaward to UCR.

    • All investigators responsible for the “design, conduct or reporting” of the NSF-funded research project or educational activities to disclose their significant financial interests related to the research project or educational activities. Investigators must also disclose the financial interests of their spouses/registered domestic partners and dependent children. UCR’s policy is consistent with the “Investigator Financial Disclosure Policy” of the NSF.
    When to Disclose
    • With the initial proposal
    • When new personnel are added
    • With any change in an investigator’s financial interest
    • Or at least annually
    What to Disclose
    • A significant financial interest related to the 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)
      • Equity interest > $10,000 or 5%
      • Intellectual Property interest in a patent, patent application, or copyright of a software (excluding intellectual property owned by the UC)
  • Research Gifts

    Research Gifts

    State policy requires research gift recipients to disclose financial interests when a gift is received from a non-governmental agency, such as a company or private foundation, which is earmarked by the donor for a specific principal investigator or a specific research project.  All research gifts for researchers or specific research projects are reviewed by a COI administrator to help ensure that the funds are appropriately classified based on UC policy.
     

    When to Disclose

    With the initial gift - these documents need to accompany the gift document collected by Gift Administration.
     

    Determining Disclosable Financial Interests

    The principal investigator must submit the Statement of Economic Interests for Principal Investigators (Form 700-U), which asks questions regarding financial interests the principal investigator, principal investigator’s spouse and dependent children may have in the donor.

    • If the principal investigator, principal investigator’s spouse and dependent children indicate “No” for all the questions in Section 3 (Filer Information), then the principal investigator only needs to submit the Statement of Economic Interests for Principal Investigators form indicating the negative disclosure.
    • If the principal investigator, principal investigator’s spouse, or dependent children indicate “Yes” for any of the questions in Section 3 (Filer Information), then the PI must submit the 1) UCR COI Addendum for Positive 700-U and NSF 925 and the 2) Extramural Funds Classification Confirmation and Certification Statement, to be reviewed by the Conflict of Interest committee.

    Please contact Advancement Administration for further information about the gift process.


What is the COI Review Process?

The COI committee is comprised of faculty from throughout the campus and is an advisory committee to the Vice Chancellor for Research and Economic Development (VC-RED). The COI committee makes recommendations to the VC-RED to accept an award or to manage, reduce or eliminate conflicts of interest in order to preserve objectivity in the design, conduct or reporting of research. The COI committee meets once per month on an as-needed basis (i.e., if there are disclosures to review). In order for the COI committee to review the disclosure and recommend an adequate management/monitoring plan, please submit your disclosures well in advance of your anticipated start date.

For a more detailed summary of the thresholds, please see the UCR COI Disclosure Chart.
 

COI Submission and Review Process Flowchart
COI submission and review process flowchart

 

Researchers should plan to submit the disclosure forms well in advance of any anticipated study start and address those issues raised during the review and approval process.

For a more detailed summary of the thresholds, please see the UCR COI Disclosure Chart.

  • Levels of Review

    Levels of Review

    Depending on the complexity associated with your research, COI staff will categorize your submission for review. Applications will be reviewed on a first-come, first-served basis. Therefore, the Research Compliance Office highly recommends accurate, thorough, and timely submission of your attachments to account for this review process.

    There are three levels of conflict review performed by the office:

    COI Review Level Review Duration
    Administrative Review 1 - 2 weeks
    Delegated Review 2 - 3 weeks
    Full Committee Review 4 - 6 weeks
     

    Most reviews are completed by COI staff, including all negative disclosures. In the event of a positive conflict of interest disclosure, COI staff will request additional background information and determine if it should go to the COI Committee for review and management.

     

  • Submission Deadlines

    Submission Deadlines

    These deadlines are only for applications that require full committee review:

    Submission Deadline Dates
    Submit all required documentaton by
    For PRO review in this month
    TBD TBD
       

     

How to Submit Disclosure Forms

Depending on the type of research funding you have obtained and/or your outside interests in addition to your research, different forms will be required. See each section below as it relates to the type of research funding obtained.

Positive disclosures may not necessarily result in full COI committee review. As noted above, there are three levels of conflict review performed by the office, administrative, delegated and full committee reviews. Reviews are completed by COI; including all negative disclosures. In the event of a positive conflict of interest disclosure, COI staff will request additional background information and determine if it should go to the COI committee for review and management.

You can find the following forms in Kuali COI.

  • For Research Funded by Non-governmental Sponsors (State Law)

    For Research Funded by Non-governmental Sponsors (State Law)

    Only the Principal Investigator (PI) completes and submits a 700-U Form per project. This disclosure will be valid for the life of the project, unless there are any changes to the funding amounts, term of the funding or PIs. Completion of the 700-U Form is not required if the State has placed the sponsor on the Exempt List. If the sponsor is not on the exempt list, the PI must:

    • Complete and sign a Form 700-U
    • Submit the originally signed Form 700-U (This is required by the State)
    • If you answered yes to any questions on the Form 700-U, you will be prompted to answer supplemental questions in Kuali.
  • For Research Funded by the Public Health Service or Organizations Following PHS Regulations

    For Research Funded by the Public Health Service or Organizations Following PHS Regulations

    If your research is sponsored by a PHS agency or an entity that has adopted the PHS rules, you must complete and submit the COI disclosure  in Kuali and the PHS COI training in LMS. Search for eCourse: General Compliance Briefing: University of California Ethical
    Values and Conduct. Please see the list of sponsors that require compliance for PHS Regulations. This list of PHS agencies is taken from the U.S. DHHS Organizational Chart

  • For Research Funded by National Science Foundation & Organizations following NSF Policy

    For Research Funded by National Science Foundation & Organizations following NSF Policy

    If your research is funded by one of the government/public entities listed below, all investigators must complete and submit a COI disclosure in Kuali.

    • National Science Foundation (NSF)
    • California Institute for Regenerative Medicine (CIRM)
    • UC Discovery Grants
    • UCOP Special Programs

Education and Training

For 700-U (State) There is no required COI training for investigators.
For PHS/DOE

All UCR Investigators applying for and/or receiving PHS/ DOE funding must complete "eCourse: General Compliance Briefing: University of California Ethical Values and Conduct" in LMS

For NSF There is no required COI training for investigators.

PHS/DOE Compliant Training- ECBR Slides is also available for review.

Researchers and committee members can find more information in the COI section of the Resources Page.
 

Contact Us

If you have questions, the Office of Research Compliance recommends you consult and engage our office as soon as possible.

Please email us at coi@ucr.edu to set up an appointment.

Conflict of Interest (COI) FAQs

  • What is a Research-Related Conflict of Interest (COI)?
  • What is the Conflict of Interest (COI) committee?

    The Conflict of Interest committee is responsible for the review and assessment of all financial disclosures related to research projects at UC Riverside, as well as determining any actions required to ensure that real or perceived financial research-related conflicts of interest are managed, reduced or eliminated.

  • How are Research-Related COIs and Conflict of Commitment (COC) related?
  • What is a Financial Conflict of Interest (FCOI)?

    In accordance with the University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Public Health Services Sponsored Awards for Research (42 C.F. Part 50, Subpart F and 45 C.F.R., Part 94): The Principal Investigator and all other UCR investigators must disclose their personal significant financial interests (and those of their spouse/registered domestic partner and/or dependent children) related to their institutional responsibilities. This includes the Principal Investigator, Co-Investigators, Senior and Key Personnel, and any other individual who is responsible for the design, conduct, or reporting of research funded by PHS or an agency or organization that follows PHS disclosure requirements (for example, American Heart Association, American Cancer Society, etc.). This Form is to be completed by the Principal Investigator, and those Project Personnel designated by the Principal Investigator as an Investigator, as defined by the 2011 Revised PHS Regulations.

  • How are FCOI’s managed?

    After COI determines that a financial interest rises to the level of a financial research-related conflict of interest, COI will create a management plan recommendation. The COI committee works with the Investigator to create the management plan that strives to be the simplest effective means of managing the conflict. Each management plan is situation-specific which is why it requires cooperation between the investigator and COI.

    The COI committee submits a recommendation to the VC-RED. The VC-RED will determine whether the management plan is sufficient and if so, the plan is presented to the investigator. The investigator will be required to review the plan and sign that they agree to comply and implement the plan.

  • What are some general principles to keep in mind when starting a company?
    • Keep your company activities separate and distinct from UC faculty activities;
    • Expect your company to be treated exactly like any other company (the fact it’s partially owned by a UC faculty member does not give it any special privileges.);
    • File a disclosure to evaluate potential conflicts and mitigate risk if necessary;
    • Not all research-related conflicts are impermissible and most are manageable;
    • When human subjects are involved, there will be a higher level of scrutiny;
    • Case-by-case analysis and management is crucial;
    • When in doubt, disclose to PRO.
  • Can I start a company?

    Yes. UCR's research-related conflict of interest and conflict of commitment policies do not prohibit investigators from starting their own company, however depending on the type of research the investigator conducts, there may be conflict of interest disclosure requirements and approvals required. Please contact COI for more information.

    In the case individuals are looking for information related to these types of start-ups and entrepreneurial activities at UCR, they can be directed to RED’s Entrepreneurial Proof of Concept and Innovation Center (EPIC) website and staff.

  • Can I serve on a board of advisors/directors?

    Yes, UCR's research-related conflict of interest policy does not prohibit investigators from serving on a board of directors, advisors, or similar. If this position also involves other financial interests such as income or equity interests, the investigator may have additional COI disclosure requirements. If COI determines that these interests could potentially be a conflict of interest 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 serving on a board should contact COI as soon as possible to discuss possible conflict of interest issues related to their research.

    Service on a board of directors carries with it legal fiduciary responsibility, but generally not management responsibility and hence, is generally permissible. The investigator’s primary commitment is to the university and service on a board of directors should not interfere with his/her primary obligations as a faculty member or university employee. For more information on COC, see this page provided by the Office of Academic Personnel.

  • Can I serve on a scientific advisory board?

    Yes, serving on a Scientific Advisory Board is permitted because such positions do not carry, nor are they perceived to carry, management responsibility. The investigator, however, should recuse himself/herself from any discussion or decision to fund his/her own research. If this position also involves other financial interests such as income or equity interests, the investigator will have additional COI disclosure requirements.

  • Can I participate in research sponsored by a company that licensed technology I invented at UCR?

    Yes. However, your participation in the research could be considered a potential research-related conflict of interest if you have a financial or equity interest in the sponsor. If you have financial interests in the sponsor, you may need to disclose and have the paperwork reviewed by COI.

    For a detailed summary of the thresholds, please see the State Law column in the UCR COI Disclosure Chart.

    If you do not have a financial or equity interest in the sponsor, you will not need to be reviewed by COI.

    If you have any questions, please reach out and contact us so we may schedule a consultation.

  • What are some examples of mitigation or management plans to address COIs?

    Here are some examples of how to address potential research-related conflicts of interest:

    • Public disclosure of significant financial interests;
    • Training on research-related conflicts of interest for all personnel involved in the research;
    • Monitoring of research by independent reviewers;
    • Double-blind study and/or randomized study
    • Modification of the research plan to ensure objectivity;
    • Have non-conflicted investigators collect data and perform data analyses;
    • Remove oneself as the Principal Investigator;
    • Disqualification from participation in all or a portion of the research;
    • Divestiture of significant financial interests;
    • Severance of relationships that create actual or potential conflicts
  • I serve as consultant to a company and want to test a product from that company. Does having non-conflicted investigators and the study being blinded assist in mitigating the conflict?

    Yes, having a non-conflicted investigator and blinding the study will help mitigate the conflict; however, COI will still need to review all the factors to determine if that is necessary and/or sufficient. As part of the COI review, these are some but not all of the other factors the COI will consider:

    • Who has supervisory authority of all research personnel involved in the study?
    • Are there any research personnel under the supervision of the conflicted individual?
    • Is (Are) the non-conflicted investigator(s) junior to the conflicted individual?
    • Are students involved and if so, who is supervising them?
    • Who’s doing the data analysis, collection, and reporting?
    • Are there Human Participants involved?

    Depending on the level of risk created from the financial interest and how the study is designed, COI may require additional measures to protect the objectivity of the research.

  • May I own stock in a publicly traded company and serve as an investigator on a study for that company’s products?

    You could serve as the investigator on a study, however depending on who the sponsor of the study is and the percentage and/or the value of the stock, you may be required to disclose and go through a COI review. For a more detailed summary of the thresholds, please see the UCR COI Disclosure Chart. If you have this type of situation, please contact us so we may schedule a consultation.

  • Through the university, I am an inventor on a patent. May I serve as an investigator testing its effectiveness?

    Potentially yes, but it depends on the sponsor of the research. It also depends on whether you have a financial interest in the sponsor or one related to the research project, and how you would manage that financial interest. If you have a financial interest in the sponsor or one related to the research, your situation may need to be reviewed by COI. If you have this type of situation, please contact us so we may schedule a consultation.

  • I’m a co-founder in a company that would like to provide funds to my lab at UCR through an industry-sponsored research agreement, am I allowed to do that? What should I be concerned about?

    It depends. One thing you will need to be concerned about is making sure you do not represent both the university and the company in the industry-sponsored research negotiations or any business transactions. For example, we would probably recommend 1) your company hire a lawyer to represent the company in business transactions with university, or 2) your company include (or add) an individual without any university affiliation so when UC Riverside is working with the company, that person is the company representative.

    However, please note that your participation in the research could be considered a potential research-related conflict of interest if you have a financial interest in the company and are the Principal Investigator or Co-Principal Investigator. If you, the Principal Investigator or Co-Principal Investigator of the study, have financial interests in the company, you will need to disclose and have the paperwork reviewed by COI. If you have any questions, please contact us so we may schedule a consultation.

  • I’m a consultant to a company that would like to provide funds to my lab at UCR through an industry-sponsored research agreement, am I allowed to do that? What should I be concerned about?

    Yes, it is allowable for the company to provide funds to your lab but that could potentially trigger a COI review. If you have a financial interest in the sponsor and you are the Principal Investigator (or Co-Principal Investigator), your disclosures may need to be reviewed and approved by COI. If you have this type of situation, please contact us so we may schedule a consultation.

  • I own stock (have equity) in a company that would like to provide funds to my lab at UCR through an industry sponsored research agreement, am I allowed to do that? What should I be concerned about?

    Yes, it is allowable for you to own stock or have equity in the company that would like to provide funds to your lab. However, if you do have a financial interest in the company and you are the Principal Investigator (or Co-Principal Investigator), your disclosures may need to be reviewed and approved by COI. If you have this type of situation, please contact us so we may schedule a consultation.

  • I have a positive disclosure for my project that will be sent to COI for review. When will I receive the results of the review, so my study funds can be released?

    Depending on the nature of the disclosure, administrative review of submitted forms can take approximately 1 – 2 weeks after all supplemental forms have been submitted. For disclosures requiring full committee review, completion of the process will take approximately 4 – 6 weeks. See the PRO website for additional information on when the PRO committee meets.

  • When not reporting COIs, what are some of the potential risks?

    If you have any concerns regarding COI issues, we strongly encourage you to contact our office immediately. There are significant risks involved for not reporting:

    • Compromise of scientific integrity (objectivity of the research);
    • Misuse of University facilities;
    • Improper direction of student’s or University employee’s work;
    • Unbalanced allocation of faculty member’s time and effort;
    • Failure to recognize the University’s right to intellectual property and related financial interests;
    • Improper channeling of research funds;
    • Inappropriate delay or restriction on publications;
    • Appearance of impropriety