Requests from COI

3 question marks in word baloons

For additional guidance on how to complete the requested COI disclosure form or task, please select the appropriate item below.  All items (excluding the online KR COI Annual Disclosure, Ethics and Compliance Briefing for Researchers, and PHS Travel Log) should be submitted to coioc@research.uci.edu.

COI Deadlines & Meetings

Deadline to submit all necessary documents for review: First business day of the month

Committee meeting: Third Thursday of the month

Initial Disclosure (Do you have an outside financial interest?)

KR COI Annual Disclosure

Who: "Investigator" on an active or proposed Public Health Service/National Institutes of Health and/or National Science Foundation or on a PHS/NSF compliant project.

What:  Complete the KR COI Annual Disclosure to disclose if you have any significant financial interests.

When:

  • Prior to PHS/NSF compliant proposal submission
  • At least annually for the duration of an active PHS/NSF compliant award
  • Within 30 days of acquiring a new significant financial interest if you have never had one (answered "No" previously)

How: Click the above "KR COI Annual Disclosure" link.  Answer two yes/no questions about whether you have a significant financial interests related to your institutional responsibilities and click "submit".

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NSF, or proposed for such funding, which may include, for example, collaborators or consultants. 
  • Significant Financial Interests (includes foreign and domestic interests): Do you, your spouse/registered domestic partner, and/or dependent children have any of the following Significant Financial Interests (including Significant Financial Interests in foreign institutions of higher education and foreign government agencies) related to your Institutional Responsibilities?
    • Total income or payment of services received over the past 12 months and/or equity interest (includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value) in a publicly traded entity exceeding $5,000 when aggregated
    • Total income or payment of services received over the past 12 months from a non-publicly traded entity exceeding $5,000
    • Any equity interest (includes any stock, stock option, or other ownership interest) in a non-publicly traded entity
    • Total payments received over the past 12 months for any intellectual property rights and interests (e.g., patent, copyright, assigned or licensed to a party other than the Regents) exceeding $5,000
    • Any intellectual property rights and interest excluding those assigned to UC Regents
    • Note: If you are an active PHS compliant Investigator, sponsored and reimbursed travel is considered a SFI that needs to be disclosed so you are also required to submit travel disclosures through the PHS Travel Log within 30 days of the new significant financial interest.
  • Institutional Responsibilities: include an Investigator’s teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California and directly related to those credentials, expertise and achievements upon which the Investigator’s University of California campus position is based.

Additional Resources:

Form 700U

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

Who: Principal Investigator or Co-Principal Investigator on a non-governmental sponsored research contract, grant, gift, or certain incoming material transfer agreement (see list of 700U exemptions).

What:  Complete California State Disclosure Form 700U to determine if you have any disclosable financial interests per their policy.

When: Prior to release of an award; with a renewal (extension of time and money of the original award)

How: Complete the Form 700U about any financial interests in the non-governmental sponsor.  Electronic copy will be used for COI review; however, original, wet-ink signed copy should be forwarded to: Office of Research, Zot Code: 7600, 160 Aldrich Hall, per the state requirements.

  • Sponsored Research Agreement
    • Know will be funded at proposal submission (ex. industry clinical trial)- upload in KR Proposal Development.
    • Unknown if will be funded at proposal submission- Contracts & Grants Officer will request when awarded.
  • Gift- submit with gift documentation to University Advancement.
  • Material Transfer Agreement- If the principal investigator of a Material Transfer, responds “Yes” to questions 16-18 on the UCI Materials Transfer Agreement form, then the principal investigator must submit the State of California’s Statement of Economic Interest for Principal Investigators (Form 700U).  The state disclosure requirement for principal investigators also applies to co-principal investigators.

Tips: 

  • Amount of Funding- check "Estimated" in case the amount may change
  • Section 3- these questions refer to your personal financial interests in the sponsor/donor. Please exclude any income or gifts from the sponsor/donor paid to UCI because those are considered part of your UCI employment.
  • Material Transfer Agreement
    • Under Section 1:  Please enter the name of the entity you are receiving a material transfer from and the estimated dollar amount of the materials (if not known, please indicate “research materials”).
    • Under Section 2:  Check “Initial” and enter the date you expect to start the research.
    • Under Section 3:  Please indicate whether or not you have any financial interests in the entity.

Additional Resources:

Form 800SR- non-UCI PHS Investigators

Who: If you are non-UCI researcher participating in a UCI Public Health Service/National Institutes of Health or PHS UCI out-going subaward without a PHS compliant policy

What:  Annual disclosure to determine if you have any significant financial interests to the PHS compliant study.

When: Prior to PHS compliant proposal submission, at least annually for the duration of an active PHS compliant award, and within 30 days of acquiring a new significant financial interest.

How: Complete the appropriate disclosure form and submit with your subaward package submission or upload in KR Proposal Development with the proposal application.

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants. 
  • Significant Financial Interests (includes foreign and domestic interests): Do you, your spouse/registered domestic partner, and/or dependent children have any of the following Significant Financial Interests (including Significant Financial Interests in foreign institutions of higher education and foreign government agencies) related to this PHS compliant project?
    • Total income or payment of services received over the past 12 months and/or equity interest (includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value) in a publicly traded entity exceeding $5,000 when aggregated
    • Total income or payment of services received over the past 12 months from a non-publicly traded entity exceeding $5,000
    • Any equity interest (includes any stock, stock option, or other ownership interest) in a non-publicly traded entity
    • Total payments received over the past 12 months for any intellectual property rights and interests (e.g., patent, copyright, assigned or licensed to a party other than the Regents) exceeding $5,000

Additional Resources:

Form 900SR- non-UCI NSF Investigators

Who: If you are non-UCI researcher participating in a UCI National Science Foundation compliant study or NSF UCI out-going subaward without its own NSF compliant policy

What:  Disclosure to determine if you have any related significant financial interests.

When: Prior to NSF compliant proposal submission and after acquiring a new significant financial interest.

How: Complete the appropriate disclosure form and submit with your subaward package submission or upload in KR Proposal Development with the proposal application.

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by NSF, or proposed for such funding, which may include, for example, collaborators or consultants. 
  • Significant Financial Interests (includes foreign and domestic interests): Do you, your spouse/registered domestic partner, and/or dependent children have any of the following Significant Financial Interests (including Significant Financial Interests in foreign institutions of higher education and foreign government agencies) related to this NSF compliant project?
    • Total income or payment of services received over the past 12 months exceeding $10,000
      • Includes salary, consultant payments, honoraria, royalty payments, dividends, loan or any other payments or consideration with value, including payments made to the University Health Sciences Compensation Plan). Please exclude income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities and income from service on advisory committees or review panels for public or nonprofit entities
    • Equity interest (e.g., stock, stock options, real estate, or any other investment or ownership interest in an entity exceeding $10,000 (current market value) or a 5% or greater ownership interest
    • Any intellectual property rights and interests (e.g., a patent, patent application, copyright of software assigned or licensed to a party other than the UC Regents)

Additional Resources:

PHS Travel Log

Who: "Investigator" on an active or proposed Public Health Service/National Institutes of Health or on a PHS compliant project.

What:  Complete the PHS Travel Log to disclose all sponsored and reimbursed travel.

When:

  • Prior to PHS compliant proposal submission
  • At least annually for the duration of an active PHS/NSF compliant award
  • Within 30 days of acquiring a new significant financial interest if you have never had one (answered "No" previously)

How: Click the above "PHS Travel Log" link.  Provide the basic information required about the trip and click "submit".  

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NSF, or proposed for such funding, which may include, for example, collaborators or consultants.

Additional Resources:

COI Addendum (Details about your outside financial interests)

Annual Form 810

Who: Investigator on active or proposed PHS compliant study who has a positive KR COI Annual Disclosure (answered "Yes" to question 1).

What:  Complete Annual Form 810 to disclose the details of your significant financial interests for the COI Team's relatedness review as required by the PHS regulations at least annually.

When: Initially at Just-in-Time or Notice of first PHS Award, then at least annually

How: Click the above "Annual Form 810" link and submit completed form to coioc@research.uci.edu.  The COI Team will notify you if a COIOC review is required.

Tips:

  • "Entity's Business Interests"- the more specific your description (if possible), the better chance that some of your PHS research will be considered unrelated
  • "Percentage of Issued & Outstanding Shares"- if this is left blank, we contact you for this information
  • If you have received consulting income over $10,000 in the past 12 months, make sure to include a copy of your consulting agreement with your 810 submission

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants. 
  • Significant Financial Interests (includes foreign and domestic interests): Do you, your spouse/registered domestic partner, and/or dependent children have any of the following Significant Financial Interests (including Significant Financial Interests in foreign institutions of higher education and foreign government agencies) related to your Institutional Responsibilities?
    • Total income or payment of services received over the past 12 months and/or equity interest (includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value) in a publicly traded entity exceeding $5,000 when aggregated
    • Total income or payment of services received over the past 12 months from a non-publicly traded entity exceeding $5,000
    • Any equity interest (includes any stock, stock option, or other ownership interest) in a non-publicly traded entity
    • Total payments received over the past 12 months for any intellectual property rights and interests (e.g., patent, copyright, assigned or licensed to a party other than the Regents) exceeding $5,000
    • Note: If you are an active PHS compliant Investigator, sponsored and reimbursed travel is considered a SFI that needs to be disclosed so you are also required to submit travel disclosures through the PHS Travel Log within 30 days of the new significant financial interest.
  • Institutional Responsibilities: include an Investigator’s teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California and directly related to those credentials, expertise and achievements upon which the Investigator’s University of California campus position is based.

Additional Resources:

COI Addendum Versions:

  • Form 820- PHS compliant studies
  • COI-1- IRB protocols and NSF compliant studies
  • COI-1CA- Non-governmental sponsored studies (Form 700U)
  • COI-3- Addendum for non-UCI researchers

Who: You disclosed a related significant/disclosable financial interest that requires COIOC review

What:  COI Addendum is the main information the COIOC will review to determine if additional COI oversight is necessary or recommend it for approval

When: Prior to the release of an award or an IRB approval.

How: Complete the appropriate version of the COI Addendum and submit to coioc@research.uci.edu.

Tips:

  • The first page of the COI Addendum includes tips to address the common COI concerns.
  • Equity interests- make sure to include the percentage of issued and outstanding shares
  • If you have received at least $10,000 in consulting income from the Entity, please attach a copy of your consulting agreement.
  • COI Point Person is required for all new studies starting June 1, 2021 as a new UCI COI standard best practice (see the COI Point Person row for more information)   
  • COI Liaison is not required for all studies.  We recommend it in cases where the Disclosing Individual has already engaged a non-conflicted, non-junior colleague to take on additional COI oversight responsibilities given the higher level COI concerns (such as the Disclosing Individual is the most senior person actively involved in many key aspects of the study that originally did not include any other non-conflicted peers of the Disclosing Individual's).  Please indicate on the COI Addendum and attach the COI Liaison Acknowledgement Form.  Note: We recommend including the COI Point Person responsibilities in the COI Liaison Acknowledgment Form to reduce how many additional individuals need to be involved.  The COI Liaison should have more responsibilities than the COI Point Person's standard responsibilities.

Additional Resources:

Gift Addendum (COI-2)

Who: Principal Investigator or Co-Principal Investigator on a research gift with financial interests in the donor

What:  Gift Addendum is the main information the COIOC will review to determine if additional COI oversight is necessary or recommend it for approval

When: Prior to the release of the gift funds.

How: Complete the Gift Addendum and submit to coioc@research.uci.edu.

Tips:

  • Equity interests- make sure to include the percentage of issued and outstanding shares

Resources:

Expedited Form

Who: If you were reviewed by the COIOC for the same financial interests for the same project last year (PHS compliant studies and IRB protocols)

What:  Simplified expedited review process to determine if there were any significant changes that would require a full committee review

When: Prior to release of continuation or with continuing IRB application

How: Complete the Expedited Form and submit to coioc@research.uci.edu

Tips:

  • Please review your previously submitted disclosures carefully before answering the questions to the Expedited Form.

Other

Who: Study teams submitting industry clinical trials or similar types of projects

What: There are two conflict of interest policies that apply to industry clinical trials, State Law and IRB COI, that require disclosures of financial interests.

When: Required prior to IRB final approval and the execution of the contract

How: 

  • State Law: Upload the completed Form 700U(s) from Principal Investigator and if applicable, Co-Principal Investigator to KR Proposal Development (KR PD)
  • IRB COI:
    • UCI is the IRB of record/reviewing IRB:  Study team submits the KR Protocols application for IRB review. KR Protocols application includes a financial interest disclosure question for each listed research personnel.  IRB will notify the COI Team of any positive disclosures.
    • UCI is relying on non-UCI IRB review: COIOC review and approval needs to occur before IRB submission. This means that the COI team needs to be notified that a review is needed prior to the submission of your application to the IRB.
      • Please email coioc@research.uci.edu with a subject heading: "Relying on non-UCI IRB Review" and attach:
        • COI Addenda for all the related disclosable financial interests
        • Master Protocol

 Procedure:

  • Contract
    • Based on the type of project, the study team emails Clinical Trials or Industry Sponsored Research and copies the COI Team to indicate that a KR PD was initiated and indicate whether the Form 700U was uploaded or pending.
      • If Form 700U pending, send a follow-up email to the group notifying the teams that the Form 700U has been uploaded.
  • Human Subjects Research
    • UCI is the IRB of record/reviewing IRB: IRB Team will notify COI Team of positive disclosures.
    • UCI is relying on non-UCI IRB review: Study team will notify COI Team of positive disclosures.
  • COI Review
    • COI Team will determine the necessary reviews based on the different policies and conduct one review for all applicable policies.  To facilitate this process, please try to initiate the KR PD  with the uploaded Form 700U around the same time as you submit the KR Protocols application.

Forms: 

Who: As of June 1, 2021, all individuals on new studies reviewed by the Conflict of Interest Oversight Committee

What: Disclosing Individual must disclose their related financial interests to the study team working on that related project and identify a COI Point Person.  

When: Required for Conflict of Interest Oversight Committee review

How: Submit a copy of the complete email (s) sent disclosing the related financial interest and the identified COI Point Person (who is copied on the email) with the COI Addendum (see Templates).  This serves to document that the research team and the chosen COI Point Person are aware of the related financial interest and the identification of the COI Point Person.

Key definitions:

  • COI Point Person: a non-conflicted individual that is the same level or higher to the Disclosing Individual that is aware of the related financial interest and has been identified through email to the study team as the person to contact with any COI related questions or concerns.  
  • COI Liaison: a non-conflicted individual that is peer-level or higher to the Disclosing Individual, who will provide additional COI oversight for the project by taking on additional responsibilities. In some cases, this COI Liaison's responsibilities may include the COI Point Person's responsibilities. Examples of some of the tasks the COI Liaison may participate in to provide additional COI oversight include but are not limited to:
    • Data collection
    • Access to project data
    • Data analysis
    • Data reporting
    • Study design
    • Review of reports
    • Co-supervising students (undergraduate, graduate, and postdoctoral students)  
  • Disclosing Individual: individual with financial interest being reviewed by the COIOC

Possible COI Point Person:

  • Disclosing Individual is is not the PI
    • If the PI is non-conflicted and of equal or higher rank to the DI, they can serve as the COI Point Person.
  • Disclosing Individual is the PI, but there is a non-conflicted investigator of equal or higher rank on the project
    • The non-conflicted investigator that is of equal or higher rank to the DI can serve as the COI Point Person.
  • Disclosing Individual is the PI and highest ranking individual on the project
    • Identify a non-conflicted individual of equal or higher rank who can serve as the COI Point Person for the study team. The Point Person should have knowledge of the research subject matter. This can be the department chair or a similar leadership role. They would not need to be added to the project.
  • COI Liaison has been identified for the project
    • Include the responsibilities of the COI Point Person on the COI Liaison Acknowledgment Form to have this individual assume both roles.  The COI Liaison must have additional responsibilities beyond the standard COI Point Person responsibilities.

If the Disclosing Individual has difficulty finding an appropriate COI Point Person, please contact the COI Team at coioc@research.uci.edu

COI Liaison Acknowledgement Form

Who: (Optional) Disclosing Individuals who determined they have a higher level COI risk can identify a non-conflicted, equal rank or higher researcher to provide additional COI oversight.

What: COI Liaison Acknowledgment Form documents and confirms the person identified as the COI Liaison in the COI Addendum is aware of and accepts their specific COI oversight responsibilities.

When: Collected along with the COI Addendum for the COIOC review when the Disclosing Individual indicates there is a COI Liaison.

How: Submit a copy of the signed COI Liaison Acknowledgement Form with the COI Addendum submission to coioc@research.edu.

Key definitions:

  • COI Liaison: a non-conflicted individual that is peer-level or higher to the Disclosing Individual, who will provide additional COI oversight for the project by taking on additional responsibilities. In some case, this COI Liaison may be the same individual identified as the COI Point Person for the study. Examples of some tasks the COI Liaison may participate in to provide additional COI oversight include but are not limited to:
    • Data collection
    • Access to project data
    • Data analysis
    • Data reporting
    • Study design
    • Review of reports
    • Co-supervising students (undergraduate, graduate, and postdoctoral students)  
  • COI Point Person: a non-conflicted individual that is the same level or higher to the Disclosing Individual that is aware of the related financial interest and has been identified through email to the study team as the person to contact with any COI related questions or concerns.  
  • Disclosing Individual: individual with financial interest being reviewed by the COIOC

Tips:

  • Make the COI Liaison also the COI Point Person by including the COI Point Person responsibilities (study team should contact this individual if they have any COI related questions or concerns) in the COI Liaison Acknowledgement Form.

Resources:

Ethics and Compliance Briefing for Researchers

Who: "Investigator" on an active or proposed Public Health Service/National Institutes of Health or on a PHS compliant project.

What:  Complete the UC Ethics and Compliance Briefing for Researchers (ECBR) at least every 2 years.

When:

  • Prior to PHS compliant award
  • At least every two years for the duration of an active PHS/NSF compliant award

How: Click the above "Ethics and Compliance Briefing for Researchers" link.  

Key definitions:

  • Investigator: include the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NSF, or proposed for such funding, which may include, for example, collaborators or consultants.

Additional Resources: