Requests from COI
For additional guidance on how to complete the requested COI disclosure form or task, please select the appropriate item below. All Microsoft Word forms and email communication should be submitted to coioc@research.uci.edu.
Initial Disclosure (Do you have an outside financial interest?)
KR Federal Disclosure and Certification
Who: "Investigator" on an active or proposed Public Health Service/National Institutes of Health, National Science Foundation, National Aeronautics and Space Administration, US Department of Agriculture or on a PHS, NSF, USDA & NASA compliant project.
For Department of Energy (DOE)/National Nuclear Security Administration (NNSA) Only: "Covered individuals" on an active or proposed DOE/NNSA financial assistance award or application (excluding Office of Indian Energy)
What: Complete the KR Federal Disclosure and Certification to disclose if you have any significant financial interests.
When:
- Prior to PHS, NSF, DOE, NASA, USDA compliant proposal submission
- At least annually for the duration of an active PHS/DOE/USDA compliant award
- For PHS/USDA Investigators, within 30 days of acquiring a new significant financial interest if you have never had one (answered "No" previously)
How: Click the above "KR Federal Disclosure and Certification" link. Answer the first two yes/no questions about whether you have a significant financial interests related to your institutional responsibilities and click "submit". The third question relates to malign foreign talent recruitment programs and the fourth question relates to certain federal agencies' requirement to upload foreign agreements (if you have any questions, contact or-rsie@uci.edu).
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, NASA, USDA or proposed for such funding, which may include, for example, collaborators or consultants.
- DOE/NNSA Only:
Covered individual means any individual, regardless of title or position, who contributes in a substantive, meaningful way to the development or execution of the scope of work of a project funded by DOE or proposed for funding by DOE; and, is designated as a covered individual by DOE.
- Designated covered individuals:
- Principal investigators and co-principal investigators;
- Project directors and co-project directors;
- Project managers;
- Individuals, regardless of title, performing these roles;
- Individuals identified in the Notice of Funding Opportunity (NOFO) or award terms and conditions; and
- Individuals required to submit biosketch/resume or a current and pending support
- Designated covered individuals:
- 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, DOE, or USDA 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 Travel Log.
- 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.
Form 700U PDF (still requires DocuSign signature)
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.
- Sponsored Research Agreement
- If know it will be funded during proposal submission (ex. industry clinical trial)- upload in KR Proposal Development.
- If do not know whether 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:
- 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
- In the DocuSign PowerForm Signer Information page, enter the PI's name and UCI email address in the first two text boxes.
- 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.
- 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, USDA Investigators
Who: If you are non-UCI Investigator participating in a UCI Public Health Service/National Institutes of Health, US Department of Agriculture or PHS/USDA out-going subaward without a PHS/USDA compliant policy
What: Annual disclosure to determine if you have any significant financial interests to the PHS/USDA compliant study.
When: Prior to PHS/USDA compliant proposal submission, at least annually for the duration of an active PHS/USDA 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/USDA, 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/USDA 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:
Subrecipient DOE COI/COC Disclosure (coming soon)- non-UCI DOE Covered Individuals
Who: If you are non-UCI Covered Individual participating in a Department of Energy or out-going subaward without a DOE compliant policy
What: Annual disclosure to determine if you have any significant financial interests to the DOE compliant study.
When: Prior to DOE compliant proposal submission, at least annually for the duration of an active DOE compliant award, prior to being added to an active DOE project and after acquiring a new significant financial interest or commitment.
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:
- Covered individual means any individual, regardless of title or position, who contributes in a substantive, meaningful way to the development or execution of the scope of work of a project funded by DOE or proposed for funding by DOE; and, is designated as a covered individual by DOE.
- Designated covered individuals:
- Principal investigators and co-principal investigators;
- Project directors and co-project directors;
- Project managers;
- Individuals, regardless of title, performing these roles;
- Individuals identified in the Notice of Funding Opportunity (NOFO) or award terms and conditions; and
- Individuals required to submit biosketch/resume or a current and pending support
- Designated covered individuals:
- Significant financial interest (SFI) means:(1) A financial interest consisting of one or more of the following interests of the covered individual (and those of the covered individual’s spouse and dependent children) that reasonably appears to be related to the covered individual’s non-Federal entity/institutional responsibilities:
- Total remuneration received from a publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through public prices or other reasonable measures of fair market value;
- Total remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure exceeds $5,000, or when the covered individual (or the covered individual’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); and
- Intellectual property rights and interests (e.g., patents, copyrights) excluding those owned by the UC Regents, upon receipt of income related to such rights and interests.
(2) Any reimbursed or sponsored travel related to their institutional responsibilities not disclosed in current and pending or other support disclosures. Exclude travel that is reimbursed or sponsored by a US Federal, State, or local government agency; US Institution of Higher Education; or US research institute that is affiliated with a US Institution of Higher Education.(3) The term significant financial interest does not include:
- Salary, royalties, or other remuneration (including non-Federal entity assigned intellectual property rights and associated agreements to share in royalties) paid by the non-Federal entity to the covered individual if they are currently employed or otherwise appointed by the non-Federal entity;
- Any ownership interest in the non-Federal entity held by the covered individual, if the non-Federal entity is a commercial or for-profit organization;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the covered individual does not directly control the investment decisions;
- Income from service on advisory committees or review panels for or seminars, lectures, or teaching engagements sponsored by a US Federal, State, or local government agency, a US Institution of Higher Education, or a US research institute that is affiliated with a domestic Institution of Higher Education.
- A new significant financial interest is obtaining a SFI in a new Entity or acquiring a different type of SFI (e.g., equity interest versus income) than what was previously disclosed in that Entity.
Additional Resources:
Form 900SR- non-UCI NSF & NASA Investigators
Who: If you are non-UCI researcher participating in a UCI National Science Foundation or National Aeronautics and Space Administration compliant study or NSF/NASA out-going subaward without its own NSF/NASA compliant policy
What: Disclosure to determine if you have any related significant financial interests.
When: Prior to NSF/NASA 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/NASA, 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/NASA 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, venture or other capital financing, 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)
- Total income or payment of services received over the past 12 months exceeding $10,000
Additional Resources:
Who: "Investigator" on an active or proposed Public Health Service/National Institutes of Health, Department of Energy, US Department of Agriculture or on a PHS/DOE/USDA compliant project.
What: Complete the Travel Log to disclose all sponsored and reimbursed travel.
Exclude:
- Travel that is reimbursed or sponsored by a US Federal, state, local government agency, a domestic Institution of higher education, or a research institute affiliated with an Institution of higher education within US
- Sponsored or reimbursed travel for the Investigator's spouse/registered domestic partner and/or dependent children
- Travel that is reimbursed or sponsored by an academic teaching hospital or medical center
When:
- Prior to PHS/DOE/USDA compliant proposal submission
- At least annually for the duration of an active PHS/DOE/USDA 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 "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 purpose (DOE only), design, conduct, or reporting of research funded by PHS/DOE/USDA, or proposed for such funding, which may include, for example, collaborators or consultants.
Additional Resources:
COI Addendum (Details about your outside financial interests)
Who: Investigator on active or proposed PHS/USDA compliant study who has a positive KR Federal Disclosure and Certification (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/USDA at least annually.
When: Initially at Just-in-Time or Notice of first PHS/USDA Award, then at least annually and when a new significant financial interest is acquired or discovered
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/USDA 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/USDA, 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 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:
Department of Energy (DOE) Conflict of Interest and Conflict of Commitment Disclosure (DOE COI/COC Form)- coming soon
Who: All covered Individuals on active or proposed DOE including National Nuclear Security Administration (NNSA) financial assistance award and flow-through, excluding Office of Indian Energy
What: Complete DOE COI/COC Disclosure to disclose the details of your significant financial interests and commitments for the COI Team's relatedness review as required by the DOE at least annually.
When: With the proposal submission, at least annually for the duration of a DOE funded award, when a Covered Individual is added to an active DOE award prior to participating in the project, and when a new significant financial interest or commitment is acquired
How: Complete the DOE COI/COC Form. 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 DOE 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:
Covered individual means any individual, regardless of title or position, who contributes in a substantive, meaningful way to the development or execution of the scope of work of a project funded by DOE or proposed for funding by DOE; and, is designated as a covered individual by DOE.
Designated covered individuals:
- Principal investigators and co-principal investigators;
- Project directors and co-project directors;
- Project managers;
- Individuals, regardless of title, performing these roles;
- Individuals identified in the Notice of Funding Opportunity (NOFO) or award terms and conditions; and
- Individuals required to submit biosketch/resume or a current and pending support
DOE means the U.S. Department of Energy and the National Nuclear Security Administration (NNSA)
Significant financial interest (SFI) means: (1) A financial interest consisting of one or more of the following interests of the covered individual (and those of the covered individual’s spouse and dependent children) that reasonably appears to be related to the covered individual’s non-Federal entity/institutional responsibilities:
- Total remuneration received from a publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through public prices or other reasonable measures of fair market value;
- Total remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure exceeds $5,000,
- Any equity interest (e.g., stock, stock option, or other ownership interest) in a non-publicly traded entity; and
- Intellectual property rights and interests (e.g., patents, copyrights) excluding those owned by the UC Regents, upon receipt of income related to such rights and interests.
(2) Any reimbursed or sponsored travel related to their institutional responsibilities not disclosed in current and pending or other support disclosures. Exclude travel that is reimbursed or sponsored by a US Federal, State, or local government agency; US Institution of Higher Education; or US research institute that is affiliated with a US Institution of Higher Education.
(3) The term significant financial interest does not include:
- Salary, royalties, or other remuneration (including non-Federal entity assigned intellectual property rights and associated agreements to share in royalties) paid by the non-Federal entity to the covered individual if they are currently employed or otherwise appointed by the non-Federal entity;
- Any ownership interest in the non-Federal entity held by the covered individual, if the non-Federal entity is a commercial or for-profit organization;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the covered individual does not directly control the investment decisions;
- Income from service on advisory committees or review panels for or seminars, lectures, or teaching engagements sponsored by a US Federal, State, or local government agency, a US Institution of Higher Education, or a US research institute that is affiliated with a domestic Institution of Higher Education.
Non-federal entity/institutional responsibilities is defined as teaching/education, research, outreach, clinical service, training and University and public service, on behalf of UCI and directly related to those credentials, expertise and achievements upon which the Covered Individual’s UCI position is based.
Conflict of interest (COI) when a covered individual or the spouse or a child of the covered individual has a significant financial interest or financial relationship, whether with a domestic or foreign entity, that could directly and significantly affect the design, conduct, reporting or funding of a project or other Federal financial assistance award related activities.
Conflict of commitment (COC) when a covered individual accepts or incurs conflicting obligations, whether foreign or domestic, between or among multiple employers or other entities. This may include: conflicting commitments of time and effort, including obligations to dedicate time in excess of institutional or DOE policies or commitments; obligations to improperly share information with, or to withhold information from, an employer or DOE, that can also threaten research, technology or economic security and integrity.
Additional Resources:
Federal Supplemental Disclosure
Who: Investigator on active or proposed NSF/NASA compliant study who has a positive KR Federal Disclosure and Certification (answered "Yes" to question 1 and/or question 2).
What: Complete Federal Supplemental Disclosure to determine if your financial interest is above the threshold set by NSF/NASA and related to the active or proposed NSA/NASA compliant study.
When: Initially at proposal submission, with new investigator added, and changes in financial interest.
How: Click the above “Federal Supplemental Disclosure” link and submit the completed form. Once submitted an automatic email will be sent to you with next step or clearance. COI Team will follow up appropriately if required.
Tips:
- If you have more than one financial interest that is above threshold or meet the disclosure criteria, please determine if each financial interest would be considered related to the study. Additional review will only be conducted for the entity that is above threshold and related to the study.
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/NASA, or proposed for such funding, which may include, for example, collaborators or consultants.
- Significant Financial Interest related to the NSF/NASA compliant research project:
Note: The KR Federal Disclosure and Certification has a lower disclosure threshold (e.g. income > $5,000 rather than NSF/NASA’s income >$10,000).
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- 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)
COI Addendum Versions:
- Form 820- PHS/DOE/USDA compliant studies
- COI-1- IRB protocols, NSF/NASA (effective 12/1/23) 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:
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:
Who: If you were reviewed by the COIOC for the same financial interests for the same project last year (PHS/DOE/USDA compliant studies)
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.
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 with disclosing individual(s) that has a positive 700U and/or meets IRB disclosure thresholds.
What: This procedure should happen before or concurrently with the study team’s preparation for the contract negotiation by the Clinical Trial Contracts team. For more information regarding the Clinical Trial Contracts Negotiation procedure, please refer to their website. 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: As the study team starts the application process, the Lead Researcher or study team coordinator should check with all study team members to determine if there will be a positive conflict of interest disclosure that would benefit from this earlier COI review process.
- IRB COI: Study team submits the IRB Protocol (ZotIRB) application for IRB review. KR Protocols application includes a financial interest disclosure question for all research personnel.
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- UCI is relying on non-UCI IRB review: COIOC clearance or approval required before IRB Staff's administrative review to issue formal "Clearance to cede" to a non-UCI IRB.
- State Law: Attach DocuSigned Form 700U(s) from Principal Investigator and if applicable, Co-Principal Investigator, in the initial COI Notification Email and also upload the DocuSigned 700U(s) to KR Proposal Development (KR PD)
Procedure:
The process below is separate from the Clinical Trial Contracts Negotiation and is specific to COI procedure for Clinical Trial Study(s). For more information regarding the Clinical Trial Contracts procedure, please refer to their website.
- Initiate IRB application to generate the ZotIRB number with the following sections as complete and accurate as possible before notifying the COI Team (IRB application does not need to be submitted prior to COI notification)
- Basic Study Information
- "HRP-325_PI Worksheet: Expanded Access" included in attachment (#9)
- Brief description (#3) should be completed.
- Study Funding Sources
- Local Study Team Members/Contacts
- List all known study team member(s)
- Disclosure of study team member(s)
- Responsibilities / duties of the study team member(s)
- Medical Devices/ Drugs (if applicable)
- Basic Study Information
- Collect the DocuSigned Form 700U(s) from the Principal Investigator and if applicable, Co-Principal Investigator
- Email COIOC@uci.edu with Master Protocol and DocuSigned Form 700U(s) attached. Include in the email the name of the Administrative contact assigned to the study.
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- CCR: will indicate designated team (or specific member) involved in the administrative side of the study.
- Stem Center: will indicate designated team (or specific member) involved in the study with additional cc to Stem Center shared email.
This procedure should happen before or concurrently with the study team’s preparation for the contract negotiation by the by the Clinical Trial Contracts team.
Forms:
- Form 700U
- COI Addendum (COI-1)
- Non-UCI Researchers- Non-UCI COI Addendum (COI-3)
Who: 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: an UCI 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 and refer to the COI Team, coioc@uci.edu, as appropriate.
- COI Liaison: an UCI 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@uci.edu. In cases where disclosure to the study team and identification of a COI contact is required, include the description of the COI Liaison's responsibilities in the email (see COI Liaison Email Templates).
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 and refer to COI Team, coioc@uci.edu, as appropriate.
- 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, Department of Energy, US Department of Agriculture or on a PHS/DOE/USDA compliant project.
What: Complete the UC Ethics and Compliance Briefing for Researchers (ECBR) at least every 2 years.
When:
- Prior to PHS/DOE/USDA compliant award
- At least every two years for the duration of an active PHS/DOE/USDA 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/DOE/USDA, or proposed for such funding, which may include, for example, collaborators or consultants. Note: DOE has discretion to expand this definition.
Additional Resources:
The Key Personnel section in the KR Proposal Development (KR PD) collects information about UCI researchers for two processes: Federal Proposal Review for Research Security & International Engagement (RSIE) and Conflict of Interest in Research for federal sponsors/prime sponsors. It is important to complete this section correctly so that the system can electronically trigger the processes as necessary.
Note: Non-UCI researchers should not be included in the KR PD Personnel tab.
KR PD Personnel Roles:
- Principal Investigator, PI/Contact, PI/Multiple, Co-PI, Key Person: This UCI individual will be sent an email with a custom link to the RSIE questionnaire they need to complete prior to the proposal being submitted to workflow. In addition, if the federal sponsor/prime sponsor has a conflict of interest policy (PHS/NSF/DOE/NASA/USDA), they also must have a current KR COI Annual Disclosure on file prior to proposal submission.
- Other Significant Contrib. (Contributor)- available February 28, 2024: Use this KR PD Personnel role when an UCI individual is required by the federal sponsor to submit a biographical sketch and other/current & pending support but does not meet the COI definition of an Investigator. This individual will be sent an email with a custom link to the RSIE questionnaire they need to complete prior to the proposal being submitted to workflow. No COI disclosure requirements.
- Investigator: This UCI individual is responsible for the design, conduct, or reporting of a research project with a federal sponsor or prime sponsor with a conflict of interest policy (PHS/NSF/DOE/NASA/USDA) but was not required by the federal sponsor to submit a biographical sketch or other/current & pending support. These UCI individuals must have a current KR COI Annual Disclosure on file prior to proposal submission. No RSIE questionnaire required.
| RSIE Biosketch & Research Support Verification Does the Federal sponsor/prime sponsor require a biographical sketch from this individual? | Conflict of Interest Is the individual an “Investigator” (responsible for the design, conduct, or reporting of the project)? | KR PD Personnel Role(s) Which KR PD Personnel Role should be used for that individual? |
|---|---|---|
| Yes | Yes | Principal Investigator, PI/Contact, PI/Multiple, Co-PI, or Key Person |
| Yes | No | Other Significant Contrib. (Contributor) (available 2/28/24) |
| No | Yes | Federal sponsor/prime sponsor with COI Policy (PHS, DOE, USDA, NSF, and NASA): Investigator |
| No | Yes | Federal sponsor/prime sponsor without a COI Policy: Do not include the individual in the KR PD Personnel tab |
| No | No | Do not include the individual in the KR PD Personnel tab |