KR COI Annual Disclosure

Who: If you are an active or proposed Public Health Service/National Institutes of Health and/or National Science Foundation Investigator or an Investigator on a PHS/NSF compliant project, then please complete the KR COI Annual Disclosure.

What:  Annual disclosure to determine 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, and 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:

• Public Health Service
• National Science Foundation

Form 700U

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

When: Prior to release of an 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 per the state requirements.

• Sponsored Research Agreement
  • At proposal submission, know will be funded (ex. industry clinical trial)- upload in KR Proposal Development.
  • At proposal submission, unknown if will be funded- Contracts & Grants Officer will request when awarded.
• Gift- submit with gift documentation to University Advancement.
• Material Transfer Agreement- submit along with MTA Intake Form.

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 700U Exemptions
• State Law

Annual Form 810

Who: If you are an active or proposed Public Health Service/National Institutes of Health Investigator who has a positive KR COI Annual Disclosure (answered "Yes" to question 1)

What:  Form to disclose the details of your significant financial interests for the  COI team's relatedness review as required by the PHS regulations.

When: At Just-in-Time or Notice of Award (at least annually)

How: Click the above "Annual Form 810" link and submit completed form to coioc@research.uci.edu.

Tips:

• Business interests- the more specific your description, the better chance that some of your NIH research will be considered unrelated
• Equity interests- make sure to indicate the estimated percentage of issued & outstanding shares
• Consulting income over $10,000 in the past 12 months- include a copy of your consulting agreement

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:

• Public Health Service

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 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.

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

Tips:

• Equity interests- make sure to include the percentage of issued and outstanding shares
• COI Liaison is not required for all studies.  It is a role primarily recommended in cases where the Disclosing Individual is actively involved in many key aspects of the study and is the most senior person.  If you have already identified a non-conflicted, non-junior colleague to take on additional COI oversight responsibilities, please indicate on the COI Addendum and attach the COI Liaison Acknowledgement Form.  Note: Recommend including the COI Point Person responsibilities in the COI Liaison Acknowledgment Form to reduce how many additional individuals need to be involved.
• COI Point Person is required for all new studies starting June 1, 2021 as a new UCI COI standard best practice.   

Key definitions:

Additional Resources:

• Potential COI Risks
• Case Studies

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.  Please include a copy of the email notification along with the Research Addendum (see Templates).

When: Conflict of Interest Oversight Committee review

How: Submit a copy of the email disclosing the related financial interest and the identified COI Point Person with the COI Addendum

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.  
• 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. Ideally, the Point Person would be in the same department or at least 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.

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: As of June 1, 2021, all individuals on new studies reviewed by the Conflict of Interest Oversight Committee who need  or have implemented additional COI oversight (not required for all new studies).

What: Form to document the non-conflicted, non-junior individual identified as the COI Liaison for the project by the Disclosing Individual in the COI Addendum is aware of those specific responsibilities.

When: Collected along with the COI Addendum for the COIOC review.

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

Key definitions:

• COI Point Person: 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)  

• Disclosing Individual: individual with financial interest being reviewed by the COIOC

Resources:

• Potential Risks
• Case Studies

Expedited Form

Who: If you were reviewed 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

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 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.

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

Additional Resources:

• Potential COI Risks
• Case Studies

Disclosure Forms for Non-UCI Investigators

• Form 800SR- PHS Investigators
• Form 900SR- NSF Investigators

Who: If you are non-UCI researcher participating in a UCI Public Health Service/National Institutes of Health and/or National Science Foundation compliant study or PHS/NSF UCI out-going subaward

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

When: Prior to PHS/NSF compliant proposal submission, at least annually for the duration of an active PHS/NSF 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.

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

Additional Resources:

• Public Health Service
• National Science Foundation