Conflict of Interest Oversight Committee (COIOC)

The Conflict of Interest Oversight Committee (COIOC) fully supports the development of relationships with outside entities as long as the appropriate measures exist to protect the objectivity of the research and interests of students and research subjects, as well as to comply with the various state and federal policies. The primary purpose of the COIOC process is to review and document how the conflict of interest issues are addressed and provide recommendations or changes when necessary, which is why openness and transparency are especially important.

The COIOC consists of faculty members from across the campus including UCI Health and ex oficio members from: Office of Research, Beall Applied Innovation, Academic Personnel, and School of Medicine Academic Affairs.  The COIOC reviews and provides recommendations to the Vice Chancellor of Research's designee on financial interests that relate to UCI research projects with conflict of interest disclosure requirements.

Conflict of Interest Process

Start

Disclosure of financial interest for research project (Researcher)

Disclose with the Initial Application

  • Human Subjects Research Project
  • Industry Sponsored Clinical Trials
  • Public Health Services/National Science Foundation sponsored projects (initial disclosure)

Disclose at Just-In-Time or Notice of Award

  • Non-Governmental sponsored projects (excluding clinical trials and after the fact projects)
  • Public Health Services/National Science Foundation sponsored projects (review and approval)

COI Administrative Review (COI Team)

Pre-review:  The COI Team reviews the disclosures to identify any potential responses that could benefit from revision or additional clarification to facilitate the COIOC's upcoming review.  Note: Please respond to these email requests for modifications from the COI Team in a timely manner to avoid a delay.

Administrative Review:  The COI Team will determine if the disclosure qualifies for administrative review based on the criteria approved by the COIOC which is processed more quickly on a rolling basis and requires no further COIOC review.

COIOC review (COIOC)

The COIOC conducts their review and if no additional information or changes is required, provides a recommendation to the Associate Vice Chancellor for Research Administration.  If changes or additional information is required, the COI Team will contact the researcher directly.

COI Approval Processed (COI Team)

After receiving the AVCR's final approval, the COI Team notifies the other teams (IRB, SPA, ISR) as appropriate that the project has been cleared by the COIOC.

Conflict of Interest Clearance/Approval

Potential Conflict of Interest Risks

Compromise of Scientific Integrity
+ -

Conflict may result in unintentional bias in the collection, analysis and interpretation of data leading to claims beneficial to the researcher and/or entity in which the investigator has a financial or management interest. In its most extreme form, conflict may lead to fabrication or falsification of data, or to plagiarism.

Misuse of University Facilities
+ -

Conflict may lead to improper use of university facilities, e.g. laboratories and equipment, to further the personal or proprietary interests of the investigators and/or entity in which the investigator has a financial or management interest.

Improper Direction of Student's or University Employee's Work
+ -

Conflict may result in requests to students or university employees to engage in work that is more clearly in the interests of a sponsor, or the entity in which the PI has a financial interest, than the University. Graduate students, for example, might be asked to do work that is more in the interest of financial gain, (of the PI, the sponsor or themselves), than to their own academic preparation.

Unbalanced Allocation of Faculty Member's Time and Effort
+ -

A conflict of commitment may lead to an improper distribution of time and effort resources away from the fundamental purposes of the University and toward the private financial interests of the faculty member and sponsoring agency.

Failure to Recognize the University's Right to Intellectual Property and Related Financial Interests
+ -

A conflict of interest may result in action or inaction that fails to recognize the University's right to intellectual property and related financial interests.

Improper Channeling of Research Funds
+ -

A conflict may lead to decisions to misrepresent the category of financial award, (e.g., as a gift rather than a grant or contract), to the University.

Inappropriate Delay or Restriction on Publications
+ -

A conflict may lead to decisions to inappropriately delay or restrict publication of findings.

Appearance of Impropriety
+ -

A conflict of interest may result in the appearance of impropriety which itself must be considered as a risk.

Addressing Potential Conflicts of Interest Risks

Per certain federal regulations, state laws, and University of California policies, researchers are required to disclose to UCI their outside financial interests (see Disclosure Chart) and disclose all inventions arising from those research projects to UCI’s Research Translation Group.

For researchers with financial interests related to their research projects, please review the following examples to consider adding appropriate safeguards that proactively address the potential risks of a conflict of interest as you design your study.  To facilitate the COIOC’s review, please highlight the safeguards you have implemented to protect the objectivity of the research in your Conflict of Interest Addendum.  Please note that the following safeguards do not guarantee the COIOC’s approval because each situation is unique.

COI Best Practices Requirements

To promote best practices in mitigating potential conflicts of interest, UCI’s standard requirements for financial interests reviewed by the Conflict of Interest Oversight Committee (COIOC) are:

  1. Identify a non-conflicted, independent individual of equal or higher rank to the Disclosing Individual (researcher with financial interest that requires COIOC review) who can serve as the “COI Point Person,” a person the research project team can contact about any COI related questions or concerns. For more information, visit COI Point Person.
  2. Disclose your related financial interest(s) to the study team involved in the project, by emailing them about your related financial interests and who the COI Point Person will be (with the COI Point Person copied). For an example email, visit our website here. Please submit a copy of that email along with the Addendum for documentation purposes.
  3. Disclose your reviewed financial interest(s) in the publications, presentations, and consent for the related research project. For examples, visit here.

Research Safeguards and Considerations

As the Disclosing Individual (researcher with financial interest that requires COIOC review), please highlight the safeguards you have already included in your study in your Conflict of Interest Addendum form and consider adding ones to help address the remaining conflict of interest risks.

Study design components that minimize the Disclosing Individual’s ability to bias the research

  • Non-conflicted, independent faculty peer to the Disclosing Individual that conducts procedures and assessments
  • Randomization of subjects
  • Masking of researchers
    • For example, a non-conflicted researcher codes different compounds to be used in a study while another non-conflicted researcher conducts the experiments, including data analysis and graphing. The Disclosing Individual not involved in the masking or data collection and only sees the results after the first non-conflicted researcher reveals the code for the experiment
  • Disclosing Individual is participating in data collection because they are blind to which patients are enrolled in each study group (for clinical trials)
  • Multi-center study
  • Highlight all aspects of the study the Disclosing Individual will not be involved including but not limited to: consenting participants; determining enrollment criteria; data collection; data analysis; and/or reporting

Steps taken to track and protect the data, and provide a non-conflicted, independent analysis of the data.

  • Data is stored and shared in a way where access and all changes are tracked
  • An independent, non-conflicted statistician analyzes the data
  • Disclosing Individual will not have access to the raw data; data will be blinded by non-conflicted researchers who will only reveal the code after the results are presented to the disclosing individual
  • Data will be made publicly available after the study has been completed
  • Entity will only have access to data and reporting after it is made publicly available
  • Have an independent data safety monitoring board to provide additional oversight
  • A contract research organization (CRO) provides the data collection and analysis for the clinical trial

Special considerations for SBIR/STTR research.

  • For SBIR/STTR research, review the UCI Guidance
  • For National Science Foundation (NSF) SBIR/STTR Phase I studies, NSF does not allow a person who is an equity holder, employee, or officer of the proposing small business to be paid under a subaward without an exception recommended by the NSF Program Director and approved by the NSF Division Director for the Division of Industrial Innovation and Partnerships

Steps taken to protect the students’ academic progress and the postdocs’ careers due to the potential conflict from their Principal Investigator/Supervisor/Advisor

  • Per the Graduate Division policy, a COI Oversight Member may be required once the advancement/dissertation committee selection process has started until the graduate student graduates when the faculty advisor has a financial interest related to the student’s dissertation or work. For more information, contact Andrea Bannigan (alanders@uci.edu)
  • Arrange to have a non-conflicted peer researcher supervise/advise or co-supervise/advise the students and postdocs on the study (see COI Liaison)

Steps taken to protect the research personnel due to the potential conflict from their Principal Investigator or Supervisor

  • Arrange to have a non-conflicted peer researcher supervise/advise or co-supervise/advise the research personnel on the study (see COI Liaison)

Steps to help adhere to the Disqualification Rule from the California Political Reform Act

  • In negotiations for research awards, service agreements, procurements, and licensing between the University and a company for which the UCI employee has a disqualifying financial interest , a non-UCI representative or employee of the company without any active UCI affiliations will represent the company’s interests in lieu of the conflicted UCI employee
  • Disclose your financial interest to your Department Chair/Center Director to enlist their help in helping you avoid conflicts of interests in business transactions

Highly recommended best practices

  • The researcher’s personal outside consulting agreement with an entity was reviewed by Beall Applied Innovation to confirm that intellectual property provisions are consistent with UC policies
  • The scope of work in a researcher’s personal consulting agreement with an entity should not overlap with the scope of work of any UCI research projects or proposals. Likewise, the consulting agreement should not augment the scope of a UCI research project which reasonably should be done as a single effort through the UCI research project
  • The services provided by the researcher can be provided without the use of UC funds, facilities, time, or resources

Steps taken to address general COI concerns (in addition to COI in research concerns) from individuals with UCI leadership/management positions and related financial interests

  • For conflicted researchers who are also in a leadership/management position at a UCI center related to their company, the conflicted researcher should engage their department or School to develop a conflict of interest plan that addresses the academic and business conflict of interest risks.
    • This plan may include: identifying the types of transactions the conflicted researcher should recuse themselves from; a department/School review of the research activities (e.g., rebudgeting requests related to UCI subcontracts to the company, invoices claiming costs incurred by the company, applications and proposals for new sponsored awards, IRB and IACUC protocol applications, etc.) related to their company
  • The conflicted individual must recuse themselves from being involved in making decisions involving the purchase of items or services from the entity with which the conflicted individual has a financial interest; any such contractual arrangements should be delegated to a non-conflicted individual, who is senior to the conflicted individual such as the department chair

Disclose the related financial interest to the Center team members to promote transparency and identify a non-conflicted, non-junior individual to contact if there are any concerns

Avoid any perception that UCI is promoting or endorsing any outside entity

  • To ensure that separation is apparent, individuals with outside financial interests should not use UCI websites (or otherwise use UCI’s names, logos, or images) to promote or publicize the entities with which they have a financial interest; and those entities should not use UCI’s names, logos, or images for the entities’ promotional or publicity purposes
Study Design

Study design components that minimize the Disclosing Individual’s ability to bias the research

  • Non-conflicted, independent faculty peer to the Disclosing Individual that conducts procedures and assessments
  • Randomization of subjects
  • Masking of researchers
    • For example, a non-conflicted researcher codes different compounds to be used in a study while another non-conflicted researcher conducts the experiments, including data analysis and graphing. The Disclosing Individual not involved in the masking or data collection and only sees the results after the first non-conflicted researcher reveals the code for the experiment
  • Disclosing Individual is participating in data collection because they are blind to which patients are enrolled in each study group (for clinical trials)
  • Multi-center study
  • Highlight all aspects of the study the Disclosing Individual will not be involved including but not limited to: consenting participants; determining enrollment criteria; data collection; data analysis; and/or reporting
Research Data & Analysis

Steps taken to track and protect the data, and provide a non-conflicted, independent analysis of the data.

  • Data is stored and shared in a way where access and all changes are tracked
  • An independent, non-conflicted statistician analyzes the data
  • Disclosing Individual will not have access to the raw data; data will be blinded by non-conflicted researchers who will only reveal the code after the results are presented to the disclosing individual
  • Data will be made publicly available after the study has been completed
  • Entity will only have access to data and reporting after it is made publicly available
  • Have an independent data safety monitoring board to provide additional oversight
  • A contract research organization (CRO) provides the data collection and analysis for the clinical trial
SBIR/STTR

Special considerations for SBIR/STTR research.

  • For SBIR/STTR research, review the UCI Guidance
  • For National Science Foundation (NSF) SBIR/STTR Phase I studies, NSF does not allow a person who is an equity holder, employee, or officer of the proposing small business to be paid under a subaward without an exception recommended by the NSF Program Director and approved by the NSF Division Director for the Division of Industrial Innovation and Partnerships
Students and Postdocs

Steps taken to protect the students’ academic progress and the postdocs’ careers due to the potential conflict from their Principal Investigator/Supervisor/Advisor

  • Per the Graduate Division policy, a COI Oversight Member may be required once the advancement/dissertation committee selection process has started until the graduate student graduates when the faculty advisor has a financial interest related to the student’s dissertation or work. For more information, contact Andrea Bannigan (alanders@uci.edu)
  • Arrange to have a non-conflicted peer researcher supervise/advise or co-supervise/advise the students and postdocs on the study (see COI Liaison)
Research Personnel

Steps taken to protect the research personnel due to the potential conflict from their Principal Investigator or Supervisor

  • Arrange to have a non-conflicted peer researcher supervise/advise or co-supervise/advise the research personnel on the study (see COI Liaison)
Business Transactions with UCI and Outside Entity

Steps to help adhere to the Disqualification Rule from the California Political Reform Act

  • In negotiations for research awards, service agreements, procurements, and licensing between the University and a company for which the UCI employee has a disqualifying financial interest , a non-UCI representative or employee of the company without any active UCI affiliations will represent the company’s interests in lieu of the conflicted UCI employee
  • Disclose your financial interest to your Department Chair/Center Director to enlist their help in helping you avoid conflicts of interests in business transactions
Outside Consulting

Highly recommended best practices

  • The researcher’s personal outside consulting agreement with an entity was reviewed by Beall Applied Innovation to confirm that intellectual property provisions are consistent with UC policies
  • The scope of work in a researcher’s personal consulting agreement with an entity should not overlap with the scope of work of any UCI research projects or proposals. Likewise, the consulting agreement should not augment the scope of a UCI research project which reasonably should be done as a single effort through the UCI research project
  • The services provided by the researcher can be provided without the use of UC funds, facilities, time, or resources
UCI Leadership/Management Position

Steps taken to address general COI concerns (in addition to COI in research concerns) from individuals with UCI leadership/management positions and related financial interests

  • For conflicted researchers who are also in a leadership/management position at a UCI center related to their company, the conflicted researcher should engage their department or School to develop a conflict of interest plan that addresses the academic and business conflict of interest risks.
    • This plan may include: identifying the types of transactions the conflicted researcher should recuse themselves from; a department/School review of the research activities (e.g., rebudgeting requests related to UCI subcontracts to the company, invoices claiming costs incurred by the company, applications and proposals for new sponsored awards, IRB and IACUC protocol applications, etc.) related to their company
  • The conflicted individual must recuse themselves from being involved in making decisions involving the purchase of items or services from the entity with which the conflicted individual has a financial interest; any such contractual arrangements should be delegated to a non-conflicted individual, who is senior to the conflicted individual such as the department chair

Disclose the related financial interest to the Center team members to promote transparency and identify a non-conflicted, non-junior individual to contact if there are any concerns

UCI Name, Logo, Images

Avoid any perception that UCI is promoting or endorsing any outside entity

  • To ensure that separation is apparent, individuals with outside financial interests should not use UCI websites (or otherwise use UCI’s names, logos, or images) to promote or publicize the entities with which they have a financial interest; and those entities should not use UCI’s names, logos, or images for the entities’ promotional or publicity purposes

Case Studies

The below cases studies highlight some but not all of the mitigating factors that reduces the potential conflict of interest, in addition to UCI’s required COI best practices.  Please note that the following safeguards do not guarantee the COIOC’s approval because each situation is unique.