COI Independent Review Committee (IRC)

The Independent Review Committee is UCSD's independent substantive review committee appointed by the Chancellor to review financial disclosure statements and relevant features of a research project. It functions as the principal advisory committee to the Chancellor for specific conflicts of interest and determines if a potential, perceived, or real conflict of interest exists by virtue of the investigator's financial interests.

The Independent Review Committee is appointed by the Chancellor with advice from the Committee on Committees of the Academic Senate, and consists of full-time, tenured faculty representatives from General Campus, Health Sciences, and Scripps Institution of Oceanography. The IRC also includes ex-officio, non-voting representatives from the Office of Research and Innovation and the Office of Innovation and Commercialization.

The Independent Review Committee was formed in October 1982 at the request of the UCSD Chancellor in response to the guidelines for disclosure and review of Principal Investigator's Financial Interest in Private Sponsors of Research issued April 8, 1982, and the California Administrative Code, Title II, Section 18705, a regulation of the Fair Political Practices Commission implementing the Political Reform Act of 1974.

The IRC recognizes that collaboration of academic researchers and educators with industry, as well as private entrepreneurial ventures is encouraged. However, such relationships may present an increased risk of potential or actual conflict between the interests of individuals and entities with which they are involved, and the public interest that federal and other sponsored funding should serve. So that the financial interests of principal investigators do not compromise the objectivity with which projects are designed, conducted, or reported, the IRC has established management strategies to eliminate, manage or reduce conflicts of interest. The IRC provides an oversight role and endeavors to safeguard the interests of the University and the individual principal investigator and ensure compliance with state and federal government mandates.

In addition, the Independent Review Committee:

• Reviews financial disclosures for both privately and federally sponsored projects
• Reviews situations where a potential, perceived or real conflict of interest exists by virtue of financial interest
• Establishes management strategies to eliminate, manage or reduce conflicts of interest
• Determines which strategies are appropriate and is responsible for ensuring their implementation
• Provides an oversight role and endeavors to safeguard the interests of the University and the individual principal investigator and ensure compliance with state and federal government mandates

The IRC members are responsible for maintaining all committee proceedings and documents in strict confidence.  Such information may not be used for any purpose other than the conflict of interest review and may not be disclosed to anyone outside of the IRC unless the Chancellor grants permission in writing.

The IRC reviews each disclosure on a case-by-case basis at their regularly scheduled monthly meetings and recommends appropriate action. The IRC may impose special conditions to manage or eliminate the conflict of interest, which can include:

• Public disclosure of the financial interest(s) in all publications of research results
• Monitoring of the project by the Conflict of Interest Management Subcommittee (COIMS)
• Divestiture of the financial interest(s)
• Revision of a PI or Researcher consulting agreement to conform to UC Policy and include the standard UC Clause and Patent Policy
• Ensuring the protection of graduate students by recommending the appointment of a co-advisor without a financial interest in the company in question
• Informing the company of the Investigator's obligations to the federal agency funding the research
• Modifying the specific aims of the project to maintain the separation between the University research program and the research objectives of the company
• Disqualification from participation in all or a portion of the project
• Severance of relationships that create actual or potential conflicts, i.e., require that the researcher resign their position with the entity for the duration of the project
• Suspension of consulting and any other recompensed activities with a company during the course of a research project that involves clinical testing of a company's drug, device, vaccine or procedure
• Independent third party review of the company's intellectual property disclosures

The IRC recommendations for management of the conflict of interest are made to the Chancellor via a concurrence letter. Should the Chancellor concur with the IRC recommendations, the person with the financial relationship, Department Chair, Vice Chancellor of Research, respective Deans or Vice Chancellors will receive a copy of the concurrence letter.

If the Investigator does not agree with one or more of the management strategies from the Independent Review Committee (IRC), the investigator must notify the COI Office immediately and prepare the following:

• The investigator is required to provide a written letter to the COI Office demonstrating the separation between the specific research project and the entity for which the financial interest or relationship exists;
• How the financial interest or relationship cannot potentially benefit the entity or bias the research; and
• Suggest an alternative to manage the conflict of interest, if applicable.

The appeal letter written by the Investigator will be presented to the IRC at the next scheduled IRC meeting for reconsideration. The IRC considers a number of factors in determining if there is the potential for conflicting financial interests to compromise the objectivity in which sponsored research is designed, conducted or reported. The IRC seeks to mitigate even the appearance of conflict of interest in the conduct of research. Therefore the IRC may accept or deny the appeal. The IRC appeal decision will be communicated to the Investigator via a letter.

If all attempts to manage the conflict of interest have not been successful, and the Investigator is still not in agreement with the recommendations made by the IRC, the investigator can discuss the matter with their Dean and/or Vice Chancellor to suggest an acceptable alternative to manage the conflict of interest and present to the IRC.

UCSD policy and State and Federal law provide that:

• Failure to complete a Disclosure of Financial Interests, submit additional information or comply with any conditions or restrictions imposed on the conduct of project under this Policy will be grounds for discipline pursuant to the Policy on Faculty Conduct and the Administration of Discipline or other applicable employee disciplinary policies.
• Federal regulations may require reports to the federal sponsor of any violations of University policy.
• Failure to file the required Statement of Economic Interests or failure to report a financial interest may subject the individual to civil liability, including fines. Government Code sections: 81000-91014.
• Sponsors, the Conflict of Interest Office or the Office of Contract and Grant Administration may suspend or terminate an award and/or bar an investigator from receipt of future awards in the event of failure to comply with applicable state and federal regulations on disclosure, review, and management of significant financial interest related to state and federally sponsored projects.

The Independent Review Committee (IRC) reviews each applicable disclosure on a case-by-case basis at their regularly scheduled monthly meetings.  Only complete submissions will be assigned to the IRC agenda.  Submissions are considered complete if all applicable materials (initial disclosure, supplement and/or addendum forms or requests for information) are submitted to the Conflict of Interest Office at least seven (7) business days prior to the IRC meeting. 

Upcoming IRC Meeting Dates:

• December 16, 2024
• January 27, 2025
• February 18, 2025
• March 31, 2025
• April 28, 2025
• May 19, 2025
• June 30, 2025

Note:  The IRC meeting dates may change due to a number of administrative factors.