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IRB COI Disclosure Requirements

Disclosure Requirements

The Application for IRB Review requires the Lead Researcher (LR) and all research personnel to disclose financial interests related to all research projects conducted at UCI or using UCI resources or facilities that involve the use of human subjects. See definition of "disclosable financial interests" below. 

Individuals disclosing the existence of a financial interest on the IRB application will be contacted by the Conflict of Interest staff and asked to complete Disclosure Form COI-1. Form COI-1 will be reviewed by the Conflict of Interest Oversight Committee (COIOC).

In addition, the informed consent document should advise potential subjects whether or not anyone involved with the research has a financial interest in the project sponsor or in any entity that would be interested in the outcome of the study. Suggested language is included in the biomedical and the social/behavioral informed consent templates. These templates are available on the Applications and Forms web page under the heading, "IRB Consent Forms."

Any potential conflict of interest related to human subject research must be reviewed by the COIOC prior to IRB review. As such, IRB review of the protocol and informed consent is held pending the COIOC assessment of the disclosure and the potential conflict of interest and the acceptance and concurrence of the COIOC's recommendation by the Vice Chancellor for Research.

EXCEPTION: In an effort to facilitate the regulatory review process, for new studies only (APPs), IRB review may run concurrent with COIOC review. However, if the COIOC report and suggested consent language are not available at the time IRB review, the IRB must "T" (table) the new study pending this information. Once the report is available, the new study must return to the full IRB for final review and approval.

For electronic continuing protocol applications (CPAs) and electronic modifications (MODs), COIOC review is required prior to IRB review. Documentation of COIOC review, including the COIOC report and suggested consent language must be provided to the IRB at the time of their review. As such, IRB review of the protocol and informed consent is held pending the COIOC assessment of the disclosure and the potential conflict of interest and the acceptance and concurrence of the COIOC's recommendation by the Associate Vice Chancellor for Research.

To ensure that IRB submissions are reviewed in a timely manner, it is strongly recommended that Lead Researchers when reporting disclosable financial interests for themselves or other research personnel submit their IRB documentation by the COIOC deadline. COIOC deadlines and meeting dates are posted on the Committee Calendar.

Disclosable Financial Interests

Investigators shall report for themselves, their spouses and dependent children the following disclosable financial interests:

  • Ownership interest, stock, stock options, or other financial interest related to the research, unless it meets all four tests:
    • Less than $10,000 when aggregated for the immediate family and
    • Publicly traded on a stock exchange and
    • Value will not be affected by the outcome of the research and
  • Less than 5% interest in any one single entity.
  • Compensation related to the research, including salary, consultant payments, honoraria, royalty payments, dividends, loans, or any other payments or consideration with value, including payments made to the University Health Sciences Compensation Plan, unless it meets both of the following tests:
    • Less than $10,000 in the past year when aggregated for the immediate family and the
    • Amount will not be affected by the outcome of the research.
  • Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement.
  • Board or executive relationship (e.g., director, officer, partner, or trustee) related to the research, regardless of compensation.

Disclosable Financial Interests do not include

  • Salary, royalties, or other remuneration paid by The Regents of the University of California, including intellectual property assigned to The Regents.

Related Financial Interests

Related financial interests occur when the investigator, their spouse or dependent children have a disclosable financial interest that would reasonably appear to be affected by the research or when the entity in which the financial interests are held would reasonably appear to be affected by the research. To assist in the disclosure process, the following examples are provided:

  • The project results could be relevant to the development, manufacturing, or improvement of products or services of the entity in which the Investigator has a financial interest.
  • The investigator has a financial interest in an entity that might manufacture, commercialize or license a drug, device, procedure or any other product used in the project or that will predictably result from the project;
  • The investigator received compensation from activities in his/her professional field during the prior twelve months, where the financial interest of the entity or the investigator would reasonably appear to be affected by the project;
  • The investigator has a financial interest in an entity and the project proposes to subcontract a portion of the work, or lease property, or make referral of participants to, or make purchases from the entity; or
  • The investigator has a financial interest in an entity that is part of a consortium or that will otherwise participate in the project.

Forms

A Lead Researcher (LR) who is conducting human subjects research at UCI or utilizing UCI resources or facilities is required to disclose for themselves and to determine from all personnel listed on the Application for IRB Review whether they have a disclosable and related financial interest. This requirement applies to all studies, both sponsored and unsponsored. The terms "disclosable" and "related" are as defined above.

If a positive disclosure is made, signifying that the Researcher has financial interests as defined by the relevant policy, the IRB will refer the case to the COIOC for evaluation. To facilitate review, additional forms may be required to describe the financial interest in more detail.

Additional Review: Studies sponsored by non-governmental entities and not considered exempt under the State of California conflict of interest policy are subject to additional reporting requirements under State disclosure process. To find additional information regarding the state process, see: Non-Govermental Sponsors (State Policy). To streamline the disclosure process, the Addendum Form is available and is used for both the IRB and State review.

COIOC Considerations for Review

The COIOC will consider the research project according to traditionally held principles of ethical conduct and academic freedom. The COIOC will evaluate whether: there is sufficient separation of University and private interests, the proposed research is appropriate to the University, the teaching and research environment is open, freedom to publish and to disseminate research results is preserved, the University's rights are protected, the University's facilities and resources are used appropriately, and that the University receives proper compensation for their use.

Considerations for Review Relating to Human Subjects

The COIOC must consider the effect of the disclosed financial interests on the rights and welfare of the human subjects participants. The COIOC must consider whether the rights of the participants would be better protected by reduction or disclosure of a financial interest, separation of responsibilities for financial and research decisions, additional oversight, elimination of a financial interest, implementation of an independent data and monitoring committee, modification of roles in research staff, or any other mechanism which would mitigate effects of the financial interest."

Final COIOC approval is conditioned upon the IRB's review of the COIOC findings and communication from the IRB that the COIOC has adequately considered the effect of the disclosed financial interests on the rights and welfare of the participants.

Questions About the IRB Requirements for Financial Disclosure?

Grace J. Park, COI Administrator (949) 824-7218