Disclosure Reminders for Clinical Researchers and Research Personnel Involved in Human Subjects Research

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Disclosure Reminders for Clinical Researchers and Research Personnel Involved in Human Subjects Research

To promote transparency and inform study participants, UCI’s IRB Conflict of Interest Policy requires all research personnel on IRB protocols to disclose whether they have any disclosable financial interests related to the IRB study.

 

What is a Disclosable Financial Interest?

A financial interest is disclosable if it meets or exceeds certain thresholds:

  • Income ≥ $10,000 received over the past 12 months

  • Equity interest (including stock, stock options, and other ownership interests) ≥ $10,000 or 5% in a publicly traded company

  • Any equity interest (including stock, stock options, and other ownership interests) in a privately held company, regardless of the value

  • Board of Directors, director, officer, partner, trustee or management position

  • Intellectual Property interest in a patent, patent application, or copyright of a software (excluding intellectual property owned by the UC) 

What Does Related to Research Mean?

If your financial interest exceeds the above amounts, then the next keyword is “related.” Related financial interests occur when the researcher, their spouse/registered domestic partner 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.

 

Some questions to help you determine whether your disclosable financial interest is related:

  • Would the financial interest or the entity (in which you have the financial interest) be interested in or affected by the results of the IRB study?

  • Is the entity the sponsor of the study?

  • Does the IRB study involve the entity’s product or a competitor’s product?

  • Would the entity be interested in licensing any intellectual property discovered in this IRB study?

If you answer “Yes” to any of the above questions, your disclosable financial interest is related and needs to be disclosed to the IRB. It is possible to have multiple disclosable financial interests related to one IRB protocol.

 

Questions? Please contact Conflict of Interest with your inquiry or to schedule a brief one-on-one Zoom meeting with a COI Team member to address specific concerns.

 

Office of Research

University of California, Irvine

324 Aldrich Hall
Irvine, CA 92697

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