Share

Human Subjects Research (IRB)

Announcements

UCI requires lead researchers, all study team members, their spouses/registered domestic partners, and/or dependent children to disclose their financial interests related to all research projects conducted at UCI or using UCI resources or facilities that involve the use of human subjects, regardless of funding source, as part of the Application for IRB Review.

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 consent form templates are available on the Applications and Forms web page under the heading, "Human Research Protections."

When to disclose:

  • Initial protocol (e-APP)
  • Any continuing IRB application (e-CPA)
  • Any modification (e-MOD) request that changes the Lead Researcher or adds Co-Researchers or other research personnel

IRB review for new studies may run concurrently with COIOC review. However, if the COIOC report and suggested consent language is not available at the time of the IRB review, the IRB cannot approve the study and may postpone review until the report is available.

For electronic continuing protocol applications (e-CPAs) and electronic modifications (e-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.  The IRB review of the protocol and informed consent is deferred pending the completion of the COIOC review process.

Determining Disclosable Financial Interests

Does the researcher (or researcher’s spouse/registered domestic partner or dependent children) have…

  1. Outside income equal to or exceeding $10,000 over the preceding 12 months or anticipated during the forthcoming 12 months (includes salary, consultant payments, honoraria, royalty payments, dividends, loan or any other payments or consideration with value, including payments made the University Health Sciences Compensation Plan)?
  2. Equity (including stock, stock options, real estate, or any other investment or ownership interest) in a publicly held company equal to or exceeding $10,000 (current market value) or a 5% or greater ownership interest?
  3. Any equity (including stock, stock options, or any other investment or ownership interest) in a privately held company, regardless of value?
  4. Any management position, such as Board of Directors, director, officer, partner, or trustee?
  5. Intellectual property interest, e.g., a patent (actual, planned, or applied for) or a copyright for software assigned or to be assigned to a party other than the UC Regents?

If a researcher, researcher’s spouse/registered domestic partner, and dependent children respond “No” to all of these questions, then the researcher does not need to submit any additional COI paperwork for this protocol.

If a researcher, researcher’s spouse/registered domestic partner or dependent children respond “Yes” to any of these questions, then the researcher must determine whether or not the disclosable financial interest is related to the protocol.

Determining Related Financial Interests

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. 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 researcher has a financial interest.
  • The researcher 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 researcher 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 researcher 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 researcher has a financial interest in an entity that is part of a consortium or that will otherwise participate in the project.

If the disclosable financial interest is related to the protocol, the researcher must submit the COI Addendum (Form COI-1) for any disclosable financial interest related to the IRB protocol.  If the researcher has related disclosable financial interests in multiple entities, then the researcher must submit an Addendum for each different entity. 

Note: If the researcher is non-UCI Personnel with a disclosable financial interest, then the researcher must submit the Addendum for Non-UCI Personnel (Form COI-3) for any disclosable financial interest related to the IRB protocol. 

Procedures

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. 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 COI Addendum Form COI-1 for UCI researchers and/or COI Addendum Form COI-3 for non-UCI researchers.   COI Addenda will be reviewed by the Conflict of Interest Oversight Committee (COIOC).  COI Staff will provide the IRB the results of COIOC review and the COIOC recommended consent language describing the financial interest.

Additional Review: Sponsored studies may be subject to additional financial disclosure requirements under the sponsor’s financial disclosure policy or regulations. Please contact the Conflict of Interest Staff for any questions regarding sponsor related disclosure requirements. 

Forms

 Relevant Policy

For IRB Protocol Questions

News & Announcements

View More