IRB COI Disclosure Requirements
- Disclosure Requirements
- Disclosable Financial Interests
- Related Financial Interests
- COIOC Considerations for Review
- Considerations for Review Relating to Human Subjects
- Questions About the IRB Requirements for Financial Disclosure?
- Disclosable Financial Interests
Disclosure Requirements
As of January 1, 2000, the Application for IRB Review required the Lead Researcher (LR) 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. This requirement was expanded to require financial disclosure from all research personnel when the application was revised and issued on June 1, 2001. And in October 2006, the IRB disclosure policy revised the disclosable financial interests. See definition of "disclosable financial interests" below.
Individuals disclosing the existence of a financial interest on the IRB application will be contacted by staff from the Office of Research Administration and asked to complete a disclosure form. This disclosure will be reviewed by the Conflict of Interest Oversight Committee.
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 consent template for medical studies and for social and behavioral studies.
Final approval of the protocol and informed consent by the IRB is postponed until the COIOC assesses the disclosure and the potential conflict of interest.
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.
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, go to http://www.research.uci.edu/ora/coi/nongovernmental.htm. To streamline the disclosure process, the Merged Addendum 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
