CONFLICTS OF INTEREST IN RESEARCH

Frequently Asked Questions about UCLA's COI Procedures for the Implementation of State of California and Federal Regulations

Questions:

1. What is a financial interest?

2. What “financial interests” need to be disclosed?

3. What is a “Significant Financial Interest”?

4. How should Investigators determine what Significant Financial Interests should be disclosed?

5. Who should disclose?

6. Who determines which project participants need to disclose financial interests?

7. Who reviews Financial Interests and Significant Financial Interests?

8. What happens if the CIRC determines that a conflict of interest exists?

9. Are disclosed financial interests treated confidentially?

Additional questions?

1. What is a financial interest?

It is a term taken from State of California regulations that require disclosure of “financial interests” in sponsors of research. As defined in UCLA Procedures 925.1, “Disclosing Financial Interests in Non-Governmental Donors of Gifts,” and 925.2, “Disclosing Financial Interests in Non-Governmental Sponsors of Contracts, Grants, and Material Transfer Agreements for Research,” the term means anything of monetary value including, but not limited to:

A position as director, officer, partner, trustee, employee, or any other position of management in the sponsor; and/or
Income from the sponsor (including, but not limited to salaries and wages, consulting income, honoraria for services performed, per diem, reimbursement for expenses, rental income, dividends and interest, and proceeds from sales) including income deposited into, or payments made directly to a health sciences compensation plan aggregating $500 or more in value received by or promised within 12 months prior to the time the award is made; and/or
An investment including stocks, bonds, warrants, and options, including those held in margin or brokerage accounts, in the sponsor worth more than $2,000; and/or
A gift of $50 or more, or multiple gifts totaling $50 or more, from the sponsor, received by or promised to the researcher within 12 months prior to the time the award is made; and/or
Loans from the sponsor for which the outstanding balance has exceeded $500 in the past 12 months.

**N.B.: Under State law, personal income that must be disclosed does not include monies received from the University of California even if the funds were derived from licensing fees or royalties paid to UC by a research sponsor. Also excluded is income from non-profit entities for seminars, lectures, teaching engagements, or service on advisory committees or review panels.

A financial interest in a research sponsor must be reported by Principal Investigators on State of California Form 700-U, and by other Investigators on the UCLA Form 700-U Addendum. If you answer “yes” to any of the questions on the Form 700-U or UCLA Form 700-U Addendum, you should complete a Disclosure Supplement to Forms 700-U & 700-U Addendum describing your financial interest(s). Principal Investigators and other Investigators who are working on industry-sponsored clinical trials should complete the on-line Industry Clinical Trial Specific Disclosure Supplement.

2. What “financial interests” need to be disclosed?

All financial relationships between an individual and a research sponsor (either directly, through a spouse or registered domestic partner, or a dependent child; or through a business entity that owns a 10% or greater equity interest in the research sponsor) should be reported to UCLA.

3. What is a “Significant Financial Interest”?

Federal regulations use the term “Significant Financial Interests” in their disclosure requirements. As defined in UCLA Procedure 925.3, “Disclosing Financial Interests Relevant to Federally Sponsored Contracts and Grants for Research,” the term means anything of monetary value including, but not limited to:

Income or other payment for services including: salary, consulting payments, honoraria, travel payments, reimbursement of expenses, royalty payments, dividends, loans or any other payments or consideration of value, including payments made to a health sciences compensation plan, during the prior twelve months or anticipated in the next twelve months, of $10,000 or more;
Equity in the form of stock, stock options, warrants, real estate, loans or any other investment or ownership interest exceeding either $10,000 (current market value if publicly traded; otherwise, amount of investment) or a 5% ownership interest, for any one enterprise;
A management position, whether paid or unpaid, such as board member, director, officer, partner, or trustee; or
Intellectual property interest in a patent, patent application or a copyright assigned or licensed to a party other than The Regents.

**N.B. Under federal regulations, personal income that must be disclosed does not include monies received from the University of California even if the funds were derived from licensing fees or royalties paid to UC from an organization in which the Investigator has other financial interests.

The Form 740 is used by Principal Investigators and other Investigators to report “Significant Financial Interests” that would reasonably appear to be affected by the research being conducted.

4. How should Investigators determine what Significant Financial Interests should be disclosed?

Investigators should ask themselves the following questions:

Do you have any “Significant Financial Interests” in an entity other than the sponsor of the research (see question #3 for the definition of Significant Financial Interests)?

AND

If my “Significant Financial Interest” were called into public view at the conclusion of the project, could a layperson reasonably consider that my financial interest, or the entity’s financial interests, could have been affected by the design, conduct, or reporting of the research?

If you answered “yes” to both these questions, you should indicate that you have a financial interest to report on Form 740 and complete a Disclosure Supplement for each organization in which you have a financial interest that could reasonably appear to be affected by the proposed research. Investigators are encouraged to think broadly in reporting their “related” financial interests and to report financial interests in more than one entity is appropriate.

These are examples of Significant Financial Interests that might be “related” to a research project:

The University of California has patented technology that you invented and licensed it to a company in which you have a personal financial interest. You want to conduct research using that technology (either as a tool for research or to further develop the invention).
You have a personal financial interest in a business that will be supplying a product for use in a sponsored project.
The proposed research might lead to improvements in a product that is manufactured and/or sold by a company in which you have a personal financial interest.
You have a financial interest in a company that will act as a subcontractor, consortium member, supplier of goods or services, or lessor under a prime sponsored award.
You have a financial interest in a company that manufactures a drug or device that is a competitor or a comparator to the drug or device being used in the sponsored research.

5. Who should disclose?

The Principal Investigator and all others on the project who share responsibility for the design, conduct or reporting of the project should disclose. Investigators must report their own personal financial interests as well as those of their spouse or registered domestic partner, and dependent children.

6. Who determines which project participants need to disclose financial interests?

The Principal Investigator makes that determination on a project-by-project basis. Anyone who meets the criteria (see number 5 above) for disclosing is considered an “Investigator.”

7. Who reviews Financial Interests and Significant Financial Interests?

At UCLA, disclosed financial interests (under State of California regulations) are reviewed by the Conflict of Interest Review Committee (CIRC), a panel of faculty members drawn from disciplines across the campus. A Designated Official reviews all “Significant Financial Interests” (under federal regulations), to make a preliminary assessment and determine if full CIRC review is required. The Designated Official confers with the Chair of the CIRC and the Vice Chancellor for Research about those that do not require full CIRC review.

8. What happens if the CIRC determines that a conflict of interest exists?

If the CIRC determines that the disclosed financial interests constitute a real or perceived conflict of interest they will try to identify one or more measures designed to eliminate, reduce, or manage the conflict so that the research can be accepted. Their recommendations are forwarded to the Vice Chancellor for Research, to whom they are advisory. It is important to realize that the fact that an Investigator has a financial interest in the sponsor or a “significant financial interest” that may be affected by the outcome of the research does not automatically mean that the research cannot be conducted.

9. Are disclosed financial interests treated confidentially?

The campus treats personal financial interest disclosures sensitively and shares them only on a need to know basis within the University, per sponsor policy, or per California Public Records Act request.

If you have additional questions about UCLA’s conflict of interest policy and procedures, please contact us at (310) 794-0390 or via e-mail at ccochrane@research.ucla.edu.