UCLA

I. PURPOSE AND SCOPE

State of California regulations require that Principal Investigators (PIs) disclose personal financial interests in non-governmental sponsors of research.  Additionally, UCLA policy requires that all Investigators on a project who share responsibility for the design, conduct, or reporting of the research disclose certain personal financial interests in non-governmental sponsors.

This procedure describes the conditions under which these financial interests should be disclosed. For more information on applicable State regulations and related campus policies concerning conflicts of interest, see section V, below.

II. DEFINITIONS

Investigator: For purposes of this procedure, any UCLA employee who shares responsibility for the design, conduct, or reporting of the results of a sponsored project.

Principal Investigator (PI): A UCLA employee (normally an academic appointee) who has primary responsibility for the scientific and technical conduct, reporting, fiscal and programmatic administration of a sponsored project.

Financial Interest: As used in this procedure, based on definitions and thresholds for reporting taken from the California Political Reform Act of 1974, 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. 

Significant Financial Interest: As used in this procedure, based on definitions that reflect the National Science Foundation policy on objectivity in science, and on federal reporting thresholds, means anything of monetary value including, but not limited to:

• Income including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, loans from an entity, 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 to or from an entity, 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;

• Intellectual property interest on a patent, patent application, or copyright assigned or licensed to a party other than The Regents.

III. DISCLOSURE OF FINANCIAL INTERESTS

In accordance with State of California regulations and UCLA Policy 925, a Principal Investigator (PI) must disclose his or her Financial Interests, and other Investigators must disclose Significant Financial Interests, if a research project is supported in whole or in part by a non-governmental entity.  Reporting of Financial Interests is required for the individual, his or her spouse or registered domestic partner, and any dependent children. Support for research includes funding or provision of equipment or materials needed to conduct a research project and can be received as contracts and grants (including cooperative agreements) and material transfer agreements.  

Financial Interests disclosed in conjunction with receipt of research support are reviewed by the UCLA Conflict of Interest Review Committee (CIRC). After review, the CIRC will determine whether the disclosed Financial Interests (for PIs) or Significant Financial Interests (for all other Investigators) reasonably appear to directly and materially affect the design, conduct, or reporting of projects and thereby constitute a conflict of interest that may need to be managed, reduced, or eliminated before support for the research can be accepted by the campus.

Certain sponsoring organizations are exempt from the reporting requirements (see list of exempt organizations ). In addition to the institutions named on the list, “all non-profit, tax-exempt educational institutions” are exempt. Private, non-profit colleges and universities are among the exempt organizations.

Other Circumstances Under Which Disclosures Must be Made

On occasion the PI and other Investigators may have to submit multiple disclosures.  If the University’s agreement is with a contract research organization or other intermediary working for a study sponsor, disclosure of Financial Interests in both organizations is required.  If the study sponsor is not the manufacturer(s) of the product(s) being tested, then disclosure of Financial Interests in the manufacturer(s) of the drug(s) or device(s) is also required.

If materials (e.g., drugs, devices, equipment, reagents, cell lines, animals, etc.) being tested or used as tools in the research are being provided by a for-profit or not-for-profit organization for use in a project being funded by the federal Public Health Service (PHS) or National Science Foundation (NSF), then disclosure of Financial Interests in the organization that is providing the materials should be made under this procedure as well as under UCLA Procedure 925.3.

If the University is receiving a subcontract or a subgrant, then disclosures should be provided for both the organization with which the University is receiving the subcontract or subgrant, and the prime sponsor of the research. 

A. When Must Disclosures be Made

Disclosures of Financial Interests and/or Significant Financial Interests must be made: 

1. Each time a new proposal for research support is submitted to a non-governmental (for-profit or not-for-profit) sponsor;

2. Each time a request for additional support is submitted to a non-governmental (for-profit or not-for-profit) sponsor;

3. With each request for negotiation of a Material Transfer Agreement to procure materials from a for-profit or not-for-profit sponsor.

All information requested on the disclosure forms is mandatory.  All reviews must be completed and if required, the sponsor notified before awards can be accepted.

B. Which Forms Should be Used

Under the State of California Political Reform Act of 1974, the PI must report Financial Interests using State Form 700-U. The PI must also complete a 700-U Addendum identifying all other Investigators who share responsibility for the design, conduct, or reporting of research, or indicating that there are no other Investigators on the project who share these responsibilities.

The PI and all other Investigators who disclose personal Financial Interests in a research sponsor should also complete a “Disclosure Supplement”, providing additional details. If the study is an industry supported clinical trial, the PI and all other Investigators who disclose personal Financial Interests should complete an “Industry Clinical Trial Specific Disclosure Supplement”.

C. Responsibilities of Collaborators and Consultants 

All collaborators from other institutions, who share responsibility for the design, conduct, or reporting of research results are expected to comply with the policies and procedures for conflict of interest reviews at the institution at which they are employed.Consultants who are affiliated with organizations that do not have their own conflict of interest review process may defer to UCLA’s procedures.  In so doing, consultants agree to abide by any determinations that UCLA may make about the management, reduction, or elimination of Financial Interests or Significant Financial Interests.

IV. PROCEDURES

A. Completion of Forms 700-U, 700-U Addendum, and Disclosure Supplement or Industry Clinical Trial Specific Disclosure Supplement 

(for all forms see the UCLA Research Policy & Compliance Web site) 

B. Access to Statements

Under California state law and University policies, completed financial disclosure forms and other information required under this procedure are available to any member of the public upon request. Sponsors may be notified about the disclosure and review of Financial Interests as required.

C. Sanctions

Failure of an individual to file a complete and truthful financial disclosure for pending proposals, or failure to comply with any conditions or restrictions directed or imposed, including failure to cooperate with appointed project monitoring bodies, will be grounds for discipline pursuant to the University Policy on Faculty Conduct and the Administration of Discipline (Academic Personnel Manual, APM-016) and/or other applicable employee disciplinary policies.

V. RELATED POLICIES, REGULATIONS AND FORMS 

1. UCLA Policy 150, Conflict of Interest.

2. Memorandum from Vice Provost Robert Shelton, February 4, 1997;

3. Disclosure of Financial Interest in Private Sponsors of Research, APM-028, dated 4/29/2010.

4. Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects, February 3, 1995.

5. UCLA Policy 925, Financial Conflicts of Interest in Research.

6. UCLA Procedure 925.3, Disclosing Financial Interests Relevant to Federally Sponsored Contracts and Grants for Research.

7. Academic Personnel Manual, APM-025 - Conflict of Commitment and Outside Activities of Faculty Members, revised July 1, 2001.

8. Academic Personnel Manual, APM-016 – University Policy on Faculty Conduct and the Administration of Discipline.

9. Academic Decisions Exception Regulation (California Code of Regulations, Title 2, §18702.4(c)(2)).

10. Political Reform Act of 1974 (California Government Code, Section 81000, et seq.).

    For the following forms and list, see the UCLA Research Policy & Compliance Web site: 

11. Form 700-U, “Statement of Economic Interests for Principal Investigators” and “Instructions for Completing Form 700-U”.

12. Form 700-U Addendum.

13. “Disclosure Supplement” to Form 700-U.

14. “Industry Clinical Trial Specific Disclosure Supplement”.

15. Sponsors of Research Exempted from University Non-Governmental Entity Financial Disclosure Requirement.