Federal regulations require investigators to disclose certain financial interests (defined below) to ensure that the design, conduct or reporting of federally-funded projects will not be biased. In accordance with UCLA Policy 925, Financial Conflicts of Interest in Research, the financial interests disclosed by UCLA investigators are reviewed by the UCLA Conflict of Interest Review Committee (UCLA CIRC).

This procedure describes the conditions under which these financial interests should be disclosed by investigators. The procedure is applicable to all proposals (research and educational activities) submitted to the National Science Foundation (NSF) and to all research proposals submitted to the Public Health Service (PHS) and other agencies and programs that specifically request review consistent with federal regulations. For more information on applicable federal regulations and related campus policies concerning conflict of interest, see section V., below.

II. DEFINITIONS

In accordance with University and UCLA policies, Investigators are required to disclose Significant Financial Interests as defined above. The UCLA CIRC will determine whether the financial interests disclosed 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.

A. Significant Financial Interests that Should be Disclosed

Significant Financial Interests should be disclosed to the University when:

• It can be reasonably presumed that the anticipated outcome of the project (e.g., the results) might affect the Investigator’s financial interests; and/or
  
  
• It can be reasonably presumed that the project results might affect the value of the entity (e.g., its earnings, sales of its products, etc.) in which the Investigator has a financial interest.
  

Examples of Significant Financial Interests include, but are not limited to, situations in which:

• An Investigator is carrying out a sponsored project, the results of which would be relevant to the development, manufacturing or improvement of the products or services of an entity in which the Investigator has a Significant Financial Interest.
  
  
• An Investigator has a Significant Financial Interest in an entity which might manufacture or commercialize a drug, device or procedure that might result from the sponsored project; or which manufactures or sells any product being tested or used in the study, or any concomitant or comparator products used in the sponsored project.
  
  
• An Investigator has consulting income from a single entity that exceeded $10,000 during the prior 12 months, and the financial interests of that entity would reasonably appear to be affected by the research.
  
  
• An Investigator has a Significant Financial Interest in an entity and under the sponsored project, work will be subcontracted to, space leased from, participants will be referred to, or purchases will be made from that entity.
  
  
• An Investigator is carrying out a sponsored project and has a Significant Financial Interest in an entity that is part of a consortium or that will otherwise participate in the sponsored project.
  

B. Who Must Disclose Significant Financial Interests

1. All Investigators who share responsibility for the design, conduct or reporting of the research results must disclose Significant Financial Interests.
   
   In all cases, reporting is required for the individual, his/her spouse or registered domestic partner, and any dependent children.
   
   
2. Any collaborators from other institutions who will share responsibility for the design, conduct or reporting of research results are expected to comply with the policies and procedures for disclosure and review of any Significant Financial Interest at the institution at which they are employed. Those institutions are responsible for sending to UCLA assurances of review and of their ability to manage, reduce or eliminate the conflicts.
   
   
3. Consultants who are affiliated with organizations that do not have their own conflict of interest review procedures may defer to UCLA’s procedures. In so doing, they agree to abide by any determinations that UCLA may make about management, reduction or elimination of Significant Financial Interests.
   

C. When Must Disclosures be Made

Disclosures of Significant Financial Interests must be made:

• Each time a request for new funds, including submission of progress reports (non-competing continuation), is submitted to PHS;
  
  
• Each time a new or competing continuation proposal is submitted to NSF;
  
  
• Each time a request for support is submitted to a University of California program or other designated agency which requires review under federal regulations;
  
  
• Any time a new Investigator is added to the project; and
  
  
• Whenever, during the term of an award, an Investigator has a change in a reportable Significant Financial Interest, or acquires a new Significant Financial Interest which was not listed on the original disclosure form.
  

In accordance with federal regulations, all disclosures must be received by the Office of Contract & Grant Administration before the application for funding can be submitted to the agency. All reviews must be completed and, if required, the agency notified before the funds can be expended.

IV. PROCEDURES

A. Completion and Review of Disclosure Forms

RESPONSIBILITY	ACTION
Principal Investigator (PI)	Identifies all other Investigators who share responsibility for the design, conduct or reporting of the research or educational activities.
	Completes the upper portion of Form 740 (see section V. 6., below) as well as line 1 of the “Disclosure and Certification” section, and uses lines 2-5 to provide the names of all other UCLA Investigators who share responsibility for the design, conduct or reporting of the research (or educational activities for NSF funding) including those who join ongoing projects. Signs the Form 740 certifying that all other Investigators required to make disclosures have been listed on the form.
	Reminds all Investigators of their ongoing responsibility to provide updated information if they obtain any new Significant Financial Interest(s) during the term of the award.
All Investigators	Sign Form 740 certifying that either no Significant Financial Interest exists or that a complete listing of all financial interests is provided on a Disclosure Supplement form (see section V. 7., below). In signing the Form 740, all individuals also acknowledge their responsibility to disclose any new Significant Financial Interest(s) obtained during the term of the award.
PI	Promptly forwards completed forms to the Office of Contract & Grant Administration (OCGA), or Office of Intellectual Property & Industry Sponsored Research (OIPISR) as appropriate.
Collaborators from Other Institutions	Must comply with their employing institution’s policies and procedures on completion and review of financial disclosures, and have their institutions send assurance of review to OCGA or OIPISR. These assurances should identify the contract/grant number, the name of the PI, the name of the Investigator with the Significant Financial Interest, whether the Significant Financial Interest was found to constitute a conflict of interest and if so, how that conflict of interest will be managed, reduced or eliminated. UCLA should also be notified if the reviewing institution determines that the conflict of interest cannot be managed.
OCGA or OIPISR	Forwards to the UCLA CIRC staff any assurances received from collaborating institutions.
Office of Contract & Grant Administration (OCGA) or Office of Intellectual Property & Industry Sponsored Research (OIPISR)	Ensures all necessary forms have been submitted and reviews for completeness.
	If Form 740 indicates that neither the PI nor other Investigators have any Significant Financial Interests to disclose (a negative disclosure), retains original in the proposal or award file, as the office of record.
	If Form 740 indicates that the PI or any other Investigators have a Significant Financial Interest, ensures that those Investigators with Significant Financial Interests have also completed supplement forms. Collects additional background information and clarification as needed to prepare a case for review by the UCLA CIRC prior to acceptance of the award.
	Contacts the UCLA CIRC staff. Provides UCLA CIRC staff with original disclosure forms and any additional materials and information as needed, retaining a copy for the proposal or award file. The UCLA CIRC will serve as the office of record for the materials that require review.
Designated Campus Official (DCO)	Reviews all positive Investigators’ Statements of Financial Interests and confers with the UCLA CIRC Chair and the Vice Chancellor for Reseach to determine whether the Significant Financial Interest(s) could reasonably appear to directly and materially affect the design, conduct or reporting of the proposed project or to determine if full UCLA CIRC review is required.
	If after review it appears that the financial interest will not directly and materially affect the design, conduct or reporting of the project and/or if the Significant Financial Interests disclosed have been previously reviewed by the UCLA CIRC, confers with the UCLA CIRC Chair and forwards a recommendation of action to the Vice Chancellor for Research.
UCLA CIRC	Reviews case materials. May also interview the PI, other UCLA officials and/or seek additional information.
	Forwards to the Vice Chancellor for Research the UCLA CIRC advice concerning whether or not the financial interest will directly and materially affect the project, and recommendation(s) intended to manage, reduce or eliminate any real or perceived conflicts of interest.
Vice Chancellor for Research	Based on the DCO or the UCLA CIRC review and recommendations, determines whether any action is needed to manage, reduce or eliminate conflicts of interest.
	Notifies PIs or other Investigators and as appropriate, other campus officials of decision. Additional notification shall be sent to the Office for Protection of Research Subjects (OPRS) if human subject research is involved.
UCLA CIRC	If required, notifies sponsors that a Significant Financial Interest has been identified either at UCLA or at a collaborating site and, as specified by the sponsor, either provides assurance that the conflict of interest has been managed, reduced or eliminated, or advises that the conflict of interest cannot be managed.

Failure of an individual to file a complete and truthful financial disclosure for pending proposals, or when a new interest is obtained, 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. Agreements with consultants who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed may be terminated for cause. In addition, federal regulations may require reports to the federal sponsor of any violations of federal regulations and University policy.

V. RELATED POLICIES, REGULATIONS & FORMS

UCLA Policy 925, Financial Conflicts of Interest in Research;


University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects, revised October 15, 1997;


National Science Foundation (NSF) "Investigator Financial Disclosure Policy," Federal Register July 11, 1995 (Vol. 60, No. 132 (PDF);


Public Health Service (PHS) "Objectivity in Research," Code of Federal Regulations (42CFR Part 50, Subpart F and 45CFR Part 94);


California Public Records Act (Government Code § 6250 et seq.).


Form 740, "University of California, Los Angeles, Investigators’ Statements of Financial Interests Related to Sponsored Projects," available from UCLA Research Policy & Compliance.


"Disclosure Supplement" to Forms 700-U & 740, available from UCLA Research Policy & Compliance.