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UCI Guidelines

Disclosure of Financial Interests Related to Sponsored Projects for Assurance of Objectivity in Research

Introduction

The University of California, Irvine is committed to the conduct of sponsored research, instruction, and public service activities within an environment that promotes the free exchange of ideas, information, and materials among students and faculty. The major support for the research component of this mission historically has been from federal and non-profit sponsors. However, with increased emphasis from the public and private sectors on the importance of the rapid transfer of scientific discoveries to marketable technologies, universities have been encouraged to develop projects with industry. These new alliances have accelerated with the growth of the biotechnology industry, domestic competitiveness within the global economic community, and legislative acts to stimulate the new industry-university linkages.

These new collaborations occasionally give rise to concerns regarding conflicts between the interests of the publicly-supported University researchers and an entity in which the researcher may have a financial or management interest. It is important to recognize that research relationships often begin with consulting or other interactions that may or may not lead to a harmful conflict of interest. A conflict of interest can develop as a function of the specific situation, independent of the character or actions of the individual.

In recognition of this potential, UC implemented a policy in 1982 that provides for the systematic review of principal investigators' financial disclosures prior to the acceptance of gifts, contracts, or grants from non-governmental sponsors. This policy was required by the State of California Political Reform Act of 1974 and seeks to provide an open and unbiased environment for the exchange of information in research and education.

These concerns also were raised at the national level, and, in October 1995, responding to Congressional mandate, officials within the Public Health Service (PHS) and the National Science Foundation (NSF) developed policies similar to those in place in the State of California. These policies are intended to ensure that federal trust and financial support are not compromised to advantage personal gain. The University of California Industry-University Cooperative Research Programs and some foundations have adopted the federal requirements for financial disclosure. The University of California issued its "Policy on Disclosure of Financial Interests and Management of Conflicts of Interests Related to Sponsored Projects" on October 15, 1997 primarily to implement federal requirements.

The Vice Chancellor for Research is responsible for implementation of and compliance with this policy at UCI.

Policy

It is the policy of the University of California that any Investigator (that is, any University employee responsible for the design, conduct or reporting of a sponsored project at the University) must disclose significant personal financial interests related to that project, when proposed to be funded by NSF or PHS or when such disclosures are required by another extramural sponsor. When the University determines that such an interest might reasonably appear to be directly and significantly affected by the sponsored project, the University will take steps either to manage or to eliminate the conflict, pursuant to the Management, Reduction or Elimination of Conflicts of Interest section of this document.

Purpose

The purpose of this policy is to establish a process of open disclosure and review, to identify any real or potential conflicts of interest between an Investigator's sponsored project obligations and personal financial interests or obligations, and to establish a process to eliminate, manage or reduce such conflicts in order to preserve objectivity in the design, conduct, or reporting of research. The policy is consistent with the Public Health Service regulations, "Objectivity in Research," 42 CFR Part 50 and 45 CFR Part 94, and the "Investigator Financial Disclosure Policy" of the National Science Foundation.

Scope

This policy applies to any University employee responsible for the design, conduct or reporting of a project submitted to the U.S. Public Health Service (PHS), which includes the National Institutes of Health (NIH), and the National Science Foundation (NSF), and will be expanded only if necessary to comply with official requirements subsequently imposed by other research sponsors. The University may apply the disclosure requirement of this Policy to certain University-managed programs, if approved by the Vice Provost for Research. This policy supplements but does not supplant the State requirements for disclosure of financial interests issued as the "University Policy on Disclosure of Financial Interests in Private Sponsors of Research" (APM-028-0).

On occasion, Investigators may have questions about whether proposed or on-going financial arrangements or relationships that would not require disclosure under the terms of this Policy appear to constitute an actual or potential conflict of interest with respect to a sponsored project. In such circumstances, Investigators may voluntarily choose to disclose the relationship in accordance with this Policy. Should the University subsequently determine that the voluntarily disclosed interest might reasonably appear to be directly and significantly affected by the sponsored project, the University may take steps to manage or to eliminate the conflict.

Investigators who are members of the faculty are reminded of their separate obligation, pursuant to the "University Policy on Outside Professional Activities of Faculty Members" (Academic Personnel Policy 025), to provide descriptive information regarding time and effort devoted to all outside professional activities related to their academic specialty in annual reports to department chairpersons or equivalent unit heads.

Definitions

Disclosure Forms and When Disclosures Are Required

  1. Administrative Approval Form (AA):

    The AA form is signed by the Principal Investigator and must accompany each proposal to the UCI Office of Sponsored Projects Administration. The AA form (as revised 7/99) solicits project-specific information and includes a financial disclosure and certification component in which the PI discloses any known Significant and Related Financial Interests for him/herself and any Investigators on proposals to PHS, NSF, or other sponsor who has adopted the federal requirements.

    If a non-UCI researcher serves on a UCI project and will be responsible for the design, conduct, or reporting of the activities being proposed, UCI must be assured that the home institution has policies that are in compliance with the PHS and NSF regulations. Disclosure need not be made directly to UCI, but must be disclosed to and managed by that Investigator's home institution.

  2. Disclosure of Financial Interests (Project Cover Sheet, Form COI-2)

    3. The PI and all Investigators are required to sign the Disclosure form, reporting any personal Significant and Related Financial Interests for a project sponsored by PHS, NSF, or other sponsor adopting the federal requirements. The campus must also assure that each sponsored project and the related financial interests were examined in the scope of an annual review. Complete disclosure is required:

    1. At the time of proposal submission or, later, when funding appears likely and prior to award acceptance
    2. Annually with non-competing continuation funding
    3. When new investigators are added to the project
    4. When investigator's financial interests change
    5. For NSF projects, the Investigator must also disclose upon receipt of any amendment to a cooperative agreement or any grant funding increment in excess of $1,000,000.

      6. It is the responsibility of the PI to submit the Disclosure form, signed by all project Investigators, in sufficient time to allow for COIOC review of projects in which an Investigator has disclosed a Significant financial or management interest in a related entity. The COIOC review must be completed and the award deemed acceptable by the Vice Chancellor for Research prior to any expenditure of funds.

      The requirement that an Investigator report a significant financial interest and the designation of an Investigator's financial interest as being related to the sponsored project, under the terms of this Policy, do not in and of themselves imply the existence of an actual or potential conflict of interest. The existence of a conflict of interest is determined subsequently by the Conflict of Interest Oversight Committee and the Vice Chancellor for Research.

  3. Investigator's Disclosure of Economic Interests Addendum (Form COI-3 Merged)

    4. The Investigator's Disclosure of Economic Interests Addendum1 has replaced the Description form and is to be completed by those Investigators who have a Significant and Related Financial Interest. It is sent with the Disclosure to the Office of Research Administration and may be placed in a sealed envelope marked "Confidential." The form solicits facts from the Investigator about the type of involvement (equity investment, income, etc.) and the level of that involvement. It also seeks information regarding the potential for direct and significant impact of the sponsored activity on the Investigator's financial interest and the Investigator's separation of University and personal financial interests. Investigators complete a separate Investigator's Disclosure of Economic Interests Addendum form for each entity in which they have a Significant and Related Financial Interest.

Review Process

The Director of the Office of Research Administration supervises the COIOC Administrator, who is responsible for reviewing all disclosures, ensuring completeness and consistency with prior disclosures, and for the initial analysis of the disclosed information. When necessary, the COIOC determines whether an investigator's consulting income from an entity, or that entity's financial interests, would reasonably appear to be related to the sponsored research. The Disclosures reporting a Significant and Related Financial Interest, the Investigator's Disclosure of Economic Interests Addendum , and other appropriate documentation are forwarded to the COIOC for review.

The COIOC considers whether the project could directly and significantly affect the financial interest or the financial interest could affect the design, conduct, or reporting of the project. A direct impact occurs when the project results would be directly relevant to the development, manufacturing, or improvement of the products or services of the organization in which the employee has a financial interest, or when the organization is a proposed subcontractor or participant in the project. A significant impact on the financial interest is one which will materially affect the value of the organization, its earnings, or the sales of its product, or when the organization is a proposed subcontractor or participant in the project.

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.

The COIOC must consider the effect of the disclosed financial interests on the rights and welfare of the 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.

On the basis of its evaluation, the COIOC forwards a recommendation to the Vice Chancellor for Research indicating one of the following outcomes:

  1. the financial interest poses little or no probability for bias in objectivity in the sponsored project; or
  2. the conflict of interest requires management, elimination, or reduction (see Section VIII); or
  3. in the case of NSF proposals only, the conflict exists but conditions to manage, reduce, or eliminate the situation would be ineffective or inequitable, and any possible bias is offset by interests of scientific progress, technology transfer, or public health and welfare.

The Vice Chancellor for Research, acting on delegated authority from the Chancellor and with advice from the COIOC, decides whether to accept the grant or contract in which a financial interest has been disclosed and, when a conflict of interest has been identified, decides how to manage, reduce or eliminate the conflict. The Vice Chancellor for Research is responsible for the final decision. When necessary, the COIOC Administrator, serving as the official communication link between the Vice Chancellor's Office and the agency, will notify the agency of the status of the disclosure review and conflict management.

Management, Reduction or Elimination of Conflicts of Interest

Under certain circumstances, the COIOC may recommend that the Vice Chancellor impose special conditions or restrictions to manage, reduce or eliminate the effect of the related financial interest(s) on the design, conduct or reporting of the project. Examples of conditions or restrictions that may be imposed upon the Investigator include the following:

  1. public disclosure of the related financial interest(s);
  2. monitoring of the project by independent reviewers appointed by the Vice Chancellor;
  3. modification of the research or project plan;
  4. disqualification from participation in all or a portion of the project;
  5. divestiture of the related financial interest;
  6. severance of relationships that create actual or potential conflicts.

Adoption of conditions or restrictions to manage or eliminate the conflict of interest must be agreed to in writing by the Investigator and the Vice Chancellor prior to the expenditure of any funds under the award.

Alternatively, if the COIOC determines that an Investigator's financial or management interest would be directly and significantly affected by the sponsored project, and the conflict cannot be managed, the Committee may recommend to the Vice Chancellor that the project not proceed.

Records Access and Maintenance

The Disclosure and Investigator's Disclosure of Economic Interests Addendum information are open to the public and subject to the Federal Freedom of Information Act (FOIA) and the California Public Records Act (CPRA).

Under federal requirements, the Disclosure information must be retained for three years following the termination or completion of the award to which the records relate, or the resolution of any government action involving the records, whichever comes last.

Sanctions

Failure to complete the Disclosure or the Investigator's Disclosure of Economic Interests Addendum or to comply with any conditions or restrictions imposed on the conduct of the project under this Policy will be grounds for discipline pursuant to the Policy on Faculty Conduct and the Administration of Discipline or other applicable employee disciplinary policies. In addition, federal regulations may require reports to the federal sponsor of any violations of University policy. Sponsors may suspend or terminate the award and/or debar an Investigator from receipt of future awards in the event of failure to comply with applicable federal regulations on disclosure, review, and management of significant financial interests related to federally-sponsored projects.

 

1 The Investigator's Disclosure of Economic Interests Addendum replaced the Federal Description form in August of 2002. The Investigator's Disclosure of Economic Interests Addendum also replaced the State Application and Completion forms and the IRB disclosure form. The new form aimed to alleviate administrative burdens.