University Interaction with Industry
Working with Industry Conflict of Interest Conflict of Commitment Consulting for Industry Research Agreements Gifts from Industry Material Transfers
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Conflict of Interest

OVERVIEW

Universities have a long history of collaboration with industry in research, education, and public service. Examples of such interactions include faculty consulting with industry, student internships in industry, industry scientists visiting university campuses to learn about and contribute to research, and industry liaison programs. More recently, there have been substantial increases in the numbers of faculty and researchers with industrial affiliations and in funding from industry to universities for research.

With increased interactions comes an increased responsibility to assure that these interactions do not compromise the University's research or educational mission or create a situation in which financial or other personal considerations compromise, or appear to compromise, a researcher's professional judgment.

Several principles guide UCSD's interactions with industry:

University-industry interactions are reviewed for potential conflicts of interest when funding comes to the University from private sponsors or certain federal agencies in the form of an unrestricted gift to benefit the work of a particular principal investigator (PI), or as a contract or grant to fund research or a clinical trial. Material transfer and service agreements may also be reviewed for conflict of interest. If a review suggests that a conflict may exist, appropriate steps may need to be taken to eliminate or mitigate the conflict before funds can be released for expenditure.

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INDEPENDENT REVIEW COMMITTEE ON CONFLICT OF INTEREST

In response to State and federal guidelines requiring disclosure and review of financial conflicts, the UCSD Chancellor established the Independent Review Committee (IRC) on Conflict of Interest. The IRC functions as the principal advisory group to the Chancellor for the resolution of specific conflicts of interest in nongovernmental and federal research.

The IRC is appointed by the Chancellor with recommendations from the Committee on Committees of the Academic Senate and consists of full-time, tenured faculty representatives from major areas of the campus, including the General Campus, School of Medicine, and Scripps Institution of Oceanography. Additionally, representatives of the Office of Contract & Grant Administration and Technology Transfer & Intellectual Property Services serve in an ex-officio, non-voting capacity. The Conflict of Interest Office provides staff support to the Committee.

The charge of the IRC is to review situations where an actual or potential conflict of interest exists because a researcher has a significant financial interest related to the sponsored project or in the company funding his or her research. A significant financial interest exists if a researcher or faculty member [or researcher's spouse or dependent child]:

As part of its review, the IRC ensures that the substance of the project meets campus standards in research and teaching, involvement of students, and disclosure of scientific information. This review allows the University to establish mechanisms to eliminate, reduce, or manage conflicts of interest, if possible, and to safeguard the interests of the University and the individual principal investigator.

The IRC will work with the Principal Investigator and his/her academic unit to develop a management strategy appropriate for a given situation. Such strategies may include one or more of the following:

All IRC recommendations are forwarded to the Chancellor for concurrence.

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DISCLOSURE REQUIREMENTS FOR NONGOVERNMENTAL SPONSORED PROJECTS

The State of California requires disclosure of financial interest of $500 or more in private sponsors of research by all principal investigators on sponsored projects administered by the University. Disclosure of financial interest is also required by all principal investigators for all unrestricted gifts, lab service and material transfer agreements administered by the University. The State of California has designated exempt sponsors that do not require a principal investigator to disclose a financial interest.

For such nongovernmental sponsored research projects, the Principal Investigator must disclose financial or management interests. The Principal Investigator's Statement of Economic Interest (730-U) form must be completed for sponsored research agreements including clinical trial agreements, as well as human and animal subject protocols, service agreements, and Industry-University Cooperative Research Programs (BioSTAR, UC MICRO, UC CoRe, UC DiMi, UC SMART, and LSI). The Industry-University Cooperative Research Programs also require completion of the IUCR Cover Sheet. Principal Investigators (PIs) are also required to complete the 730-U form when they receive an unrestricted gift or a transfer of research material.

All required forms must be completed and submitted to the appropriate office:

  1. Campus Office of Contract and Grant Administration or SIO Contract & Grant Office for research agreements and material transfers.
  2. Dean's Office, School of Medicine for clinical trial agreements.
  3. Human Subjects Office (with proposal package) for human subject protocols.
  4. Animal Subjects Office for animal subjects protocols.
  5. Office of Gift Administration for unrestricted gifts.

Funds will not be available for expenditure until all information has been received and verified.

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DISCLOSURE REQUIREMENTS FOR NIH AND NSF SPONSORED RESEARCH

For NIH and NSF sponsored research projects, the Disclosure of Financial Interests Related to Federally-Sponsored Projects (9510) cover sheet must be completed by the PI(s), as well as other key personnel on the project. A Principal Investigator is any individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project. Other key personnel includes Co-Investigators, Researchers and any other individual who has independent responsibility for designing, conducting or reporting the results of the sponsored project.

Disclosure forms are submitted to Campus OCGA (or SIO Contract and Grant office for SIO projects) and are then routed to the COI office. Investigators must disclose significant financial interests related to the sponsored project.

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CONFLICT OF INTEREST DISCLOSURE FORMS

  1. Nongovernmental Sponsored Research, Unrestricted Gifts, and Material Transfers
    Principal Investigator's Statement of Economic Interests (730-U)
    Addendum to Principal Investigator's Statement of Economic Interests (730-A) [Complete for positive disclosure]

  2. Industry-University Cooperative Research Programs (BioSTAR, UC MICRO, UC CoRe, etc.)
    IUCR Cover Sheet
    Principal Investigator's Statement of Economic Interests (730-U)
    Addendum to Principal Investigator's Statement of Economic Interests (730-A) [Complete for positive disclosure]

  3. Federal Sponsored Research - DHHS/NIH (including SBIR and STTR) and NSF
    Disclosure of Financial Interests Related to Federally-Sponsored Projects (9510)
    Description of Financial Interest Related to Federally-Sponsored Projects (9510-U) [Complete for positive disclosure]

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DIFFERENCE BETWEEN CONFLICT OF INTEREST AND CONFLICT OF COMMITMENT

A conflict of interest occurs when (1) an employee has a significant financial interest in a company that is providing funding for the employee's research or other University activity or (2) the research might directly and significantly affect the significant financial interest of an employee responsible for the conduct of the research project. A conflict of commitment occurs when a University employee's commitment and time to an outside activity interferes with the employee's performance of University duties. For more on Conflict of Commitment, click here.

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CONFLICT OF INTEREST IN PURCHASING

It is the University policy (Employee-Vender Policy PPM 523-9) to separate an employee's University and private interests and to safeguard the University and its employees against charges of favoritism in the purchase of goods and service. No purchase of goods or services shall be made from any employee or near relative thereof unless there has been a specific determination that such goods or services are not available from either commercial sources or the University's own facilities.

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UNIVERSITY OF CALIFORNIA POLICIES

  1. Disclosure of Financial Interest in Private Sponsors of Research (April, 1984)

  2. Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects (October 1, 1995; revised October 15, 1997)

  3. Conflict of Commitment and Outside Professional Activities of Faculty Members (Academic Personnel Manual 025, revised February 8, 2001, and effective July 1, 2001)


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