Approved by Committee on Graduate Studies on May 8, 1995; Academic Council on April 11, 1996; Administration 1996
University of the Pacific Policy Disclosure of Financial Interests for Projects Sponsored by the National Science Foundation and the Public Health Service
INTRODUCTION As advances in the fields of science and medicine continue at an unprecedented pace, academic institutions and their faculty, are increasingly encouraged to enter into collaborative arrangements with industry to foster development of research programs. Over the past decade, there have been significant legislation and federal funding initiatives aimed at stimulating such collaborative arrangements in an effort to bolster the national economy and to promote international competitiveness.
These developments have generally been mutually beneficial, with industry drawing from the collective intellectual and creative talents of University faculty, and academia benefiting from additional resources. Technology developed with government funding at universities further stimulates interactions to facilitate the transition of basic research findings into commercially viable products. However, this climate also gives rise to a concern that the results of research not be compromised.
Acknowledging that research and commercial activities will continue to expand, and in an effort to ensure that publicly funded research will be conducted with objectivity and freedom from bias, this policy is directed to identify one potential source of bias— investigator financial interests. This policy also sets forth the University’s responsibilities to review disclosed financial interests, and when it determines that any disclosed interest might reasonably appear to be directly and significantly affected by a sponsored project, its responsibilities to manage or eliminate the financial interest.
POLICY It is the University’s policy that investigators responsible for the design, conduct, or reporting of a sponsored project must disclose financial interests that could be affected by the project at the time a proposal is submitted to the National Science Foundation or the Public Health Service. Further, such investigators are also required to disclose any new financial interest related to that project, acquired during the period of the award. |
Employees with disclosure responsibility include the Principle Investigator and Co-Principle Investigators, and any other Investigators deemed appropriate by the Principle Investigator. When the University determines that a disclosed financial interest or the entity in which it is held, 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 financial interest.
DEFINITION OF FINANCIAL INTEREST The term “financial interest” as used in the policy means the following when aggregated for an investigator and the investigator’s spouse and dependent children:
Income from a single business entity, including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, loans from the entity, or any other payments or consideration with value, including payments made to a University Medical Compensation Plan, during the prior twelve months or anticipated in the next twelve months of $10,000 or more;
Income from a single public or nonprofit entity, including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, or any other payments or consideration with value, including payments made to the University Medical Compensation Plan, during the prior twelve months or anticipated in the next twelve months, of $10,000 or more, excluding income from seminars, lectures, teaching engagements, or service on advisory committees or review panels; and,
Equity in the form of stock, stock options, real estate, loans to the 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 one enterprise.
The term also includes the following for an investigator and spouse:
A management position, such as board member, director, officer, partner, or trustee, held in any business entity; or
Interest on a patent, patent application or a copyright assigned or licensed to a party other than the University.
A “financial interest” does not include payments made by the University, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from the University.
REVIEW OF INVESTIGATOR’S STATEMENT OF FINANCIAL INTERESTS
Reviewing Officials All positive Statements of Financial Interests will be reviewed by the designated administrator from the Provost’s office and Chair of the Independent Substantive Review Committee (ISRC) to determine if the disclosed financial interest in an entity, or the entity, could reasonably appear to be directly and significantly affected by the research or educational activities funded, or proposed for funding by the agency. An entity would be directly and significantly affected, for example, if the project results would be relevant to the development, manufacturing, sales, or improvement of products or services of the entity, or the value of the entity’s stock. A financial interest would be directly and significantly affected, for example, if the monetary value of the interest would increase depending upon the result of the project.
If the Reviewing Officials determine there could be such a direct or significant impact, the Statement of Financial Interest is referred to the ISRC for review. If it is determined that the project will not reasonably have a direct and significant impact on the financial interest of the Investigator, or the entity, the Reviewing Officials may determine that no further review is required. In making the determination, the Reviewing Officials may consult with Deans, Department Chairs, administrators or others.
Independent Substantive Review Committee (ISRC) The ISRC is composed of five members of the faculty, representing a range of disciplines, one of whom chairs the Committee. The ISRC is appointed by the Dean of the Graduate School in consultation with the Faculty Research Committee. The ISRC is chartered with reviews of all positive Investigator Statements of Financial Interests referred to it by the Reviewing Officials, together with a review of the proposal, or award documents if applicable. The ISRC may request any additional information deemed necessary from an investigator to complete a thorough review of cases submitted to it.
When the ISRC determines that a disclosed financial interest, or the entity in which the interest is held, would be directly and significantly affected by the sponsored project, the ISRC must determine if the extant conflict of interest is manageable or not. Based on its review, the ISRC recommends actions to manage or eliminate the conflict of interest to the Dean of the Graduate School (or Provost’s designate).
Recommended actions to eliminate conflicts may include, but are not limited to: Withdrawal of a proposal, divestment of the investigator’s interest, and severance of relationships creating or contributing to the conflict of interest. Recommended actions to manage conflicts may include, but are not limited to: Modification of a pending proposal; monitoring of the project by independent reviewers; disqualification of the investigator from participation in all or some project activities; and identification of the financial interest on all publications resulting from the project.
SANCTIONS An individual’s failure to file a complete and truthful Statement of Financial Interest 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 by the Provost.