Disclosure of Financial Interest

Who Must Disclose

  • Investigators as defined by RA 20: "Any University faculty, employee, or student who has the ability to make independent decisions related to the design, conduct or reporting of a University research project, but not including individuals who perform only incidental or isolated tasks related to the project."
    • Students include undergraduate, graduate, and postgraduate students, residents, and fellows
    • Any employee named as an investigator or co-investigator on the study protocol or grant application would be considered an "investigator" by definition for disclosure purposes
    • A study's principal investigator would have the responsibility to identify and name as a co-investigator in COINS any additional employees or students who they believe meet the definition of "investigator" for any funded or unfunded study conducted as part of their University employment
  • IN ADDITION, all paid College of Medicine or Hershey Medical Center employees with a College faculty appointment as determined by the Office of Faculty Affairs
    • Including full time and part time employees
    • Not including unpaid affiliate faculty members with prefix or suffix titles
    • Not including occasional or PRN employees ( < 0.1 FTE), or those who have a primary job elsewhere
  • The following designated administrators:
    • CEO and Dean of the College of Medicine
    • Executive Director of the PSHMC
    • All persons reporting directly to CEO and Dean of the College of Medicine and/or
    • Executive Director of the PSHMC, including Basic Science Academic Chairs, Clinical Academic Chairs, Institute and Center Directors
    • Treasurer of the PSHMC
    • Chief Financial Officer of the PSHMC
    • Chief Compliance Officer for the PSHMC
    • Clinical department administrators, Clinical Division Directors, and Center Directors
    • All materials management/purchasing department employees
    • Associate Dean for Research
    • Associate Dean for Technology Development
    • All members, including members ex officio of the Conflict of Interest Review Committee

 

 

What Must Be Disclosed

  • All Significant Financial Interest of an investigator, faculty member or designated administrators (or their spouse and/or dependent children) that is related to their institutional responsibilities.
  • A Significant Financial Interest is defined as financial interests consisting of one or more of the following interests of the Investigator, faculty member or designated administrator (and those of the their spouse and dependent children) that reasonably appear to be related to their institutional responsibilities:
    • Publicly Traded Entity – a significant financial interest in a publicly traded entity exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure plus the value of any equity interest in the entity as of the date of the disclosure, when aggregated, exceeds $5,000. For the purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    • Non Publicly Traded Entity – a significant financial interest exists when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) in the entity or if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or
    • Intellectual Property (IP) Rights and Interest – upon receipt of income related to such rights and interests that exceed $5,000 in the previous 12 months
    • Human Subjects Research or Penn State Related Purchasing Authority - Any financial interest in a for-profit entity or any intellectual property, regardless of income generated, if related to human subjects research conducted at Penn State or to Penn State purchasing authority
    • Travel – the occurrence of any travel of the investigator, their spouse, or dependent children, for the last year from any one entity, exceeding $5,000 in the 12 months preceding disclosure, which is reimbursed or sponsored (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities
  • EXCEPTIONS: Financial interests that do not require disclosure include:
    • Salary, royalties, or other remuneration paid by the University (this includes any intellectual property rights assigned to the University and any agreements to share in royalties or licensing revenue related to the intellectual property rights);
    • Income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
    • Additional EXCEPTIONS: for faculty members who are also investigators as defined above, all of the following are exempt from disclosure, as described in NIH 2011 regulations
      • Income from seminars, lectures, or teaching engagements sponsored by a  Federal, state, or local government agency, an Institution of higher education as defined at 20.U.S.C.1001(a), an academic teaching hospital, a medical center, or a research institute, within the United States, that is affiliated with an institution of higher education; or
      • Income from service on advisory committees or review panels for a U.S. Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
      • For any faculty member who are also investigators as defined above, income or travel reimbursement from any not for profit entity not specified in i and ii above (including professional and 501(c)(3) organizations) does need to be disclosed.
  • Additional EXCEPTIONS: for faculty members NOT considered investigators, all of the following are exempt from disclosure
    • Any income for services provided to, or travel expenses from, non-profit entities including
      • a U.S. Federal, state, or local government agency
      • an Institution of higher education as defined at 20.U.S.C.1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education
      • A foreign institution of higher education, academic teaching hospital, medical center, or research institute that is affiliated with an institute of higher education
      • A non-profit 501(c)(6) professional association which is not a subsidiary of a for profit entity
      • A charitable 501(c)(3) organization

 

 

When Must Disclosures be Made

  • All investigators, faculty members and designated administrators are required to make a disclosure of all significant financial interest (SFI) on an annual basis.
  • Financial interest disclosures each year are based upon the last calendar year (January 1-December 31)
  • A new disclosure or an update of an existing disclosure is required for all investigators, faculty members, and designated administrators prior to submitting an application for research funding, whenever the proposed Research is related to any new or previously disclosed SFI, and within 30 days of:
    • Beginning employment with the University or the Milton S. Hershey Medical Center in a job requiring disclosure
       
    • When an SFI is acquired with a new entity not already included in your current COINS disclosure
       
    • In cases of non-compliance
       
    • As a part of the required annual disclosure
       
  • In addition, all faculty members and administrators that are considered Investigators are required to disclose SFI within 30 days of acquiring, discovering or receiving any equity, income, intellectual property rights and interest and/or the occurrence of reimbursed or sponsored travel