Financial Conflict of Interest (FCOI) Updates Office of Sponsored Programs April 2014

Key Definitions Financial Conflict of Interest (FCOI) in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of an Investigator* when designing, conducting, or reporting research. * (any individual responsible for the design, conduct, or reporting of research)

Key Definitions Significant Financial Interest - Anything of monetary value - aggregated for the Investigator and the Investigator's spouse, domestic partner, and dependent children - that reasonably appears to be related to the Investigator's institutional responsibilities including but not limited to: Salary or other payment for services (e.g. consulting fees) that exceeded in the previous twelve months or is reasonably expected to exceed in the next twelve months $5,000

Key Definitions Equity interests (e.g. stocks, stock options or other ownership interests) that meet the following tests: exceeds $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value (e.g. most recent sales price recognized by the company), or constitutes more than a 5% ownership interest in any single entity. Intellectual property rights (e.g. patents, copyrights and royalties from such rights) upon receipt of income related to such rights and interests. Services as an officer, director, or in any other executive position in an outside business, whether or not remuneration is received for such service. Travel that is related to the Investigators institutional responsibilities, that is paid for by external sources (but not through sponsored programs).

Key Definitions Institutional Responsibilities are an Investigator’s “professional responsibilities on behalf of the institution” Examples include but are not limited to – Research – Research consultation – Teaching – Professional practice – Speaking Engagements – Institutional committee memberships – Service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards

What is the Guiding Principle behind federal FCOI regulations? To promote objectivity in research by defining a set of standards that provide a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from investigator financial conflicts of interest. The objectivity of research is of key importance and the basis for obtaining and maintaining public trust (i.e. – taxpayers)

Who requires the FCOI process? Federal funding agencies, namely PHS and NSF, require recipients of federal funding to have financial conflict of interest policies in place. SU’s implementation of FCOI regulation applies the PHS standards to all sponsored projects for consistency. With the release of the ‘Omni-Circular’, all federal funding agencies will be required to have their own conflict of interest guidance. We’ll have to wait and see how the federal agencies decide to implement this new guidance. SU may need to revise its FCOI policy accordingly.

How often do Investigators need to disclose SFIs? On an annual basis  In April/May timeframe each year, the Myslice SFI disclosure process will be initiated and Investigators will be prompted to disclose SFIs for the last 12 months, including projections for next 12 months. Prior to application submissions, certify that SFI disclosures are current. Within thirty days of discovering or acquiring a new Significant Financial Interest.

Is there a problem if I answer yes to any of the questions? Answering “yes” to any of the questions does not mean the Significant Financial Interest is inappropriate, it means only that disclosure and evaluation, and in some cases, approval and oversight, are required. The VPR may determine that an SFI does not constitute an FCOI. Disclosures are held in the strictest of confidence.

Excluded Sources – No disclosure Required when…….. You DO NOT have to disclose if the SFI comes from the following sources: Salary, royalties, or other remuneration from SU Agreements to share in royalties related to Intellectual Property Rights assigned to SU Mutual funds and retirement accounts with no investigator control of investment Income from service on committees or review panels; teaching engagements; or consulting for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or an academic research institute. Travel paid for external sources not related to your Institutional Responsibilities. 10

MySlice SFI Module Features  ‘Hover over’ question guidance to provide quick access to definitions and examples  Ability to create new SFI disclosures in real- time  Carry-forward of previous year disclosure for ease of editing  System generated s for reminders

MySlice SFI Module Features  Quick review feature that allows Investigators to review, at a glance, the sponsored projects they are associated with  Self-contained video viewer that tracks and ‘remembers’ the last time FCOI training was viewed, to ensure compliance with federal regulations (required training every 4 years).  Ability to easily create multiple disclosure entries  Ability to print

Contact information If you have any questions regarding the new MySlice module for reporting Significant Financial Interests please contact us at or