Transcript EFFORT REPORTIG (ERS) IMPLENTATION SYRCUSE UNIVERSITY
Financial Conflict of Interest (FCOI) Updates Office of Sponsored Programs March 2013
The Result of Collaborative Efforts
This project was a collaborative effort between: 1. Office of Research, 2. Office of Sponsored Programs, 3. Office of Audit and Management Advisory Services, and 4. Information Technology & Services
Overarching Project Goals
1. Create a system that assures compliance and achieves regulatory intent 2. Streamline the disclosure process and create efficiencies to minimize burden on Investigators (e.g. – merge the COI & FCOI processes into the same portal and due at the same point in time).
3. Infuse the new MySlice FCOI module with faculty feedback obtained throughout the ‘paper’ disclosure processes. (Yes, we were listening…….)
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. Reimbursed or sponsored Travel (i.e., that which is paid on behalf of the Investigator and is not reimbursed)
• •
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?
• Public Health Service (PHS) FCOI regulation update, effective on August 24, 2012.
• PHS Agencies include, but not limited to: National Institutes of Health (NIH) Centers for Disease Control & Prevention (CDC) Food & Drug Administration (FDA) Agency for Healthcare Research & Quality (AHRQ) Health Resources & Services Administration (HRSA) Substance Abuse & Mental Health Services Administration (SAMHSA) Administration for Children and Families (ACF) Centers for Medicare & Medicaid Services (CMS) • SU’s implementation of FCOI regulation applies the PHS standards to all sponsored projects for consistency.
How often do Investigators need to disclose SFIs?
• • • On an annual basis Beginning in April 2013, the new Myslice SFI disclosure portal will align with the existing University COI process.
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 or in conflict with your
Institutional Responsibilities
, 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.
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 teaching engagements or other forms of consulting sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center or an academic research institute • Income from service on committees or review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, a medical center, or an academic research institute.
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MySlice SFI Module Features
‘Hover over’ question guidance to provide quick access to definitions and examples Single point of access for both COI and FCOI processes through the Myslice portal (i.e.- the paper process for FCOI goes away) Ability to add to or edit existing disclosures systematically and in real-time Ability to look back at past disclosures on the system System generated e-mails for reminders
MySlice SFI Module Features
Expandable entry fields that allow for entries that exceed the size of ‘the box’ 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