Transcript EFFORT REPORTIG (ERS) IMPLENTATION SYRCUSE UNIVERSITY

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.
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MySlice SFI Module Features
‘Hover over’ question guidance to provide
quick access to definitions and examples
Ability to create new SFI disclosures in realtime
Carry-forward of previous year disclosure for
ease of editing
System generated e-mails 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 [email protected] or
[email protected]