Financial Conflict of Interest
In the sponsored research setting, a potential conflict
exists when there is a possibility that an individual's outside
financial interests could directly and significantly affect the
design, conduct, or reporting of the research.
Managing Conflicts of Interest - presentation to Business
The Public Health Service (PHS) has issued “Responsibility
of Applicants for Promoting Objectivity in Research for Which
PHS Funding is Sought” (42 CFR Part 50 Subpart F) which will go
into effect on August 24, 2012. We refer to this as The
National Institutes of Health (NIH) Financial Conflicts of
Interest (FCOI). Universities receiving sponsored research
funding from the NIH are required to comply with these new
regulations. All NIH proposals and awards, increments and
continuations here at Rensselaer with an award notice start
date of August 24, 2012 or later will be subject to these new
This policy change at PHS is being instituted to promote
objectivity in research by establishing standards that provide
a reasonable expectation that the design, conduct and reporting
of sponsored research, including grants, cooperative agreements
and contracts, will be free from bias resulting from
investigator financial conflicts of interest.
The new requirements include mandatory training for any
investigator as defined by NIH; a decreased threshold for
determining Significant Financial Interests (SFI) – a drop from
$10,000 to $5,000; and the requirement that an institution
receiving NIH funding have a mechanism in place to publicly
disclose certain SFI events upon request. SFI’s must be
disclosed at each of these five separate points in time:
• When responding to the Annual Conflict of Interest
• When submitting a proposal.
• At the Just in Time (JIT) stage.
• Within 30 days of acquiring/discovering a SFI.
• Annually during the project period at the time of a
Please view the full text of the NIH Notice and FAQ, along
with Federal Register Notice for additional information.
NIH Notice NOT-OD-11-109
FAQs to 2011 Revised Regulation
Grants and Funding - Financial Conflict of
NIH FCOI Tutorial
Federal Register Notice