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SfN FCOI Policy 5/1 3 /
SOCIETY FOR NEUROSCIENCE (SfN)
Financial Conflict of Interest Policy (FCOI)
for Public Health Service (PHS)-Supported Funding
Purpose of Policy
This Financial Conflict of Interest (FCOI) policy provides guidelines for identifying, disclosing,
and managing significant financial conflicts of interest related to Public Health Service (PHS)-
funded SfN programs. This policy is intended to meet or exceed requirements under the 2011
Revised Financial Conflict of Interest regulation, 42 CFR Part 50 Subpart F, "Responsibility of
Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.”
This policy applies to each Investigator, as defined by the regulation, who is planning to
participate in or is participating in PHS-funded SfN activities, including serving as a Principal
Investigator (PI) or Co-Principal Investigator (Co-PI) on NIH-supported SfN grants. This policy
outlines the administrative process for identifying FCOIs, promoting and enforcing Investigator
compliance with the regulation, managing FCOIs, providing initial and ongoing FCOI reports,
and making FCOI and Significant Financial Interest (SFI) information available to HHS.
SfN’s Signing Official (SO) for PHS-supported activities serves as the Institutional Official for
this policy and is responsible for ensuring the implementation of this policy. This policy operates
in addition to other SfN Conflict of Interest policies by which SfN employees, Council,
committee members, and other volunteers must abide.
Training ( 42 CFR 50. 604 (b))
For each new Investigator for any planned or actual PHS-funded SFN projects, the SfN
Institutional Official will inform the Investigator of this FCOI policy, the federal regulation, and the
Investigator’s disclosure responsibilities. The Institutional Official will provide each Investigator
with a copy of this policy and a FCOI Disclosure Form to complete, sign, and return to SfN.
Each PHS-supported Investigator will be required to complete training on this FCOI policy: (1)
prior to engaging in research related to any PHS-funded grant; (2) at least every four years; and
(3) immediately, if SfN revises its FCOI policy in such a way that affects Investigator
requirements, if an Investigator is new to the SfN project, and/or if an Investigator is not in
compliance with the policy or management plan.
Disclosure ( 42 CFR 50. 603 , 42 CFR 50. 604 )
The Institutional Official will provide a SfN FCOI Disclosure Form to each Investigator. This
Disclosure Form must be completed and signed by the Investigator: (1) no later than at the time
of application for PHS-funded research, (2) at least annually during the period of the award; and
(3) within 30 days of discovering or acquiring a new SFI.
Each Investigator must disclose any SFI, and those of the Investigator’s spouse and dependent
children, related to the Investigator’s institutional responsibilities that meets or exceeds the
regulatory definition of SFI outlined in 42 CFR 50. 604 (e)( 1 )-( 3 ):
(1) A financial interest consisting of one or more of the following interests of the Investigator
(and those of the Investigator's spouse and dependent children) that reasonably appears to be
related to the Investigator's institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of
any remuneration received from the entity in the twelve months preceding the disclosure and
the value of any equity interest in the entity as of the date of disclosure, when aggregated,
SfN FCOI Policy 5/1 3 /
exceeds $5,000. For 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;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value
of any remuneration received from the entity in the twelve months preceding the disclosure,
when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or
dependent children) holds any equity interest (e.g., stock, stock option, or other ownership
interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income
related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel ( 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;
provided, however, that this disclosure requirement does not apply to travel that is reimbursed
or 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 that is affiliated with an Institution of higher education. The Institution's FCOI policy will
specify the details of this disclosure, which will include, at a minimum, the purpose of the trip,
the identity of the sponsor/organizer, the destination, and the duration. In accordance with the
Institution's FCOI policy, the institutional official(s) will determine if further information is needed,
including a determination or disclosure of monetary value, in order to determine whether the
travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial
interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the
Investigator is currently employed or otherwise appointed by the Institution, including intellectual
property rights assigned to the Institution and agreements to share in royalties related to such
rights; any ownership interest in the Institution held by the Investigator, if the Institution is a
commercial or for-profit organization; income from investment vehicles, such as mutual funds
and retirement accounts, as long as the Investigator does not directly control the investment
decisions made in these vehicles; 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 that is affiliated with an Institution of higher education; or income from service on
advisory committees or review panels for 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 that is affiliated with an Institution of higher education.
Review (42 CFR 50.604(d)(f)(g), 42 CFR 50. 605 (a)( 1 - 4))
The Institutional Official or his/her designee will review all Investigator SFI disclosures and
determine: ( 1 ) whether an Investigator’s SFI is related to PHS-funded research; and ( 2 ) if so
related, whether the SFI is an FCOI (i.e., a SFI that could directly and significantly affect the
design, conduct, or reporting of the PHS-funded research).
If the Institutional Official determines the FCOI can be managed, the Institutional Official will
develop and implement a written management plan, intended to reduce or eliminate the conflict,
as appropriate, within 60 days. The affected Investigator must formally agree to the proposed
management strategies and sign the written management plan before participating or continuing
participation in any related PHS-sponsored activity. The Institutional Official will monitor
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the PHS relating to the research, specifying actions to be taken to manage the FCOI. If bias is
found, the Institution will submit a Mitigation Report in accordance with PHS regulations. The
Mitigation Report will identify elements documented in the retrospective review, a description of
the impact of the bias on the research project, and the plan of action to eliminate or mitigate the
effect of the bias.
In any case in which the Department of Health and Human Services determines that a PHS-
funded research project of clinical research whose purpose is to evaluate the safety or
effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported
by an Investigator with an FCOI that was not managed or reported by the Institution as required
by the regulation, the Institutional Official shall require the Investigator involved to disclose the
FCOI in each public presentation of the results of the research and to request an addendum to
previously published presentations.
Violation of any part of this policy by SfN employees may also constitute cause for disciplinary
or other administrative action pursuant to SfN policy.
Subrecipient Requirements (42 CFR 50.604(c))
In cases where a subrecipient Investigator is planned to participate in a PHS-funded SfN project, the
Institutional Official will establish in a written agreement, whether the subrecipient will follow SfN
FCOI policy or the FCOI policy of the subrecipient. If applicable, the Institutional Official will
obtain a certification from the subrecipient that its FCOI policy complies with the regulation. If
applicable, the Institutional Official will include in the written subrecipient agreement a
requirement for the subrecipient to report identified FCOIs for its Investigators in a timeframe
that allows SfN to report identified FCOIs to the NIH as required by the regulation. Alternatively,
if applicable, the Institutional Official will include in the written agreement a requirement to solicit
and review subrecipient Investigator disclosures that enable the SfN to identify, manage and
report identified FCOIs to the NIH.
Public Accessibility ( 42 CFR 50. 604 (a))
The Institutional Official or his/her designee will ensure that the Institution’s FCOI policy is
placed on the SfN website and publicly accessible. The Institutional Official or his/her designee
will also ensure that available information concerning identified FCOIs held by senior/key
personnel (as defined by the regulation), will be publicly accessible prior to the expenditure of
funds. Per 42 CFR 50. 605 (a)( 5 )(i)- (iv), the information will:
(1) Include the minimum elements as provided in the regulation.
Be posted on a public SfN website or made available within 5 calendar days of a written
request.
(3) Be updated, at least annually (website only but any response to a written request should
include the updated information).
(4) Be updated, within 60 days of a newly identified FCOI (website only but any response to a
written request should include the updated information).
(5) Remain available for three years from the date the information was most recently updated.
