February 2, 2022
This Financial Conflict of Interest Policy (this “Policy”) describes certain legal
obligations applicable to Investigators’ disclosure of potential financial conflicts of
interest (“FCOI”). The purpose of this policy is to comply with applicable law and to
ensure the objectivity of the research conducted by GeneCentrix, Inc.
(“GeneCentrix”), its employees, contractors, and consultants.
Investigators applying for and working on Public Health Services (“PHS”), National
Institutes of Health (“NIH”), or National Science Foundation (“NSF”) funded research
must disclose significant financial interests that are related to the Investigator’s
institutional responsibilities. Investigators are all persons, regardless of title or position,
who are responsible for the design, conduct, or reporting of research proposed for
funding by the PHS, NIH, or NSF (the foregoing agencies, together with any other
organizations providing funding through grant or contract to which the regulations
contemplated herein apply, collectively, the “Funding Agencies”), including
collaborators or consultants. This policy provides the framework to identify, evaluate
and correct or remove real, apparent and potential conflicts of interest.
This policy requires that each investigator, subrecipient, subgrantee and collaborator
affiliated with GeneCentrix on a Funding Agency project be in compliance with 42 CFR
Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for
contracts). In addition, this legislation spells out NIH’s commitment to preserving the
public’s trust that the research supported by them is conducted without bias and with
the highest scientific and ethical standards. GeneCentrix intends to use this same
FCOI standard for all other Federal agency grant and contract efforts, as tailored or
With respect to subrecipients, GeneCentrix shall establish, via a written agreement,
whether a subrecipient will follow the FCOI policy of GeneCentrix or the FCOI policy of
the subrecipient. If applicable, GeneCentrix shall obtain a certification from a
subrecipient that its FCOI policy complies with the applicable regulation. If applicable,
GeneCentrix shall include in the written subrecipient agreement a requirement for the
subrecipient to report identified FCOIs for its Investigators in a time frame that allows
GeneCentrix to report identified FCOIs to the applicable Funding Agencies as required
by the regulation. Alternatively, if applicable, GeneCentrix shall include in the written
agreement a requirement to solicit and review subrecipient Investigator disclosures
that enable GeneCentrix to identify, manage and report identified FCOIs to the
The following definitions apply to this policy:
“Funded Research” means any research funded by a Funding Agency.
“Investigator” means any person (including subrecipients, subgrantees and
collaborators) who is responsible for the design, conduct or reporting of research
funded by a Funding Agency.
“Training Requirement” means training related to Financial Conflict of Interest (FCOI)
and required under law. All GeneCentrix Investigators and all defined sub-level
vendors are required to complete the Training Requirement. If any conflicts of interest
are found or known, they must be disclosed. The training must be updated no less
frequently than every four years or as designated based on grant or role
circumstances. Information and other resources developed by NIH will be updated as
appropriate and can be accessed through the NIH Web site:
“Significant financial interest” means a financial interest consisting of one or more of
the following interests of the investigator (including those of the investigator’s spouse
and dependent children) that reasonable appears to be related to the Investigator’s
1. 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 exceeds $5,000. For the 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 in stock, stock options or other ownership interest, as determined
through reference to public prices and other reasonable measures of fair market
2. With regard to any privately held entity, a significant financial interest exists if
the value of any remunerations 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 interests (e.g.
stock, stock options, or other ownership interest); or
3. Intellectual property rights and interests (e.g. patents, copyrights), upon receipt
of income related to such rights and interests.
With respect to Significant Financial Interest, Investigators also must disclose (and
such disclosure shall constitute an SFI Disclosure, defined below) 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, medical
center, or research institute that is affiliated with an institution of higher education. This
disclosure will include, at a minimum, the purpose of the trip, the identity of the
sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure,
the Policy Coordinator will determine if further information is needed, including a
determination or disclosure of monetary value, in order to determine whether the travel
constitutes a FCOI with the Funding Agency research.
The term Significant Financial Interest does not include the following types of financial
interests: salaries, royalties or other remuneration paid by GeneCentrix to the
Investigator if the Investigator is currently employed or otherwise appointed by
GeneCentrix, including intellectual property rights assigned to GeneCentrix and
agreements to share in royalties related to such rights; any ownership interest in the
Institution held by the investigator; income from investment vehicles, such as mutual
funds and retirements 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, 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.
A ”Financial Conflict of Interest” or “FCOI” exists when GeneCentrix reasonably
determines that a significant financial interest could directly and significantly affect the
design, conduct or reporting of Funded Research.
An “SFI Disclosure” is a report that each Investigator shall submit: (a) annually to the
Policy Coordinator; (b) in the event of certain sponsored travel, as set forth in the
definition of “significant financial interest,” above; (c) within thirty (30) days of an
Investigator discovering or acquiring any significant financial interest; and (d) no later
than at the time of application for PHS-funded research.
“Management” of an FCOI means taking action to address a FCOI, which can include
reducing or eliminating the FCOI, to ensure, to the extent possible, that the design,
conduct, and reporting of Funded Research will be free from bias.
An “Awarding Component” is the applicable sub-agency of a Funding Agency.
Each Investigator shall submit SFI Disclosures to the Policy Coordinator as follows:
1. An updated general SFI Disclosure annually;
2. promptly in the event of certain sponsored travel, as set forth in the definition
of “significant financial interest,” above;
3. within thirty (30) days of an Investigator discovering or acquiring any
significant financial interest; and
4. no later than at the time of application for PHS-funded research.
Additionally, the Policy Coordinator shall solicit SFI Disclosures from each investigator,
if applicable, during a reasonable period of time preceding the commencement of any
research conducted hereunder.
Prior to the expenditure of funds, the Policy Coordinator will review each SFI
Disclosure and determine if any SFIs relate to funded research, determine if an FCOI
exists, and develop and implement management plans as needed to manage FCOIs.
In determining whether an Investigator’s SFI is related to funded research, and if so
related, whether the SFI is an FCOI, the Policy Coordinator shall consider all available
evidence in light of the following concepts, in addition to any other concepts the Policy
Coordinator may reasonably consider:
Safety of human subjects
The Investigator’s reputation
Relationship between the SFI and the Research
Is the subject of the SFI or its products or services involved in the research, and how?I
Is the SFI in a diversified enterprise generally, or in a specific division orsubsidiary more closely related to the research?
Nature of the SFI
Equity, cash compensation, or in-kind compensation?
Part of a diversified portfolio or a specific investment?
Publicly-traded or private company?
Does compensation exceed fair market value?
Likelihood of influence
Role of the Investigator in the research
Potential gain to Investigator if research yields particular results
Safeguards built into design
If no FCOI is found, the SFI Disclosure will be filed with the Policy Coordinator’s SFI
Disclosure records. If a FCOI is identified it will be put on the FCOI report through
the eRA Commons FCOI module (or, where GeneCentrix is a subgrantee or
subawardee, then GeneCentrix will report the FCOI as required under the applicable
subgrant or subaward agreement) prior to expending any Funding Agency funds.
GeneCentrix will then report any new FCOIs to the Awarding Component within 60
days. If an Investigator with an FCOI conducts a Funded Research, GeneCentrix shall
disclose the FCOI in each public presentation related to the results of the Funded
GeneCentrix shall make available information concerning identified FCOIs held by
senior/key personnel publicly accessible prior to the expenditure of funds. The
information will include the minimum elements as provided in the regulation, be posted
on a public website or made available within five calendar days of a written request, be
updated at least annually, be updated within 60 days of a newly identified FCOI, and
remain available for three years from the date the information was most recently
GeneCentrix will maintain records of all SFI disclosures, and records of resulting
GeneCentrix action, for at least three years from the date of submission of the final
expenditures report for the applicable funding, or for such other periods of time as
be required under 45 CFR 75.361, if applicable.
Funded Research Exclusions
Funded Research is any project governed by Funding Agency regulations, but
excluding applications for Phase I support under the Small Business Innovation
Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Compliance and Penalties for Non-Performance
If an investigator fails to comply with the GeneCentrix FCOI policy, within 120 days,
GeneCentrix shall complete a retrospective review of the Investigator’s activities to
determine bias. If as a result of that determination, or at any other time, any bias is
found, GeneCentrix shall submit a mitigation report to the applicable Funding Agency,
in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on
the research project and the actions it has taken to mitigate the bias. GeneCentrix will
work with the Investigator to set up an FCOI management plan to mitigate the
situation. Company wide, GeneCentrix is required to mandate the Investigator disclose
the FCOI in each public presentation with research results, and to request an
addendum disclosing the FCOI in previously published presentations, if it was not
reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.