Peak Diagnostic Partners, Inc. Company Policy

Financial Conflict of Interest (FCOI) Policy

December 1, 2020

 

Objective research, performed with care and integrity, is a very important requirement of Peak Diagnostic Partners
technology development goals.  This requirement extends to any subgrantees or vendors that our organization
interacts with.  This is necessary in order to engender public trust and meet the ethical goals of our National
Institutes Health (NIH) grant efforts.  The financial interests of biomedical researchers can be very complicated and
the Public Health Service (PHS) and the Office of the Secretary of the U.S.  Department of Health and Human
Services (HHS) has published rules governing these interests.  Peak Diagnostic Partners (as well as any defined sub-
level vendors) believes we are in full compliance with these regulations although we will continue to update this
policy as needed.  Updates and revisions will accompany changes in personnel FCOI issues or additional DHHS
guidance.

Effective December 1, 2020, Peak Diagnostic Partners’ policy requires that each investigator, subrecipient,
subgrantee and collaborator affiliated with Peak Diagnostic Partners, by NIH or any other applicable grant or
contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR
Part 94 for contracts).  This legislation spells out NIH’s commitment to preserving the public’s trust that NIH-
supported research is conducted without bias and with the highest scientific and ethical standards.  Peak Diagnostic
Partners intends to use this same FCOI standard for all other Federal agency grants and contracts modified in those
instances where necessary.

Training

Peak Diagnostic Partners and all vendors are required to complete training related to Financial Conflict of Interest.
If any conflicts of interest are found or known, they must be disclosed.  The training must be updated no-less 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.
(https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html).

Important Definitions

The following are key term definitions and Peak Diagnostic Partners’ policy guidance for principal or program
investigators, subrecipients, subgrantees and collaborators affiliated with Peak Diagnostic Partners.  This policy and
all FCOI Peak Diagnostic Partners guidance are also available at https:peakdxpartners.com/fcoi so that all interested
parties, including the general public have access to this policy.

Financial Conflict of Interest (FCOI) — A Financial conflict of interest exists when Peak Diagnostic Partners
reasonably determines that a Significant Financial Interest (defined below) could directly and significantly affect the
design, conduct or reporting of NIH-funded research.

Management of a FCOI – This 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 research will be free from bias.

PHS Awarding Component — The PHS awarding component is any sub-agency of the Public Health Service or
Department of Health and Human Services.

Records Management — The records of all financial disclosures and all actions taken by Peak Diagnostic Partners
will be maintained for at least three years from the date of submission of the final expenditures report.

Research — PHS research is any project governed by PHS regulation, but excluding applications for Phase I support
under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Investigator — An Investigator is any person who is responsible for the design, conduct or reporting of research
funded by PHS.  This includes subrecipients, subgrantees and collaborators.

What is a Significant Financial Interest?

Significant Financial Interest (SFI) is defined as 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 reasonable appears
to be related to the Investigators institutional responsibilities:

+ A Significant Financial Interest in a PUBLICLY TRADED ENTITY exists where 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, exceeds $5,000 in total.  This can include 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 value.

+ A Significant Financial Interest in a NON-PUBLICLY TRADED ENTITY exists if the value of any
remunerations from the entity in the twelve months preceding the disclosure, exceeds $5,000 in total, 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).

+  INTELLECTUAL PROPERTY rights and interests (e.g.  patents, copyrights), upon receipt of any income related
to such rights and interests.

A Significant Financial Interest also exists in cases where 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.

There is no requirement to disclose a Significant Financial Interest related 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.  Such an 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 a FCOI with the PHS-funded research.

A Significant Financial Interest is NOT represented by several other types of financial interests: salaries, 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 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.

Disclosures and Reporting

Peak Diagnostic Partners designated official(s) will review all “disclosure” and evaluate whether they contain any
FCOI.  If no FCOI is found, the “disclosure forms” will be scanned where applicable or otherwise stored in
electronic format.  If a FCOI is identified it will be put on the FCOI report through the eRA Commons FCOI module
prior to expending any funds.  If any interests are identified as conflicting subsequent to the initial report, they must
be reported to Peak Diagnostic Partners within 30 days.  Peak Diagnostic Partners will then report it to the PHS
awarding component that has issued the award within 60 days.  Each investigator must submit an updated disclosure
of an SFI not less than annually.  If a PHS-funded project is conducted by an investigator or SO with a conflict that
was not disclosed or managed, Peak Diagnostic Partners is required to disclose the conflict in each public
presentation related to the results of the research.

Penalties for Non-Compliance

If an investigator fails to comply with the Peak Diagnostic Partners FCOI policy, within 120 days, Peak Diagnostic
Partners will review the Investigator’s activities to determine bias.  If a bias is found, Peak Diagnostic Partners will
submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that will address the impact of the
bias on the research project and the actions it has taken to mitigate the bias.  Peak Diagnostic Partners will work
with the Investigator to set up an FCOI management plan to mitigate the situation.  Peak Diagnostic Partners is
required to mandate disclosure by the Investigator FCOI in each public presentation with research results if it was
otherwise reported explicitly.  In extreme cases of bias, the Investigator may lose the right to work on the project or
receive any future NIH funding.


Disclosure statements for submission are available upon request.

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