Financial conflict of interest (FCOI) policy
VersaPeutics.Inc is committed to protecting the integrity and objectivity of its research activities
by ensuring that the design, conduct, and reporting of research will not be biased or appear to
be biased by a personal financial conflict of interest. VersaPeutics.Inc has implemented this
policy to identify, manage, reduce, or eliminate financial conflicts of interest.
The procedures described in this policy were created and designed primarily to comply with the
specific regulatory requirements for US Public Health Service (PHS)-sponsored research and
are intended to provide a basic framework and standards for identifying, evaluating, and
managing potential financial conflicts of interest relating to VersaPeutics.Inc research activities.
This policy and related procedures have been developed to identify, manage, mitigate,
neutralize, or eliminate actual, apparent, and potential financial conflicts of interest. The policy
was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50,
Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public
Health Service (PHS) Funding Is Sought and 45 CFR Part 94, Responsible Prospective
42 CFR 50 outlines the 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.
VersaPeutics.Inc is committed to using this same FCOI standard for all grant- and non-grant-
- Investigator means the project director or principal Investigator and any other person,
regardless of title or position, who is responsible for the design, conduct, or reporting of
research funded by the NIH, or proposed for such funding, which may include, for example,
collaborators or consultants.
- PHS means the Public Health Service of the U.S. Department of Health and Human
Services, and any components of the PHS including the NIH. PHS Awarding Component means
the organizational unit of the PHS that funds the research that is subject to this subpart.
- Significant Financial Interest (SFI) is a financial interest consisting of one or more of
the interests listed below of the Investigator (and those of the Investigator’s spouse and
dependent children) that reasonably appears to be related to the Investigator’s responsibilities
on the PHS funded project.
A Significant financial Interest include:
(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 for the investigator, investigator’s spouse and dependent
children, 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) With regard to intellectual property rights and interests (e.g., patents,
copyrights), a significant financial interest exists upon receipt of income of greater than
$5,000 related to such rights and interests.
(iv) Third party reimbursed or sponsored travel (i.e., that which is paid on
behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater
than $5,000 and reasonably appears related to the Investigators project responsibilities
must be disclosed. Excludes travel paid for by VersaPeutics or affiliated companies and
does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or
local government agency, or an U.S. Institution of higher education.
A Significant financial Interest does not include
(i) Salary, royalties, or other remuneration paid by VersaPeutics.
(ii) Any ownership interest in VersaPeutics held by the investigator.
(iii) Income from investment vehicles, such as mutual funds and retirement
accounts, where the Investigator does not directly control the investment decisions.
(iv) Income from seminars, lectures, or teaching engagements sponsored by an
U.S. federal, state, or local government agency, an Institution of higher education or
(v) Income from service on advisory committees or review panels for an U.S.
federal, state, or local government agency or an Institution of higher education.
- Financial Conflict of Interest (FCOI) is an SFI that could directly and significantly
affect the design, conduct, or reporting of NIH-funded research.
VersaPeutics Investigators and all applicable sub-awardees are required to complete training
related to FCOI. If any conflicts of interest are found or known, they must be disclosed.
All investigators on a PHS funded project shall receive training to include:
– Awareness of the Federal Regulation
– Review of this procedure
– Disclosure responsibilities.
Training shall be completed:
– prior to participating in PHS funded research
– at least every 4 years
– at any time when
– this procedure is revised
-a new employee is engaged on a PHS funded project
– an investigator is not in compliance with this procedure or a FCOI management
Training may be achieved by use of the NIH provided web-based tutorial at
Further training materials are available at:
and Updated Frequently Asked Questions
Significant Financial Interest (SFI) shall be disclosed by any investigator (spouse, dependent,
No later than at the time of application for PHS/NIH-funded research
At least annually during the period of the award
Within thirty (30) days of discovering or acquiring a new SFI
The Principal Investigator (PI) is responsible for ensuring that SFI’s of all key personnel are
identified and disclosed. All disclosures are reviewed by the Company President for approval,
prior to Institution’s expenditure of funds. If a significant FCOI is determined, a management
plan is defined and implemented to mitigate the FCOI effect on the project.
- An SFI is related to PHS/NIH-funded research when the Institution through its designated
official(s), reasonably determines that the SFI: could be affected by the PHS/NIH-funded
research; or is in an entity whose financial interest could be affected by the research.
- The Investigator may be involved in making the determination of whether the SFI is related
to the PHS/NIH-funded research.
Company President review of FCOI and Disclosures:
— before work on a particular PHS-Funded Research project begins for any Investigator that
is known to VersaPeutics prior to such time; and
— within 60 days whenever VersaPeutics identifies an SFI that was not disclosed by an
Investigator or not previously reviewed by the VersaPeutics.
If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module
prior to expending any funds.
The Company President must establish a process to monitor an Investigator’s compliance with
management action plans until completion of the PHS-Funded Research project. For any report
of an SFI involving travel reimbursement or sponsorship, the designated individual/s must be
provided information relating to the purpose, destination, and duration of each trip and the
identity of the relevant sponsor or organizer. If requested by the Company President, additional
information, including the monetary value of the trip, must be disclosed to determine whether
the reimbursement or sponsorship constitutes an FCOI.
Reporting requirements to NIH
Routine FCOI Reports are provided to NIH via the eRA Commons FCOI Module for the
Institution and sub-awardees.
- Prior to the expenditure of funds
- Within sixty (60) days of identification for an Investigator who is newly participating in the
- Within sixty (60) days for new, or newly identified, FCOIs for existing Investigators.
- At least annually (at the same time as when the Institution is required to submit the
annual progress report, multi-year progress report, if applicable, or at time of extension).
The annual report will provide the status of the FCOI and any changes to the
management plan, if applicable, until the completion of the project.
- After a retrospective review to update a previously submitted report, if new information is
discovered following completion of the review.
Whenever VersaPeutics identifies an SFI that was not disclosed, identified, reviewed or
managed in a timely manner, VersaPeutics Company President will, within 60 days, review and
makethe determination of whether an FCOI exists, and report the FCOI if it exists to the relevant
- If an FCOI exists, VersaPeutics will within 120 days of the VersaPeutics determination of
noncompliance/nondisclosure complete a retrospective review of the Investigator
activities and PHS-Funded Research to determine whether any of the PHS-Funded
Research conducted during the time period of the noncompliance/nondisclosure biased
the design, conduct or reporting of such Research.
- VersaPeutics will document the retrospective review as required by PHS Regulations.
- Subsequent to the retrospective review, if applicable, VersaPeuticswill update the
existing FCOI report and, if bias is found, Regeneron will notify the relevant PHS
Organization promptly and submit a mitigation action plan with details required by PHS
VersaPeutics will notify the relevant PHS Organization promptly if a Investigator fails to
comply with the FCOI Policy or an FCOI management plan and inform the relevant PHS
Organization of the corrective action taken or to be taken.
Elements of an FCOI Report
a. Grant number
b. PD/PI or contact PD/PI
c. Name of Investigator with the FCOI
d. Name of the entity with which the Investigator has an FCOI
e. Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria)
f. Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amts between $20K-
100K by increments of $20K; amts above $100K by increments of $50K or a statement
that a value cannot be readily determined
g. A description how the financial interest relates to NIH-funded research and the basis
for the Institution’s determination that the financial interest conflicts with such research
h. Key elements of the Institution’s management plan
VersaPeutics will maintain adequate enforcement mechanisms and provide for corrective action
to promote Investigator compliance.
1. Whenever an FCOI is not identified or managed in a timely manner, including failure
by the Investigator to disclose an SFI, failure by the Institution to review or manage an FCOI, or
failure to comply with the management plan, the institution shall within 120 days of the
determination of noncompliance, complete a retrospective review of the Investigator’s activities
and the project to determine bias in the design, conduct or reporting of such research
2. Notify NIH promptly and submit a Mitigation Report when bias is found
3 Documentation of the key elements of a retrospective review
a. Project number;
b. Project title;
c. PD/PI or contact PD/PI if a multiple PD/PI model is used;
d. Name of the Investigator with the FCOI;
e. Name of the entity with which the Investigator has an FCOI;
f. Reason(s) for the retrospective review;
g. Detailed methodology used for the retrospective review (e.g., methodology of
process, composition of the review panel, documents reviewed);
h. Findings and conclusions of the review
Violations of this Policy and implementing procedures, including the failure to file timely
disclosures; filing incomplete, erroneous, or inaccurate disclosures; or failure to comply with
prescribed procedures for managing or resolving conflicts of interest, will result in appropriate
disciplinary action. Additionally, individuals may be subject to the loss of institutional resources
Maintenance of records
VersaPeutics will maintain all FCOI-related records: for at least 3 years from the date on which,
for grants and cooperative agreements, the final expenditure report is submitted to the relevant
PHS Organization or, for contracts, final payment is made; or for the time periods specified in 45
CFR 75.361 or 48 CFR Part 4, Subpart 4.7, as applicable.
During the applicable period identified above, VersaPeutics will also make all FCOI-related
records available to each relevant PHS Organization upon request.
VersaPeutics will establish procedures for public access to information concerning any SFI that
is disclosed to VersaPeutics and (a) continues to be held by key personnel for a particular
project, (b) is determined by VersaPeutics to be related to the project, and (c) is determined by
VersaPeutics to constitute an FCOI. VersaPeutics will make this information available within 5
business days of receiving a written request for at least 3 years after the information was most
recently updated. VersaPeutics will include details specified in PHS Regulations when
responding to any such request. VersaPeutics will also make this FCOI Policy available on a
publicly accessible website.
- The public access will be updated, within sixty (60) days of a newly identified
- The public access will be updated annually.
a. Incorporate as part of a written agreement terms that establish whether the FCOI policy of
the awardee Institution or that of the subrecipient will apply to subrecipient Investigators and
include time periods to meet SFI disclosure, if applicable, and FCOI reporting requirements
b. Subrecipient Institutions who rely on their FCOI policy must report identified FCOIs to the
awardee Institution in sufficient time to allow the awardee Institution to report the FCOI to the
PHS/NIH Awarding Component (i.e., to NIH through the eRA Commons FCOI Module) to
meet FCOI reporting obligations.