Financial Conflicts of Interest
Last updated July 9, 2025
Policy Statement
Clevyr 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. Clevyr 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 U.S. Public Health Service (PHS)-sponsored research but are
also intended to provide a basic framework and standards for identifying, evaluating, and managing
potential financial conflicts of interest relating to Clevyr’s other research activities. For non-PHS
research, the specific steps, timing, determinations, documentation, and notifications may be tailored
as appropriate but will remain focused on maintaining Clevyr high standards for research integrity
and effectively eliminating or managing actual or potential financial conflicts of interest.
Reason for Policy
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[1] and 45 CFR Part 94, Responsible Prospective Contractors.
[1]These regulations do not cover Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR)
Program Phase 1 applications or awards but do apply to applicants and recipients under the SBIR/STTR Program Phase II.
SBIR is the extramural research program for small business that was established by the Awarding Components of PHS and
certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. The
term SBIR Program includes the STTR Program, which was established by Pub. L. 102-564.
Definitions
For purposes of this policy, the following definitions shall apply:
Designated Official is the individual designated by Clevyr to oversee the financial conflicts of interest
process, including solicitation and review of disclosures of significant financial interests.
Equity Interest includes any stock, stock option, or other ownership interest, and its value may be
determined through reference to public prices or other reasonable measures of fair market value.
Financial Conflict of Interest means a significant financial interest that could directly and significantly
affect the design, conduct, or reporting of research as determined by Clevyr through the Designated
Official.
Financial Interest means anything of monetary value, whether or not the value is readily
ascertainable.
Immediate Family refers to an Investigator’s spouse and dependent children.
Investigator means the project director/principal investigator and any other person who is
responsible for the design, conduct, or reporting of the research or proposed research.
PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health
and Human Services (HHS), and any components of the PHS to which the authority involved may be
delegated, including the National Institutes of Health.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is
subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or
contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Remuneration includes, for example, salary and any payment for services not otherwise identified as
salary (e.g., consulting fees, honoraria, paid authorship).
Research means a systematic investigation, study, or experiment designed to develop or contribute
to generalizable knowledge relating broadly to public health, including behavioral and social
sciences research. The term encompasses basic and applied research (e.g., a published article,
book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded
Research, the term includes any such activity for which research funding is available from a PHS
Awarding Component through a grant, cooperative agreement, or contract, whether authorized
under the PHS Act or other statutory authority.
Significant Financial Interest means a financial interest consisting of one or more of the following
interests of the Investigator and his/her immediate family that reasonably appear to be related to the
Investigator’s Clevyr project responsibilities, including:
1. With regard to interests in any publicly traded entity, a financial interest consisting of any
remuneration received from the entity in the 12 months preceding the disclosure and any
equity interest (e.g., stock, stock option, or other ownership interest) in the entity as of the
date of disclosure, in which the value when aggregated exceeds $5,000;
2. With regard to interests in any non-publicly traded entity, a financial interest consisting of any
remuneration received from the entity in the 12 months preceding the disclosure, in which
the value when aggregated exceeds $5,000, or when the Investigator or his/her immediate
family holds any equity interest (e.g., stock, stock option, 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.
Significant Financial Interests also include 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 the Investigator’s Clevyr project 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.
Significant Financial Interest does not include the following:
● Salary, royalties, or other remuneration paid by Clevyr (or a subrecipient as applicable) to the
Investigator if the Investigator is currently employed or otherwise appointed by Clevyr
including that paid for intellectual property rights assigned or licensed to Clevyr and
agreements to share in royalties related to such rights;
● Any ownership interest in Clevyr (or a subrecipient as applicable) held by the Investigator
(e.g., Employee Stock Ownership Plan);
● 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.
Procedures
Responsibilities of Clevyr Designated Official
The Designated Official or his/her designee shall be responsible for the following:
● Informing Clevyr Investigators of their obligations under this policy and any related
regulations;
● Reviewing disclosures of significant financial interest with Clevyr’s Administrator to
determine whether they are related to the subject research and, if so, whether they constitute
financial conflicts of interest;
● Screening and managing potential financial conflicts of interest;
● Maintaining all records relating to disclosures of financial interests, Clevyr’s review of and
response to such disclosures, and any related actions under this policy;
● Ensuring inclusion of any required certifications in applications for funding or contract
proposals; and
● Reporting and disclosure as required under this policy and applicable regulations.
For PHS-funded research, the Designated Official shall also have the following responsibility:
● Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees,
subcontractors, or collaborators) fully comply with this policy or provide Clevyr with sufficient
assurances to enable Clevyr’s compliance with all applicable laws or regulations. To this end,
the written agreement between Clevyr and the subrecipient will specify whether Clevyr’s or
the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s
Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
○ Obtain certification from the subrecipient that its policy complies with Clevyr’s policy
and the applicable regulations (absent such certification, Clevyr’s policy will apply to
the subrecipient’s Investigators), and
○ Establish time periods for subrecipient reporting of financial conflicts of interest to
Clevyr that enable Clevyr to report such conflicts in a timely manner, as required
under its policy and the applicable regulations.
If Clevyr’s policy will apply to the subrecipient Investigators, Clevyr will be responsible for meeting
the requirements of this policy and the reporting obligations reflected in the applicable regulations.
Internal Reporting Requirements
For PHS-funded research in particular, as part of the funding application or proposal and prior to
performing any work on the research, each Investigator who is planning to participate in the research
is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and
submit the SFID Form to Clevyr’s Administrator. This requirement also applies to Investigators who
are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID
Forms will be provided to Investigators in conjunction with the annual training and will be otherwise
made available. Clevyr’s Administrator will review SFID submissions with the Designated Official.
The information reported on the SFID Form includes a listing of the Investigator’s known significant
financial interests and those of his/her immediate family that reasonably appear to be related to the
research or that are in entities whose financial interests could be affected by the research.
Clevyr Investigators in non-PHS-funded research who have any significant financial interest that may
reasonably appear to be affected by the research are also expected to complete the SFID Form and
submit it to Clevyr’s Administrator.
Investigators are expected to submit an updated SFID Form during the period of the award as
necessary (at least annually for PHS-funded research). The annual update will typically be done in
conjunction with completion of the annual training. Such disclosures shall include any information
that was not previously disclosed; any change in information regarding any previously disclosed
significant financial interest; or, within 30 days of discovery or acquisition, any new significant
financial interest (e.g., an interest acquired through purchase, marriage, or inheritance).
Determination and Management of Financial Conflicts of Interest
Upon receipt of a completed SFID Form, the Designated Official shall determine whether an
Investigator’s significant financial interest is related to the subject research and, if so, whether the
interest constitutes a financial conflict of interest under this policy and any applicable regulations.
The Investigator may be required to submit additional information as part of the process. A disclosed
interest may be related to the subject research either because the interest could be affected by the
research or because it is in an entity whose financial interest could be affected by the research. A
financial conflict of interest exists if the significant financial interest could directly and significantly
affect the design, conduct, or reporting of the research.
If Clevyr determines that a financial conflict of interest exists, a financial conflicts of interest
management plan will be implemented and monitored on an ongoing basis. The management plan
will include appropriate steps to manage, reduce, or eliminate the conflict. The following are
examples of conditions or restrictions that might be imposed:
● Disclosure to research participants or the public of significant financial interests (e.g., when
presenting or publishing the research);
● Monitoring of research by independent reviewers;
● Modification of the research plan;
● Disqualification of staff from participation in all or a portion of the research;
● Reduction or divestiture of a financial interest; or
● Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, Clevyr may require the management of
conflicting financial interests in other ways as it deems appropriate.
External Reporting Requirements
Clevyr will disclose financial conflicts of interest as required by applicable laws or regulations. Before
expending any funds under a PHS award, Clevyr will ensure public accessibility by posting financial
conflicts of interest information on a publicly available website or by responding in a timely manner to
written requests as required under the regulations. The Designated Official will also report to the
PHS Awarding Component, as detailed in the regulations, the existence of any financial conflict of
interest that has not been eliminated and will ensure that Clevyr has implemented a plan to manage
the conflict.
If a financial conflict of interest is identified after its initial reporting and during ongoing research
(e.g., through participation of a new Investigator) and has not been eliminated, Clevyr will provide
the PHS Awarding Component with an update within 60 days and ensure that it has implemented a
plan to manage the conflict. If the financial conflicts of interest report involves a significant financial
interest that was not disclosed by an Investigator or not previously reviewed or managed by Clevyr
(e.g., not reviewed or reported by a subrecipient in a timely manner), Clevyr will undertake a
retrospective review. Such retrospective review will determine whether there was bias in the design,
conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the
identification and management of the conflict. If bias is found, Clevyr will promptly notify the PHS
Awarding Component and submit a mitigation report. Upon request, Clevyr will provide HHS with
information relating to any Investigator disclosure of significant financial interests; Clevyr review of,
and response to, such disclosure; and whether the disclosure resulted in Clevyr determination of a
financial conflict of interest.
Confidentiality
Clevyr will, to the extent possible, protect the confidentiality of disclosures. In every instance, Clevyr
will endeavor to balance the privacy interests of individuals with its responsibility and obligation to
identify and manage conflicts of interest. Disclosures will be available to Clevyr staff only on a
need-to-know basis and will not be disclosed outside of Clevyr unless necessary to comply with
contractual, legal, or regulatory requirements.
Investigator Noncompliance
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential
financial conflict of interest), Clevyr may take appropriate disciplinary action, which may include,
without limitation, termination of the Investigator’s participation in the research. In addition, for
PHS-funded research, failure to comply with this policy or the applicable regulations shall result in
the following:
● If the Investigator’s failure to comply with this policy or a financial conflicts of interest
management plan has biased the design, conduct, or reporting of the PHS-funded research,
Clevyr shall promptly notify the PHS Awarding Component of the corrective action taken or
to be taken;
● Clevyr will make available to HHS all records pertinent to financial conflicts of interest and
the management of those conflicts; and
● If HHS determines that a clinical PHS-funded research project 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 a financial conflict of interest that was neither
disclosed nor managed, Clevyr shall require disclosure of the conflicting interest in each
public presentation of the results of the research and shall request an addendum to
previously published presentations, if necessary.
Training and Education
Investigators receive training to promote objectivity in research and to ensure Investigator
compliance with regard to the applicable regulations and significant financial interest disclosure
obligations.
Clevyr requires Investigators to complete such training annually, and when any of the following
occurs:
● Clevyr revises its financial conflicts of interest policy or procedures in any manner that affects
the Investigator’s obligations;
● An Investigator is new to Clevyr; or
● Clevyr finds that an Investigator is not in compliance with this policy or a financial conflicts of
interest management plan.
Retention of Records
The Designated Official will retain financial conflicts of interest disclosure forms and other supporting
information consistent with Clevyr Record Retention policy. For PHS-funded research, records of all
financial disclosures, whether or not they result in a reporting obligation, and all actions taken by
Clevyr with respect to each financial conflict of interest will be retained for at least 3 years from the
date of submission of the final expenditures report or final payment on the contract or, where
applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.
Point of Contact
If you have a conflict of interest or if you have a question to discuss, contact the Clevyr Conflict of
Interest Administrator at fcoi@clevyr.com.