Financial Conflict of Interest Policy for US Public Health Service (PHS) Funded Research

Last Updated: April 2026

I. PURPOSE

The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research conducted at Evidation Health, Inc. and its subsidiaries (collectively, “Evidation”) and funded under the Public Health Service (PHS)/National Institutes of Health (NIH) grants, or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

This policy is written in accordance with 42 CFR Part 50 Subpart F - “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought” as well as all other relevant policies of federal funding and oversight agencies.

II. SCOPE

In-Scope:‍

This policy applies to all Evidation employees, contractors, and consultants (collectively, “Employee(s)”) and third parties who meet the definition of “Investigator” and are participating in research funded or proposed for funding by the U.S. PHS/NIH including those funded under applicable grants or cooperative agreements.

Out-of-Scope:‍

This policy does not apply to Research funded under an SBIR/STTR Phase I (as this research is exempt).

This policy also does not apply to Research that is funded by Evidation, and/or other third parties outside of the federal government, specifically PHS/NIH grants. For these projects Evidation shall adhere to its standard Financial Conflict of Interest Policy documented in the Code of Conduct (POL002).

III. DEFINITIONS

Term / Acronym	Definition
Designated Official (DO)	The individual appointed by Evidation to solicit and review disclosures of significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this policy, and develop management plans for identified FCOI.
Disclosure	An Investigator’s disclosure of Significant Financial Interest (SFI) to Evidation.
Financial conflict of interest (FCOI)	A significant financial interest that is related to the PHS/NIH-funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.
Financial Interest	Anything of monetary value, whether or not its value is readily ascertainable.
HHS	The United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institution	Any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS/NIH research funding.
Institutional responsibilities	An Investigator’s professional responsibilities on behalf of Evidation, as defined by Evidation and performed within the scope of their role or engagement, including but not limited to research oversight, consultation, collaboration, and execution of research studies; product and technology development; testing and validation; development of datasets, models, or systems; analysis and interpretation of data; publication and communication of research results; and any other activities or services conducted on behalf of Evidation.
Investigator	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 PHS/NIH, or proposed for such funding, which may include, for example, collaborators or consultants. The institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. The Institution will consider the individual’s role, rather than the title (e.g., senior/key personnel, faculty, MD, PHD, etc.), of those individuals involved in the research and the degree of independence in carrying out the work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research.
Manage	Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
NIH	The National Institute of Health is the biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.
PD/PI	A Project Director or Principal Investigator of a PHS/NIH-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.
PHS	Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS-Funded Research	Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.
PHS Awarding Component	The organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act	Or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research	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). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel	The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or other submission to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement, which mandates disclosure only of financial conflicts of interest held by these Senior/Key Personnel, as described in Section 18.0 Public Accessibility.
Significant financial interest (SFI)	A foreign or domestic 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: With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 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 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; 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 Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income exceeding $5000 during the 12 months preceding the disclosure, related to such rights and interests. Travel: Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities, if reimbursed or sponsored amount exceeding $5000. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip. The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: a federal, state, or local government agency located in the United States, a United States Institution of Higher Education, an academic teaching hospital, a medical center, or a research institute affiliated with a United States Institution of Higher Education Exclusions: 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 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.

IV. COMMITMENT TO OBJECTIVITY

Evidation is committed to maintaining the highest standards of integrity, transparency, and objectivity in research. Financial conflicts of interest must be identified and appropriately managed to ensure that research is free from bias or the appearance of bias.

V. TRAINING REQUIREMENTS

Each PHS/NIH supported Investigator shall be required to complete Financial Conflict of Interest (FCOI) training in accordance with Evidation’s Training Matrix LIST003 and SOP002 Employee Training and Personnel Qualifications Procedure, and relevant regulatory requirements regarding their responsibility to disclose foreign and domestic Significant Financial Interests (SFIs) under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training is comprised of this Policy and the PHS/NIH FCOI Training Tutorial (or equivalent). All training is assigned and traced via Evidation’s eQMS.

Training must be completed prior to engaging in research related to any PHS/NIH-funded grant and at least every four (4) years, when the policy is updated, and upon hire. Additional training may be required in the event an Investigator is found to be not in compliance with this policy.

At a minimum, Investigator(s) must be informed of:

The institution’s policy (this Policy)
Federal regulation associated with FCO
Investigator’s disclosure responsibilities of of all foreign and domestic significant financial interests (SFI)

VI. SUBRECIPENT COMPLIANCE

A subrecipient relationship exists when federal funds flow from or through Evidation to another individual or entity that carries out a substantive portion of a PHS/NIH-funded research project and is accountable to Evidation for programmatic outcomes and compliance. Evidation will take reasonable steps to ensure that all subrecipient (e.g. collaborators, consultants, contractors, subcontractors, and sub-awardees) Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F.

Written agreements between Evidation and the subrecipient, such as a Statement of Work (SOW) or Master Service Agreement (MSA) may specify whether Evidation’s FCOI Policy or the subrecipient’s own FCOI policy applies to subrecipient Investigators

If the subrecipient’s FCOI policy applies:
- The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations.
- The agreement specifies the timeframe for the subrecipient to report identified FCOIs to Evidation in time for Evidation to meet PHS/NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI).
- Typically, this means requiring subrecipients to report FCOIs to Evidation within 50–55 days of identification. Evidation’s Designated Official (DO) then submits the subrecipient FCOI report to PHS/NIH through the eRA Commons FCOI Module.
If the subrecipient cannot certify compliance:
- The agreement specifies that Evidation’s FCOI Policy applies.
- In this case, subrecipient Investigators must disclose their SFIs to Evidation. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for Evidation.
- The agreement allows sufficient time for the DO to review, manage, and report any resulting FCOIs. When an FCOI is identified, the DO implements a Management Plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to PHS/NIH via the eRA Commons FCOI Module.

VII. REQUIREMENTS FOR INVESTIGATOR DISCLOSURE

Each Investigator (as defined in this policy) is required to disclose their foreign and domestic SFIs (and those of the Investigator’s spouse and dependent children) related to the Investigator’s institutional responsibilities (as defined in this policy). The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation.

Investigators are required to disclose SFIs, using the POL026-F1 SFI Disclosure Form, at the following times:

At the time of the application for PHS/NIH-funded research
At least annually for the duration of the award period. Annual disclosures must include:
‍
- Any new information that was not previously disclosed under this policy
- Updated details for any previously disclosed SFI (such as change in the value of an equity interest).
Within 30 days of discovering or acquiring a new SFI (e.g. through purchase, marriage, or inheritance).
When an investigator is new to participating in a PHS/NIH-funded research project
Within 30 days of any new reimbursed or sponsored travel

Disclosures must include sufficient detail to allow a determination of whether or not a FCOI exists.

VIII. REVIEW OF INVESTIGATOR’S DISCLOSURE

Evidation has designated its Chief Financial Officer (CFO) as the Designated Official (DO). The CFO can delegate this responsibility as required (such as in the instance the DO has a disclosed SFI related to the research under review, or where additional independence is warranted).

The DO must solicit and review Investigator SFI disclosure (and those of the Investigator’s spouse and dependent children) related to an Investigator’s institutional responsibilities for a determination of a FCOI related to PHI/NIH-funded research. Review of SFI must occur:

No later than at the time of the application for PHS/NIH-funded research
Prior to the issuance of a new award or before any expenditure of award funds
At least annually for the duration of the award period
Within 30 days of discovering or acquiring a new SFI
Within 60 days in the event an investigator is new to participating in a PHS/NIH-funded project, or an Investigator discovers or acquires a new SFI during the project

SFI review responsibilities include:

Review all Investigator SFIs disclosed
Determine if any SFIs related to the Investigators PHS/NIH-funded research
Determine if a FCOI exists (i.e. an SFI that could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research)
Develop and implement a Management Plan to manage the FCOI(s) (as required)

IX. REVIEW AND DETERMINATION OF FCOI

The DO is responsible for assessing the relatedness of SFIs to PHS/NIH-funded research and determining when they constitute a FCOI.

SFIs are reviewed by the DO in collaboration with the Investigator to determine whether or not the SFI is related to PHS/NIH-funded research such as in the event 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

A FCOI exists when the Institution, through its designated official(s), reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research (“significantly” meaning that the financial interest would have a material effect on the research).

X. MANAGEMENT OF FCOI

In the event Evidation identifies a FOCI related to PHS/NIH-funded research, the DO shall implement a Management Plan prior to the expenditure of funds, or within regulatory timelines (if identified later). Investigators are required to comply with all Management Plans.

Management strategies may include:

Public disclosure of the FCOI (e.g. in publications or presentations, to study personnel, to the IRB etc.). While public posting of FCOIs is required only for senior/key personnel the DO may require disclosure of any Investigator’s FCOI as a condition of a Management Plan.
Disclosure to research participants (e.g. in the Informed Consent document)
Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of research
Modification of the research plan
Change of personnel, responsibilities, or roles
Reduction or elimination of the financial interest
Severance of relationships creating the conflict

The DO communicates the determination and the Management Plan in writing to the Investigator and the appropriate supervisor. The Management Plan should include the following key elements:

The role and principal duties of the conflicted Investigator in the research project;
Conditions of the Management Plan;
How the Management Plan is designed to safeguard objectivity in the research project;
Confirmation of the Investigator’s agreement to the Management Plan (e.g. Investigator Signature)
How the Management Plan will be monitored to ensure Investigator compliance; and
Other information as needed.

No expenditures on a PHS/NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO submits an FCOI report to PHS/NIH via the eRA Commons FCOI Module.

XI. MONITORING INVESTIGATOR COMPLIANCE

In the event FCOI are identified and a Management Plan is required, Investigator compliance with the Management Plan is monitored for the duration of the award period in accordance with the monitoring requirements defined in the Monitoring Plan.

XII. NONCOMPLIANCE & RETROSPECTIVE REVIEW OF INVESTIGATOR DISCLOSURE

If an FCOI is identified that was not disclosed or managed in accordance with this policy and regulatory requirements, including:

Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI
Failure by the institution to review or manage an FCOI
Failure by the Investigator to comply with an established management plan

The DO will:

Review the SFI within 60 days of disclosure to determine whether the SFI is related to the PHI/NIH-funded research and determine whether an FCOI exists.
Implement a Management Plan (as described in section 12: Management of FCOI), if necessary
Conduct a Retrospective Review within 120 days to identify occurrence of noncompliance, and/or bias in the design, conduct or reporting of PHS/NIH-funded research.
- If the Retrospective Review identifies a noncompliance, and an update to a previously identified FCOI is needed, a Revised Report is required.
- If the Retrospective Review found that bias occurred, a Mitigation Report is Required.
Revised Report includes at a minimum:
- Project number
- Project title
- Project Director/Principle Investigator (PD/PI) or contact PD/PI if a multiple PD/PI model is used
- Name of Investigator with the FCOI
- Name of the entity with which the Investigator has a financial conflict of interest
- Reason for Retrospective Review
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
- Findings of the review
- Conclusion of the review (determination of bias)
The Mitigation Report must include at a minimum:
- All elements included in the Retrospective Review (as described above)
- A description of the impact of the bias on the research project
- The Institution’s plan of action, or actions taken to eliminate or mitigate the effect of bias
If no bias is found, no additional action is required.

XIII. CLINICAL RESEARCH REQUIREMENTS

If Health and Human Services (HHS) determines that a PHS/NIH-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, Evidation requires the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations.

XIV. INSTITUTION REPORTS TO PHS/NIH

Evidation will designate an institutional official to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to PHS/NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e. no award means no FCOI report, and no FCOI means no FCOI report).

Evidation will report FCOIs to the PHS Awarding Component:

Initial Report
- Prior to the expenditure of funds
- Within 60 days of identifying a new, or newly existing FCOI for an existing investigator
- Within 60 days of an identification of a FCOI for an Investigator who is newly participating in the project
Revised Report (within 150 days of submission of the Initial Report)
- After a Retrospective Review (to update a previously submitted report)
- In the event new information is obtained regarding a previously identified FCOI
Mitigation Report
- After Retrospective Review (when bias is identified)
Annual Report (required at least, annually, for the duration of the award)

Annual Reports indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable. The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report and at the time of any grant extension in accordance with PHS/NIH guidance.

Initial Report includes the following at a minimum:

Project number
Project title
PD/PI or contact PD/PI if a multiple PD/PI model is used
Name of Investigator with the FCOI
Name of the entity with which the Investigator has a financial conflict of interest
Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999;$10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value
A description of how the financial interest relates to the PHS/NIH-funded research and the basis for the Institution's determination that the financial interest conflicts with such research
A description of the key elements of the Institution's Management Plan, including:
- Role and principal duties of the conflicted Investigator in the research project;
- Conditions of the Management Plan;
- How the Management Plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator's agreement to the Management Plan (e.g. Investigator Signature);
- How the Management Plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
The Annual Report must include at a minimum:
‍
- All elements included in the Initial Report
- Status of the FCOI (whether it is still being managed or no longer exists) and any changes to the management plan, if applicable.

XV. MAINTENANCE OF RECORDS

Evidation maintains FCOI-related records, for at least 3 years, in accordance with Evidation’s Record Retention Schedule (LIST009) and applicable regulatory requirements. Evidation will retain all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable. Records retained may include:

Disclosures
Retrospective Reviews
Responses to Disclosures and FCOI Determinations
Management Plans and Mitigation Plans
Initial and Annual Reports
Any other documentation regarding actions taken under this policy or through retrospective review.

XVI. PUBLIC ACCESSIBILITY

Evidation’s policy for Financial Conflicts of Interests (this policy) shall be made available via Evidation’s publicly available website (https://evidation.com)

Identified FCOIs held by Senior/Key Personnel will be publically available upon request. Evidation ensures public accessibility, by providing a written response within five business days to request for information about any SFI that meets all three of the following criteria:

The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by Evidation as Senior/Key Personnel in the application, progress report, or other PHS/NIH submission)
Evidation has determined that the SFI is related to the PHS/NIH-funded research.
Evidation has determined that the SFI constitutes a FCOI.

When applicable, Evidation will make available at least the following information:

Investigator name
Investigator’s title and role on the research project
Name of entity in which the SFI is held
Nature of the SFI
Approximate dollar value of the SFI (in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000) or a statement that value cannot be readily determined

The written response notes that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor.

XVII. ENFORCEMENT AND NONCOMPLIANCE

Failure to comply with this policy, including failure to disclose Significant Financial Interests, failure to comply with a Management Plan, or failure to complete required training may result in corrective action(s), which may include:

Additional training
Increased oversight
Restrictions on participation in research activities
Disciplinary action, up to and including termination

Corrective action(s) may be documented in a CAPA in accordance with Evidation’s Corrective and Preventative Action Procedure (SOP015).