FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY

 

I. PURPOSE AND POLICY STATEMENT

Lachman Consultant Services, Inc. (“Lachman”) adopts this Financial Conflict of Interest Policy (the “Policy”), to promote objectivity in research by establishing standards and procedures reasonably designed to ensure that the design, conduct, and reporting of research performed under U.S. Public Health Service (“PHS”) contracts will be free from bias resulting from Investigator financial conflicts of interest.

This Policy implements the requirements of 45 C.F.R. Part 94 applicable to institutions submitting proposals for, or receiving, PHS research funding by means of a contract.

Lachman will identify, review, manage, and, where required, report financial conflicts of interest in a timely manner for all Investigators covered by this Policy.

II. DEFINITIONS

For purposes of this Policy, the following definitions apply.

Designated Official(s): A person designated by Lachman to determine whether an Investigator’s significant financial interest is related to PHS-funded research, and if related, whether the significant financial interest is a financial conflict of interest. The Designated Official is the person responsible for the procedures under this Policy but may designate one or more individuals to assist in any or all of these responsibilities and/or may delegate any or all of these responsibilities to one or more individuals.

Financial conflict of interest (“FCOI”): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial interest: Anything of monetary value, whether or not the value is readily ascertainable.

Institutional responsibilities: The professional activities an Investigator performs on behalf of Lachman, including, to the extent applicable, research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator: The project director (“PD”) or principal investigator (“PI”) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, which may include collaborators or consultants.

Non-Significant Financial Interests (“Non-SFI”) include the following:

  • Any income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator (or the Investigator’s spouse or domestic partner and dependent children) does not control the investment decisions made in these vehicles; or
  • Income from seminars, lectures or teaching engagements sponsored by a U.S. 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 U.S. 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
  • Salary, royalties or other remuneration paid by Lachman to the Investigator if the Investigator is currently employed or otherwise appointed by Lachman, including intellectual property (“IP”) rights assigned to Lachman and royalty-sharing arrangements; or
  • Travel reimbursement or sponsorship by a U.S. 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.

Manage: Taking action to address a FCOI, which can include reducing or eliminating the conflict, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PHS: The Public Health Service 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 (“NIH”) and Biomedical Advanced Research and Development Authority (“BARDA”).

PHS Awarding Component: The organizational unit of the PHS that funds the research that is subject to this part.

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 part, the term includes any such activity for which research funding is available from a PHS Awarding Component through a contract, whether authorized under the PHS Act or other statutory authority.

Significant Financial Interest (“SFI”): A financial interest consisting of one or more of the following interests of the Investigator (and of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities, but specifically excluding any Non-SFI:

  • 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 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
  • Income related to IP rights and interests (e.g., patents, copyrights); or
  • Any travel reimbursement or sponsorship.

III. ROLES AND RESPONSIBILITIES

Lachman will inform each Investigator of this Policy, the Investigator’s disclosure responsibilities, and training requirements, as set forth in this Policy. Lachman will designate officials to solicit and review Investigator disclosures of SFI for work under PHS-funded research.

Investigators participating or planning to participate in PHS-funded research are responsible for timely, complete, and accurate SFI disclosures, including those of the Investigator’s spouse and dependent children. Investigators must comply with any management plan imposed under this Policy.

IV. DISCLOSURE REQUIREMENTS AND TIMING

Each Investigator participating or planning to participate in PHS-funded research must disclose to the Designated Official all SFIs (and those of the Investigator’s spouse and dependent children).

Disclosures must be made no later than the date of submission of Lachman’s proposal for PHS-funded research, provided that the Investigator’s participation is known at proposal submission.

During the period of the award/performance, each participating Investigator must submit an updated disclosure at least annually, on or before January 1, and the disclosure must include updated information about previously disclosed SFIs (including updated values where applicable).

Each participating Investigator must submit an updated disclosure within 30 days of discovering or acquiring a new SFI (including through purchase, marriage, or inheritance).

For reimbursed or sponsored travel subject to disclosure, the Investigator must provide at least the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Designated Official may request additional information, including monetary value, to evaluate whether the travel constitutes a FCOI.

V. REVIEW OF DISCLOSURES

The Designated Official will review all SFI disclosures and determine whether any SFIs relate to PHS-funded research, and if so, whether the SFIs constitute a FCOI under this Policy. The Investigator may be required to submit additional information as part of the process.

An SFI is related to PHS-funded research when the Designated Official reasonably determines that the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research.

A FCOI exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Lachman may request additional information from the Investigator as needed to complete the review.

VI. MANAGEMENT OF FINANCIAL CONFLICTS OF INTEREST

If it is determined that a FCOI exists, the Designated Official will develop and implement a written management plan specifying the actions that have been and will be taken to manage the conflict. Management may include reducing or eliminating the conflict to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Examples of conditions or restrictions that may be imposed in a management plan include public disclosure of FCOIs (e.g., in presentations or publications), disclosure to human subjects (where applicable), appointment of an independent monitor, modification of the research plan, change of personnel or responsibilities (including disqualification), reduction or elimination of the financial interest (e.g., sale of equity), or severance of relationships that create conflicts.

Whenever Lachman implements a management plan, Lachman will monitor Investigator compliance with the management plan on an ongoing basis until completion of the PHS-funded research project.

VII. TIMING STANDARDS FOR REVIEW, MANAGEMENT, INTERIM MEASURES

Prior to Lachman’s expenditure of any funds under a PHS-funded research project, the Designated Official will review all disclosures, determine whether any SFIs relate to the PHS-funded research, determine whether a FCOI exists, and, if so, develop and implement a management plan.

When, during an ongoing PHS-funded research project, an Investigator new to the project discloses an SFI, or an existing Investigator discloses a new SFI, the Designated Official will complete review, determination, and, if a FCOI exists, implementation (at least on an interim basis) of a management plan within 60 days.

Whenever Lachman identifies an SFI that was not timely disclosed or not previously reviewed during an ongoing project (including where a subrecipient did not timely report), the Designated Official will complete review, determination, and, if warranted, implementation of a (interim) management plan within 60 days.

Depending on the nature of the SFI, Lachman may impose additional interim measures between disclosure and completion of review.

VIII. REPORTING TO THE PHS AWARDING COMPONENT

Prior to the expenditure of any funds under a PHS-funded research project, Lachman will provide a FCOI report to the PHS Awarding Component regarding any Investigator SFI found to be conflicting and will ensure that a management plan has been implemented.

If Lachman identifies and eliminates a conflict prior to the expenditure of PHS-awarded funds, Lachman will not submit an FCOI report to the PHS Awarding Component.

For any SFI identified as conflicting after an initial report during an ongoing project (including when a new Investigator joins the project), Lachman will provide an FCOI report to the PHS Awarding Component within 60 days and ensure implementation of a management plan.

Each FCOI report will include sufficient information for the PHS Awarding Component to understand the nature and extent of the conflict and assess the appropriateness of Lachman’s management plan.

FCOI report elements will include the project/contract number; PD/PI (or contact PD/PI); Investigator name; entity name; nature and value (or value range) of the interest; description of how the interest relates to the research and the basis for the conflict determination; and key elements of the management plan (including role/duties, conditions, safeguarding design, Investigator agreement, monitoring, and other information as needed).

For any FCOI previously reported for an ongoing project, Lachman will submit annual FCOI reports for the duration of the project period (including extensions) addressing the status of the FCOI and any changes to the management plan, in the time and manner specified by the PHS Awarding Component.

IX. TRAINING

Lachman will require each Investigator to complete training regarding this Policy, disclosure responsibilities, and the applicable federal requirements prior to engaging in research related to any PHS-funded contract and at least every four years thereafter.

Training will also be required immediately when Lachman revises this Policy in a manner that affects Investigator requirements, when an Investigator is new to Lachman, or when Lachman finds an Investigator is not in compliance with this Policy or a management plan.

X. PUBLIC ACCESSIBILITY

Before the expenditure of any funds under a PHS-funded research project, Lachman will ensure public accessibility by written response to any requestor within five business days of a request for information concerning any SFI disclosed that meets the following three criteria:

    1. The significant financial interest was disclosed and is still held by key personnel;
    2. Lachman determines that the SFI is related to the PHS-funded research; and
    3. Lachman determines that the SFI is a FCOI.

The information that Lachman will make available via a publicly accessible Web site or in a written response to any requestor within five days of request will include, at a minimum, the following:

  • The Investigator’s name;
  • The Investigator’s title and role with respect to the research project;
  • The name of the entity in which the Significant Financial Interest is held;
  • The nature of the Significant Financial Interest; and
  • The approximate dollar value of the Significant Financial Interest in the following ranges: $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.

If Lachman uses a publicly accessible website to comply with the public disclosure requirements, the information posted will be updated at least annually and within sixty days of receipt or identification of information concerning any additional SFI of the key personnel for the PHS-funded research project that had not been previously disclosed, or upon the disclosure of a SFI of key personnel new to the PHS-funded research project, if it is determined by the Designated Official that the SFI is related to the research and is a FCOI.

Information concerning an individual’s SFI, as limited by this Policy, will remain available for responses to written requests or for posting via the Lachman’s publicly accessible web site for at least three years from the date that the information was most recently updated.

XI. SUBRECIPIENT REQUIREMENTS

A subrecipient is established when federal funds flow down from or through Lachman to another individual or entity, and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to Lachman for programmatic outcomes and compliance matters. Subrecipients, who include but are not limited to collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to Lachman’s terms and conditions, and as such, Lachman will take reasonable steps to ensure that any subrecipient Investigator complies with FCOI regulation at 45 C.F.R. Part 94.

Lachman will by agreement require any subrecipient or subcontractor performing PHS-Funded Research to either (a) mandate that its Investigators comply with this FCOI Policy or (b) comply with the subrecipient’s or subcontractor’s FCOI policy if the subrecipient or subcontractor certifies that this policy complies with PHS regulations. Lachman will require all disclosures and reports by a subrecipient’s or subcontractor’s Investigators under either policy to be made to Lachman at least 15 days before any corresponding disclosure or report is due to the Government.

XII. NONCOMPLIANCE, RETROSPECTIVE REVIEW, MITIGATION

If a FCOI is not identified or managed in a timely manner due to Investigator nondisclosure, Lachman’s failure to review or manage, or Investigator failure to comply with a management plan, Lachman will, within 120 days of determining noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether research conducted during the period of noncompliance was biased in design, conduct, or reporting.

Lachman will document the retrospective review and, at a minimum, will document the project number and title, PD/PI, Investigator name, entity name, reason(s) for the review, methodology, findings, and conclusions.

Based on the results of the retrospective review, if appropriate, Lachman will update any previously submitted FCOI report specifying the actions to manage the FCOI going forward.

If bias is found, Lachman will promptly notify the PHS Awarding Component and submit a mitigation report that includes the key elements documented in the retrospective review and describes the impact of the bias and Lachman’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

If failure to comply with this Policy or a management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, Lachman will promptly notify the PHS Awarding Component of the corrective action taken or to be taken.

XIII. CLINICAL RESEARCH DISCLOSURE REMEDY

If HHS determines that a PHS-funded project of clinical research evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported as required, Lachman will require the Investigator to disclose the FCOI in each public presentation of results and to request an addendum to previously published presentations.

XIV. RECORDKEEPING AND RETENTION

Lachman will retain records relating to FCOI disclosure forms and other supporting information, including actions taken to manage actual or potential conflicts of interest, for at least three (3) years from the date of final payment or, where applicable, for the time periods specified in 48 C.F.R. Part 4, subpart 4.7.

If requested by the PHS Awarding Component and/or HHS, Lachman will submit, or permit an on-site review of, all records pertinent to compliance with this Policy, including records related to any Investigator disclosure of financial interests and Lachman’s review of, and response to, such disclosure, regardless of whether or not the disclosure resulted in Lachman’s determination of a FCOI.

XV. ENFORCEMENT AND SANCTIONS

Lachman will establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions, as appropriate, to ensure Investigator compliance with this Policy and management plans.

Compliance with this Policy and applicable management plans is a condition of participation in covered PHS-funded research activities.

XVI. POLICY ADMINISTRATION AND UPDATES

Policy Owner / Designated Official: William Littman, Esq./Executive Director, Corporate Counsel (the “Designated Official”) is responsible for administering this Policy, including solicitation and review of disclosures, determinations, management, reporting, training administration, and recordkeeping oversight.

This Policy is effective as of January 1, 2026 and will be reviewed and updated as needed to remain consistent with applicable federal requirements and subcontract/prime award terms governing PHS-funded research.