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Financial Conflicts of Interest Policy

POLICY NAME: Financial Conflicts of Interest 
POLICY OWNER: Sampled Legal & Compliance Department 
POLICY #: GCC-003-01
EFFECTIVE DATE: 12/01/2023 

Purpose and Scope 

This Financial Conflicts of Interest Policy (“Policy”) applies to all Infinity BiologiX LLC d/b/a Sampled (“Sampled”, or the “Company”) full time, part time and temporary managers and employees, and all Sampled contractors, consultants and agents (collectively “Sampled Personnel” or “Personnel”). 

A conflict of interest exists or may arise when an employee’s personal, financial, or other interests do or could influence an employee’s decisions when acting on behalf of the Company. A conflict can also occur when an employee competes against the Company in any business activity, diverts business from the Company, or uses Company assets, property, information, or resources for a purpose other than the Company’s business interests. It is every employee’s duty to avoid conflicts of interest, and to disclose promptly any actual, perceived, or potential conflict of interest. 

Further, because we are an institution that works with entities in the Public Health Service (PHS), additional obligations exist specific to Financial Conflicts of Interest (FCOI) that must be carefully managed. The regulation, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought” seeks to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS grants or cooperative agreements, including those awarded by the National Institutes of Health (NIH), will be free from bias resulting from an investigator’s financial conflicts of interest. This Policy is designed to ensure compliance with federal regulations when applying for or receiving PHS funding. 

Definitions 

  • Designated Official(s): Designated Officials are those identified by Sampled as the person(s) responsible for management of PHS FCOI disclosure reviews, investigations, reporting, and compliance generally with the regulation. 
  • FCOI Report: An FCOI Report is an Institution’s report of a financial conflict of interest to a PHS Awarding Component, such as NIH. 
  • Financial Conflict of Interest (FCOI): A financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. 
  • Financial Interest: Financial Interest means anything of monetary value, whether or not the value is readily ascertainable. This may include transactions involving cash, securities, loans, forgiveness of debt, non-cash trades or benefits, or ownership interests. 
  • Institution: Refers to any domestic or foreign, public or private, entity or organization that is applying for, or that receives, PHS research funding. Sampled is an “Institution” under the regulation. 
  • Investigator: Refers to 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 PHS-funded research, including subgrantees, contractors, consortium participants, collaborators, or consultants. 
  • Public Health Service (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 Awarding Component: means the organizational unit of the PHS that funds the research that is subject to the regulation, such as the Agency for Healthcare Research and Quality (AHRQ); the Agency for Toxic Substances and Disease Registry (ATSDR); the Centers for Disease Control and Prevention (CDC); the Food and Drug Administration (FDA); the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS); the National Institutes of Health (NIH), the Office of the Assistant Secretary for Health (OASH), the Office of the Assistant Secretary for Preparedness & Response (ASPR); the Office of Global Affairs (OGA), and the Substance Abuse and Mental Health Services Administration (SAMHSA). 
  • Research: 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). As used in the regulation, 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. 
  • Significant Financial Interest (SFI): means: 
    • 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 reasonably appears to be related to the Investigator’s institutional responsibilities:
      • 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, 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. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. 
    • Investigators also must disclose the occurrence of 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 their institutional 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. The 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 an FCOI with the PHS-funded research. 
    • The term significant financial interest does not include the following types of financial interests: 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; 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. 
  • Small Business Innovation Research (SBIR) Program: Means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of the regulation and this policy, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564. 
  • Substantial Interest: A substantial interest is one which will or may be perceived as or actually significant or of relevance to any Company transaction or its results.

Policy 

All actual, possible, or perceived Conflicts of Interest must be disclosed to the Compliance Department by emailing compliance@sampled.com. Certain types of Conflicts of Interest must be avoided entirely, while others may be acceptable with certain protective measures that mitigate the risk and must be approved by the Legal and Compliance Department. 

All PHS SFI and/or suspected FCOI must be disclosed at least annually and within 15 days of identification or existence of a new FCOI to the designated official at the Company. 

All Investigators must complete training prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply: 

  • The Company revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; 
  • An Investigator is new to the Company; or 
  • The Company finds that an Investigator is not in compliance with this Policy or management plan. 

Those involved in the contract management process, must identify FCOI-related requirements and ensure a designated official is identified and trained, and that a compliance plan is implemented for the program, if awarded. Failure to comply with this policy may result in disciplinary action up to and including termination, subject to local laws. 

Common Types of General Business Conflicts of Interest 

Business Financial: Certain personal or familial financial investments could give rise to a conflict of interest. You must disclose whether you or any of your immediate family members own a substantial investment or ownership, directly or indirectly, in any vendor, supplier, customer, or competitor of the Company. 

Personal Relationships: 

  • You may not influence or attempt to influence any Company decisions or transactions with any customers, partners, vendors, or suppliers in which an immediate family member or close personal friend has a direct or indirect interest. 
  • You may not manage or supervise work, directly or indirectly, of any immediate family member or close personal friend. 
  • If, during your employment, you develop a romantic relationship with anyone in your direct or indirect reporting line, you must immediately disclose that information to Human Resources at SampledHR@sampled.com. 

Outside Employment Opportunities, including Public Service or Elected Office: 

  • It is important that all employees devote the requisite time and energy to their positions at Company. It is possible that outside “freelance” or “moonlighting” activities could materially infringe on the time and efforts needed for employment activities. 
  • It is the policy of Company that no employee is to have a “freelance” or “moonlighting” job or activity, related to the pharmaceutical or life sciences industry, which will materially encroach on the time or attention that should be devoted to the employee’s duties, adversely affect the quality of work performed, cause conflicts of interest, limit the employee’s ability to work required overtime, compete with Company activities, imply sponsorship or support by Company of the outside employment or organization, or adversely affect the good name of Company. 
  • All other freelance or moonlighting jobs or activities outside of what is material, as defined above, require the prior written approval of the employee’s supervisor. When there is any question about the materiality of the activity, the employee should consult with the supervisor and Human Resources. Employees who freelance or moonlight with permission may not use Company time, facilities, resources, or supplies for such work, and cannot use other Company employees to help with scheduling, photocopying, phone calls, etc. 
  • Approval of all employee requests to serve on a board of directors of an outside entity is contingent upon the employee’s agreement to abide by the following conditions:
    • 1. The employee will not share confidential or proprietary information of Company or its affiliates with the outside entity; 
    • 2. The employee will not share confidential or proprietary information of the outside entity with Company. 
    • 3. The employee will disclose to Company the potential for a conflict that arises in board matters concerning Company or its affiliates, or assets Company or its affiliates are then considering, without disclosing confidential or proprietary information to the outside entity; 
    • 4. The employee will recuse themselves from considering board matters at the outside entity that can be harmful to Company or its affiliates; 
    • 5. Notwithstanding the employee’s service on the board of the outside entity, the employee will continue to abide by their obligations to Company; and, 
    • 6. The correct filing of income tax returns or other tax statements, the payment of respective income and other taxes as well as the correct deduction and payment of social security contributions (if any) in respect of any compensation the employee receives from the outside entity, is the exclusive responsibility of the outside entity and/or the employee. The employee will hold Company harmless in this regard. 
  • You may not serve as a board member or technical advisor of any entity that is a competitor or may become a competitor of the Company. Prior to accepting any non-competing board or advisory roles, whether paid or unpaid, with a current or potential customer, partner, vendor or supplier, you must obtain written pre-approval from compliance@sampled.com. 
  • You may not serve in any role, elected or appointed, for any government entity that is or could become a customer, or which directly or indirectly has the ability to influence the operations of the Company. 

Outside Business Opportunities: 

  • You may not divert any business opportunities away from the Company and to any other entity with which you, an immediately family member or close personal friend may have an interest. 
  • You may not, under any circumstance, take a business opportunity that is meant for the Company for yourself, even if you think the Company would not want the opportunity. 
  • Employees should not conduct any business other than the Company’s business on the Company’s time or property. Employees may not use the Company’s resources and information for any non-Company business-related activities.  

Other Engagements: 

  • Employees can participate as speakers in conferences and write any professional/academic articles on the subjects that are not related to the business and activities of Company. A written approval from Compliance Department must be obtained to use your title or relationship to Company in these activities. 
  • Employees may provide financial or other support to non-profit organizations and universities as long as they do not present any actual or perception of conflict with their Company duties.

Public Health Service Financial Conflicts of Interest 

PHS FCOI includes any significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. Please refer carefully to the definition of a significant financial interest (SFI) provided in this policy. An SFI is, generally speaking, any financial interest of the Investigator (and the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities. 

General business conflicts of interest should be disclosed to compliance@sampled.com using the COI Disclosure Form. 

Management and reporting of PHS FCOI 

Prior to the Company’s expenditure of any funds under a PHS-funded research project, the designated official(s) of the Company must: review all Investigator disclosures of SFIs; determine whether any SFIs relate to PHS-funded research; determine whether an FCOI exists; and, if so, develop and implement a management 

plan that specifies the actions that have been, and will be, taken to manage the FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to: 

  • Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research); 
  • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; 
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; 
  • Modification of the research plan; 
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; 
  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or 
  • Severance of relationships that create financial conflicts. 

Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses an SFI or an existing Investigator discloses a new SFI to the Company, the Designated Official(s) of the Company must, within sixty days: review the disclosure to determine whether it is related to PHS-funded research; determine whether a FCOI exists; and, if so, implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage the FCOI. Depending on the nature of the SFI, the Company may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of the Company’s review. 

Reporting FCOI 

Prior to the Company’s expenditure of any funds under a PHS-funded research project, the Company must provide to the PHS Awarding Component an FCOI report regarding any Investigator’s SFI found by the Company to be conflicting and ensure that the Company has implemented a management plan in accordance with the regulation. If the Company identifies an FCOI and eliminates it prior to the expenditure of PHS-awarded funds, the Company does not need to submit an FCOI report to the PHS Awarding Component. 

For any SFI that the Company identifies as conflicting subsequent to the Company’s initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the Company must provide to the PHS Awarding Component, within sixty days, an FCOI report regarding FCOI and ensure that the Company has implemented a management plan in accordance with the applicable regulation. Pursuant to the regulation, where such FCOI report involves an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the Company (e.g., was not timely reviewed or reported by a subrecipient), the Company is also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of FCOI was biased in the design, conduct, or reporting of such research. If bias is found, the Company is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. 

Any FCOI report required under the regulation must include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Company’s management plan. Elements of the FCOI report must include, but are not necessarily limited to the following: 

  • Project number; 
  • PD/PI or Contact PD/PI if a multiple PD/PI model is used; 
  • Name of the Investigator with the FCOI; 
  • Name of the entity with which the Investigator has a FCOI; 
  • 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 with respect to which 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-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and 
  • A description of the key elements of the Institution’s management plan, including: o 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; 
    • How the management plan will be monitored to ensure Investigator compliance; and 
    • Other information as needed. 

Each PHS Awarding Component will provide methods for reporting FCOIs. For NIH, reports are submitted via eRA Commons FCOI Module. 

For any FCOI previously reported by the Company with regard to an ongoing PHS-funded research project, the Company must provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report must specify whether the financial conflict is still being managed or explain why the FCOI no longer exists. The Company must provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component. 

Addressing Non-Compliance Issues 

If the Company identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Company during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the Designated Official must, within sixty days: review the SFI; determine whether it is related to PHS-funded research; determine whether an FCOI exists; and, if so: 

  • Immediately implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage the FCOI going forward; 
  • Conduct, within 120 days of the Company’s determination of noncompliance, a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Please consult the regulation for details regarding what must be included and considered in the review process and resulting documentation as well as reporting and disclosure requirements. 

Based on the results of the retrospective review, if appropriate, the Company must update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, the Company is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Company’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Company will submit FCOI reports annually. Depending on the nature of the FCOI, the Company may determine that additional interim measures are necessary with regard to the Company’s participation in the PHS-funded research project between the date that the FCOI or the Investigator’s noncompliance is determined and the completion of the Company’s retrospective review. 

If the Company implements a management plan pursuant to the applicable regulation, the Company must monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project. 

Providing Public Access to FCOI Information 

Prior to the Company’s expenditure of any funds under a PHS-funded research project, the Company must ensure public accessibility, via a publicly accessible website or written response to any requestor within five business days of a request, of information concerning any SFI disclosed to the Company that meets the following three criteria: 

  • The SFI was disclosed and is still held by the senior/key personnel; 
  • The Company determines that the SFI is related to the PHS-funded research; and 
  • The Company determines that the SFI is an FCOI. 

The information that the Company makes available via a publicly accessible website or written response to any requestor within five business days of a request, must 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 SFI is held; the nature of the SFI; and the approximate dollar value of the SFI (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 with respect to which value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

Information concerning the SFIs of an individual subject to the regulation must remain available, for responses to written requests or for posting via the Institution’s publicly accessible website for at least three years from the date that the information was most recently updated. 

Reporting Concerns and Protection from Retaliation 

Employees have an obligation to report any suspected violation of this Policy, the Company Code of Conduct, or of any applicable law or regulation. Suspected misconduct may be reported to Helpline via the web at www.lighthouse-services.com/sampled or by telephone at 1.855.222.0981. The Company is committed to investigate all allegations of misconduct. In addition, the Company has a zero tolerance policy around retaliation. The Company will protect any individual who, in good faith, raises a complaint or cooperates with any investigation. Please see the Speak Up Policy for more information. 

Revision History

SUMMARY OF CHANGES  EFFECTIVE DATE  APPROVED BY 
Initial publication  12/01/2023  Andrew Gayed