Financial Conflict of Interest Policy

This document defines Charles River Analytics, Inc. policy and procedures regarding financial conflicts of interest with respect to projects funded under Public Health Service (PHS) grants or cooperative agreements. Federal regulations require Charles River Analytics, Inc. (Charles River) to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by the financial interests of its employees. The purpose of this policy is to ensure that the design, conduct, and reporting of research funded under PHS funds are free from bias resulting from financial conflicts of interest.

This policy is designed to comply with federal regulations and hereby incorporates by reference 42 C.F.R. 50 subpart F. This policy is adopted in addition to and as a supplement to the Charles River Employee Handbook.

This policy applies to all Charles River employees who are involved with PHS-funded research. Legal Affairs is responsible for ensuring implementation of this policy and may suspend all relevant activities until a potential conflict of interest is resolved or other appropriate action is implemented. Violation of any part of this policy may constitute cause for disciplinary or other administrative action.

A. Definitions

1. A Financial Conflict of Interest (FCOI) exists when Charles River reasonably determines that an Investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
2. An Investigator is the project manager, principal investigator, or any other person identified as senior or key personnel in a grant application; and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, including consultants.
3. The Institutional Official is the individual within Charles River who is responsible for the solicitation and review of disclosures of significant financial interests related to the Investigator’s institutional responsibilities; Charles River’s Institutional Official is the manager of Legal Affairs.
4. Institutional Responsibilities are the Investigator’s professional responsibilities on behalf of Charles River (e.g., research, research consultation, teaching, committee memberships, service on panels, etc.).
5. PHS means the 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.
6. A Significant Financial Interest means:

1. 1. 1. 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:
      1. 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
        Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
    2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities (excluding travel that is reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education); disclosures must include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
    3. The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Charles River to the Investigator if the Investigator is currently employed or otherwise appointed by Charles River, including intellectual property rights assigned to Charles River and agreements to share in royalties related to such rights; any ownership interest in Charles River held by the Investigator; 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, 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

B. Disclosure of Significant Financial Interests

All Investigators are required to disclose their outside financial interests to Charles River on an annual and ad hoc basis using the Significant Financial Interest Disclosure Form (“Disclosure Form”) available. Each Investigator is required to disclose the following Significant Financial Interests:

Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.

Regardless of the above minimum requirements, any Charles River staff, in their own best interest, may choose to disclose any other financial interest that could present an actual conflict of interest or be perceived to present a conflict of interest.

The proposal coordinator for a proposed PHS application is responsible for obtaining a Disclosure Form from all participating Investigators. Each Investigator shall complete a Disclosure Form and attach all required supporting documentation. The proposal coordinator must submit completed Disclosure Forms to the manager of Legal Affairs for review and approval before the proposal is submitted. All Significant Financial Interests must be disclosed prior to the time a proposal for PHS-funded research is submitted. All Disclosure Forms must be updated by Investigators during the period of the award on an annual basis and within 30 days of discovering or acquiring (through, e.g., purchase, marriage, or inheritance) a new Significant Financial Interest. Individuals who intend to contribute as an Investigator to an ongoing PHS-funded project must submit a Disclosure Form prior to contributing to the PHS-funded project.

C. Review of Disclosure Forms

The Institutional Official shall review all Disclosure Forms to determine whether each Significant Financial Interest relates to PHS-funded research and whether a Financial Conflict of Interest exists. This review will occur prior to Charles River’s expenditure of any funds under a PHS-funded research project, and in the course of a PHS-funded research project, within 60 days of an Investigator’s disclosure of a new Significant Financial Interest or discovery of a Significant Financial Interest that was not timely disclosed by an Investigator.

A Significant Financial Interest is related to PHS-funded research when the Intuitional Official reasonably determines that the Significant Financial Interest could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. A Financial Conflict of Interest exists when the Institutional Official reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project.

D. Management of FCOI

If the Institutional Official determines that a Charles River or subrecipient Investigator has a potential Financial Conflict of Interest, then the Institutional Official will determine what conditions or restrictions, if any, should be imposed by the institution to eliminate, reduce, or manage actual or potential conflicts of interest.

Prior to submitting a proposal that involves disclosure of Significant Financial Interests or after a new Significant Financial Interest has been discovered or acquired, the Investigator should discuss with the Institutional Officer proposed measures that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest (e.g., public disclosure of significant financial interests; review of research protocol by independent reviewers; monitoring of research by independent reviewers; and/or modification of the research plan).

Following review of the Disclosure Forms for each Investigator on a particular proposal, the Institutional Officer may impose additional conditions or restrictions (e.g., modification of the research plan; disqualification from participation in all or a portion of the research funded; divestiture of significant financial interests; and/or severance of relationships that create actual or potential conflict of interest). The Institutional Official will require that a plan for reducing or eliminating conflicts of interest be incorporated into a memorandum of understanding between Charles River and the Investigator, providing a management plan on an on-going basis until completion of the PHS-funded research project.

E. Reporting to PHS

Prior to Charles River’s expenditure of funds under a PHS-funded research project, the Institutional Official shall provide to the PHS awarding component an FCOI Report regarding any Financial Conflicts of Interest that have not been eliminated prior to the expenditure of PHS-awarded funds, if any remain. A FCOI Report must also be submitted within 60 days of Charles River’s identification of a new Financial Conflict of Interest during an ongoing PHS-funded project.

The FCOI Report must include the following information, plus any additional information that will enable the PHS awarding component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Charles River’s management plan:

Grant number; project number; PM/PI; name of Investigator with FCOI; name of entity with which the investigator has a FCOI; nature of FCOI (e.g., consulting fees, travel, equity); value of financial interest; description of how the financial interest relates to PHS-funded research and the basis for Charles River’s determination that the financial interest conflicts with such research; and the key elements of the Institution’s management plan (e.g., role and principal duties of the conflicted Investigator; how the management plan is designed to safeguard objectivity in the research project; how the management plan will be monitored to ensure Investigator compliance, etc.).

F. Violations of Conflict of Interest Policy

Whenever an Investigator has violated this policy or the terms of any resolution plan (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Institutional Official shall notify the Chief Compliance Officer, who will impose sanctions or institute disciplinary proceedings against the violating individual, including suspension of all relevant activities and FCOI training until the matter is resolved. Additionally, Charles River shall follow federal regulations regarding the notification of the sponsoring agency and/or PHS.

G. Retrospective Review

If the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner(e.g., an Investigator failed to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest; an Investigator failed to comply with a management plan for a Financial Conflict of Interest) a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct, or reporting of the research. Documentation of the retrospective review must be in accordance with 42 C.F.R. 50.605 and shall take place within 120 days of the Institutional Official’s determination of noncompliance. The Institutional Official will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.

H. Record Maintenance

Records of Investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Institutional Official for at least three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

I. Subawards

Subcontractors and consultants that carry out PHS-funded research on behalf of Charles River must either comply with this policy or provide a certification that they have a financial conflicts of interest policy that complies with the requirements of 42 C.F.R. 50, subpart F.

Subcontractors and consultants must report all identified Financial Conflicts of Interest to Charles River prior to expenditure of PHS-funds or, at the latest, within 30 days of: (i) execution of the subaward; or (ii) a subcontractor or consultant Investigator’s discovery or acquisition of a new Significant Financial Interest during a PHS-funded project.

J. Training

Each Investigator must complete training on this policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that the FCOI policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.

K. Public Accessibility

As required by federal regulations and upon written request, Charles River will provide to any requestor written information about Financial Conflicts of Interest of an individual who is listed as a Senior or Key Personnel on a PHS award. Requests must be in writing addressed to Charles River Analytics, Inc., Legal Affairs, 625 Mt. Auburn Street, Cambridge, MA 02138, and received through the US mail. The request must identify the specific PHS project number and the name of the Investigator for whom information is being requested. The request must include a named recipient and return address with a physical street address (P.O. boxes are not acceptable). Charles River will note in its written response that the information is current as of the date of the correspondence and is subject to updates at least annually and within 60 days of Charles River’s identification of a new Financial Conflict of Interest, which must be requested under separate cover by the requestor.

The following information will be provided in response to a properly submitted request: project number, name of the Investigator with a Financial Conflict of Interest; the Investigator’s title and role with respect to the research project; the nature of the Financial Interest; and the value of the Financial Interest (in ranges), or a statement that the interest is one whose valued cannot be readily determined through reference to public prices or other reasonable measure of fair market value.

Last updated: 27 April 2022