Policy

2Morrow Financial Conflict of Interest Policy

Policy Overview

Institutions, organizations, and companies engaged in research funded by the Public Health Service (PHS) are required to develop a Financial Conflict of Interest (FCOI) policy that is maintained and enforced and meets or exceeds the current Federal regulatory requirements.  

This policy is designed to comply with PHS regulations (42 CFR Part 50 Subpart F, Promoting Objectivity in Research; 45 CFR Part 95, Responsible Prospective Contractors). These standards and procedures are intended to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator FCOIs. 

This policy applies to each Investigator, as defined by the regulation, who is planning to participate in or is participating in PHS funded research. Subcontractors and sub-awardees are expected to have FCOI policies in place or to adopt 2Morrow’s FCOI Policy (see Subrecipient section below).

Under this policy, 2Morrow will inform each Investigator of the company’s policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same 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:

  • 2Morrow revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

  • An Investigator is new to an Institution; or

  • 2Morrow finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.

Availability of the Policy

2Morrow will maintain an up-to-date written, enforced policy on financial conflicts of interest that complies with applicable regulations, including any federal financial conflict of interest regulations. The policy will be posted and available via the company’s publicly accessible website.  2Morrow will inform covered individuals of the policy and of their responsibilities regarding disclosure. 2Morrow will inform covered individuals in the event the policy is revised and updated.

Institutional Responsibilities

2Morrow will designate an institutional official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research. In the event of Investigator bias or failure to comply with mitigation requirements, 2Morrow will notify PHS promptly.  

Application Certification

In each application for PHS funding, 2Morrow will certify that it:

Has in effect an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects;

  • Shall promote and enforce Investigator compliance with this subpart's requirements including those pertaining to disclosure of significant financial interests;

  • Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this subpart;

  • Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest; and

  • Shall fully comply with the requirements of this regulation.

Maintenance of Records

2Morrow shall maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (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, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

Management of Financial Conflicts of Interest

2Morrow will take actions necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient Investigator.  Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report pursuant to § 50.605 (42 CFR § 50.605 Management and reporting of financial conflicts of interest - Code of Federal Regulations (ecfr.io))

Prior to the Institution's expenditure of any funds under a PHS-funded research project or within 60 days of any disclosure by a new or existing Investigator during the course of an ongoing PHS-funded research, the Institution designated official(s) of an Institution shall,

  • Review all Investigator disclosures of significant financial interests; 

  • Determine whether any significant financial interests relate to PHS-funded research;

  • Determine whether a financial conflict of interest exists; and, if so,

  • Develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. 

    • Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest 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 financial conflict of interest; 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.

Failure of Timely Investigator Reporting or Institutional Review

Whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete 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.

Financial Conflicts of Interest Reporting

Provide initial and ongoing FCOI reports to the PHS as required by this regulation- prior to the expenditure of funds, per annual reporting requirements, and within 60 days of any new or newly identified FCOI for newly participating or existing Investigators.

Any FCOI report shall 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 Institution's management plan. Elements of the FCOI report shall 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 financial conflict of interest;

  • 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-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.

For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. 

Investigator Disclosure of Significant Financial Interests Requirements

Each Investigator who is planning to participate in the PHS-funded research must disclose to the 2Morrow’s designated official(s) any significant financial interests (and those of the Investigator's spouse and dependent children) no later than the time of application for PHS-funded research.  

Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of significant financial interests at least annually during the period of the award.  Such disclosure shall include any information that was not disclosed initially and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

Each Investigator who is participating in the PHS-funded research must submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

The following describes Significant Financial Interest and Exclusions

Significant Financial Interests (SFI):

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:

  • 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.

  • 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. 

Significant Financial Interest Exclusions

  • Salary, royalties, or other remuneration paid by 2Morrow to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;

  • Intellectual Property Rights assigned to the Institution and agreements to share in royalties related to such rights;

  • Any ownership interest in 2Morrow 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.

Subrecipient Policy

Subcontractors and sub-awardees are expected to have FCOI policies in place or to adopt 2Morrow’s FCOI Policy. 

2Morrow will assure this by incorporating as part of a written agreement with the subrecipient terms that establish whether 2Morrow’s FCOI policy or that of the subrecipient will apply to the subrecipient's Investigators.

  • If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart.

  • If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to 2Morrow’s FCOI policy for disclosing significant financial interests that are directly related to the subrecipient's work for 2Morrow.

  • Additionally, if the subrecipient's Investigators must comply with the subrecipient's FCOI policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient for 2Morrow to provide timely FCOI reports, as necessary, to the PHS.

  • Alternatively, if the subrecipient's Investigators must comply with 2Morrow' financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to 2Morrow. Such time period(s) shall be sufficient for 2Morrow to comply timely with its review, management, and reporting obligations under this subpart.

  • 2Morrow will provide FCOI reports to the PHS regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

Definitions

Disclosure means an Investigator's disclosure of significant financial interests to an Institution.

Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.  Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

FCOI Report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.

Investigator means 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, or proposed for such funding, which may include, for example, collaborators or consultants.

Manage means 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.

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 (NIH).

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. 

Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.

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Policy Title: 2Morrow Financial Conflict of Interest Policy

Number: 2MI_FCOI_2021

Effective Date: September 26, 2022

Revised Date: September 22, 2022

Original Policy Date: April 12, 2021

For More Information: If you have a conflict of interest or if you have a question to discuss, please contact the 2Morrow Policy Coordinator by email at policies@2morrowinc.com.