MEDICAL OUTCOMES MANAGEMENT

Financial Conflict of Interest Policy

1.0 Policy

1.1 This policy intends to promote objectivity in research funded by Public Health Service (PHS) Agencies by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS contracts will be free from bias resulting from Medical Outcomes Management, Inc. (MOM) Investigators’ Financial Conflicts of Interest.

1.2 This corporate policy applies to all MOM Employees and persons working on MOM PHS contracts who, regardless of title or position, are responsible for the design, conduct or reporting of research funded by a PHS Agency, or collaborate with or consult with individuals responsible for the design, conduct or reporting of research funded by a PHS Agency (“Investigators”). This may include any principal Investigator, co-Investigator, research technologist, staff member, fellow or administrator. This policy also applies to any MOM Employee working on a PHS-funded contract proposal. Each person covered under this policy must disclose to MOM Institutional Officials any “Significant Financial Interests” (SFIs) that they, their spouse, and / or dependent children may have.

1.3 MOM Investigators must disclose any such SFIs to the appropriate Institutional Officials at least annually and within thirty days of acquisition and / or discovery of a new SFI. The Institutional Official(s) will review these SFIs to determine whether a Financial Conflict of Interest (FCOI) exists. If an FCOI does exist, MOM will enter into a management plan with the MOM Employee or subcontractor to address the FCOI and to report any FCOI as required.

1.4 Pursuant to 42 CFR Part 50 and 45 CFR Part 94, MOM will publish this policy

on a publicly available website and will provide any PHS Agency funding MOM

research with a report regarding any existing FCOI.

2.0 Applicability

2.1 This procedure applies to all MOM Employees and subcontractors who,

regardless of title or position:

  • (1) are responsible for the design, conduct or reporting of research funded by a PHS Agency

  • (2) collaborate with or consult with individuals responsible for the design, conduct or reporting of research funded by a PHS Agency

  • (3) are identified as key personnel or an Investigator in the PHS-funded contract or contract proposal

2.2 For each person that must disclose their SFIs under this policy, they must also disclose any SFIs of their spouses and dependent children.

3.0 Definitions

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 means anything of monetary value, whether or not the value is readily ascertainable.

Institution: means any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, PHS research funding (including, but not limited to, Medical Outcomes Management, Inc.)

Institutional Responsibilities: means a covered MOM Employee or subcontractor’s professional responsibilities on behalf of the Institution, and as defined by the Institution on its policy on financial conflicts of interest, which may include for example:

  • activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

MOM Employee: includes MOM Employees (including all types and levels of staff and management, whether full or part-time), and sub recipient and contract personnel who are subject to the MOM corporate policies, processes, and procedures through the terms of their contract.

Public Health Service (PHS) Agency includes:

  • Administration for Children and Families (ACF)

  • Administration on Aging (AoA)

  • Agency for Healthcare Research and Quality (AHRQ)

  • Agency for Toxic Substances and Disease Registry (ATSDR)

  • Centers for Disease Control and Prevention (CDC)

  • Centers for Medicare & Medicaid Services (CMS)

  • Federal Occupational Health (FOH)

  • Food and Drug Administration (FDA)

  • Health Resources and Services Administration (HRSA)

  • Indian Health Service (IHS)

  • National Institutes of Health (NIH)

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

  • Significant Financial Interests (SFIs) are financial interests of the covered MOM Employee or subcontractor, the MOM employee or subcontractor's spouse and dependent children that appear to be related to the MOM employee or subcontractor's Institutional responsibilities including:

    • For any publicly traded company, a SFI exists where the Investigator has received any salary or payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship) within the twelve month period preceding the disclosure or has any equity interest in the entity as of the date of disclosure (equity interest includes any stock, stock option, or other ownership interest), aggregating over $5,000;

  • For any non-publicly traded company, an SFI exists if the value of any payments received from the company exceeds $5,000, or if the Investigator (or spouse or dependent children) holds any equity interest in the company;

  • If the Investigator receives income related to intellectual property rights and interests (e.g., patents or copyrights), an SFI exists;

  • For any reimbursed or sponsored travel (paid on behalf of the Investigator and not reimbursed to the Investigator), an SFI exists where the travel is related to their responsibilities but paid by an entity other than:

    • A federal, state or local government agency;

    • An institution of higher learning (as defined in 20 U.S.C. 1001(a));

    • An academic teaching hospital; a medical center; or a research institute affiliated with an institution of higher education.

SFI does not include:

  • Payments by the institution, including intellectual property rights agreements or royalties;

  • Income from investment vehicles such as mutual funds or retirement accounts (as long as the Investigator does not directly control the investment decisions made);

  • Any income from seminars, lectures, or teaching engagements sponsored by:

    • A federal, state or local government agency;

    • An institution of higher learning (as defined in 20 U.S.C. 1001(a));

    • An academic teaching hospital; a medical center; or a research institute 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 learning (as defined in 20 U.S.C. 1001(a));

    • An academic teaching hospital (e.g., UNMH);

    • A medical center; or a research institute affiliated with an institution of higher education.

4.0 Implementation

4.1 MOM's designated institutional officials will consider the Investigators proposed PHS work, institutional responsibilities, and declared SFIs to determine if a "Financial Conflict of Interest" (FCOI) exists.

4.2 A FCOI exists when a MOM employee or subcontractor responsible for the design, conduct or reporting of research funded by a PHS Agency, or collaborating with or consulting for such an individual has a SFI that could impair her or his ability to act impartially in the design, conduct or reporting of the PHS-funded contract. FCOIs may arise from:

  • Compensation, including wages, salaries, commissions, professional fees, or fees for business referrals.

  • Investment in the form of stock or bond ownership or partnership interest, excluding:

    • diversified mutual fund investments.

  • Consulting relationships, including commercial and professional consulting and service arrangements, scientific and technical advisory board memberships, or serving as an expert witness in litigation.

  • Patents, copyrights, and other intellectual property interests.

  • Services provided in exchange for honorariums or travel expense reimbursements.

  • Research funding or other forms of research support.

  • Real estate investments.

  • Business ownership and investment interests.

Required Training

4.3 Prior to engaging in a task related to any PHS-funded grant and at least every four years, MOM Employees and subcontractors will be required to complete training regarding this policy and the procedures required to comply with this policy. The Institutional Official (s) responsible for implementation of this policy will provide this training.

4.4 At least annually, covered MOM Employees and subcontractors will be required to certify that their current financial disclosures are up to date or, if needed, update their disclosures, by completing the corporate Medical Outcomes Management, Inc. Conflict of Interest training.

Required Disclosures

4.5 Each covered MOM Employee or subcontractor will be required to disclose to the Institutional Official(s) the MOM Employee or subcontractor's SFIs (and those of the MOM Employee or subcontractor's spouse and dependent children) no later than the date of submission of MOM's proposal for PHS-funded research.

4.6 Each covered MOM Employee or subcontractor must immediately update the disclosure if the personal or financial information disclosed changes such that a new SFI arises while the MOM Employee or subcontractor is continuing to be responsible for the design, conduct, or reporting, consulting or collaborating, or are still named as a key personnel under a PHS-funded contract in such a way that a new Financial Conflict of Interest may have arisen.

Required Sub recipient Compliance and Reporting

4.7 All proposed sub recipients under a PHS-funded project must have a FCOI

policy that conforms to the requirements of the FCOI regulations. MOM requires that these sub grantees, subcontractors, and collaborators certify in writing to MOM at the time of the award that its FCOI policy complies with FCOI regulations. If a sub recipient entity does not have its own FCOI policy, it is subject to the terms and conditions of MOM's FCOI policy. MOM will report to the PHS funding agency any FCOIs which are identified by any sub grantee, subcontractor, or collaborator to

MOM on a PHS funded project prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

4.8 Prior to expending any funds through a PHS funded grant, the Institutional

Official will report to the applicable PHS funding agency the existence of any FCOI

and assure that MOM has implemented a management plan. If MOM identifies a

FCOI and eliminates it prior to the expenditure of PHS-awarded funds, MOM is not required to submit a FCOI report to the respective agency. Prior to expending any funds through a PHS funded grant, MOM will ensure public accessibility of information about the FCOI via a written response to any requestor within five (5) business days of the request. For any FCOI reported to the respective PHS agency, annual update reports will be submitted to the funding agency for the duration of the project.

 For any Significant Financial Interest MOM identifies subsequent to the initiation of the project, MOM will report that information to the applicable PHS funding agency and a management plan will be implemented within sixty (60) days of that identification.

Required Management Plan

4.9 Before performing under a PHS-funded contract, if MOM determines that the covered MOM Employee or subcontractor's SFI constitutes a PCOI, MOM will require the covered MOM Employee or subcontractor to enter into and comply with a FCOI Management Plan. This plan will be based on the particular FCOI of the MOM

Employee or subcontractor, and the MOM Employee or subcontractor must adhere to the plan until completion of the PHS-funded contract.

Violations

4.10 Management will initiate prompt action if an actual or potential FCOI occurs that was not disclosed by the MOM Employee or subcontractor, including notifying Legal Counsel (and Human Resources in the case of a violation). After consultation with Legal Counsel, Legal will report to the PHS awarding agency any violation of

the disclosure of Financial Conflicts of Interest as required


Violations

4.10 Management will initiate prompt action if an actual or potential FCOI occurs that was not disclosed by the MOM Employee or subcontractor, including notifying Legal Counsel (and Human Resources in the case of a violation). After consultation with Legal Counsel, Legal will report to the PHS awarding agency any violation of the disclosure of Financial Conflicts of Interest as required by this policy.

5.0 Responsibilities of Institutional Official(s)

5.1 Ensure that personnel who have FCOIs timely disclose and comply with

applicable FCOI management plans.

5.2 Comply with MOM's "Institutional Official Guidelines for PHS Funding" for

determining whether a covered MOM Employee or subcontractor's significant

financial interest is related to their Institutional responsibilities and, if so related, whether the SFI is a FCOI.

5.3 Maintain all records relating to all covered MOM Employees and subcontractors' disclosures of financial interests and MOM's review of, and response to, such disclosures (whether or not a disclosure resulted in MOM's determination of a FCOI), and all MOM actions under this policy for a period of three years from the date of submission of the final expenditures report to the PHS funding agency.

For further questions or to request information, contact Alan F. Kaul, Institutional Official, at:

Alan F. Kaul, Institutional Official

Medical Outcomes Management, Inc.

15 S. Main Street, #208

Sharon, MA 02067

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©2020 by Medical Outcomes Management.