Financial Conflict of Interest Policy

Meso Scale Diagnostics, LLC. (MSD) takes seriously each potential Conflict of Interest that could affect the integrity of any Public Health Service (PHS)-funded Research performed by its employees and Subrecipients. As a result and in compliance with federal law and regulations, an MSD Investigator shall not participate in any PHS-funded Research if he or she has a Financial Interest that could influence the design, conduct or reporting of such Research activity. MSD will take immediate action under this policy to manage, reduce or eliminate any such Conflict of Interest. As set forth herein, all PHS-funded Research undertaken at MSD shall be conducted in full compliance with this policy and with all applicable federal and state laws pertaining to financial conflicts of interest, including, without limitation, Title 42 Code of Federal Regulations (CFR) Part 50 Subpart F for grants and cooperative agreements and Title 45 CFR Part 94 for Research contracts (collectively, FCOI Regulations). Investigators failing to comply with all FCOI Regulations shall be subject to sanctions, up to and including termination of employment. All capitalized terms shall have the meanings as set forth herein.

  

DEFINITIONS

Conflict of Interest: means an interest that MSD's Research Management Team reasonably determines is a Significant Financial Interest related to PHS-funded Research and could directly and significantly affect the design, reporting, or conduct of such Research.

Financial Interest: means any interest of economic value in or relationship with an entity, including, but not limited to, ownership of stocks, bonds, stock options, partnership or other equity interests, rights to patent or royalty payments, receipt of consulting fees, speaking fees, salary, loans, gifts, lectureship fees, compensation for serving on boards of directors, scientific and other advisory boards, reimbursed or sponsored travel expenses related to Investigator's Institutional Responsibilities, or other remuneration.

Immediate Family and Dependents: means a (i) spouse; (ii) child; and (iii) any other person residing in the same household as the Investigator who is a dependent of the Investigator or of whom the Investigator is a dependent.

Institutional Responsibilities: means an Investigator's professional responsibilities on behalf of MSD, including, but not limited to, activities such as research, research consultation, teaching, professional practice, committee memberships, and service on panels such as institutional review boards or data and safety monitoring boards.

Investigator: means any person who is responsible for the design, conduct or reporting of Research under PHS contracts, grants or cooperative agreements, including Investigators working for Subrecipients.

Management Plan: means a written plan for the management, reduction or elimination of a Conflict of Interest relating to PHS-funded Research.

PHS Awarding Component: means the organizational unit of the PHS that funds the Research that is subject to the FCOI Regulations.

Research: means any systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health. The term encompasses basic and applied research and product development. This term includes any such activity for which research funding is available from a PHS Awarding Component through a contract, grant, or cooperative agreement, excluding Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase I Programs.

Research Management Team: means (1) Deborah Wohlstadter, (2) Jonathan Klein-Evans, (3) Hans Biebuyck, and (4) Bill Fefe.

Public Health Service: means an operating division of the U.S. Department of Health and Human Services, which includes, without limitation, the National Institutes of Health and the Centers for Disease Control.

Senior or Key Personnel: means the Project Director, Principal Investigator, Co-Principal Investigator, and any other persons identified as senior or key personnel in MSD's grant or contract application or proposal, progress report, or other report submitted to the PHS funding agency.

Significant Financial Interest: means a Financial Interest consisting of one or more of the following interests of the Investigator (and those of its Immediate Family and Dependents) that reasonably appears to be related to Investigator's Institutional Responsibilities:

  • Remuneration received from a publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of the disclosure that, when aggregated, exceeds $5,000. For the 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 a fair market value
  • Remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000 or any equity interest in such entity
  • Intellectual property rights and interests (e.g., patents, copyrights, trademarks) upon receipt of income related to such rights and interests
  • Non-MSD reimbursed or sponsored travel expenses

A Significant Financial Interest does not include any of the following:

  • Salary or other remuneration from MSD
  • Any ownership interests in MSD
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as Investigator does not directly control the investment decisions made in such 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
  • Reimbursed or sponsored travel expenses 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

Subrecipient: means an individual or entity receiving federal funds flowed down from or through MSD to conduct a substantive portion of the PHS-funded Research and is accountable to MSD for programmatic outcomes and compliance matters.

 

TRAINING

Each Investigator who is an MSD employee will be trained prior to engaging in any PHS-funded Research and then periodically, but no less than once every four years. Each such Investigator must complete training on MSD's Financial Conflict of Interest Policy to ensure the Investigator understands and is compliant with this policy. Additional training may be necessary in the following circumstances:

  • MSD's financial conflict of interest policies change in a manner that affects Investigator requirements.
  • An Investigator is found to be noncompliant with MSD's Financial Conflict of Interest Policy or Management Plan.

 

DISCLOSURE

It is each Investigator's responsibility to disclose all of his or her (including Immediate Family and Dependents) Financial Interests as set forth herein.

Reporting Prior Research Submission and Pursuant to a Management Plan

Prior to the submission of an application or proposal for PHS-funded Research and as required pursuant to a Management Plan, each Investigator shall submit the "MSD Investigator Report of Financial Interests in Research" form (MSD Disclosure Form) to MSD's Chief Legal Officer in accordance with the reporting instructions set forth below.

Reporting an After-Acquired Financial Interest

Each Investigator shall submit an MSD Disclosure Form identifying any new or increased Significant Financial Interest within thirty (30) days of acquiring such Financial Interest. These reports shall be submitted to MSD's Chief Legal Officer in accordance with the reporting instructions set forth below.

Reporting Annually

All Investigators shall submit an MSD Disclosure Form annually during the period of the applicable PHS-funded Research program. Annual reporting shall include submission of any new Significant Financial Interest. These reports shall be submitted to MSD's Chief Legal Officer in accordance with the reporting instructions set forth below.

Reporting Instructions

The MSD Disclosure Form should be sent to the MSD Chief Legal Officer via mail or email to the following addresses:

Deborah Wohlstadter, Chief Legal Officer
Meso Scale Diagnostics, LLC.
1601 Research Blvd.
Rockville, Maryland, 20850-3173
Email: FCOI@mesoscale.com

REVIEW

Research Management Team Review

If any Financial Interests are disclosed on an MSD Disclosure Form, MSD's Chief Legal Officer will forward each such form and any supporting materials to the appropriate members of the Research Management Team. A member of the Research Management Team will then contact the Investigator for any additional information and documentation necessary to complete the review. Reviews will be completed by the Research Management Team within forty-five (45) days of receipt of the Investigator's disclosure form and any necessary supporting documentation. The review must be completed before any expenses are incurred under an award and before any Research can begin. An Investigator shall not conduct Research activity for any PHS-funded project if he or she receives notification from MSD's Chief Legal Officer that the Research Management Team has not approved such participation.

Standards for Approval

Proposed Research activities will only be approved if the Research Management Team determines that (1) no Conflict of Interest exists or that (2) an adequate Management Plan can be implemented to manage or eliminate a Conflict of Interest.

Management Plan

The Research Management Team shall determine the terms, conditions and restrictions, if any, that are required as part of a Management Plan. The Research Management Team may convey the Management Plan either verbally or in writing to the persons deemed appropriate.

The Management Plan may require that one or more of the following actions be taken in order to manage, reduce, or eliminate a potential Conflict of Interest:

  • Disclosure of Significant Financial Interests, including to the public, human subjects, researchers and other participants and publishers;
  • Monitoring of PHS-funded Research by independent researchers and/or reviewers, disinterested individuals or committees;
  • Disqualification from participation in all or a portion of the PHS-funded Research;
  • Requiring that Significant Financial Interests be divested, restructured, or placed in blind trust;
  • Modification or severance of relationships that create a potential Conflict of Interest;
  • Changing terms of agreement relating to the PHS-funded Research;
  • Requiring that Investigator participation in the recruitment or consent of subjects in human subjects PHS-funded Research be prohibited or restricted;
  • Requiring additional disclosures or actions with respect to matters before the Research Management Team; or
  • Requiring non-participation in any business transactions between MSD and parties to agreements involving sponsored PHS-funded Research.

Retrospective Review

The Research Management Team will conduct and document a retrospective review in the case of non-compliance with this policy. This review will be conducted within one hundred and twenty days (120) days of the Research Management Team's determination of such non-compliance.

Summary Disposition Procedures

The Research Management Team may implement procedures for the disposition of matters involving compliance with this policy that it deems reasonable and appropriate. These procedures may include written approvals for annual reports, renewals, and no-cost extensions where the Research Management Team reasonably determines that the facts and circumstances pertaining to the matter being approved have not materially changed since the date of the original review and approval. All such summary approvals shall be in writing.

PUBLIC ACCESSIBILITY

The nature and monetary value of any Significant Financial Interest of Senior or Key Personnel that is determined to be a Conflict of Interest will be posted on MSD's website prior to spending any funds for any related PHS-funded Research or provided by written response to any requestor within five (5) business days of receipt of a request for such information. MSD will update such publicly accessible information on its website at least annually or within sixty (60) days of any of the following: (a) MSD's receipt of information concerning any Significant Financial Interest that is determined to be a Conflict of Interest that was not previously disclosed, or (b) disclosure of any Significant Financial Interest of new Senior or Key Personnel to a PHS-funded Research program that is determined to be a Conflict of Interest.

SANCTIONS AND REMEDIES FOR VIOLATION OF POLICY

Whenever an Investigator has violated this policy, including failure to make a required disclosure of Financial Interests or failure to comply with the requirements of any Management Plan, the Research Management Team shall be responsible for enforcing this policy, and shall take reasonable steps to respond appropriately to violations, including, but not limited to: (1) suspending expenditures on applicable Research account, (2) administratively suspending approval and (3) instituting disciplinary measures to include suspension or termination of such employee.

SUBRECIPIENT REQUIREMENTS

Each Subrecipient must provide assurances to MSD that it has policies and procedures no less stringent than this policy and that such policies and procedures are enforced prior to submission of PHS-funded Research proposals or applications and execution of a written agreement between MSD and the Subrecipient. MSD must take reasonable steps to confirm that all Investigators who are Subrecipients participating in PHS-funded Research are subject to conflict of interest rules and procedures that are no less stringent than those contained in this policy. Subrecipients must report any Significant Financial Interest to MSD prior to submission of a proposal or an application for PHS-funded Research and within thirty (30) days of acquiring a Significant Financial Interest.

REPORTING TO PHS FUNDING AGENCY

MSD shall be responsible for reporting to the applicable PHS funding agency all Significant Financial Interests in accordance with federal requirements. MSD will promptly notify the applicable PHS funding agency in accordance with federal regulations if bias is found with the design, conduct, or reporting of any Research. This report will address the impact of the bias of the Research and the actions MSD has taken, or will take, to eliminate or mitigate the bias.

RECORD RETENTION

Records of and related to Significant Financial Interest disclosures shall be retained by MSD no less than three (3) years after the termination or completion of the PHS-funded Research activity to which they relate or from the date the final expenditure report is submitted to the PHS funding agency, whichever is later.

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