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Financial Conflict of Interest Policy

I. Background

Federal regulations require all institutions applying for or receiving research funding from the Public Health Service to maintain a financial conflict of interest policy. The goal of the regulations is to “promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.” 42 C.F.R. § 50.601.

Boston Micromachines Corporation has adopted this policy in accordance with the 2011 revisions to the PHS regulations. These regulations are 42 C.F.R. § 50 (relating to PHS grants and cooperative agreements) and 45 C.F.R. § 94 (relating to PHS contracts). You can view the regulations and the final rule implementing the regulations published in the Federal Register here.

II. Definitions

The following definitions apply to this policy:

Employee refers to any person that is employed by Boston Micromachines Corporation, whether part-time or full-time.

Investigator means any 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 those working for Subrecipients.

Subrecipient refers to any Investigator that is not considered an employee, including, for example, collaborators, consultants, subcontractors and consortium members.

Senior/Key Personnel means the Project Director, Principal Investigator 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 the regulation.

Institution means Boston Micromachines Corporation.

Employee’s Institutional Responsibilities means an Employee’s professional responsibilities on behalf of the Institution, 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.

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

Public Health Service (PHS) is an operating division of the United States Department of Health and Human Services.  The term includes any component(s) of the PHS to which the authority involved may be delegated, including the National Institutes of Health.

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

Significant Financial Interest (SFI) means a Financial Interest consisting of one or more of the following interests of the Employee, and those of the Employee’s spouse and dependent children, that reasonably appears to be related to the Employee’s Institutional Responsibilities:

  1. 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, exceed $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.
  2. 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.
  3. Intellectual property rights and interests (e.g., patents, copyrights, trademarks) upon receipt of income related to such rights and interests.
    1. Reimbursed or sponsored travel related to an Employee’s Institutional Responsibilities.
    2. Sponsored travel means travel expenses paid on behalf of an Investigator (or relevant family member) rather than reimbursed to the Employee, meaning that the exact monetary value may not be readily available.  Travel reimbursed or sponsored by the following is excluded: 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.

Financial Interests that are not considered SFIs:

  1. Salary or other remuneration from the Institution, including, for example, intellectual property payments and/or royalty payments;
  2. Any stock options or ownership interests in the Institution;
  3. Travel expenses paid or reimbursed by the Institution;
  4. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Employee does not directly control the investment decisions made in such vehicles;
  5. Income from seminars, teaching engagements, or lectures, 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;
  6. Income from service on advisory committees or review panels 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.

Financial Conflict of Interest (FCOI) exists when the Company’s designated review committee reasonably determines that an SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research. The regulations set forth herein and in 42 CFR 50.F and 45 CFR 94 are used as guidance to determine whether an SFI is considered a FCOI.

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

III. Investigator Obligations

Compliance 
All Investigators must comply with this FCOI policy to reduce, manage or eliminate potential FCOIs. In the event that an FCOI is identified or noncompliance with the policy occurs, Investigators must comply with the Management Plan set forth to remedy the FCOI or noncompliance.

Training
All Investigators must complete training about FCOI at the following time points:

  1. Within 30 days of hire, if new to the Institution;
  2. At least every four years;
  3. Immediately, if:
    1. The Institution revises its FCOI policy in a manner that affects Investigator requirements; or
    2. An Investigator is not in compliance with this policy or with a Management Plan.

The training presentation is available here. Upon completion of the training, a certificate of completion should be printed and submitted to the designated institutional official identified at the end of this document.

Disclosure
Investigators must disclose to the designated institutional official named at the end of this document all of their SFIs (and those of their spouses and dependent children) which reasonably appear to be related to their Institutional Responsibilities.

Investigators must make such disclosures at the following time points:

Prior to the submission of a proposal or application for PHS-funded research;
At least annually during the period of the applicable PHS-funded Research program;
Within 30 days of discovering or acquiring a new SFI.

All disclosure forms should be submitted to the designated institutional official identified at the end of this document. If there is any uncertainty about what classifies as an SFI or if you have questions about our Institutional FCOI policy, please contact the designated official. The designated official will review all disclosures and determine if there appears to be a potential conflict of interest. If a potential conflict exists, a committee shall be appointed as described below (see Disclosure and Review of SFI in Section IV) to review the potential conflict of interest and initiate steps to manage or eliminate the conflict(s) if appropriate.

Except to the extent required by law and federal regulations, the information disclosed will be kept confidential. You should know, however, that the Institution is required to report the existence of real or potential conflicts of interest to certain federal agencies.

IV. Institutional Obligations

​Policy Creation and Information
Federal Regulations require that the Institution develop, maintain, and enforce a written FCOI policy.

Training
The Institution is required to inform all Investigators of this policy and of FCOI regulations and appropriately train Investigators in the policy and regulations, the Institution must require Investigators to complete the training described in Section III above.

Solicit Disclosure of SFIs
The Institution must designate an institutional official, named at the end of this document, to solicit and collect SFI disclosure forms from Investigators. It is the responsibility of the designated institutional official to ensure he/she receives the disclosure forms from each Investigator upon the respective due dates as designated in Section III above.

Review and Evaluation of Financial Interests Disclosed
A disclosure of a Significant Financial Interest does not, by itself, create an impermissible conflict of interest. Each SFI disclosure will be reviewed by the designated institutional official.

If the designated institutional official suspects a potential conflict of interest, he or she will bring it to the attention of the CEO. At that time, a review committee will be selected by the designated official and CEO to consist of at least 2 unbiased personnel to review the SFI.

A member of the review committee will contact the Investigator for any additional information and documentation necessary to complete the review. The review committee will meet to discuss and determine whether or not the SFI constitutes a conflict of interest.

The review must be completed before any expenses are incurred under an award and before any Research can begin.

Management of FCOI
If it is determined that an FCOI exists, a Management Plan must be developed by the review committee to report, manage and eliminate the conflict of interest. This Management Plan must be shared with the Investigator along with a list of tasks and/or sanctions to resolve the conflict of interest. The review committee must meet regularly to ensure the Management Plan has been appropriately executed until it determines that the conflict has been sufficiently resolved.

The Management Plan may require that one or more of the following actions be taken in order to manage, reduce, or eliminate a 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;
Modification of the research plan, including, for example, change of personnel or personnel responsibilities with respect to particular tasks;
Disqualification from participation in all or a portion of the PHS-funded Research;
Divestment, restructuring, or placement into a blind trust of Significant Financial Interests;
Modification or severance of relationships that create a Conflict of Interest;
Changing terms of the agreement relating to the PHS-funded Research;
Prohibition or restriction of Investigator participation in the recruitment or consent of human subjects in PHS-funded Research;
Requiring additional disclosures or actions with respect to matters before the review committee; and/or
Requiring non-participation in any business transactions between the Institution and parties to agreements involving PHS-funded Research.

The Institution will comply with federal agency requests to make information available about any conflicts of interest and how they have been managed, reduced, or eliminated.

Reporting to Federal Agencies
In applications for research funding from federal agencies, the Institution may be required to certify the existence of this policy and to identify any existing conflicts of interest and assure that they have been managed, reduced or eliminated. The Institution also must report any conflicting interests to the appropriate federal agency at the following time points:

Prior to expenditure of any PHS grant funds;
Within sixty (60) days of any new conflicts of interest that become apparent after the initial report to the relevant federal agency;
Within sixty (60) days of the identification of a new Investigator participating in the research project;
At least annually based on the requirements for the annual progress report, multi-year report, if applicable, or at time of extension to provide the status of the FCOI and updates to the management plan, if applicable, until the end of the project;
Following a retrospective review to make appropriate changes to the previously submitted report. If applicable, a mitigation report must be filed when bias is found as a result of a retrospective review.

The Institution is required to submit FCOI reports to the NIH through the eRA Commons FCOI Module.  The Institution will comply with NIH requests for information about Investigators’ disclosure of SFI and the Institution’s review of and response to the disclosure, whether or not it resulted in a FCOI.

Enforcement Mechanisms, Remedies and Noncompliance
Federal regulations require the Institution to impose sanctions where appropriate. the Institution maintains the right to impose sanctions on Investigators for failure to disclose SFIs and for failure to abide by this policy. Sanctions may include suspension of expenditures on applicable Research accounts, restrictions on future submission of Research proposals, and other disciplinary actions up to and including dismissal.

Retrospective Review
If it has been determined that an Investigator or the Institution is in noncompliance with this policy (for example, if SFI were not disclosed, reviewed or managed in a timely or appropriate manner), then the Institution must complete and document a retrospective review within 120 days. The retrospective review should be conducted by the SFI review committee as designated by the CEO and designated institutional official. The results of the retrospective review shall be documented and attached to the disclosure documents. If bias is found, the Institution must immediately notify the PHS by submitting a mitigation report.

Subrecipient Requirements
A Subrecipient and its employees may comply with its own institutional FCOI policy provided that the Subrecipient institution has a suitable policy in place and that it supplies the Institution with the necessary disclosure information to meet all reporting obligations and deadlines. Prior to the Subrecipient’s participation in the research project, it must submit details to the Institution demonstrating that its institutional FCOI policy complies with regulations. If the Subrecipient institution does not have a suitable FCOI policy in place, then it shall adhere to this policy set forth for Employees of the Institution. The subaward agreement shall specify whether the Subrecipient’s FCOI policy or the Institution’s policy applies to the Subrecipient. The Subrecipient must agree in writing to comply with the FCOI policy and to provide the required information to the Institution at specified times such that the Institution may provide timely FCOI reports to the funding agency as required.

Maintenance of Records
The Institution is required to keep certain FCOI-related documents including the review and response to each SFI disclosure on file for at least three (3) years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53 (b) and 92.42 (b) for different situations.

Public Accessibility
As required by federal regulations, this FCOI policy is publicly available through our website, at https://www.bostonmicromachines.com/legal/FCOI_policy.htm.

Prior to the expenditure of funds, information regarding FCOIs held by Senior/Key Personnel must be accessible via the website or by written response within five business days of a request. To make a request, see Resources, below. The publicly available FCOI information must be updated annually and within sixty (60) days of a new FCOI being identified. The FCOI information shall remain publicly available for three (3) years from the date the information was last updated. The required FCOI information that shall be publicly available is provided below:

Investigator’s name;
Investigator’s title and role with respect to the research project;
Name of the entity in which the SFI is held;
Nature of the SFI; and
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 whose value cannot be readily determined through references to public prices or other reasonable measures of fair market value.

The Institution is required to submit to the PHS, or permit on site review of, all records pertinent to compliance with the regulation.

V. Resources

​http://grants.nih.gov/grants/policy/coi/index.htm
FCOICompliance@mail.nih.gov

Designated Institutional Official: (as of 1/1/21)
Paul Bierden
moreinfo@bostonmicromachines.com
617-868-4178

For a summary of the FCOIs held by Senior/Key Personnel of Boston Micromachines Corporation, please submit a request to moreinfo@bostonmicromachines.com.