Copy of FCOI Policy | Miro research

Miro Health Financial Conflict of Interest (FCOI) Policy

Last updated: August 2, 2022

Background and rationale

Miro Health is committed to conducting rigorous, peer-reviewed research. The Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (DHHS) have published rules and regulations regarding the management of financial conflicts of interest for government-sponsored research. The regulations were developed to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements to mitigate potential financial conflicts of interest.

Miro Health’s Financial Conflict of Interest Policy was created to ensure objectivity in research and development, including the research and development funded by governmental agencies. The Financial Conflict of Interest Policy applies to employees, collaborators, sub-recipients, consultants, or any other covered organizations or persons involved in research funding that has been awarded to Miro Health by industry or governmental institutions.

This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F). Miro Health will continue to update this policy as needed, particularly related to any changes in personnel, FCOI issues, or upon further DHHS guidance.

Implementation

Investigators and key personnel are required to submit a Significant Financial Interests (SFI) Disclosure Form annually and at the beginning of each new governmentally-funded research program. SFI (see Definitions) shall be disclosed on the SFI Disclosure Form by an Investigator requesting government-sponsored, industry-sponsored, or company-sponsored research programs. It is the Investigator's responsibility to ensure that Key Personnel and/or research program staff who hold financial interests in the research are identified and provide the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.

The SFI Disclosure Form and supporting materials are forwarded to the Chief Financial Officer (CFO) for review. The Finance Department will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy.

Training

Investigators shall complete FCOI training prior to engaging in research related to externally-funded research and then every two years thereafter. Immediate training will be required if the Institution revises this policy in a manner that affects the Investigator, when an Investigator is new to the Institution, or as a result of a policy noncompliance finding or other related misconduct. Miro Health uses the NIH web-based training which can be accessed at: (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm).

Investigators must save and print the FCOI Certificate as proof of completion. All Investigators and Key Personnel at Miro Health must sign a written statement confirming that they have reviewed and agree to abide by all FCOI requirements.

Disclosure and reporting processes

The Financial Disclosure by Clinical Investigators regulation (21 CFR part 54) requires applicants to government-funded research programs to either (1) certify the absence of certain financial interests of clinical investigators and staff that could affect the reliability of data submitted to FDA or (2) disclose those financial interests and describe steps taken to minimize the potential for undue influence (21 CFR § 54.4(a)).

Miro Health will collect Financial Disclosure information from all study Investigators, Key Personnel, affected research staff and Signing Officials. Miro Health’s CFO will review all disclosures and evaluate whether they constitute a FCOI. If no FCOI is found, the disclosure forms will be stored electronically in a secure location. Annual updates are required of all Investigators and key personnel participating in research.

Any Investigator who has acquired a new or increased financial interest during a research project shall report it immediately to the CFO. Annual updates and newly acquired interests are reported using the SFI Disclosure Form.

If an FCOI pertaining to a government-funded research program is identified prior to the commencement of funded research, it will be included in the FCOI report through the eRA Commons FCOI module.

If an FCOI is identified subsequent to the commencement of funded-research, it must be reported to Miro Health’s CFO within 7 days from the date of discovery. Miro Health’s CFO will then report it to the NIH within 30 days from the date of discovery. Each Investigator, Key Personnel, and affected research staff must submit an updated disclosure of SFI not less than annually.

If a government-funded project is conducted by an Investigator or involves Key Personnel, research staff or a Signing Official with a FCOI that was not disclosed, Miro Health must disclose the conflict in each public presentation related to the results of the research.

Records management

The records of financial disclosures and actions taken by Miro Health will be maintained for at least three years from the submission date of the final expenditures report.

Compliance and penalties for non-compliance

If an Investigator fails to comply with Miro Health’s FCOI policy, Miro Health shall complete a retrospective review of the Investigator’s activities to determine bias within 120 days. If bias is found, Miro Health shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that addresses the impact of the bias on the research project and the actions it has taken to mitigate the bias. Miro Health will work with the Investigator to set up an FCOI management plan to mitigate the situation. Miro Health is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.

Subrecipient requirements

Miro Health must obtain certification from subrecipient(s) that their FCOI policy complies with the regulation. This includes a written subrecipient agreement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the awardee Institution to report identified FCOIs to the NIH as required by the regulation. Alternatively, if applicable, included in the written agreement will be a requirement to solicit and review subrecipient Investigator disclosures so as to enable the awardee Institution to identify, manage and report identified FCOIs to the NIH.

Public accessibility requirements

Miro Health agrees to post this FCOI policy as well as information concerning identified FCOIs held by Investigators, Key Personnel, affected research staff and Signing Officials on its public website at least 5 calendar days of a written request and prior to the expenditure of government- or industry-funds. Miro Health’s FCOI will be reviewed and updated annually and within 60 days of a newly identified FCOI. This information will remain available for three years from the date of the research program’s final expenditure report.

The information that Miro Health must make available via a publicly accessible website or written response for each externally-funded program are listed below:

Grant: 1R44AG079760

Investigator’s name: Shenly Glenn

Investigator’s title and role with respect to the research project: Primary Investigator

Name of the entity in which the Significant Financial Interest is held: Miro Health

Nature of the Significant Financial Interest: Significant shareholder in Miro Health

Approximate dollar value of the Significant Financial Interest 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: The current value cannot be determined as Miro Health is a privately-held company

Key Personnel: Joel Mefford

Key Personnel role with respect to the research project: Statistician

Name of the entity in which the Significant Financial Interest is held: Miro Health

Nature of the Significant Financial Interest: Shareholder in Miro Health

Definitions

The following are key definitions and Miro Health’s policy guidance for Investigators, subrecipients, subgrantees, and collaborators affiliated with the company.

Affected Research Staff: Research program staff who hold SFI in Miro Health.

Financial Conflict of Interest (FCOI): A Financial Conflict of Interest exists when Miro Health reasonably determines that a Significant Financial Interest (defined below) could directly and significantly affect the design, conduct, or reporting of externally-funded research.

Investigator: An Investigator is any person (including subrecipient, subgrantee or collaborator) who is responsible for the design, conduct, or reporting of externally-funded research.

Management of an FCOI: Means taking action to address a FCOI, which can include reducing or eliminating the FCOI to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Key Personnel: Means any person identified as key personnel by the Institution in the grant application, progress report, or any other report submitted to the funding agency by the Institution under the regulation.

Significant Financial Interest (SFI): Significant Financial Interest is defined by the regulations as:

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:

a. 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;

b. 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

c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests, when aggregated, exceeds $5,000.

2. 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. The required disclosure includes the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with Miro Health’s policy, the CFO will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes an FCOI with the PHS-funded research.

3. The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution 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.

Point of contact

If you have a conflict of interest or if you have a question to discuss, contact the Miro Health FCOI Policy Coordinator, Moira Xu, at: research@mirohealth.com

Last updated August 02, 2022