Neurotrack Financial Conflict of Interest (FCOI) Policy
Overview
Neurotrack is committed to conducting high quality, rigorous, and objective research. The Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) 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 ensuring the design, conduct, and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
Neurotrack’s Government Awards Compliance Program was created to cover all projects conducted with government funds and is applicable to all employees, subrecipients, consultants, or any other covered organizations or persons involved in governmental awards. 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). Neurotrack will continue to update this policy as needed, particularly related to any changes in personnel, FCOI issues, or upon further DHHS guidance.
Summary of Process
Significant Financial Interests (SFI) (as defined below) shall be disclosed on the Significant Financial Interest Disclosure Form by an Investigator requesting government-sponsored or company-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during a research study. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFI Disclosure Form annually.
It is the Principal Investigator's responsibility to ensure those with financial interests in the research are identified and make the required disclosures in conjunction with submission of a research proposal or application for human subjects’ approval.
The Significant Financial 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.
Advance approval by the CFO is required prior to engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.
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 Significant Financial Interest Disclosure Form.
Training
FCOI training will be required for all Investigators 1) prior to engaging in research related to any PHS-funded grant, 2) at least every four years or 3) immediately, if Neurotrack revises its FCOI policy that affects the Investigator requirements, investigator is new to the Institution, or if an Investigator is not in compliance with the plan. To complete the training, each Investigator will review this document along with the following tutorial provided by the NIH: http://grants.nih.gov/grants/p...
All Investigators at Neurotrack must sign a written statement confirming that they have reviewed and agree to abide by all FCOI requirements.
Disclosures/Reporting Process
Neurotrack’s designated official(s) 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 folder. If a FCOI is identified, it will be included in a FCOI report through the eRA Commons FCOI module prior to expending any funds. If any FCOIs are identified subsequent to the initial report, they will be reported to Neurotrack within 30 days. Neurotrack will then report it to the NIH within 60 days. Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, Neurotrack is required to disclose the conflict in each public presentation related to the results of the research.
Records Management
The records of all financial disclosures and all actions taken by Neurotrack will be maintained for at least three years from the date of submission of the final expenditures report.
Compliance and Penalties for Non-Performance
If an investigator fails to comply with Neurotrack’s FCOI policy, Neurotrack shall complete a retrospective review of the Investigator’s activities to determine bias within 120 days. If a bias is found, Neurotrack 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. Neurotrack will work with the Investigator to set up a FCOI management plan to mitigate the situation. Companywide, Neurotrack 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
Neurotrack has obtained a certification from subrecipient(s) that its 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
Neurotrack agrees to post this FCOI policy on its public website. Neurotrack will also make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation), publicly accessible prior to the expenditure of funds. The information will: 1) Include the minimum elements as provided in the regulation, 2) Be posted on a Public Website or made available within 5 calendar days of a written request, 3) Be updated, at least annually, 4)Be updated, within 60 days of a newly identified FCOI, 5) Remain available for three years from the date the information was most recently updated.The information that the Institution makes available via a publicly accessible website or written response shall include, at a minimum, the following:
1) Investigator’s name;
2) Investigator’s title and role with respect to the research project;
3) Name of the entity in which the Significant Financial Interest is held;
4) Nature of the Significant Financial Interest; and
5) Approximate dollar value of the Significant 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.
Definitions
The following are key definitions and Neurotrack’s policy guidance for investigators, subrecipients, subgrantees, and collaborators affiliated with the company. This policy is also available on Neurotrack’s website so that all interested parties, including the general public, have access to it.
Investigator
An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct, or reporting of research funded by PHS.
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:
(i) 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;
(ii) 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
(iii) 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 Neurotrack’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.
Financial Conflict of Interest (FCOI)
A Financial Conflict of Interest exists when Neurotrack reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
Management of a 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.
Research
PHS research is any project governed by PHS regulation, excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Point of Contact
If you have a conflict of interest or if you have a question to discuss, contact the Neurotrack FCOI Policy Coordinator, Katie Wallace (katie@neurotrack.com)
Revised June 16, 2021