Financial Conflict of Interest (FCOI) Policy
July 21, 2021
Purpose of this policy:
Neural Dynamics Technologies, LLC (“NDT”) is dedicated to maintaining public trust in the integrity of our research-related activities. The identification and management of financial conflicts of interest (FCOI) will safeguard research objectivity and ensures compliance with federal regulations and NDT policies. This Financial Conflict of Interest Policy describes certain legal obligations applicable to Investigators’ disclosure of putative financial conflicts of interest (“FCOI”). The purpose of this policy is to comply with applicable law and to ensure the objectivity of the research conducted by NDT, its employees, contractors, and consultants.
Investigators applying for and receiving research funding from the Public Health Services (“PHS”), National Institutes of Health (“NIH”), or National Science Foundation (“NSF”), must disclose significant financial interests that are related to the Investigator’s institutional responsibilities. Investigators are all persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research funded by the PHS, NIH, or NSF (the foregoing agencies, together with any other organizations providing funding through grant or contract to which the regulations contemplated herein apply, are collectively referred to as the “Funding Agencies”), including collaborators or consultants. This policy provides the framework to identify, evaluate and correct or remove actual, apparent and potential conflicts of interest. NDT will use one FCOI standard for all Federal agency grant and contract efforts.
The PHS has implemented regulations (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) (“FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. This policy (the “FCOI Policy”) is implemented to fulfill NDT’s obligation under the FCOI Regulations to maintain an up-to-date, written, enforced policy and process on Investigator conflicts of interest. This policy requires that each investigator, subrecipient, subgrantee and collaborator affiliated with NDT on a Funding Agency project be in compliance with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts).
This policy also applies to sub-recipients of funding to NDT from any Funding Agency. NDT shall establish, via a written agreement, whether subrecipients will follow NDT’s FCOI policy or the FCOI policy of the sub-recipient. If applicable, NDT shall obtain a certification from a sub-recipient that its FCOI policy complies with the applicable regulation. If applicable, NDT shall include in the written sub-recipient agreement a requirement for the sub-recipient to report identified FCOIs for its Investigators in a time frame that allows NDT to report identified FCOIs to the applicable Funding Agencies as required by the regulation. Alternatively, if applicable, NDT shall include in the written agreement a requirement to solicit and review sub-recipient Investigator disclosures that enable NDT to identify, manage and report identified FCOIs to the Funding Agency.
The Signing Official is the person responsible for the procedures under this FCOI Policy but may designate one or more other individuals to assist in any or all of these responsibilities and/or may delegate any or all of these responsibilities to one or more individuals.
The following definitions apply to this policy:
“Awarding Component” is the applicable sub-agency of a Funding Agency.
“Financial Conflict of Interest” or “FCOI” exists when NDT reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of Funded Research.
“Funded Research” means any research funded by a Funding Agency.
“Investigator” means any person (including sub-recipients, sub-grantees and collaborators) who is responsible for the design, conduct or reporting of research funded by a Funding Agency.
“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 Funded Research will be free from bias.
“Training Requirement” means training related to FCOI and is required under law. All NDT Investigators and all defined sub-level vendors or sub-recipients are required to complete the Training Requirement. If any FCOI are found or known, they must be disclosed. Investigators are required to complete the FCOI training module prior to engaged in PHS-supported research at least every four years, and immediately under the designated circumstances: (1) NDT FCOI policies change in a manner that affects Investigator requirements, (2) an Investigator is new to NDT, or (3) NDT finds an Investigator noncompliant with NDT’s FCOI policy. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site: (https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html).
“Significant financial interest (SFI)” means a financial interest consisting of one or more of the following interests of the Investigator (including those of the Investigator’s spouse and dependent children) that reasonable appears to be related to the Investigator’s institutional responsibilities:
- With regard to any publicly-traded entity, a SFI 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 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value.
- With regard to any privately held entity, a SFI exists if the value of any remunerations 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 interests (e.g. stock, stock options, or other ownership interest).
- Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose (and such disclosure shall constitute an SFI Disclosure, defined below) 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, medical center, or research institute that is affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the Funding Agency research.
The term SFI does not include the following types of financial interests: salaries, royalties or other remuneration paid by NDT to the Investigator if the Investigator is currently employed or otherwise appointed by NDT, including intellectual property rights assigned to NDT and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator; income from investment vehicles, such as mutual funds and retirements 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, 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.
“SFI Disclosure” is a report that each Investigator shall submit: (a) annually to the Policy Coordinator; (b) in the event of certain sponsored travel, as set forth in the definition of “SFI” above; (c) within thirty (30) days of an Investigator discovering or acquiring any significant financial interest; and (d) no later than at the time of application for PHS-funded research.
Each Investigator shall submit SFI Disclosures (using the NDT SFI Disclosure Form) to the Policy Coordinator as follows:
- Annually on or before the anniversary date of their initial disclosure.
- Promptly in the event of certain sponsored travel, as set forth in the definition of “SFI,” above.
- Within thirty (30) days of an Investigator discovering or acquiring any SFI.
The Policy Coordinator will review each SFI Disclosure and evaluate whether any such SFI Disclosure has given rise to a FCOI. If no FCOI is found, the SFI Disclosure will be filed with the Policy Coordinator’s SFI Disclosure records. If a FCOI is identified it will be put on the FCOI report through the eRA Commons FCOI module (or, where NDT is a sub-grantee or sub-awardee, then NDT will report the FCOI as required under the applicable subgrant or subaward agreement) prior to expending any Funding Agency funds. NDT will then report any new FCOIs to the Awarding Component within 60 days. If an Investigator with an FCOI conducts Funded Research, NDT shall disclose the FCOI in each public presentation related to the results of the Funded Research.
NDT shall maintain all disclosure forms and related records of determinations made and actions taken for a period of three years from the date of submission of the final expenditures report to the PHS (or, where applicable, from other dates specified in 45 CFR 74.53(b)).
Funded Research Exclusions:
Funded Research is any project governed by Funding Agency regulations, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Compliance and Penalties for Non-Performance:
If an Investigator fails to comply with the NDT FCOI policy, within 120 days, NDT shall complete a retrospective review of the Investigator’s activities to determine bias. If as a result of that determination, or at any other time, any bias is found, NDT shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. NDT will work with the Investigator to set up an FCOI Management plan to mitigate the situation. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future funding from any of the Funding Agencies.
Public Accessibility Requirements:
This FCOI Policy will be posted on NDT’s publicly accessible website, as required by the FCOI Regulations. Prior to expending any funds under a PHS-funded grant or cooperative agreement, NDT shall ensure public accessibility to information concerning an FCOI held by a senior/key personnel member by providing a written response to any written request, such response to be postmarked or dated (if replying by electronic means) within five (5) business days of the receipt of the written request. Such information shall consist of that required to be provided under the FCOI Regulations [§50.605(a)(5)(ii), (iii)], shall be updated at least annually and within 60 days of the receipt or identification of information concerning an additional SFI, and shall remain available for three years from the date the information was most recently updated.
Authorized Organizational Representative:
Ingrid van Welie