Neurolign Technologies Inc. and Neurolign USA LLC
Financial Conflict of Interest (FCOI) Policy for Public Health Service (PHS)-Funded Research
Purpose of the FCOI Policy
Neurolign Technologies Inc. and Neurolign USA LLC (henceforth “Neurolign”) are committed to preserving the integrity of our research-related activities. The purpose of this Financial Conflict of Interest (FCOI) policy is to promote objectivity in research by establishing standards that ensure a reasonable expectation that the design, conduct, or reporting of Public Health Service (PHS)-funded research, grants, or cooperative agreements will be free from bias resulting from an Investigator’s financial conflicts of interest. The present FCOI policy complies with requirements under the 2011 Revised Financial Conflict of Interest regulation, 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought. These standards have been implemented to fulfil Neurolign’s obligation to maintain a current, written, and enforceable FCOI policy to outline the process governing Investigator conflicts of interest within our organization.
This FCOI policy applies to all Investigators, as defined by the regulation, that are planning to participate in or are actively participating in Neurolign activities that are PHS-funded, including acting as a Principal Investigator (PI) or Co-Principal Investigator (Co-PI) on PHS-supported grants. The policy describes the administrative process for identifying FCOIs, promoting and enforcing Investigator compliance with the regulation, managing FCOIs, creating initial and ongoing FCOI reports, and making FCOI and Significant Financial Interest (SFI) information available to the Department of Health and Human Services.
Neurolign’s Signing Official (SO) for PHS-funded activities acts as the Institutional Officer for this policy and is responsible for ensuring the implementation of and adherence to the policy. The SO may choose to designate one or more individuals to assist in any or all of these responsibilities.
FCOI Training (42 CFR 50.604(b))
For all planned or actual Neurolign projects receiving PHS support, each Investigator will be informed of this FCOI policy, the federal regulation, and the Investigator’s disclosure responsibilities by the Institutional Officer. The Institutional Officer will provide each Investigator with a copy of this policy and a FCOI Disclosure Form to complete, sign, and return to Neurolign.
All Investigators involved in any manner with PHS-funded research at Neurolign will be required to complete training on this FCOI policy (1) prior to engaging in research funded by a PHS grant; (2) at least once every four (4) years; and (3) immediately, in the case that Neurolign revises its FCOI policy in such a way that Investigator requirements are affected, if an Investigator is new to a PHS-funded Neurolign project, and/or if an Investigator is not in compliance with this FCOI policy.
FCOI Disclosure (42 CFR 50.603, 42 CFR 50.604)
The Institutional Officer is responsible for providing a Neurolign FCOI Disclosure Form to each Investigator. The Disclosure Form is required to be completed and signed by all Investigators (1) no later than at the time of application for PHS-supported research; (2) at least once per calendar year throughout the duration of the PHS-funded grant; and (3) within 30 days of discovering or acquiring a new SFI.
Each Investigator is required to disclose any SFI, including those of the Investigator’s immediate family members, that is related to the Investigator’s institutional duties that meets or exceeds the regulatory definition of SFI outlined in 42 CFR 50.604(e)(1)-(3):
- A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s immediate family members) that can reasonably be construed as related to the Investigator’s institutional duties;
- With regard to any publicly traded entity, a significant financial interest (SFI) exists if the value of any remuneration received from the entity in the year 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, renumeration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship, etc.); equity interests refers to any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measure of fair market value;
- In regard to any non-publicly traded entity, a significant financial interest exists if the value of any renumeration received from the entity in the year preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s immediate family members) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Each Investigator must also disclose any reimbursed or sponsored travel (i.e., travel paid on the behalf of the Investigator and not reimbursed to the Investigator) that is related to their institutional duties; provided, however, that this disclosure requirement does not apply to travel 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 affiliated with an Institution of higher education. The Institution’s FCOI policy will outline the details of this disclosure, which will include, at the least, the purpose of the travel, the identity of the sponsor/organizer, the destination, and the duration of the trip. In accordance with the Institution’s FCOI policy, the Institutional Official(s) will determine whether further information is needed, including a determination or disclosure of monetary value, in order to determine if the travel constitutes an FCOI with the PHS-funded research.
- The definition of significant financial interest does not include the following kinds of financial interests: salary, royalties, or other renumeration 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 royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit business; income from investment vehicles, such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions made for these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, and Institution of higher education as defined in 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 in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an Institution of higher education.
Review of FCOI Disclosures (42 CFR 50.604(d)(f)(g), 42 CFR 50.605(a)(1-4))
The Institutional Officer or their designated representative will review all SFI disclosures submitted by each Investigator to determine (1) if the Investigator’s SFI is related to PHS-sponsored research; and (2) if it is related, whether the SFI is a FCOI (i.e., a SFI that could directly and significantly affect the design, conduct, or reporting of the PHS-funded research).
In the event the Institutional Officer determines the FCOI is manageable, the Institutional Officer will develop and implement a written management plan that is intended to reduce or eliminate the conflict, as appropriate, within 60 days. The affected Investigator must formally agree to the proposed management plan and sign the written management plan before participating or continuing to participate in any PHS-funded research activities. The Institutional Officer will monitor the Investigator to ensure compliance with the management plan throughout the duration of the PHS-funded project.
In the event the Institutional Officer determines the FCOI cannot be managed, the Institutional Officer will suspend the Investigator’s involvement with the planned or actual PHS-funded project and provide the Investigator with a written explanation of their decision.
The procedures described above also apply to cases in which an Investigator discloses a new SFI or the Institution identifies a SFI that was not disclosed by the Investigator in a timely manner or previously reviewed by the Institution. The above review procedure also applies to any financial conflicts or subrecipient Investigators.
FCOI Monitoring and Reporting (42 CFR 50.604(h), 42 CFR 50.605(b), 42 CFR 50.605(a)(3)(iii))
The Institutional Officer or their designated representative will submit initial, annual, and revised FCOI reports, including all reporting elements required by the regulation, to PHS for Neurolign and its subrecipients, if applicable, as required by the regulation:
- Prior to the expenditure of the PHS funds.
- Within 60 days of adding a new Investigator to a PHS-supported project.
- Within 60 days for any new or newly identified FCOIs for existing Investigators on a PHS-funded project.
- To update the status of any FCOIs and any changes to the FCOI management plan, if applicable, at least once yearly until the PHS-funded project is completed.
- Following a retrospective review to update a previously submitted FCOI report, if necessary.
The Institutional Officer is responsible for promptly notifying the PHS if any bias is found in the design, conduct, or reporting of PHS-funded research and will submit a Mitigation Report in accordance with the reporting elements outlined in 42 CFR 50.605(a)(3)(iii). The Institution Officer will also notify PHS in a timely manner if an Investigator fails to comply with the Institution’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the funded research (42 CFR 50.606(a)).
Maintenance of FCOI Records (42 CFR 50.604(i))
The Institutional Officer is required to ensure all FCOI-related records are maintained at the Institution for at least three (3) years from the date that the final spending report is submitted to PHS and/or from other dates specified in 45 CRF 75.361, where applicable.
Enforcement Plan and Investigator Noncompliance (42 CFR 50.604(j), 42 CFR 50.605(a)(3), 42 CFR 50.606(c))
In the event an Investigator fails to comply with Neurolign’s FCOI policy, the Institutional Officer may suspend all related activities or take other disciplinary action until the matter is resolved or other appropriate steps have been taken by the Institutional Officer. The Institutional Officer must submit a written explanation to the Investigator explaining their decision to suspend activities or take other action against the Investigator. The Institutional Officer will notify the Investigator of their right to appeal this decision. The Institutional Officer is required to promptly notify the PHS funding agency concerning any action taken or to be taken.
In the event the Institutional Officer determines a FCOI was not identified or managed promptly, including but not limited to an Investigator’s failure to disclose a SFI that is determined to be a FCOI, or failure of an Investigator to comply with the management plan for a FCOI, the Institutional Officer must complete, within 120 days of this decision, a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether the research performed during the period of noncompliance was biased in the design, conduct, or reporting of that research. The Institutional Officer must update any previously submitted report to the PHS relating to the research, outlining all actions taken to manage the FCOI. If bias is discovered, the Institution must submit a Mitigation Report in according with PHS regulations. This Mitigation Report must identify elements documented in the retrospective review, a description of the impact of the bias on the PHS-funded research project, and the step that have or will be taken to eliminate or mitigate the effect of the bias.
In any case for which the Department of Health and Human Services determines that a PHS-supported research project of clinical research whose purpose is to evaluate the safety and/or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the Institution as required by the regulation, the Institution Officer will require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to any previously published presentations related to the PHS-funded project.
Violation of any part of this FCOI policy by Neurolign employees may result in disciplinary or other administrative action pursuant to Neurolign’s institutional policies.
Subrecipient Requirements (42 CFR 50.604(c))
If there are plans for a subrecipient Investigator to participate in a PHS-funded Neurolign research project, the Institutional Officer must establish a written agreement stating whether the subrecipient will follow Neurolign’s FCOI or the FCOI policy of the subrecipient. If applicable, the Institutional Officer will obtain a certification from the subrecipient that its FCOI policy complies with the regulation. If applicable, the Institutional Officer must provide a written subrecipient agreement with a requirement for the subrecipient to report any identified FCOIs for its Investigators promptly such that Neurolign can report the identified FCOIs to the PHS as required by the regulation. Alternatively, if applicable, the Institutional Officer will include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that will enable Neurolign to properly identify, manage, and report identified FCOIs to the PHS.
Public Accessibility of the FCOI (42 CFR 50.604(a))
The Institutional Officer or their designated representative will ensure that Neurolign’s FCOI policy is available on Neurolign’s website and is publicly accessible. The Institutional Officer or their designated representative will also ensure that available information concerning any identified FCOIs held by executive or key personnel (as defined by the regulation) will be made publicly available prior to the spending of PHS funds. Per 42 CFR 50.605(a)(5)(i)-(iv), this information must:
- Include the minimum elements as listed in the regulation.
- Be posted on a publicly accessible Neurolign website or made available within 5 calendar days of a written request.
- Be updated at least annually (for the website only, but any response to a written request must include the updated information).
- Be updated within 60 days of a newly identified FCOI (for the website only, but any response to a written request must include the updated information).
- Remain available for three (3) years from the date the information was most recently updated.