diff --git a/website/docs/Policies/FCOI_Policy.md b/website/docs/Policies/FCOI_Policy.md index a94e495c2..98c39cc0c 100644 --- a/website/docs/Policies/FCOI_Policy.md +++ b/website/docs/Policies/FCOI_Policy.md @@ -3,136 +3,276 @@ id: FCOI title: Financial Conflicts of Interest Policy --- -### 1. PURPOSE AND SCOPE +### 1. Introduction -The purpose of this policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest (“FCOI”) to safeguard the integrity of OpenBCI, Inc. (“OpenBCI” or “Company”) research, and to comply with federal regulations (42 CFR Part 50 Subpart F). While our collaborations may be governed by their own FCOI policies and processes, the purpose of this policy is to ensure that when there is no institutional FCOI to rely upon, Company research will still be in compliance with federal regulations. Specifically, our research agreements with subawardees and subrecipients will clearly establish whether they will follow OpenBCI’s FCOI policy or an equivalent policy of their own employing institution. -The Company must be able to certify, in each application for funding, that the Company: +The purpose of this policy is to ensure that research funded by the National Institutes of Health (NIH) is designed, conducted, and reported objectively and without bias resulting from Investigator financial conflicts of interest (FCOI). The 2011 revised regulations are [42 CFR Part 50 Subpart F](https://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm), “Promoting Objectivity in Research” and [45 CFR Part 94](https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94), “Responsible Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreement, and research contracts, respectively. The regulations do not apply to SBIR or STTR Phase I applications or awards. -1. has in effect an up-to-date, written and enforced administrative process to identify and manage FCOI; -2. promotes and enforces Investigator compliance with the regulation; -3. manages FCOI and provides initial and ongoing FCOI reports; -4. agrees to make FCOI and Significant Financial Interests (SFI) information (including related Institutional reviews and determinations) available to HHS, promptly, upon request; and -5. fully complies with the regulation's requirements. +This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements. -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). This regulation was 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. An electronic version of the regulation is found at [http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf](http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf). +OpenBCI, Inc. (“OpenBCI”, “The Institution”) adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator financial conflicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH- supported research. -### 2. KEY DEFINITIONS +### 2. Applicability -The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI. A complete list of official definitions can be found at 42 CFR 50.603. +This policy implements the regulatory requirements provided in [42 CFR Part 50 Subpart F](https://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm) for grants and cooperative agreements issued by the NIH. This policy applies to individuals who meet the regulatory definition of “Investigator” (as defined below) who are planning to participate in or who participate in PHS/NIH-funded research. -**Institution** – means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for or receiving NIH research funding. +### 3. DEFINITIONS -**Investigator** – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, which may include, for example, collaborators or consultants. +For the purpose of these policies and procedures, the following definitions apply: -**Institutional responsibilities** – means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, 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. +**Financial Conflict Of Interest (FCOI)**: A significant financial interest that is related to the PHS/NIH-funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research) and could directly and significantly affect the design, conduct, or reporting of PHS-funded research. -**Financial interest** – means anything of monetary value, whether or not the value is readily ascertainable. +**Financial Interest**: Anything of monetary value, whether or not its value is readily ascertainable. -**Financial conflict of interest (FCOI)** – means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research. +**Institutional Responsibilities**: This term refers to an Investigator's professional duties conducted on behalf of OpenBCI, Inc. ("OpenBCI" or the "Company"), specific to its domain as a neurotechnology, biosensing hardware, and open-source software developer. These activities include, but are not limited to: -**Manage** – means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. +- Biosensing R&D: Designing, prototyping, and executing internal or collaborative research involving brain-computer interfaces (BCIs), biosensing systems (EEG, EMG, ECG), and signal processing algorithms. +- Product Engineering: Developing or maintaining core software applications, GUI frameworks, SDKs, data pipelines, hardware firmware, and electronic architecture. +- Data & Validation Studies: Collecting, analyzing, and validating biosensing datasets, including managing human subject protocols via independent IRBs. +- Customer Support & Enablement: Providing technical support, engineering integration, product onboarding, and consulting to academic and commercial clients. +- Promotion & Public Representation: Representing the Company at scientific conferences, trade shows, public panels, and open-source developer forums. +- Fundraising & Strategic Alliances: Participating in fundraising activities, managing corporate sponsor relations, and structuring strategic technology partnerships or grant proposals. +- IP & Technical Writing: Contributing to Company patent applications, scientific publications, white papers, and grant progress reporting. +- Oversight & Regulatory Service: Serving on internal research review panels or safety committees, and representing the Company on external advisory or scientific review boards. -**Senior/Key Personnel** – means the PD/PI 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 NIH by the Institution under the regulation. +**Designated Official (DO)**: The individual appointed by OpenBCI to solicit and review disclosures of significant financial interests, determine FCOIs in accordance with 42 CFR 50.604(f) and this policy, and develop management plans for identified FCOI. -**Significant Financial Interest (SFI)** – Includes any one or more of the following from any single entity OUTSIDE THE COMPANY for activity that is related to the investigators professional qualifications: 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: +**Institution**: Any public or private organization, domestic or foreign (excluding a federal agency) that is applying for or receives PHS/NIH research funding. -- 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; -- 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 -- Upon receipt of income related to intellectual property rights and interests (e.g., patents, copyrights). +**Investigator**: The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding, which may include, for example, collaborators or consultants. The institution determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research. The Institution will consider the individual’s role, rather than the title (e.g., senior/key personnel, faculty, MD, PHD, etc.), of those individuals involved in the research and the degree of independence in carrying out the work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research. -Foreign Financial Interests: Investigators must disclose all foreign financial interests received from any foreign entity, including foreign institutions of higher education, foreign academic teaching hospitals, foreign medical centers, foreign research institutes, or foreign governments, when such interests relate to the Investigator's institutional responsibilities. +**Manage**: means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. -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 excluded sources provided in regulation. For example, if the PI travels to a scientific seminar but does not pay or receive reimbursement by the Company directly (i.e., the travel was paid for by a third party/sponsor), the PI is required to disclose basic information to the Company relating to the trip, such as purpose of the trip, identify of the payer/sponsor, destination and duration. The Company is required to determine if additional information is required (e.g., monetary value) and whether the travel constitutes a FCI with NIH-funded research. +**Research**: means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). As used in the regulation, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award. -The term significant financial interest does not include the following types of financial interests: +**PHS-Funded Research**: Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority. -- salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution; -- intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; -- any ownership interest in the Company held by the Investigator, if the Company 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 domestic federal, state or local government agency, a domestic Institution of higher education as defined at 20 U.S.C. 1001(a), a domestic academic teaching hospital, a medical center, or a research institute that is affiliated with a domestic Institution of higher education; or -- income from service on advisory committees or review panels for a domestic federal, state or local government agency, domestic Institution of higher education as defined at 20 U.S.C. 1001(a), a domestic academic teaching hospital, a medical center, or a research institute that is affiliated with a domestic Institution of higher education. +**PHS**: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH). -For simplicity, a Significant Financial Interest of Conflict would exist in the following (non-exclusive) examples: +**NIH**: The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge. -- the Investigator (or spouse/dependent) has a Significant Financial Interest in an entity that sponsors their research project; -- the Investigator (or spouse/dependent) has a Significant Financial Interest in an entity that produces products (equipment, software, compounds, drugs, devices, etc.) or services used in their research project; -- the Investigator (or spouse/dependent) has a Significant Financial Interest in an entity that develops product or services their research project intends to evaluate or develop; or -- the Investigator (or spouse/dependent) has a Significant Financial Interest in an entity with whom they are consulting in an area that overlaps with or is the main subject of his/her research. +**Senior/Key Personnel**: The PD/PI and any other individual identified as senior/key personnel by the Institution in a grant application, progress report, or other submission to PHS/NIH. For this policy, the term applies specifically to the public accessibility requirement, which mandates disclosure only of financial conflicts of interest held by these senior/key personnel, as described in Section 9. -**Significant Financial Interest Disclosure Form (SFIDF)** – Company form by which the required person provides an itemized disclosure statement with regard to SFI categories. The form is submitted to the Financial Administrator upon assignment of work sponsored by a federal, state, or local government grant, yearly thereafter, and when any occurrences of a new SFI arise. +**Significant Financial Interest (SFI)**: -- Training Requirement: FCOI training must be completed by each Investigator prior to engaging in research related to any NIH-funded grant, and at least every four years thereafter. Training must also be completed immediately under the following circumstances: (1) OpenBCI revises its FCOI policy in a manner that affects Investigator requirements; (2) An Investigator is newly appointed or new to the Company; or (3) The Company finds that an Investigator is noncompliant with this policy or an established management plan. +1. A domestic or foreign 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 performed on behalf of OpenBCI, and that consists of one or more of the following: + - Publicly traded entity: An SFI exists if the total of remuneration received from the entity in the previous 12 months and the value of any equity interest in the entity on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services (e.g., consulting fees, honoraria, paid authorship). Equity interest includes stock, stock options, or other ownership interests measured by public prices or other reasonable market value. + - Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000, or if the Investigator (or their spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest). + - Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests (e.g., patents, copyrights) exceeds $5,000 during the 12 months preceding the disclosure, related to such rights and interests. +2. Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities in excess of $5,000. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip. + The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following: + - A federal, state, or local government agency located in the United States + - A United States Institution of Higher Education + - A domestic academic teaching hospital + - A domestic medical center + - A research institute affiliated with a United States Institution of Higher Education +3. The term “significant financial interest” does not include, and therefore investigators are not required to disclose, the following types of financial interests: + - Salary, royalties, or other remuneration paid by OpenBCI to the Investigator if the Investigator is currently employed or otherwise appointed by OpenBCI, including intellectual property rights assigned to OpenBCI and any agreements to share royalties related to those rights. + - Any ownership interest in OpenBCI held by the Investigator, since OpenBCI is a commercial or for-profit organization. This exclusion applies only if the applicant or recipient (including a sub-recipient) is a for-profit or commercial institution. + - Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles. + - Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education. + - Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S. institution of higher education. -### 3. SUMMARY OF PROCESS +**Foreign Financial Interests**: Investigators must disclose all financial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel, received from any foreign entity. This includes foreign institutions of higher education and foreign governments (including local or provincial governments). Disclosure is required when the aggregated amount of such income meets the threshold for disclosure (e.g., income in excess of $5,000). -Significant Financial Interests (SFI) (as defined below) shall be disclosed on the Significant Financial Interest Disclosure Form (SFIDF) 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 the course of research. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFIDF annually. +### 4. Significant Financial Interest (SFI) Disclosure Requirements -It is the Principal Investigator's responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal or application for approval of experiments involving human subjects. +Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy. +The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the 2011 regulation. +The Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements. +Investigators are required to disclose SFIs at the following times: -The SFIDF and supporting materials are forwarded to the Financial Administrator for review. The Financial Administrator will be responsible for (in consultation with the CEO or Board of Directors) 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. +- **At the time of application**: The PI and all other individuals who meet the definition of “Investigator” must disclose their SFIs to the DO(s). Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose their SFI(s) to the DO(s) promptly and before participating in the project, using the SFI Disclosure Form. +- **Annual disclosure during the award**: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually (on or before June 1) during the award period. The annual disclosure must include: (1) any new information that was not previously disclosed to the DO under this policy, including SFIs associated with NIH-funded projects transferred from another institution; and (2) updated details for any previously disclosed SFI, such as changes in the value of an equity interest. +- **Ad-hoc disclosure during the award**: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence. -Advance approval by the Financial Administrator is required prior to engaging in government-sponsored research. An SFI review must be completed before any expenses are incurred under an award. Typically, the CEO or other Company Officer provides approval as signatory of the research agreement, simple agreement, or engagement contract, or provides written approval for the Financial Administrator (an AOR) or Company signatory to sign in their stead. +### 5. Review of SFI Disclosures -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 the course of a research project shall report it immediately to the Financial Administrator. Annual updates and newly acquired interests are reported using the SFIDF. +OpenBCI’s President serves as the Designated Official (DO) responsible for reviewing all SFI disclosures. In cases where the DO has a disclosed SFI related to the research under review, or where additional independence is warranted, the DO will recuse themselves from the review and determination. In such cases, an alternate qualified designee or external advisor will be appointed to perform the review. The use of such alternative review arrangements will be documented. -### 4. PROCEDURES +Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes a Financial Conflict of Interest (FCOI). -1. **Identification of Persons Required to Disclose a Significant Financial Interest** - It shall be the responsibility of the Principal Investigator of a Research project to identify all Investigators who have a SFI requiring disclosure under this policy and to ensure that a SFIDF is prepared and submitted. In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed. To assist PIs with this responsibility, the Financial Administrator will send out reporting reminders, SFIDF forms, and receive completed SFIDFs. This will occur yearly and prior to application submissions. PIs are responsible for reporting SFIs that occur between these reporting timelines. +The SFI disclosures will be reviewed as described below: +**Prior to the issuance of a new award or before any expenditure of any awarded funds (e.g., during Just-in-Time stage):** The DO will review the Investigator’s SFIs before NIH issues a new award. If an FCOI is identified, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds. -This process is established to require each Investigator to disclose SFIs (and those of the Investigator's spouse and dependent children) related to the Investigators institutional responsibilities that meets or exceeds the regulatory definition of SFI (42 CFR 50.03): (i) no later than at the time of application for PHS-funded research; (ii) at least annually during the period of award; and (iii) within 30 days of discovering or acquiring a new SFI (42 CFR 50.604(e)(1)-(3)). +**Annual SFI disclosure:** As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs (e.g., revised value of an equity interest). The DO will review these updates to determine whether changes to an existing management plan are needed. Any modifications will be reflected in the next Annual FCOI report submitted to NIH, if applicable. -2. **Submission and Review of SFIDF** - Every individual having a SFI requiring disclosure under this policy shall prepare a fully completed SFIDF that shall be submitted to the Financial Administrator. An initial review of the SFIDF will be conducted by the Financial Administrator to determine whether a potential for conflict of interest exists. To make this determination, the Financial Administrator will evaluate the focus, contractual involvements, and research goals of the project against the SFIDF financial interests provided by the researcher to establish if the SFI is related to the funded research and if it constitutes an FCOI. All review determinations will be formally documented. If it is determined that there is a potential financial conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFIDF. A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy. The management plan may require one or more of the following actions (but not limited to these actions) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest: +**Ad hoc basis during award period:** If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the DO will, within 60 days: - a) Public disclosure of significant financial interests; - b) Review of research protocols by independent reviewers; - c) Monitoring of research by independent reviewers; - d) Modification of research plan; - e) Disqualification from participation in all or a portion of the research funded; - f) Divestiture of significant financial interests; - g) Severance of relationships that create actual or potential conflicts. +1. review the disclosure; +2. determine whether the SFI is related to the PHS/NIH-funded research; +3. determine whether an FCOI exists; and, if so, +4. implement, on at least an interim basis, a management plan. -All management plans are required to be signed by the Investigator and the Financial Administrator (in consultation with the CEO or Board of Directors). Compliance of the management plan shall be monitored by the Financial Administrator and implemented within 60 days of identified FCOI. +An FCOI report will be submitted to NIH within 60 days of identifying the FCOI. -3. **Annual Reporting and After-Acquired Significant Financial Interests** – All Investigators shall provide annual SFIDFs or more frequently if required by a management plan or newly acquired interests. Any Investigator who acquires a new or increased SFI shall promptly submit a new SFIDF within 30 days of discovering or acquiring the new SFI. It is the Principal Investigator's responsibility to ensure that any newly added Investigator on a research project submits the required SFIDF to the Financial Administrator. The Financial Administrator must report to NIH any newly identified FCOIs within sixty (60) days of determining that a new financial conflict of interest exists. Additionally, if any FCOI is not identified or managed in a timely manner, the Financial Administrator must immediately complete a retrospective review to determine if there was any bias in the design, conduct, or reporting of NIH-funded research. If bias is found, the Company must submit a Mitigation Report in accordance with NIH regulations. All FCOI reports submitted to the NIH must include the following items: +**Independent Evaluation of Leadership SFIs** +If an Investigator requiring review is the CEO, PI, Designated Official, Financial Administrator, or a Board member with a reportable SFI related to the research, they must be strictly recused from all internal evaluations and management determinations. In such cases, authority to evaluate the disclosure, determine an FCOI, and enforce a binding management plan automatically escalates to a non-conflicted member of the Board of Directors or an independent executive designee. If no internal leadership or Board member can satisfy independence requirements due to shared corporate equity ties, OpenBCI shall retain an independent external compliance counsel or third-party reviewer to establish and execute the management plan. - a) The name of the Investigator with the FCOI - b) The name of the entity with which the Investigator has an FCOI - c) The nature of the Significant Financial Interest (SFI) - d) The value of the financial interest - e) Description of how the financial interest relates to the NIH-funded research and why the institution determined that the financial interest conflicts with such research - f) Description of the key elements of the Company's management plan, including other required information +### 6. Relatedness of SFIs to PHS/NIH-Funded Research and FCOI -4. **Violations of Conflict of Interest Policy** – Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, the Financial Administrator shall make recommendations to the CEO regarding the impositions of sanctions or disciplinary proceedings against the violating individual. The Financial Administrator and CEO will review together with the employee or Investigator the specific behaviors and consequences that are determined relevant based upon review, and any other administrative actions to assure Investigator compliance, including but not limited to supervised research activities. The Financial Administrator and either the CEO or Board of Directors must conduct retrospective reviews within 120 days of the Institution determining noncompliance for SFIs not disclosed in a timely manner or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation. The documented retrospective review shall include, at a minimum, the following key elements: - 1. Project Number - 2. Project Title - 3. PD/PI or contact PD/PI - 4. Name of the Investigator with the FCOI - 5. Name of the entity with which the Investigator has an FCOI - 6. Reasons for the retrospective review - 7. Detailed methodology used for the review (including review panel composition and documentation checked) - 8. Findings - 9. Conclusions +The DO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI. -If the retrospective review finds bias in the design, conduct, or reporting of the NIH-funded research, the Company will submit a Mitigation Report to the NIH in accordance with federal regulations. -In addition, the Company shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. +**Relatedness Test**: The DO determines whether an Investigator’s SFI is related to research under an NIH award. An SFI is considered “related” when the DO reasonably determines that: -Clinical Research Noncompliance Mandate: In any case in which the Department of Health and Human Services (HHS) determines that an NIH-funded clinical research project designed to evaluate the safety 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 Company as required, the Company shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations. +- The SFI could be affected by the PHS/NIH-funded research, or +- The SFI is an entity whose financial interests could be affected by the PHS/NIH-funded research. -5. **Record Keeping** – Records of Investigator SFIDFs, and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Financial Administrator for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 74.53(b) and 92.42(b) (currently updated to 45 CFR 75.361) for different situations. +**Investigator Involvement**: The DO may consult with the Investigator when assessing whether an SFI is related to the research. -6. **Sub-recipient Requirements** – Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies. +**Designated Official FCOI Determination**: An FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research (“significantly” meaning that the financial interest would have a material effect on the research). - a. Prior to Notification of Award, Company and sub-awards will establish in a written agreement which FCOI policy will be followed by which Investigator. If applicable, this agreement will include a certification that the sub-award policy complies with the federal regulations. The written agreement shall explicitly require the subrecipient to report any identified FCOIs to the Company within thirty (30) days of discovery or acquisition, thereby providing a clear and specific timeframe that permits the Company to review, manage, and report identified FCOIs to the NIH within the federally mandated 60-day reporting window. Alternatively, the agreement will specify that the Company will solicit and review subrecipient Investigator disclosures within timelines sufficient to enable the identification, management, and reporting of FCOIs as required by the NIH. +### 7. Management of SFIs that Pose an FCOI - b. If an SFI is identified by the subaward recipient, they are required to notify the Financial Administrator of the existence of the conflicting interest within 30 days of the identification of the interest. In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations. +When an FCOI is identified, the DO will determine and implement management strategies to ensure the research is conducted objectively. Examples of management conditions include, but are not limited to: -7. **Federal Reporting** – The Financial Administrator is responsible for the reporting disposition of matters involving disclosures of SFI in accordance with applicable federal requirements. The following reports are required by the NIH: +1. Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, to the IRB, IACUC, or Data Safety Monitoring Board). While public posting of FCOIs is required only for senior/key personnel, the DO may require disclosure of any Investigator’s FCOI as a condition of a management plan. +2. For human subjects research, disclosure of the FCOI to participants in the informed consent document +3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research +4. Modification of the research plan +5. Change of personnel roles or removal from portions of the research +6. Reduction or elimination of the financial interest (e.g., divesting equity) +7. Severance of relationships creating the conflict - a) Initial report – prior to the Company's expenditure of any funds under a NIH-funded research project, the Company must provide to the NIH an FCOI report regarding any Investigator SFI found by the Company to be a financial conflict of interest in accordance with the regulation. +The DO will communicate the determination and the management plan in writing to the Investigator and the appropriate supervisor. - b) During on-going NIH-funded research projects – the Company shall submit an FCOI report within 60 days after its determination that a new FCOI exists. If a FCOI was not disclosed timely, the Company shall submit an FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance. +No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The DO will submit an FCOI report to NIH via the eRA Commons FCOI Module. - c) Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan. +In addition to FCOI, OpenBCI recognizes that certain financial interests at the institutional level, including company equity, intellectual property interests, commercialization activities, sponsored research relationships or financial relationships of senior leadership, may present potential conflicts related to PHS/NIH-funded research. Such interests will be evaluated and managed as appropriate to ensure the objectivity of the research. -8. **Public Accessibility Requirements** – The Company will provide public access to this policy on the publicly accessible page of [https://docs.openbci.com/Policies/FCOI/](https://docs.openbci.com/Policies/FCOI/) and submit it to the NIH via eRA Commons as required. Prior to the Company’s expenditure of any funds under an NIH-funded research project, the Company will ensure public accessibility of information concerning any identified FCOI held by Senior/Key Personnel that meets the regulatory criteria. The Company will fulfill this requirement by providing a written response to any requestor within five (5) business days of a written request. The written response will include the minimum elements required by 42 CFR 50.605(a)(5)(ii), will note that the information is current as of the date of correspondence, and will remain available for compliance requests for three years from the date the information was most recently updated. +### 8. Monitoring Investigator Compliance + +OpenBCI will monitor Investigator compliance with the management plan for the duration of the NIH award. FCOIs are made in publications, presentations, and other communications. Investigators must also disclose the FCOI in writing to study personnel and provide a copy of this disclosure to the DO for recordkeeping. + +### 9. Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel + +**FCOI Policy**: A copy of this FCOI policy is available on OpenBCI’s public website at https://docs.openbci.com/Policies/FCOI/, as required by Section 4.1.10 Financial Conflict of Interest of the [NIH Grants Policy Statement](https://grants.nih.gov/policy-and-compliance/nihgps). + +**Identified FCOIs held by Senior/Key Personnel**: Before any funds are spent under an NIH award, OpenBCI will ensure public accessibility, by providing a written response within five business days to requests for information about any SFI that meets all three of the following criteria: + +- The SFI was disclosed, and is still held by Senior/Key Personnel (the PD/PI and any other individual identified by OpenBCI as senior/key personnel in the application, progress report, or other NIH submission). +- OpenBCI has determined that the SFI is related to NIH-funded research. +- OpenBCI has determined that the SFI constitutes an FCOI. + +When applicable, OpenBCI will make available at least the following information: + +- 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 +- Approximate dollar value of the SFI in the following ranges: $0–$4,999; + $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined by public prices or reasonable fair market value measures + +The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the institution’s identification of a new FCOI, which should be requested subsequently by the requestor. + +If OpenBCI uses a publicly accessible website to meet this requirement, the information will be updated at least annually and within 60 days of: + +- Receiving or identifying an additional SFI of Senior/Key Personnel related to the NIH-funded research that was not previously disclosed, or +- A new SFI being disclosed by Senior/Key Personnel joining the project and determined by the DO to be related and an FCOI. Information on SFIs subject to public accessibility will remain available for at least three years from the most recent update + +### 10. Reporting Identified Financial Conflicts of Interest + +Prior to spending any funds under an NIH-funded award, OpenBCI will submit an identified FCOI report to NIH, in accordance with the FCOI regulations, for any Investigator’s SFI determined to be an FCOI. OpenBCI will also ensure that the Investigator has agreed to and begun implementing the associated management plan. +OpenBCI will designate an institutional official with appropriate eRA commons authority to act as the FCOI Signing Official (FCOI SO) in the eRA Commons FCOI Module. The FCOI SO is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identified (i.e., no award means no FCOI report, and no FCOI means no FCOI report). +The NIH eRA Commons FCOI Module User Guide, available at the following location, provides instructions for preparing and submitting FCOI reports. https://www.era.nih.gov/files/fcoi_user_guide.pdf + +**Initial (Original) FCOI Reports**: The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in the [NIH FAQ H.5](https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=11119). + +- **Prior to the expenditure of funds**: If an FCOI is identified at the time a new NIH award is issued, the FCOI SO will submit an “Original” FCOI report (2011 FCOI) through the eRA Commons FCOI Module before any funds are spent. +- **Within 60 days during the award**: If an FCOI is identified during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), the Institution must submit an Original FCOI report within 60 days of identifying the FCOI. +- **Annual FCOI Reports**: For the duration of an award, including any extensions with or without funds, the Institution must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable. +- The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance (see [NIH’s FAQ H.2](https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=11123)). NIH creates the opportunity for the FCOI SO to submit the Annual report 75 days prior to the next budget period start date for continuation awards. NIH will notify the Institution by an email when an annual report is due. +- Annual FCOI reports are not required at grant closeout. + +**Revision (or Mitigation) FCOI Reports**: After completing a retrospective review, the Institution will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review finds that bias has occurred. + +Required FCOI Reports to NIH via eRA Commons FCOI Module + +| REPORT | CONTENT | REQUIRED WHEN | +| ------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- | +| New FCOI Report (Initial submission) | Grant number; PI; name of entity with FCOI; nature of FCOI; value of the financial interest (in required increments); description of how the financial interest relates to the research; key elements of the management plan. | Prior to the expenditure of funds on a new award; within 60 days of identifying any new FCOI during the award period. | +| Annual FCOI Report | Status of the FCOI (whether it is still being managed or no longer exists) and any changes to the management plan, if applicable. | Submitted annually at the same time as the annual progress report, multi-year progress report, or at the time of a grant extension. | +| Revised FCOI Report | If applicable, updates to a previously submitted FCOI report to describe actions that will be taken to manage the FCOI going forward or to revise the original report. | Following a retrospective review when noncompliance with the regulation is identified, if applicable. | +| Mitigation Report | Project number; project title; contact PI/PD; name of Investigator with FCOI; name of entity with FCOI; reason for review; detailed methodology, findings, and conclusions. | After a retrospective review when bias is found. | + +### 11. Training Requirements for Investigators + +Each Investigator will be informed of OpenBCI’s FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly (as described below) when any of the following occur: + +- OpenBCI revises this policy or related procedures in a way that affects Investigator requirements. +- An Investigator is new to OpenBCI research under an NIH award (training must be completed before participating in the research). +- OpenBCI determines that an Investigator has not complied with this policy or with a management plan issued under it (training must be completed within 30 days as directed by the DO). + +To meet the NIH training requirement, OpenBCI requires Investigators to complete the NIH FCOI Training Tutorial. OpenBCI also requires Investigators to review the NIH Virtual Seminar presentation on FCOI compliance from the following location: https://www.youtube.com/watch?v=D292YZ6BX24. Investigators will send DO the date of completion through email for audit purposes. + +### 12. Noncompliance With FCOI Policy and Corrective Actions + +If OpenBCI identifies an SFI that was not disclosed, reviewed, or managed in a timely manner, the DO will, within 60 days: review the SFI; determine whether it is related to NIH-funded research; determine whether it constitutes an FCOI; and, if so, implement an interim management plan describing actions that have been and will be taken to manage the FCOI going forward. OpenBCI will also submit an FCOI report to NIH via the eRA Commons FCOI Module. +In cases of noncompliance, including: + +- Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI +- Failure by the institution to review or manage an FCOI +- Failure by the Investigator to comply with an established management plan + +OpenBCI will, within 120 days of identifying noncompliance: + +1. Conduct a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting. +2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or [NIH’s FAQ I.2](https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52888). + If bias is found, OpenBCI will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii) or as described in [NIH’s FAQ I.3](https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52888) to NIH via the FCOI Module. + +The report will include: + +- The impact of the bias on the research project, and +- The plan of action or corrective steps taken to eliminate or mitigate the effect of the bias. + +OpenBCI will thereafter submit FCOI reports annually to NIH as required by the regulations and the terms and conditions of the award. Depending on the circumstances, OpenBCI may implement additional interim measures regarding the Investigator’s participation in the research until the retrospective review is complete. +If bias is not found following completion of the retrospective review, no further action will be taken unless new information is discovered that needs to be reported to the NIH. If applicable, the Institution will update an existing FCOI report to specify the actions that have been, and will be, taken to manage the FCOI going forward or update a previously submitted report information (e.g., increase in value of the SFI or add any newly identified SFIs) following the completion of the retrospective review. +If the failure of an Investigator to comply with an Institution's FCOI or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research, the Institution shall promptly notify the PHS/NIH Awarding Component of the corrective action taken or to be taken. The PHS/NIH Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS/NIH-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS/NIH award or when the transfer of a PHS/NIH grant(s) involves such an Investigator. + +### 13. Clinical Research Requirements + +If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, OpenBCI will require the Investigator to disclose the conflict in every public presentation of the research results and to request an addendum to previously published presentations. + +### 14. Subrecipient Requirements + +A subrecipient relationship exists when federal funds flow from or through OpenBCI to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to OpenBCI for programmatic outcomes and compliance. +Subrecipients (e.g. collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees) are subject to OpenBCI’s terms and conditions. OpenBCI will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. OpenBCI will include in each written agreement with a subrecipient terms specifying whether OpenBCI’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators (see [NIH Grants Policy Statement Section 15.2.1 on Written Agreements](https://grants.nih.gov/grants/policy/nihgps/html5/section_15/15.2_administrative_and_other_requirements.htm)). + +- **If the subrecipient’s FCOI policy applies**: + The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to OpenBCI in time for OpenBCI to meet NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI). Typically, this means requiring subrecipients to report FCOIs to OpenBCI within 50–55 days of identification. OpenBCI’s DO will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module. + +- **If the subrecipient cannot certify compliance**: + The agreement will specify that OpenBCI’s FCOI Policy applies. In this case, subrecipient Investigators must disclose their SFIs to OpenBCI. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for OpenBCI. The agreement will allow sufficient time for OpenBCI to review, manage, and report any resulting FCOIs. When an FCOI is identified, OpenBCI will implement a management plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to NIH via the eRA Commons FCOI Module. + +### 15. Maintenance of Records + +OpenBCI will maintain records of all Investigator financial interest disclosures, OpenBCI’s review and response to those disclosures (whether or not they resulted in a determination of an FCOI), and any actions taken under this policy or through retrospective review. These records will be retained for at least three years from the date of submission of the final expenditures report, or for longer periods as specified in 2 CFR 200.334 for specific situations. OpenBCI will retain these records for each competitive segment as required by regulation. +Copies of management plans will be retained as part of the record maintenance requirements. + +### 16. Enforcement Actions for Investigator Noncompliance + +For all applicable Investigators, compliance with this policy is a condition of employment and/or participation. Failure to comply with this policy, including the failure to complete required training, disclose Significant Financial Interests, or comply with a Conflict Management Plan, may result in appropriate corrective or disciplinary actions. +As appropriate, such actions may include, but are not limited to, + +1. formal notification or disciplinary measures, +2. restrictions on the use of research funds or participation in research activities, +3. suspension or termination of a contractual relationship or employment, +4. and/or disqualification from participation in Government Award–funded research. + In addition, OpenBCI will take all actions required under applicable federal regulations and sponsor requirements, including conducting retrospective review, implementing mitigation measures where necessary, and notifying the sponsor when required. + +### 17. Useful FCOI and NIH Resources + +- NIH e-mail address for FCOI-related inquiries: fcoicompliance@mail.nih.gov +- [FCOI Regulation 42 CFR Part 50 Subpart F - Promoting Objectivity in Research](https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F) +- [Financial Conflict of Interest](https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi) +- [FCOI Training](https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training) +- [NIH “Welcome Wagon” Letter: Information for New Recipient Organizations](https://grants.nih.gov/policy-and-compliance/welcome-wagon) + +### 18. Point Of Contact + +If you have a question related to the FCOI Policy of OpenBCI, contact us using the information below: + +Joseph Artuso\ +President & Chief Commercial Officer\ +OpenBCI Inc.\ +67 West St. Ste. 612, Brooklyn, NY 11222\ +contact@openbci.com