FCOI Policy

FINANCIAL CONFLICT OF INTEREST POLICY

Policy Implementing 42 CFR Part 50 Subpart F (Promoting Objectivity in Research)

1. Purpose and Policy Statement

Spike Neuro, LLC (“Spike Neuro” or the “Institution”) is committed to maintaining objectivity in research it conducts or supports with funds from the U.S. Public Health Service (PHS), including the National Institutes of Health (NIH).

The purpose of this policy is to ensure that research funded by the NIH is designed, conducted, and reported objectively and without bias resulting from Investigator financial conflicts of interest (FCOI). This Financial Conflict of Interest Policy (this “Policy”) establishes the standards, procedures, and responsibilities that implement the requirements of 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research” (the “Regulation”), and 45 CFR Part 94 “Responsible Prospective Contractors” for applicable contracts. This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements.

Spike Neuro adopts this policy for all Investigators (as defined below) engaged in PHS/NIH-funded research. It established process to identify, disclose, and manage Investigator FCOI to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH-supported research.

2. Scope and Applicability

This Policy applies to all PHS-funded grants and cooperative agreements awarded to Spike Neuro, except Phase I Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applications and awards, which are excluded from the Regulation. This Policy applies to:

Every Investigator (as defined in Section 3) who is planning to participate in, or who participate in, PHS-funded research conducted by or through Spike Neuro;
Every subrecipient, subcontractor, consortium member, consultant, or collaborator performing a substantive portion of PHS-funded research under a subaward or agreement issued by Spike Neuro, as further addressed in Section 10; and
All applications for PHS funding submitted by Spike Neuro (other than Phase I SBIR/STTR applications), including new, renewal, competing continuation, revision, and supplemental applications.

This Policy remains in effect for the duration of the relevant award and for the records-retention period specified in Section 13, regardless of whether the Investigator continues to be affiliated with Spike Neuro.

3. Definitions

Capitalized terms used in this Policy have the meanings set out below. Terms not defined here have the meanings given in 42 CFR 50.603.

3.1 Financial Conflict of Interest (FCOI)

A Significant Financial Interest that the Designated Institutional Official reasonably determines 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 interests could be affected by the research) and could directly could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

3.2 Institutional Responsibilities

An Investigator’s professional responsibilities performed on behalf of Spike Neuro, including but not limited to research, product and services development and testing, publication and communication of research, consulting, mentoring, training, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

3.3 Designated Institutional Official (DIO)

The individual designated by Spike Neuro to solicit and review disclosures of Significant Financial Interests, determine FCOIs in accordance with 42 CFR Part 50 Subpart F and this policy, develop management plans for identified FCOI, and to implement this Policy. The Chief Executive Officer of Spike Neuro serves as the DIO. The DIO may, in writing, delegate specific operational responsibilities to a qualified alternate where doing so does not create a conflict of interest; ultimate authority for determinations under this Policy rests with the DIO.

3.4 Investigator

The project director or principal investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research or proposed for such funding, which may include, for example, collaborators or consultants. This 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 work when determining who is responsible for the design, conduct, or reporting of the PHS/NIH-funded research.

3.5 Significant Financial Interest (SFI)

A domestic or foreign financial interest of an Investigator (or of the Investigator’s spouse, domestic partner, or dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities performed on behalf of Spike Neuro, consisting of one or more of the following:

With respect to any publicly traded entity: An SFI exists if the total remuneration received from the entity in the twelve months preceding the disclosure, plus the value of any equity interest in the entity as of the date of disclosure, that together exceed $5,000. Remuneration includes salary and any payment for services (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.
With respect to any non-publicly traded entity: An SFI exists if (i) remuneration received from the entity in the twelve months preceding the disclosure that exceeds $5,000; or (ii) the Investigator (or their spouse, domestic partner, or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest), regardless of amount.
With respect to any intellectual property: An SFI exists if receipt of income related to intellectual property rights and interests (e.g., patents, copyrights), exceeds $5,000 during the twelve months preceding the disclosure, related to such rights and interests.
Investigators must disclose any reimbursed or sponsored travel related to the Investigator’s Institutional Responsibilities with a value exceeding $5,000, subject to the exclusions in 42 CFR 50.603. 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 twelve months. For Investigators, Spike Neuro requires disclosure of the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

3.6 Exclusions from SFI

The term SFI does not include:

Salary, royalties, or other remuneration paid by Spike Neuro to the Investigator if the Investigator is currently employed or otherwise appointed by Spike Neuro, including intellectual property rights assigned to Spike Neuro and agreements to share in royalties related to such rights;
Any ownership or equity interest in Spike Neuro held by an Investigator who is a member, manager, officer, director, employee, or founder of Spike Neuro. Because Spike Neuro itself is the Institution conducting the research, an Investigator’s ownership interest in Spike Neuro does not create a financial conflict of interest within the meaning of the Regulation. Management of any actual or apparent conflicts arising from Investigator ownership of Spike Neuro is addressed through Spike Neuro’s governance and Section 4 recusal provisions, not through SFI disclosure under this Policy;
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 U.S. federal, state, or local government agency, a U.S. 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 a U.S. institution of higher education; or
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 as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education.
Travel reimbursed or sponsored by a U.S. federal, state, or local government agency, a U.S. 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 a U.S. institution of higher education.

For the avoidance of doubt, the exclusions in this Section 3.6 apply only to U.S. sources. Income, remuneration, honoraria, compensation, or other financial interests received from a foreign government, a foreign government agency, a foreign institution of higher education, a foreign academic teaching hospital, a foreign medical center, a foreign research institute, or any other foreign entity, are NOT excluded by this Section 3.6 and must be disclosed in accordance with this Policy.

Two points of particular emphasis for this Section 3.6:

The term “institution of higher education” as used in 42 CFR 50.603 and incorporated into this Policy by reference to 20 U.S.C. 1001(a) refers exclusively to institutions located in the United States. It does not cover foreign universities, colleges, or their equivalents. Income from teaching, lectures, seminars, visiting appointments, advisory panels, or review panels at or for a foreign institution of higher education is NOT excluded.
The references in 42 CFR 50.603 to a “federal, state, or local government agency” refer exclusively to U.S. federal, state, or local government agencies. They do not cover foreign governments, foreign government agencies, foreign ministries, foreign instrumentalities, foreign defense or military research organizations, foreign funding agencies (including non-U.S. equivalents of NIH, NSF, or similar bodies), or any other foreign government-related entity. Income from advisory panels, review panels, seminars, lectures, teaching engagements, grants, contracts, or other compensation from any foreign government source is NOT excluded.

3.7 Foreign SFIs

All SFIs of foreign origin or from foreign entities must be disclosed when the aggregated amount of such include meets the threshold for disclosure (e.g., income in excess of $5,000) within twelve months preceding the disclosure within the previous. Foreign entities subject to this Section 3.7 include, without limitation:

Foreign institutions of higher education (that is, any university, college, or equivalent academic institution located outside the United States);
Foreign governments and foreign government agencies, ministries, instrumentalities, and related entities;
Foreign academic teaching hospitals, medical centers, and research institutes;
Foreign commercial entities (for-profit companies organized or headquartered outside the United States);
Foreign nonprofits, academies, foundations, and professional societies; and
Foreign talent recruitment programs, including programs of the kind described in NIH guidance on foreign talent recruitment.

Examples of foreign SFIs that must be disclosed under this Section 3.7 include, but are not limited to:

Salary, consulting fees, honoraria, or other remuneration received from a foreign institution of higher education;
Salary, consulting fees, honoraria, grants, contracts, stipends, or other remuneration received from a foreign government, a foreign government agency, a foreign ministry, a foreign funding agency (including a non-U.S. equivalent of NIH, NSF, DARPA, DOE, or similar), a foreign military or defense research organization, or any other foreign government instrumentality;
Income from teaching engagements, seminars, lectures, or visiting appointments at a foreign institution of higher education or sponsored by a foreign government (these are expressly not covered by the U.S.-only exclusions in Section 3.3);
Compensation for service on advisory committees, scientific advisory boards, or review panels of a foreign institution of higher education, a foreign government, a foreign funding agency, or any other foreign entity;
Research funding, grants, or contracts paid directly to the Investigator (rather than to Spike Neuro) by a foreign institution of higher education, a foreign government, or any other foreign source;
Participation in any foreign talent recruitment program, including but not limited to programs sponsored or operated by a foreign government (for example, programs of the kind identified in NIH guidance on foreign talent recruitment);
Equity or other ownership interests in a foreign entity;
Intellectual property rights, royalties, or licensing income from a foreign source, including a foreign government or a foreign institution of higher education;
Reimbursed or sponsored travel paid for by a foreign source that is not excluded under Section 3.6 (all foreign travel of this type must be disclosed, including travel sponsored by a foreign government or a foreign institution of higher education); and
In-kind support from a foreign source, including laboratory space, staff, students, or materials, provided to the Investigator in a personal capacity by a foreign government, a foreign institution of higher education, or any other foreign entity.

If the Investigator is uncertain whether a particular foreign interest falls within this Section 3.7, the Investigator should disclose it on the SFI Disclosure Form and let the DIO (or IAR) make the relatedness and FCOI determinations. Over-disclosure is preferred to under-disclosure for foreign interests.

3.8 Public Health Service (PHS)

The Public Health Service of the U.S. Department of Health and Human Services and any components to which its authorities have been delegated, including the National Institutes of Health.

3.9 National Institutes of Health (NIH)

The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientific knowledge.

3.10 Subrecipient

Any entity that receives a subaward, subcontract, or consortium agreement from Spike Neuro to perform a substantive portion of PHS-funded research, including but not limited to universities, academic medical centers, hospitals, nonprofit research institutes, other small businesses, consultants, and individual collaborators.

3.11 Additional Defined Terms

The following additional terms are used throughout this Policy and have the meanings set forth in 42 CFR 50.603 or as specified below:

“Disclosure of significant financial interests” means an Investigator’s disclosure of Significant Financial Interests to Spike Neuro.
“Equity interest” means any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
“Manage” means taking action to address a Financial Conflict of Interest, which may 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.
“PHS-funded research” means 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.
“PHS Awarding Component” means the organizational unit of the PHS that funds the research that is subject to the Regulation, for example, the specific NIH Institute or Center.
“Research” has the meaning given in 42 CFR 50.603 and generally includes a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development. As used in the Regulation, 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.
“Senior/Key Personnel” means the PD/PI and any other person identified as senior/key personnel by Spike Neuro/Institution in a grant application, progress report, or any 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 11.
“Financial interest” means anything of monetary value, whether or not the value is readily ascertainable.

4. Designated Institutional Official

The Chief Executive Officer of Spike Neuro, LLC serves as the Designated Institutional Official (DIO) and is responsible for implementation of this Policy, including:

Soliciting and reviewing Investigator SFI disclosures;
Determining whether any disclosed SFI is related to the PHS-funded research and, if so, whether the SFI constitutes an FCOI;
Developing and approving written management plans for identified FCOIs and monitoring Investigator compliance with such plans;
Overseeing Investigator training, records retention, and public accessibility requirements; and
Reviewing subrecipient certifications and FCOI reports received from Subrecipients under Section 10.

If the DIO is the Investigator whose SFI is under review, or otherwise has a personal financial, family, or other conflict of interest with respect to a disclosure or determination under this Policy, the DIO will recuse himself or herself from that matter and refer the matter to an Independent Alternate Reviewer (the “IAR”) designated by Spike Neuro pursuant to this Section 4.

Spike Neuro will designate the IAR in writing (by resolution of its members, written manager consent, or a standing engagement letter, as applicable). The IAR may be:

A qualified outside attorney retained for the purpose;
An independent member of any board, advisory body, or scientific advisory board of Spike Neuro who is not subordinate to the DIO and has no conflicting interest; or
A Spike Neuro officer who (i) is not the DIO, (ii) does not report to the DIO with respect to the matter under review, and (iii) has no conflicting interest in the matter.

The IAR designation, and any change to it, will be documented in writing and retained with Spike Neuro’s FCOI records. For any matter properly referred to the IAR under this Section 4, the IAR will exercise the full authority of the DIO under this Policy, including determinations of relatedness and FCOI, approval of management plans, and authorization of any required reports to the PHS Awarding Component. The DIO will not participate in the review, decision, or implementation of the management plan for any matter referred to the IAR, and all related records will reflect the IAR’s authorship.

4.1 Current IAR Designation

As of the Effective Date, Spike Neuro designates Dr. Charla Howard, PhD, President and Chief Clinical Officer of Spike Neuro, as the Independent Alternate Reviewer. Dr. Howard meets the criteria in Section 4(c): as President and as Chief Clinical Officer she holds independent officer authority within Spike Neuro’s governance, she does not report to the DIO with respect to matters within the scope of this Section 4, and her only financial interest in Spike Neuro — as a co-inventor of intellectual property assigned to Spike Neuro and any equity or compensation interests in Spike Neuro itself — is an excluded interest under Section 3.3 of this Policy.

The IAR will recuse herself from any specific matter in which she has a conflicting personal financial interest (for example, a matter involving a prospective third-party counterparty in which the IAR also holds an SFI, or a matter involving the IAR’s own external SFI). When the IAR recuses, or is otherwise unavailable to act within a timeframe required to meet Spike Neuro’s obligations under the Regulation, the matter will be referred to a Backup IAR. A Backup IAR may be designated or engaged in any of the following ways, at Spike Neuro’s discretion and as documented in the internal IAR designation record:

A specific individual (for example, an independent board or advisor member, or another Spike Neuro officer meeting the criteria of Section 4) designated in writing in advance of any referral;
Qualified outside legal counsel pre-engaged under a standing engagement letter for Backup IAR services, available on call when a referral occurs; or
Qualified outside legal counsel engaged on a matter-by-matter basis when a referral occurs, provided that Spike Neuro will identify the preferred counsel relationship in the internal IAR designation record so that engagement can be executed without material delay and the matter can be reviewed within the timeframes required by the Regulation.

Whichever path is used, the Backup IAR must meet the criteria of Section 4. The DIO is responsible for ensuring that the chosen Backup IAR path is operable at all times — that is, that a Backup IAR can be engaged and a referral completed in time to meet Spike Neuro’s obligations under the Regulation, including the sixty (60)-day review windows under Section 6.3 and any applicable reporting deadlines.

The current IAR designation under this Section 4.1 may be updated by written designation of the Spike Neuro members or manager(s), as applicable, without amendment of the remainder of this Policy, provided the designation continues to satisfy the criteria of Section 4.

5. Investigator Disclosure Requirements

5.1 What Must Be Disclosed

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 Regulation.

The Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements.

5.2 When Disclosure Must Occur

Investigators must submit an SFI disclosure on the Spike Neuro Significant Financial Interest Disclosure Form (the “SFI Disclosure Form”), which is maintained by the DIO as a companion to this Policy, at each of the following times:

At the time of application for PHS-funded research: The PI and all other individuals who meet the definition of Investigator must disclose their SFIs to the DIO. 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 DIO promptly and before participating in the project, using the SFI Disclosure Form.
At least annually during the period of any PHS award: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually (on or before April 1) during the award period. The annual disclosure must include: (i) any new information that was not previously disclosed to Spike Neuro under this policy, including SFIs associated with NIH-funded projects transferred from another institution; and (ii) updated details for any previously disclosed SFI, such as changes in the value of an equity interest.
Within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).
Immediately upon engaging a new Investigator (including a replacement or newly added senior/key personnel) on a PHS-funded project.
New reimbursed or sponsored travel: Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

5.3 Investigator Responsibilities and Certifications

Each Investigator:

Is responsible for providing timely, complete, and accurate SFI disclosures under this Policy;
Will cooperate with the DIO in the review of disclosures, including providing requested supporting documentation;
Will comply with any FCOI management plan developed under this Policy; and
Will complete FCOI training as required by Section 9.

5.4 Required Contents of the SFI Disclosure Form

The SFI Disclosure Form will, at a minimum, solicit the following information from each Investigator, consistent with 42 CFR 50.603 and NIH guidance:

The Investigator’s name and role on any relevant PHS-funded research project;
A certification that the Investigator has reviewed this Policy and the Regulation and understands the disclosure obligations, including the obligation to disclose all foreign SFIs regardless of amount;
For each SFI: the name of the entity; whether it is publicly traded or non-publicly traded; the nature of the interest (e.g., salary, consulting fees, honoraria, paid authorship, equity, intellectual property, reimbursed or sponsored travel); the value in the ranges specified by 42 CFR 50.605(b)(3)(i)(G) or a statement that the value cannot be readily determined; and the dates covered;
For each SFI held by the Investigator’s spouse or dependent children that is subject to disclosure under this Policy: the same information as above, to the extent reasonably available to the Investigator;
For reimbursed or sponsored travel: the purpose of the trip, identity of the sponsor/organizer, destination, and duration, as required by 42 CFR 50.603;
The Investigator’s preliminary indication of whether the SFI relates to any PHS-funded or PHS-applied-for research, together with any facts the Investigator believes are relevant to the relatedness determination (the final determination rests with the DIO or IAR, as applicable);
The Investigator’s signed certification that the disclosure is true, correct, and complete to the best of the Investigator’s knowledge; and
The date of the disclosure.

The DIO maintains the current version of the SFI Disclosure Form as a companion document to this Policy and may revise it from time to time without amendment of this Policy, provided the form continues to collect the information required above.

5.5 Confidentiality of Disclosures

Spike Neuro treats SFI disclosures and all supporting materials as confidential business information and will use and share them only as necessary to carry out this Policy, to comply with the Regulation and other applicable law, and to respond to authorized requests from the PHS Awarding Component, auditors, or other regulators. Publicly accessible information under Section 11 will be limited to the categories of information required to be made public by the Regulation, and will not include information beyond what 42 CFR 50.605(a)(5) requires.

6. Review and Determination of FCOIs

6.1 Relatedness Determination

The DIO is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI.

Relatedness Test: The DIO determines whether an Investigator’s SFI is related to research under an NIH award. An SFI is considered “related” when the DIO reasonably determines that:

The SFI could be affected by the PHS/NIH-funded research, or
The SFI is in an entity whose financial interests could be affected by the PHS/NIH-funded research.

Investigator involvement: The DIO may consult with the Investigator when assessing whether an SFI is related to the research.

Designated Official FCOI Determination: An FCOI exists when the DIO 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).

6.2 Timing

Prior to the issuance of a new award or before any expenditure of any awarded funds (e.g., during Just-in-Time stage): The DIO will review the Investigator’s SFIs before NIH issues a new award or prior to any expenditure of any awarded funds. 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.
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 DIO 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.
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 DIO will, within 60 days:

review the disclosure;
determine whether the SFI is related to the PHS/NIH-funded research;
determine whether an FCOI exists; and, if so,
implement, on at least an interim basis, a management plan.

An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

6.3 Documentation

The DIO will document all determinations, including the basis for any conclusion that an SFI is or is not an FCOI, and will retain the documentation in accordance with Section 13.

7. Management of Financial Conflicts of Interest

7.1 Management Plan

When an FCOI is identified, the DIO will develop and implement a written management plan to ensure the research is conducted objectively. The management plan will specify the actions that have been, and will be, taken to manage the FCOI, and may include, as appropriate:

Public disclosure of the FCOI (e.g., in publications, presentations, or informed-consent documents);
For human subjects research, disclosure of the FCOI to participants in the informed consent document
Appointment of an independent monitor to oversee the research;
Modification of the research plan;
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
Reduction or elimination of the financial interest (e.g., sale of equity); or
Severance of relationships that create the FCOI.

7.2 Signature and Acknowledgment

Each management plan will be signed and dated by the Investigator and the DIO (or the IAR, as applicable). By signing, the Investigator acknowledges that the Investigator has read and understood the management plan and agrees to comply with all of its terms. Where a signed management plan is not feasible within the sixty (60)-day interim-management window, the DIO will document the Investigator’s written agreement (including by email) and secure a signed management plan promptly thereafter. The DIO will submit a FCOI report to NIH via the eRA Commons FCOI Module. The executed management plan will be retained in the FCOI records for the applicable project.

7.3 Monitoring and Compliance

The DIO will monitor Investigator compliance with the management plan on an ongoing basis and until the completion of the PHS-funded project, and will update the management plan as needed based on changes in circumstances.

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 DIO for recordkeeping.

8. Reporting to the PHS Awarding Component

8.1 Initial (Original) FCOI Reports

Prior to the expenditure of PHS funds, the DIO will submit an “Original” FCOI report to the PHS Awarding Component via the eRA Commons FCOI Module for each FCOI identified with respect to the PHS-funded research. 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. Spike Neuro will also ensure that the Investigator has agreed to and begun implementing the associated management plan. Initial reports will include all elements required by 42 CFR 50.605(b)(3), including:

Project number; PD/PI or contact PD/PI (for multiple PD/PI awards); name of the Investigator with the FCOI; name of the entity with which the Investigator has the FCOI; nature of the FCOI (e.g., equity, consulting fees, intellectual property rights); and value of the financial interest in the applicable ranges specified by the Regulation, or a statement that the interest is one whose value cannot be readily determined;
A description of how the financial interest relates to the PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and
A description of the key elements of the management plan, including the role and principal duties of the conflicted Investigator in the research project, the conditions of the management plan, how the management plan is designed to safeguard objectivity in the research, confirmation of the Investigator’s agreement to the management plan, how the management plan will be monitored to ensure Investigator compliance, and other information as needed.

Spike Neuro will designate an institutional official 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).

8.2 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). 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.

8.3 Revised 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.

8.4 Types of FCOI Reports Summary Chart for NIH

*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.

8.5 Prompt Notification of Noncompliance

In addition to any mitigation report required under Section 8.4, the DIO will notify the PHS Awarding Component promptly whenever an Investigator (including a Subrecipient Investigator) fails to comply with this Policy, or whenever noncompliance with an FCOI management plan appears to have biased the design, conduct, or reporting of PHS-funded research, consistent with 42 CFR 50.606(a). Spike Neuro will take corrective action as required by the Regulation and will cooperate with any action taken by the PHS Awarding Component.

8.6 Noncompliance Corrective Action

If Spike Neuro identifies an SFI that was not disclosed, reviewed, or managed in a timely manner, the DIO 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. Spike Neuro 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

Spike Neuro 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.

If bias is found, Spike Neuro 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 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.

Spike Neuro 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, Spike Neuro may implement additional interim measures regarding the Investigator’s participation in the research

8.7 Public Disclosure Requirement for Clinical Research

In any case in which HHS determines that a PHS-funded project of clinical research whose purpose is 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 disclosed or managed as required by the Regulation, Spike Neuro 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 previously published presentations.

9. Investigator Training

Spike Neuro will train its Investigators regarding this Policy, the Regulation, and the Investigator’s responsibilities under this Policy. At a minimum, Investigator training will cover:

The requirements of 42 CFR Part 50 Subpart F (and, where applicable, 45 CFR Part 94);
The provisions of this Policy, including the definition of SFI, categories of exclusions, and the Investigator’s affirmative disclosure obligations (including the obligation to disclose all foreign SFIs regardless of amount);
The timing of required disclosures (at application, at least annually, within thirty (30) days of a new SFI, and upon joining an ongoing PHS-funded research project);
The process for review and determination of FCOIs by the DIO (or IAR), including the Investigator’s role in any management plan; and
The consequences of noncompliance with this Policy or a management plan, including potential sanctions under Section 12 and federal enforcement consequences.

Training must be completed:

Prior to engaging in PHS-funded research;
At least every four (4) years thereafter;
As soon as practicable, and no later than thirty (30) days, after any of the following events: (a) Spike Neuro revises this Policy in any manner that affects Investigator requirements; (b) an Investigator is new to Spike Neuro; or (c) Spike Neuro determines that an Investigator has not complied with this Policy or with an approved management plan.

Spike Neuro will accept completion of the NIH Office of Extramural Research FCOI training module, or NIH Virtual Seminar presentation on FCOI compliance from the following location: https://www.youtube.com/watch?v=D292YZ6BX24. Investigators must provide the DIO with documentation of completed training. Spike Neuro will retain training completion records in accordance with Section 13.

10. Subrecipients

This Section 10 applies to all Subrecipients on any PHS-funded research project conducted by Spike Neuro, including — without limitation — current Subrecipients and any future Subrecipients added during the life of a project or on future projects. A subrecipient relationship exists when federal funds flow from or through Spike Neuro to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to Spike Neuro for programmatic outcomes and compliance. Subrecipients (e.g. collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees) are subject to Spike Neuro’s terms and conditions. Spike Neuro will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. The requirements of this Section 10 are incorporated by reference into every subaward, subcontract, or consortium agreement issued by Spike Neuro for PHS-funded research, and the absence of project- or party-specific language in the body of this Policy does not limit its application to any Subrecipient.

10.1 Written Agreement Required

Before PHS funds are expended at or through any Subrecipient, Spike Neuro will enter into a written agreement with the Subrecipient that incorporates the FCOI terms required by 42 CFR 50.604(c) and the written-agreement requirements of NIH Grants Policy Statement Section 15.2.1, together with the provisions of this Policy. No funds will flow to a Subrecipient until the written agreement is fully executed.

10.2 Which FCOI Policy Applies

The written agreement must specify, for each Subrecipient, whether the Subrecipient’s Investigators will comply with the Subrecipient’s FCOI policy or with this Policy. Spike Neuro’s default practice is as follows:

Subrecipients that maintain their own FCOI policy compliant with 42 CFR Part 50 Subpart F (for example, U.S. research universities and academic medical centers) will apply their own FCOI policy to their Investigators. The Subrecipient will provide the written certification described in Section 10.3.
Subrecipients that do not maintain an FCOI policy compliant with the Regulation — including individual consultants and collaborators, and small businesses or nonprofits without a compliant policy — will be subject to this Policy, and their Investigators will disclose SFIs directly to the DIO in accordance with Sections 5 and 6. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for Spike Neuro. The agreement will allow sufficient time for Spike Neuro to review, manage, and report any resulting FCOIs. When an FCOI is identified, Spike Neuro 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.

10.3 Subrecipient Certification

Where the Subrecipient’s own FCOI policy applies, the Subrecipient must provide to Spike Neuro a written certification, signed by an authorized institutional official, that the Subrecipient’s policy complies with 42 CFR Part 50 Subpart F and that the Subrecipient will comply with that policy for the duration of the award. The agreement will specify the timeframe for the subrecipient to report identified FCOIs to Spike Neuro in time for Spike Neuro to meet NIH reporting deadlines, see 10.4 (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI). Spike Neuro will retain each certification with the FCOI records for the applicable project.

10.4 Reporting Timelines Within Subawards

The written agreement will require the Subrecipient to report all identified FCOIs of its Investigators to Spike Neuro in a manner and on a timeline sufficient to enable Spike Neuro to provide timely FCOI reports to the PHS Awarding Component under 42 CFR 50.605(b). Spike Neuro’s default subaward terms require:

Initial FCOI reports from the Subrecipient to Spike Neuro no later than forty-five (45) days after the Subrecipient’s FCOI determination, and in all events sufficiently in advance of any PHS reporting deadline to allow Spike Neuro to report to the PHS Awarding Component within the sixty (60)-day window required by the Regulation;
Annual FCOI reports from the Subrecipient to Spike Neuro no later than thirty (30) days before the Spike Neuro annual-report due date for the applicable project; and
Prompt (not to exceed thirty (30) days) notice to Spike Neuro of any determination of noncompliance by a Subrecipient Investigator, to support any required retrospective review and mitigation report under Section 8.3.

The DIO may approve alternative timelines in a specific subaward if the alternative timelines are nonetheless sufficient to meet Spike Neuro’s obligations under the Regulation. Any such alternative must be memorialized in the written agreement.

10.5 Flow-Down of Training and Recordkeeping

Subrecipients are responsible for ensuring that their Investigators have completed FCOI training consistent with Section 9 (or an equivalent training under the Subrecipient’s own FCOI policy) and for maintaining records of SFI disclosures, FCOI determinations, and management plans for the period required by the Regulation. Spike Neuro reserves the right to request and receive such records upon reasonable notice.

10.6 Subrecipient-Level Transparency

Spike Neuro will include in every PHS-funded subaward the requirement that the Subrecipient respond, through Spike Neuro or directly, to any request for publicly available information concerning FCOIs of Subrecipient senior/key personnel, as required by Section 11.

11. Public Accessibility

11.1 Public Posting of This Policy

A copy of this Policy is publicly accessible at www.spikeneuro.com, as required by Section 4.1.10 Financial Conflict of Interest of the NIH Grants Policy Statement. This Policy will be maintained there for the duration of this Policy’s effectiveness. If Spike Neuro ceases to maintain a publicly accessible website, it will make this Policy available in writing to any requester within five (5) business days of a request.

11.2 Public Response to FCOI Inquiries

Prior to the expenditure of PHS funds, Spike Neuro will ensure public accessibility of information concerning any FCOI held by a senior/key personnel member as defined by the NIH Grants Policy Statement. Spike Neuro will respond to any written request from the public for such information within five (5) business days of receiving the request about any SFI that meets all three of the following criteria:

The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identified by Spike Neuro as senior/key personnel in the application, progress report, or other NIH submission).
Spike Neuro has determined that the SFI is related to the NIH-funded research.
Spike Neuro has determined that the SFI constitutes an FCOI.

The response will include, for each FCOI of a senior/key personnel member:

The Investigator’s name;
The Investigator’s title and role with respect to the research project;
The name of the entity in which the SFI is held;
The nature of the SFI; and
The approximate dollar value of the SFI (in the ranges specified by the Regulation), or a statement that the interest is one whose value cannot be readily determined.

Information made publicly accessible under this Section 11.2 will be updated within sixty (60) days of any newly identified FCOI of a senior/key personnel member and will be reviewed and, as needed, updated at least annually. Information will remain available for at least three (3) years from the date that the information was most recently updated.

12. Enforcement and Sanctions

Failure by an Investigator to comply with this Policy or with an approved management plan, or failure to timely and accurately disclose SFIs, may result in one or more of the following sanctions, as determined by the DIO:

Written warning and required additional training;
Modification of the management plan, including additional monitoring or restrictions;
Removal from the PHS-funded research project, in whole or in part;
Ineligibility for future PHS-funded research at or through Spike Neuro;
Disciplinary action consistent with Spike Neuro’s employment policies and applicable law; and
Any other action the DIO reasonably determines is necessary to safeguard the objectivity of the research or to bring Spike Neuro into compliance with the Regulation.

Sanctions applied to Subrecipient Investigators will be pursued under the terms of the applicable subaward and, as applicable, the Subrecipient’s own FCOI policy.

12.1 Application Certification

In each application for PHS funding (other than Phase I SBIR/STTR applications), Spike Neuro will certify that it has in effect an up-to-date, written, and enforced administrative process to identify and manage FCOIs consistent with the Regulation and this Policy, that this Policy is posted on a publicly accessible website, that Spike Neuro will promote and enforce Investigator compliance with the Regulation, that Spike Neuro will provide the required initial and ongoing FCOI reports to NIH via the eRA Commons FCOI Module, and that Spike Neuro will make FCOI and SFI information (including related institutional reviews and determinations) available to NIH promptly upon request.

12.2 Non-Retaliation

Spike Neuro prohibits retaliation against any Investigator, employee, Subrecipient Investigator, or other person for making a good-faith disclosure, report, or inquiry under this Policy, for cooperating with the DIO, the IAR, the PHS Awarding Component, or any other regulator in connection with an FCOI matter, or for otherwise engaging in activity protected by applicable whistleblower law. Any Investigator or employee who believes they have experienced retaliation in connection with activity protected by this Section may report the matter directly to the DIO or, where appropriate, to the IAR.

13. Records Retention

Spike Neuro will maintain records of all Investigator SFI disclosures, DIO reviews and determinations, management plans, FCOI reports submitted to the PHS Awarding Component, subrecipient certifications and FCOI reports, training records, and all other actions taken under this Policy for at least three (3) years from the date the final expenditures report is submitted to the PHS Awarding Component for the applicable award, or for such longer period as may be required by 45 CFR 75.361 or other applicable law or award terms.

14. Policy Review and Amendment

The DIO will review this Policy at least every four (4) years, and promptly upon any amendment of the Regulation or the NIH Grants Policy Statement affecting FCOI requirements. Amendments take effect upon approval by the DIO and will be communicated to all Investigators and current Subrecipients. The most current version of this Policy will be maintained on Spike Neuro’s public website pursuant to Section 11.1.

15. Contact Information

Questions about this Policy or SFI disclosures should be directed to:

Designated Institutional Official / Chief Executive Officer

Spike Neuro, LLC

315 E. Eisenhower Pkwy, Suite 9B

Ann Arbor, MI 48108

Email: lawrence@spikeneuro.com

Phone: 1-734-234-3076

Fax: 1-734-234-3076

Website: www.spikeneuro.com