I. INTRODUCTION
Optimal Mobility LLC (the “Company”) is committed to maintaining the integrity and transparency of its research activities. The public and our partners rightly expect that our work is based on sound, unbiased science. When Investigators receive external compensation or hold financial interests in third-party entities, this may result in a Financial Conflict of Interest (FCOI). This policy outlines our commitment to compliance with the U.S. Department of Health and Human Services regulations (42 CFR Part 50 Subpart F), which require institutions to identify, manage, and report financial conflicts of interest in research funded by the Public Health Service (PHS), including NIH.
II. DEFINITION
For the purpose of these policies and procedures the following definitions apply:
Company: Optimal Mobility LLC
Investigator: Any individual, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the Public Health Service (PHS), including NIH. This includes the Principal Investigator (PI) or Project Director (PD), as well as co-investigators, key personnel, collaborators, consultants, or subrecipient staff contributing significantly to a project. The PD/PI is always considered an Investigator, even if their level of effort is minimal. The designation of “Investigator” is based on the individual’s role and responsibility on the research project, not their job title or employment classification.
Institutional Responsibilities: Professional activities an Investigator performs on behalf of Optimal Mobility, which may include conducting research or consultation, teaching, participating in institutional committees (such as IRB, IACUC, or DSMBs), or serving on advisory boards or peer review panels.
Financial Interest: Anything of monetary value held by the Investigator, or the Investigator’s spouse or dependent children, whether or not the value is readily ascertainable.
Significant Financial Interest (SFI):
A. A domestic and foreign financial interest that consists of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably related to the Investigator’s Institutional Responsibilities performed on behalf of Optimal Mobility:
a. With any publicly traded entity: A significant financial interest exists if the value of any remuneration received from the entity in the past 12 months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition:
b. With any non-publicly traded entity: A significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
c. Intellectual property rights and interests: A significant financial interest exists upon receipt of income related to such rights (e.g., patents, copyrights) that exceed $5,000 in the 12 months preceding disclosure.
B. Investigators must disclose the occurrence of any reimbursed or sponsored travel that exceeds $5,000 and is reasonably related to their Institutional Responsibilities. This includes travel paid on behalf of the Investigator and not reimbursed directly to the Investigator (such that the exact monetary value may not be readily available). The disclosure must include, at a minimum:
This disclosure requirement does not apply to travel reimbursed or sponsored by:
C. The term ‘significant financial interest’ does not include the following types of financial interests:
Foreign Interests:
Investigators must disclose all foreign financial interests regardless of amount, including income from foreign governments, universities, or businesses. Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).
Financial Conflict of Interest (FCOI):
An FCOI exists when Optimal Mobility reasonably determines that an Investigator’s SFI could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
Management of an FCOI:
Actions taken to address an FCOI, which may include:
Subrecipient:
External organization or individual engaged to perform a substantive portion of a federally funded research project under a subaward agreement with Optimal Mobility. Subrecipients must either certify that their own FCOI policy complies with federal requirements or agree in writing to comply with Optimal Mobility’s policy, including applicable disclosure and reporting timelines.
All definitions used in this policy are consistent with the requirements in 42 CFR Part 50 Subpart F.
III. POLICY SCOPE AND APPLICABILITY
This Financial Conflict of Interest (FCOI) policy applies to all Investigators who are planning to participate in, or are currently engaged in, research funded by the Public Health Service (PHS), including but not limited to the National Institutes of Health (NIH). It governs any situation where the design, conduct, or reporting of such research could be influenced by a Significant Financial Interest (SFI) that may compromise the objectivity and integrity of the research.
Optimal Mobility LLC adopts this policy to ensure compliance with the U.S. Department of Health and Human Services regulation at 42 CFR Part 50 Subpart F. In addition to PHS-funded research, the policy may also be applied, at the discretion of Optimal Mobility’s leadership, to other federally funded or high-impact research initiatives where objectivity and transparency are critical.
All Investigators are expected to comply fully with this policy as a condition of their participation in applicable research projects. The policy also extends to subrecipient Investigators, collaborators, and consultants performing work under a subaward or similar agreement with Optimal Mobility.
IV. TRAINING REQUIREMENTS
All Investigators will be informed about Optimal Mobility’s Financial Conflict of Interest and must be trained on the investigator’s responsibility to disclose foreign and domestic SFIs per this policy and of the FCOI regulation at including subrecipient Investigator(s), must complete training prior to engaging in NIH-funded research and at 42 CFR Part 50 Subpart F. The training ensures Investigators understand the requirements of this policy and the applicable federal regulations regarding disclosure of Significant Financial Interests (SFI).
A. Timing of Training
Training must be completed by each Investigator:
B. Training Content Requirement
In fulfillment of the FCOI training requirement of the FCOI regulations, Optimal Mobility requires its investigators to complete the National Institutes of Health's Financial Conflict of Interest tutorial located at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html in accordance with the requirements and expectations of this Policy. Additionally, Optimal Mobility also requires its investigators to acquaint themselves with NIH Virtual Seminar presentation containing helpful information on developing or refining institutional FCOI policies to ensure compliance with the FCOI regulation (https://www.youtube.com/watch?v=D292YZ6BX24).
C. Documentation of Training
All investigators must print a certification of completion at the end of training. Proof of training completion must be submitted to the Company’s Compliance Officer and retained for a minimum of three years from the date of the final expenditure report or other applicable retention period.
V. DISCLOSURE REQUIREMENTS
A. Initial Disclosure
Each Investigator must submit an accurate and complete disclosure of all SFIs that are related to their Institutional responsibilities:
Disclosures must include:
B. Ongoing Disclosure
Investigators are responsible for updating their disclosures annually by January 31 for the duration of the award and within 30 calendar days of acquiring or discovering any new SFI. All disclosures will be reviewed promptly to determine whether they constitute an FCOI that must be reported and managed prior to continuing NIH-funded work.
C. Public Accessibility of FCOI Information
Prior to the expenditure of any funds under an NIH award, Optimal Mobility will ensure public accessibility by written response to any requestor within five business days of a request of information concerning any SFI disclosed that meets the following three criteria:
VI. GUIDELINES FOR DETERMINING ‘RELATEDNESS’ OF SFI TO PHS/NIH-FUNDED RESEARCH AND A FINANCIAL CONFLICT OF INTEREST
The designated official will determine whether an Investigator's SFI is related to the research under an NIH award and, if so, whether the SFI is a financial conflict of interest.
An Investigator's SFI is related to the research when the designated official reasonably determines the SFI:
The designated official(s) may involve the Investigator in determining whether a significant financial interest is related to the PHS-funded research.
A financial conflict of interest exists when the designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. (‘Significantly’ means that the financial interest would have a material effect on the research).
VII. REVIEW AND MANAGEMENT OF FCOIS
All SFI disclosures will be reviewed by the Company’s designated FCOI Officer in coordination with the Principal Investigator, the Investigator(s), and Legal/Compliance teams as necessary. The review process includes:
When a Financial Conflict of Interest is found, the designated official will determine what management conditions and/or strategies will be put in place to manage the FCOI. Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:
All management plans must be signed by the Investigator, PI, and the Company CEO. If the designated official determines that a conflict exists, it will communicate its determination and the means it has developed for managing the FCOI in writing to the individual, to the relevant Principal Investigator/Project Director, and to the appropriate direct supervisor.
No expenditures on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the Financial Conflict of Interest. The designated FCOI SO of Optimal Mobility will submit the FCOI report to NIH via the eRA Commons FCOI Module.
VIII. REPORTING REQUIREMENT TO PHS/NIH
A. Initial Report
To ensure compliance with the Public Health Service (PHS) regulations (42 CFR Part 50 Subpart F), Optimal Mobility will submit timely and complete reports of all identified Financial Conflicts of Interest (FCOIs) for NIH-funded research via the eRA Commons FCOI Module. The FCOI Module User Guide is available at https://www.era.nih.gov/files/fcoi_user_guide.pdf. The Original (initial) FCOI report will include the information required in the regulation at 42 CFR Part 50.605(b)(3) or as outlined in NIH's FAQ H.5. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52888.
B. Subsequent Reports
For any Significant Financial Interest that is identified as conflicting subsequent to an initial FCOI report during an ongoing NIH-funded research project (e.g., a new SFI is identified for an Investigator who is participating in the NIH-funded research, upon the participation of an Investigator who is new to the research project, etc.), Optimal Mobility will provide to NIH within 60 days of identifying an FCOI, an FCOI report regarding the financial conflict of interest and ensure that Optimal Mobility has implemented a management plan and the Investigator has agreed to the relevant management plan. Annually, Optimal Mobility will submit annual report to provide updates on the status of previously disclosed FCOIs (including whether they are still being managed, resolved, or no longer exist).
C. Retrospective Review
When an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a FCOI, failure by the Institution to review or manage such an FCOI; and failure by the Investigator to comply with a management plan; Optimal Mobility will within 120 days of determining non-compliance:
Complete a retrospective review of the Investigator's activities and the PHS/NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research;
Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B) or as described in NIH's FAQ I.2. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52895.
The retrospective review documentation will include:
If bias is found, Optimal Mobility shall notify NIH promptly and submit a mitigation report to NIH via the eRA Commons FCOI Module that shall address the following:
Thereafter, Optimal Mobility shall submit FCOI reports annually to NIH in accordance with the regulations and terms and conditions of the award agreement. Depending on the nature of the Financial Conflict of Interest, Optimal Mobility may determine that additional interim measures are necessary with regard to the Investigator's participation in the research project between the date that the Financial Conflict of interest is identified and the completion of Optimal Mobility independent retrospective review. If bias is not found, no further action is required.
Types of FCOI Reports Summary Chart for NIH:
REPORT: New FCOI Report (Initial submission)
CONTENT: Grant Number, PI, Name of Entity with FCOI, Nature of FCOI, Value of financial interest (in increments), Description of how FI relates to research, Key Elements of Management Plan.
REQUIRED WHEN? Prior to expenditure of funds. Within 60 days of any subsequently identified FCOI.
REPORT: Annual FCOI Report
CONTENT: Status of FCOI (i.e., whether FCOI is still being managed or no longer exists) and Changes to Management Plan, if applicable.
REQUIRED WHEN? Annual report due at the same time as when the Institution is required to submit annual progress report, multi-year progress report, or at time of extension.
REPORT: Revised FCOI Report
CONTENT: If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward or make changes to originally submitted FCOI report.
REQUIRED WHEN? Following the completion of a retrospective review when there is noncompliance with the regulation, if needed.
REPORT: Mitigation Report
CONTENT: Project Number, Project Title, Contact PI/PD, Name of Investigator with FCOI, Name of Entity with FCOI, Reason for review, Detail Methodology, Findings and Conclusion.
REQUIRED WHEN? When bias is found as a result of a retrospective review.
IX. NONCOMPLIANCE AND SANCTIONS
Optimal Mobility is committed to upholding the highest standards of integrity and transparency in research. Failure to comply with this Financial Conflict of Interest (FCOI) policy, including failure to disclose a Significant Financial Interest (SFI), failure to comply with an established management plan, or failure to complete required training, will be considered a violation of institutional policy and federal regulations.
A. Types of Noncompliance
Noncompliance includes, but is not limited to:
B. Institutional Response
Upon identification of noncompliance, Optimal Mobility will take immediate action to assess and mitigate potential research bias, including:
C. Possible Sanctions
Appropriate corrective actions and sanctions may be imposed based on the nature and severity of the noncompliance. These may include:
D. Restoration of Compliance
To restore compliance, Investigators must:
X. SUBRECIPIENT REQUIREMENTS
A subrecipient relationship is established when federal research funds are passed from or through Optimal Mobility LLC to another organization or individual, and that subrecipient is responsible for conducting a substantive portion of a PHS-funded research project. The subrecipient is accountable to Optimal Mobility for both programmatic and compliance responsibilities.
Subrecipients may include, but are not limited to, external collaborators, consortium partners, consultants, subcontractors, and sub-awardees. As part of its commitment to regulatory compliance, Optimal Mobility will take reasonable steps to ensure that all subrecipient Investigators comply with the Financial Conflict of Interest (FCOI) regulation outlined in 42 CFR Part 50 Subpart F.
Optimal Mobility will incorporate terms into written agreements with subrecipients that clearly establish which FCOI policy will apply to subrecipient Investigators:
If the subrecipient’s FCOI policy will apply, the subrecipient institution must certify that its policy complies with 42 CFR Part 50 Subpart F. In this case, the agreement must specify:
If the subrecipient does not have a compliant FCOI policy, or is unable to certify compliance, then the subrecipient Investigator(s) must follow Optimal Mobility’s FCOI Policy. In this situation:
The agreement must establish sufficient timelines for Optimal Mobility to review the disclosures, determine whether an FCOI exists, implement a management plan if needed, and report the FCOI to NIH as required.
Optimal Mobility will develop and implement management plans for any identified FCOIs, monitor the subrecipient’s compliance with those plans, and submit FCOI reports for subrecipient Investigators through the NIH eRA Commons FCOI Module.
This approach ensures that all research conducted under a subaward from Optimal Mobility maintains scientific integrity and complies with federal regulations. Optimal Mobility remains responsible for monitoring subrecipient compliance and for the timely reporting of any identified financial conflicts of interest to the NIH.
XI. PUBLIC ACCESS AND RECORD RETENTION
This policy will be posted publicly on the Optimal Mobility website: https://www.optimal-mobility.com.
Optimal Mobility will maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in a determination of a Financial Conflict of Interest), and all actions taken under this policy or any retrospective review, for a minimum of three years from the date of:
• The final expenditure report submitted to the PHS/NIH, or
• The final resolution of any action involving those records (e.g., audit, litigation, or sponsor inquiry),
whichever is longer
These records will be maintained in accordance with 42 CFR Part 50 Subpart F and are subject to audit and inspection by NIH and other authorized entities.
XII. HUMAN SUBJECTS RESEARCH
When research involves human subjects, Optimal Mobility LLC applies heightened scrutiny to ensure the protection of participants and uphold the integrity of scientific outcomes. Any financial conflict of interest (FCOI) identified in such research must be addressed with additional care due to the ethical sensitivities involved.
Before research involving human subjects may begin or resume, any FCOI management strategies must be reviewed and approved by the Institutional Review Board (IRB). This includes assessing the adequacy of public disclosures, the appointment of independent monitors, or the implementation of other safeguards that mitigate the risk of bias or harm. The IRB will consider whether the proposed conflict management plan sufficiently protects human subjects and maintains scientific objectivity. The final management plan must be in place and approved prior to participant enrollment or data collection activities.
XIII. USEFUL RESOURCES
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.