Compliance

RESOLUTE SCIENCE, INC. FINANCIAL CONFLICT OF INTEREST POLICY

Updated: 6/18/2024

Purpose

Introduction: The federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. The regulations were first developed in 1995, and in 2011, the regulations were revised. These regulations describe the actions an individual and an organization must take to promote objectivity in PHS-funded research. The regulations apply to all Public Health Service (PHS) (e.g., National Institutes of Health [NIH])-funded grants, cooperative agreements, and research contracts. The regulations are not applicable to Phase 1 Small Business Innovation Research or Small Business Technology Transfer applica)ons and/or awards. This policy implements the regulatory requirements for RESOLUTE SCIENCE, INC.

Scope: This policy applies to all personnel, including all Members and full-time, part-time, temporary, and contract employees of RESOLUTE SCIENCE, INC., who are participating in, or planning to participate in, the design, conduct, or reporting of Public Health Service (“PHS”) funded research and research proposals. This policy does not apply to research and development conducted under Phase I Small Business Innova)on Research (SBIR) or Small Business Technology Transfer (STTR) awards.

For federally-supported research projects involving subawardees or contractors (collectively “subrecipients”), the subrecipient institutions are required to provide writen assurance that a FCOI policy is in effect that is compliant with all applicable federal regulations, or that the subrecipient will conform to and abide by RESOLUTE SCIENCE, INC. FCOI policy and procedures. Consistent with PHS regulations, this policy will be made available via a publicly accessible website. All RESOLUTE SCIENCE, INC. Investigators (that is, individuals who, regardless of position or title, are responsible for the design, conduct or reporting of PHS supported research, and Investigators seeking PHS research support) shall be informed where this policy and relevant reporting requirements may be accessed via the web. The purpose of this policy is to prevent potential bias resulting from any Financial Conflict of Interest (FCOI) by individuals who have influence in the allocations and use of public funding in the conduct of research. This policy applies to research and initiatives funded by US Public Health Service (PHS) grants wherein RESOLUTE SCIENCE, INC. is the recipient of such funds. This policy aligns to the requirements within regulation 42 CFR Part 50-Subpart F (FCOI regulation) with the goal of promoting objectivity and transparency in research.

Responsible Parties:

The FCOI Manager will solicit and review Investigator disclosures to determine whether an Investigator’s SFI related to an Investigator’s institutional responsibilities is an FCOI.

The Authorized Organization Representative (AOR), when submitting a grant application, will certify the applicant Institution’s compliance with the requirements of the FCOI Regulations.

This policy will be reviewed every 2 years.

Policy Statement:

NIH requires applicant and recipient institutions (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR Part 50, Subpart F, “Promoting Objectivity in Research” for which PHS funding is sought, as implemented in the 2011 Final Rule for grants and cooperative agreements.

This Financial Conflict of Interest policy (FCOI Policy) has been established to align with standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under the Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest (FCOI).

This FCOI policy defines the requirements and processes for RESOLUTE SCIENCE, INC. to identify and properly manage any FCOIs. In addition, it outlines activities related to management, enforcement, and remedies for noncompliance.

DEFINITIONS

Investigator(s) include the Principal Investigator (PI)/Project Director and any other individuals, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS/NIH-funded research, or proposed for such funding, and which may include, for example, collaborators or consultants. This definition is not limited to titles such as senior/key personnel, PhDs, MDs, etc.

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 PHS/NIH by the Institution. This term is defined only as it relates to the public accessibility requirements described under the section labeled “PUBLIC ACCESSIBILITY REQUIREMENTS” explained below.

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). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

PHS means 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).

NIH means the biomedical research agency of the PHS.

Institutional responsibilities mean an Investigator’s professional responsibilities on behalf of RESOLUTE SCIENCE, INC., and as defined by RESOLUTE SCIENCE, INC., 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 for PHS-funded research.

Financial interest means anything which has monetary value, and if the value is readily ascertainable.

A Financial Conflict of Interest (FCOI) exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to an NIH-funded research project (i.e., the Significant Financial Interest could be affected by the research or the Significant Financial Interest 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 the NIH-funded research.

FCOI Manager is the grant recipient’s designated official for managing the FCOI process related to a specific PHS grant, reviewing SFI disclosures, making determinations of FCOI, and developing management plans. The FCOI Manager, or designee, may be assigned to submit FCOI reports to the NIH. The current FCOI Manager for RESOLUTE SCIENCE, INC. is Andre Basbaum (President).

Significant Financial Interest (SFI) is 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 (e.g., research, research consultation, administrative, etc.):

1. Regarding 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
2. Regarding 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
3. With regard to Intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income greater than $5,000 related to such rights and interests;

In addition, Investigators must disclose the occurrence of any reimbursed or sponsored travel that exceeds $5,000 (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. The initial disclosure of reimbursed or sponsored travel must include income received over the previous twelve (12) months. The disclosure requirement does not apply to travel that is reimbursed or sponsored by:

• a Federal, state, or local government agency located in the United States,
• a United States 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 United States institution of higher education.

The disclosure will include, at a minimum:

• the purpose of the trip,
• the identity of the sponsor/organizer,
• the destination, and
• the duration.

In accordance with this FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, to determine whether the travel constitutes an FCOI with the PHS-funded research.

The term significant financial interest does not include the following types of financial interests:

• salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization.
• income from investment vehicles, such as mutual funds and retirement accounts, if the Investigator does not directly control the investment decisions made in these vehicles.
• income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency located in the United States, a United States 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 United States institution of higher education; or
• income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States 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 United States institution of higher education.

Foreign Financial Interests and Foreign SFIs Related to the Exclusions above:

• 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).

Subrecipient is a subcontractor or consortium participant who may indirectly receive grant funding via RESOLUTE SCIENCE, INC. that holds the prime contract with the US Government.

FCOI TRAINING

In compliance with federal regulations, all RESOLUTE SCIENCE, INC. Investigators who are planning to participate in or are participating in Public Health Service (PHS) funded research are required to:

• Review this FCOI policy, which is compliant with federal regulation.
• Complete the NIH’s online FCOI Training module: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
  • Prior to engaging in research related to any PHS/NIH-funded grant
  • At least every four (4) years
  • Immediately, if:
    • RESOLUTE SCIENCE, INC. revises its FCOI policy that affects requirements of investigators.
    • An Investigator is new to the RESOLUTE SCIENCE, INC.
    • An Investigator is not in compliance with the policy or management plan.
• Understand the disclosure responsibilities of all foreign and domestic significant financial interests (SFI) per this policy.

Upon completion of the training, a certificate of completion must be sent to the FCOI Manager. Investigators should also retain a copy for their records.

DISCLOSURE, REVIEW AND MONITORING REQUIREMENTS

Disclosure

The Principal Investigator of a research project and all other individuals who meet the definition of Investigator must disclose their SFIs that are related to the responsibilities performed on behalf of INSTITUTION to the FCOI Manager. The FCOI Manager is responsible for collecting these disclosures for all Investigators:

• Not later than at the time of application for PHS-funded research
• At least annually (June 1st) during the period of award, and
• Within 30 days of discovering or acquiring a new SFI
• Within 30 days of each occurrence for reimbursed or sponsored travel.

Review

RESOLUTE SCIENCE, INC. will designate an FCOI manager. Prior to expenditure of funds, the FCOI Manager will solicit and review Investigator disclosures to determine whether an SFI is related to the research and is an FCOI per the regulatory criteria explained below.

An Investigator’s significant financial interest is related to PHS-funded research when the FCOI Manager reasonably determines that the significant financial interest:

• could be affected by the PHS-funded research; or
• is in an entity whose financial interest could be affected by the research.

The FCOI Manager may involve the Investigator in making the determination of whether the SFI is related to the NIH-funded research.

An Investigator’s SFI is an FCOI if the SFI is related to the research and the FCOI Manager determines the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research (“significantly” means that the financial interest could have a material effect on the research).

If it is determined that there is a financial conflict of interest, steps will be taken to manage the FCOI to promote objectivity regarding the design, conduct, or reporting of research. The FCOI manager will develop an FCOI management plan to manage the FCOI. The plan may outline terms, conditions, and restrictions, if any, to manage the conflict.

Investigators must formally agree to the proposed management strategies. All management plans are required to be signed by the Investigator. Compliance with the management plan will be monitored by the FCOI Manager.

If the FCOI Manager 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. Examples of conditions or management strategies that might be imposed to manage a financial conflict of interest include, but are not limited to:

Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution’s Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.)

• For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants in the informed consent document.
• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest.
• 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 an equity interest);
• Severance of relationships that create financial conflicts.

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 FCOI Manager necessary to manage the Financial Conflict of Interest.

REPORTING REQUIREMENTS

When an FCOI is identified during the period of an NIH-funded award, the assigned FCOI SO will submit an Original Report (initial report) to the NIH via the eRA Commons FCOI Module (FCOI Module).

The FCOI Manager or assigned FCOI SO in the FCOI Module is responsible for reporting the identified FCOI to the NIH. The FCOI reports include an initial report, annual report to report on the status of the FCOI (e.g., is the FCOI being managed or does it no longer exist) (i.e., ongoing) and revised FCOI reports following a retrospective review, if applicable. The following reporting times are required:

• Prior to the expenditure of funds under a new award
• Within sixty (60) days of identifying an FCOI for an Investigator who is newly participating in the project
• Within sixty (60) days for newly identified FCOIs, for existing Investigators
• At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension).
• After any retrospective review, to update a previously submitted report, if new information is discovered following completion of the review, including a Mitigation report if bias is found following completion of a retrospective review.

NIH is to be notified promptly if:

• an Investigator fails to comply with this FCOI policy.
• noncompliance with an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research.

MAINTENANCE OF RECORDS

Records of Investigator SFI Disclosure forms, the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and of actions taken to manage actual or potential FCOI, shall be retained by the FCOI Manager for:

• three (3) years from the date of the final expenditure report or
• where applicable, from other dates specified in 45 CFR 75.361 for different situations.

ENFORCEMENT MECHANISMS AND REMEDIES AND NONCOMPLIANCE