NIH-RELATED FINANCIAL CONFLICT OF INTEREST POLICY AND PROCEDURE FOR INHERENT BIOSCIENCES

The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take to promote objectivity in research. The regulations apply to all PHS funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is PHS. The regulations require that investigators submitting applications for funding on behalf of a subrecipient, where the prime sponsor is PHS (e.g., funding from the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control), prior to the submission of the subaward application to the PHS Grantee organization, disclose to Inherent Biosciences any significant financial interests related to their institutional responsibilities at Inherent Biosciences.

Definitions

Institutional responsibilities mean an Investigator’s professional activities on behalf of Inherent Biosciences (e.g., teaching, administration, research or clinical care). Specifically, these include [Identify those that are applicable to Inherent Biosciences and/or include others more appropriate]:

  • Externally sponsored research or scholarly activities (includes activities such as proposing, conducting, and analyzing research and disseminating results);

  • Research (includes participation in study sections, peer review of manuscripts, or effort on non-sponsored research);

  • Instruction/University Supported Academic activities (including preparation for and presentations of formal and informal courses to students/trainee groups, mentoring students and trainees, and participation in resident training);

  • Clinical Service activities such as performing services for the University’s Faculty Practice Plan and affiliated hospitals;

  • Administrative activities including serving as Department Chair, Program Director, or service on institutional committees, participation in department activities or faculty advisory boards, etc.;

  • Special Service activities on behalf of Inherent Biosciences including institutional community service.

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by a subaward, or proposed for such funding, which may include, for example, collaborators or consultants. Inherent Biosciences’ Principal Investigator/Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

Significant Financial Interest means:

(1) 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 appear to be related to the Investigator’s institutional responsibilities on behalf of Inherent Biosciences

(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated for the investigator, investigator’s spouse and dependent children, 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;

(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

(iii) With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.

(iv) Third party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater than $5,000 that is related to the Investigator’s institutional responsibilities (i.e., administrative, teaching, research, or clinical activities) must be disclosed to Inherent Biosciences. The details of this disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. This disclosure requirement excludes travel paid for by Inherent Biosciences and does not apply to travel that is 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 an Institution of higher education.

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

(i) Salary, royalties, or other remuneration paid by Inherent Biosciences to the Investigator if the Investigator is currently employed or otherwise appointed by Inherent Biosciences, including intellectual property rights assigned to Inherent Biosciences and agreements to share in royalties related to such rights;

(ii) 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;

(iii) Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or

(iv) Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Disclosure

Prior to the submission of an application to the PHS Grantee for funding, the Principal Investigator and all other Investigators at Inherent Biosciences must have disclosed to Inherent Biosciences’ Conflict of Interest Committee (COIC)/designated official an up-to-date listing of their Significant Financial Interests [SFIs] (and those of their spouse and dependent children), as defined above. Any new Investigator, who, subsequent to the submission of an application to the PHS Grantee for funding from the PHS Grantee, or during the course of the research project, plans to participate in the project, must similarly disclose their SFI to the COIC/designated official promptly and prior to participation in the project.

Each Investigator who is participating in research under a subaward where the prime award originates from PHS must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to Inherent Biosciences, pursuant to this Policy, or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on a PHS-funded project directly as a P

HS Grantee and/or indirectly through a subaward) that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

Each Investigator who is participating in research under a subaward where the prime award originates from PHS must submit an updated disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

Review by Inherent Biosciences’ COIC/Designated Official

The COIC/designated official will conduct reviews of disclosures. The COIC/designated official will review any SFI that has been identified in a disclosure; these interests will be compared to each research subaward funded under a PHS prime award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research subaward.

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The COIC/designated official will determine whether an Investigator’s SFI is related to the research under a subaward supported by a PHS prime award and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is related to the research under the subaward when the COIC/designated official reasonably determines that the SFI:

  • Could be affected by the research conducted under the subaward; or

  • Is in an entity whose financial interest could be affected by the research.

The COIC/designated official may involve the Investigator in the determination of whether a SFI is related to the research supported by the subaward.

A financial conflict of interest exists when the COIC/designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

In determining if an Investigator’s SFI is related to the research under a subaward supported by a PHS prime award, and if so, whether the relationship creates a FCOI, the COIC/designated official considers the role of the Investigator and the opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the SFI in relation to the size and value of the entity. In addition, the COIC/designated official may also consider the following factors (Inherent Biosciences may define others):

  • Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or

  • Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely; or

  • Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or

  • Where the research involves human subjects, whether there are double-blind conditions or the involvement of a data and safety monitoring board; or

  • Where the SFI is in a privately held company, whether the researcher’s SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs); or

  • The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or

  • Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future; or

  • The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or

  • Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or

  • Whether other scientific groups are independently pursuing similar questions; or

  • Whether sufficient external review of the research conducted and the reporting of research results exist to mitigate undue bias; or

  • Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has a SFI; or

  • Whether the project involves a subaward to an entity in which the Investigator has a SFI.

Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest

If a conflict of interest exists, the COIC/designated official will determine by what means – such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed to mitigate undue bias. In making those determinations, the COIC/designated official will be guided by the principles discussed in this Policy, and the COIC/designated official will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications. Examples of conditions 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);

  • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants;

  • 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;

  • For research projects involving human subjects research, use of a data and safety monitoring board;

  • Double-blind conditions;

  • Provisions to conduct the work simultaneously at multiple sites;

  • Written disclosure of the conflict to all individuals working on the research project;

  • Annual reports on the research progress to the COIC/designated official.

If the COIC/designated official determines that a conflict exists, it will communicate its determination and the means it has identified for eliminating or managing the conflict, in writing, to the individual, to the relevant Principal Investigator/Project Director, and the appropriate direct supervisor. The COIC/designated official will keep a record of the disclosure and other relevant information for at least three years. If the COIC/designated official prescribes monitoring of the activity, it will describe what monitoring shall be performed and what records are to be kept. No expenditures on a subaward supported by a PHS prime 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 COIC/designated official necessary to manage the Conflict of Interest. The COIC/designated official will communicate, in writing, with the PHS Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until the PHS Grantee has reported the FCOI to PHS. The PHS Grantee will notify Inherent Biosciences when it may incur expenditures. The COIC/designated official will keep a record of Investigator disclosures of financial interests and the COIC/designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant PHS Regulations.

Reporting Requirements to NIH for Financial Conflicts of Interest

Inherent Biosciences will:

  • Send initial, annual (i.e., ongoing) and revised FCOI reports for the Institution’s Investigators and those of its subrecipients, if applicable, including all required information defined in the regulation and in NIH’s FAQ H.5, to the NIH via the eRA Commons FCOI Module, as required by the regulation and as stated below:

    • Prior to the expenditure of funds 

    • Within sixty (60) days of identification for an Investigator who is newly participating in the project 

    • Within sixty (60) days for new, or 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). The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project. 

    • After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review. 

  • Based on the results of a retrospective review, notify NIH promptly if bias is found with the design, conduct or reporting of NIH-funded research and submit the required Mitigation Report. The Mitigation report includes the key elements of the Retrospective review plus information to explain what action(s) have been or will be taken to mitigate the effects of the bias (i.e., a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias. 

    • To ensure compliance with retrospective review and bias mitigation reporting requirements, the policy and/or procedures should include all of the key elements documented in the retrospective review as well as the elements of a mitigation report that must be submitted to NIH. 

  • Notify NIH promptly if an Investigator (or subrecipient Investigator) fails to comply with the Institution’s FCOI policy or noncompliance with a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research. 

    • Notify NIH promptly and take corrective action for noncompliance with the Revised 11-20-2023 4 Institution’s policy or the management plan.

Training Requirements

Inherent Biosciences will inform each Investigator of the:

  • Institution’s policy

  • Investigator’s disclosure responsibilities of all foreign and domestic significant financial interests (SFI) per the SFI definition and NIH’s FAQs E.9. and E.20.

  • Federal regulation (See NIH’s FAQ L.1., “FCOI Training” tutorial and other training resources on NIH’s FCOI Training website)

Each Investigator must complete training on Inherent Biosciences’ Conflict of Interest Policy Applicable to A Subaward Issued Under A Public Health Services Prime Award prior to engaging in research related to any PHS-funded subaward and at least every four years, and immediately (as defined below) when any of the following circumstances apply:

  • Inherent Biosciences revises this Policy or procedures related to this Policy in any manner that affects the requirements of Investigators; or

  • An Investigator is new to Inherent Biosciences; or

  • Inherent Biosciences finds that an Investigator is not in compliance with this Policy or a management plan developed by the COIC/designated official to manage a Financial Conflict of Interest.

Inherent Biosciences will require each Investigator to complete the training before the Investigator can engage in PHS-funded research, and at least every four years thereafter.

Subrecipients

For any subrecipient whose role includes the design, conduct, or reporting of research subject to PHS regulations on Promoting Objectivity in Research requirements must, in accordance with the PHS regulations, adhere to a FCOI policy that complies with the requirements of FCOI regulation. 

Inherent Biosciences will:      

  • Address FCOI subrecipient requirements including compliance with NIH subaward/consortium written agreement requirements provided in the NIH Grants Policy Statement Section 15.2.1.

  • Establish, via a written agreement, whether the subrecipient will follow the FCOI policy of the awardee Institution or the FCOI policy of the subrecipient.

    • Obtain a certification from the subrecipient that its FCOI policy complies with the regulation.

    • Include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators in a time frame that allows the awardee Institution to report identified FCOIs to the NIH as required by the regulation.

    • Alternatively, include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable the awardee Institution to identify, manage and report identified FCOIs to the NIH.

Public Health Service Definition of Senior/Key Personnel

Inherent Biosciences will apply the PHS definition of senior/key personnel to its subaward application to the PHS Grantee and any reporting requirements under the subaward. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by Inherent Biosciences in the subaward application to the PHS Grantee, progress report, or any other report submitted to the PHS Grantee.

Responsibility for Oversight of this Policy

The Inherent Biosciences’ COIC/designated official is responsible for the ongoing oversight of this Policy, including the initiation of the development of new subpolicies and procedures as needed, the periodic review of the effectiveness of this Policy and related subpolicies and procedures, and the initiation of revisions as necessary.

Non-compliance

If the COIC/designated official determines that an Investigator is not in compliance with this Policy or a management plan developed by the COIC/designated official to manage a Financial Conflict of Interest, the COIC/designated official will, within one hundred and twenty  (120) days of determining non-compliance:

  • Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance (e.g., letters of reprimand, restriction on the use of funds, etc.).

  • Complete a retrospective review within 120 days of the Institution’s determination of noncompliance when an SFI is not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner, including:

    • Failure by the Investigator to disclose an SFI that is determined by the Institution to constitute a financial conflict of interest;

    • Failure by the Institution to review or manage such a financial conflict of interest;

    • Failure by the Investigator to comply with the financial conflict of interest management plan;

  • Document the retrospective review which shall include at a minimum the following key elements:

    • Project Number

    • Project Title

    • PD/PI or contact PD/PI if multiple PD/PI model is used;

    • Name of the Investigator with the FCOI;

    • Name of the entity with which the Investigator has an FCOI;

    • Reasons for the retrospective review;

    • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed); 

    • Findings of the review; and 

    • Conclusions of the review                     

  • Ensure that in any case in which the Department of Health and Human Services determines that an NIH-funded research 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 managed or reported by the Institution as required by the regulation, the Institution shall require the Investigator involved to:

  • Disclose the FCOI in each public presentation of the results of the research, and

  • Request an addendum to previously published presentations

The COIC/designated official will work with the Investigator to develop a management plan to ensure, to the extent possible, that any such bias found in the retrospective review is corrected and that future research will be conducted in an unbiased manner.

If the COIC/designated official determines that a PHS-funded research project of a subaward has not been conducted in accordance with this Policy or that an Investigator has not complied with this Policy, the COIC/designated official will promptly notify the PHS Grantee. Inherent Biosciences is committed to taking all necessary steps to ensure compliance with the PHS regulations on Promoting Objectivity in Research.

Definitions Applicable to This Policy

FCOI is the existence of a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

  • Financial Interest means anything of monetary value, whether or not the value is readily ascertainable, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

  • Human Subject Research means any systematic investigation, including research development, testing, and evaluation, utilizing human subjects, that is designed to develop or contribute to generalizable knowledge. Systematic investigation encompasses both basic and applied research and includes any such activity for which funding is requested, e.g., research proposals.

  • Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by a subaward or proposed for such funding, which may include, for example, collaborators or consultants.

  • Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

  • PD/PI is the abbreviation for Principal Investigator or Project Director.

  • Promoting Objectivity in Research is a federal regulation described in 42 CFR Part 50 Subpart F and 45 CFR Part 94 on Promoting Objectivity in Research.

  • PHS is the abbreviation for the Public Health Service.

  • PHS Grantee is an institution that has applied for and received a federal research award from the Public Health Service.

  • PHS-funded research is research funded by the Public Health Service through a prime award (e.g., grant, cooperative agreement, contract) issued directly to Inherent Biosciences or via a subaward under a prime award issued to a PHS Grantee.

  • Research means a systematic investigation, including research development, testing, and evaluation, utilizing human subjects, that is designed to develop or contribute to generalizable knowledge. Systematic investigation encompasses both basic and applied research and includes any such activity for which funding is requested.

  • Retrospective Review means an assessment conducted by the COIC/designated official, working with the Investigator, to determine whether the PHS-funded research conducted during the period of non-compliance with this Policy was biased in the design, conduct, or reporting of such research.

This Policy may be updated from time to time as deemed necessary by Inherent Biosciences. Inherent Biosciences is committed to taking all necessary steps to ensure compliance with the PHS regulations on Promoting Objectivity in Research.

This Policy was last updated on February 1, 2024.