Financial Conflict of Interest (FCOI) Policy Effective Date: February, 2024 Summary The National Institutes of Health (NIH) expects that the design, conduct and reporting of NIH research should be free from bias that could result from investigators’ financial conflicts of interest (FCOI). NIH is committed to preserving the public’s trust that the research it supports is conducted with the highest scientific and ethical standards. NanoDiagnostic Technology, LLC (NDT) has established the policy herein that is aligned with NIH’s requirements and underspin the highest standards of research integrity, ethics, and governance expected of all our researchers. This policy provides the framework to identify, evaluate, and correct/remove real, apparent, and potential conflicts of interest. We will continue to update this policy whenever needed to address any changes in personnel FCOI matters or upon further NIH guidance. NDT’s policy requires that each NDT investigator and anyone affiliated with NDT (e.g., by way of a contract) should comply with all relevant external research funding bodies’ policies pertaining to conflicts of interests and external interests. Where funder policies contain additional requirements beyond what is required by the NDT’s Conflict of Interest Policy, the funder’s additional requirements should be complied with in full. In addition, NDT’s policy requires that each investigator, collaborator, sub-grantee, contractor, or consultant affiliated with NDT be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). This legislation ensures the public’s trust that the research supported by NIH is conducted without bias and with the highest scientific and ethical standards. NDT adopts this same FCOI standard for all other Federal agency grants and contract efforts, as tailored or amended accordingly. The following sections define key-term and state NDT’s policy guidance for principal investigators, collaborators, sub-grantees, contractors, and/or consultants affiliated with NDT. Definitions Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. FCOI report means an Institution's report of a financial conflict of interest to a PHS Awarding Component. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding. Institutional responsibilities mean an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: 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. 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 the PHS, 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 means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart. 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). PHS Awarding Component means the organizational unit of the PHS that funds the research. Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). 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 by the Institution under this subpart. 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 appears to be related to the Investigator's institutional responsibilities: (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, 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) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a 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. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research. (3) 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, 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 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 income from service on advisory committees or review panels for a 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. Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564. Financial Conflict of Interest (FCOI) Policy I. Training requirements NDT shall: (a) Maintain the up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation (42CFR part 50 Subpart F). Before this policy is available on NDT’s website, NDT shall make its written policy available to any requestor within five business days of a request. (b) Inform each Investigator of the NDT's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of all foreign and domestic significant financial interests, and of these regulations (see NIH’s FAQ L.1.; FCOI training tutorial, and other training resources on NIH’s FCOI training website) (c) require each Investigator to complete training at https://grants.nih.gov/grants/policy/coi/fcoi-training.htm regarding the same prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply: (i) NDT revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; (ii) An Investigator is new to NDT; or (iii) NDT finds that an Investigator is not in compliance with the NDT's financial conflict of interest policy or management plan. II. Disclosure, Review, Monitoring, Management Requirements NDT shall: a. Require each investigator to disclose their foreign and domestic Significant Financial interests (SFIs) (and those of investigator’s spouse and dependent children) related to the investigator’s institutional responsibilities that meet the regulatory definition of SFI (i) no later than the time of application for PHS-funded research; (ii) At least annually during the period of the award; (iii) Within thirty (30) days of discovering or acquiring a new SFI. b. Designate an institutional official Dr. Sri Muthialu, a signing official of NDT, to solicit and review disclosures of significant financial interests from each Investigator (and those of the investigator’s spouse and dependent children) who is planning to participate in, or is participating in, the PHS-funded research related to their responsibility for a determination of FCOI. c. Provide adequate guidelines consistent with the regulation for the designated institutional official to determine whether an investigator’s SFI is related to PHS/NIH-funded research and if so related, whether the SFI is an FCOI. An SFI is related to PHS/NIH-funded research when the designated official determines that SFI: (i) Could be affected by the PHS/NIH-funded research; or (ii) Is in the NDT whose financial interest could be affected by the research. The Investigator may be involved in making the determination of whether the SFI is related to the PHS/NIH-funded research. An FCOI exists when NDT, through its designated official, reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. The examples of conditions or restrictions are included that might be imposed to manage conflicts of interest (e.g., full public disclosure, appointment of an independent monitor, modification of the research plan, etc.). See regulation and NIH’s FAQ F.1. for more information on how to manage an FCOI). d. Require the designated official, prior to institution’s expenditure of funds, to
Review all investigator SFI disclosures
Determine if any SFIs related to the investigator’s PHS/NIH-funded research
Determine if an FCOI exits (e.g., an SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research)
Develop and implement a management plan to manage the FCOI if an FCOI exists.
e. Require when an Investigator who is new to participating the research project or when an existing Investigator discloses a new SFI, the designated official will review within sixty days disclosure of SFI, determine whether the SFI is related to the Investigators PHS/NIH funded research; determine whether an FCOI exists; and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been and will be, take to manage the FCOI. f. Require whenever NDT identifies an SFI that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing NIH-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official will review within sixty (60) days disclosures of SFIs, determine whether the SFI is related to the Investigator’s PHS/NIH-funded research; determine whether an FCOI exists; and if so, implement, at least on an interim basis, a management plan that specifies the actions that have been, and will be taken to manage the FCOI going forward. g. Take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator compliance with management plans until completion of the project. III. Reporting Requirements a. NDT will send initial, annual (i.e., ongoing) and revised FCOI reports to the PHS awarding component regarding the investigators and those of its subrecipients, if applicable, inducing 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: (i) Prior to the expenditure of any funds under a PHS-funded research project. NDT shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by the Institution to be conflicting and ensure that NDT has implemented a management plan in accordance with this 42 CFR 50 subpart F. In cases in which NDT identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, NDT shall not submit an FCOI report to the PHS Awarding Component. (ii) Within sixty (60) days of identification for an Investigator who is newly participating in this project. (iii) Within sixty (60) days for new, or newly identified, FCOIs for existing. (iv) At least annually (at the same time as when NDT 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. (v) After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review. b. Based on the results of a retrospective review, NDT will notify NIH promptly if bias is found with the design, conduct or reporting of PHS/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 actions 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 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. c. NDT will notify NIH promptly if an Investigator (or subrecipient Investigator) fails to comply with the NDT’ FCOI policy or noncompliance with a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS/NIH-funded research. NDT will notify NIH promptly and take corrective actions for noncompliance with the Institution’s policy or the management plan. d. Any FCOI report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following: (i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the Investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) Value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; (vii) 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 (viii) A description of the key elements of the Institution's management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator's agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed. IV. Maintenance of Records NDT will maintain all FCOI-related records relating to all investigator disclosures of financial interests and the NDT’s review of, and response to, such disclosure (whether or not a disclosure resulted in the NDT’s determination of a financial conflict of interest.) and all actions under the NDT’s policy or retrospective review, if applicable. (i) For at least three (3) years from the date the final expenditures report (Final Federal Financial Report) is submitted. (ii) Or, where applicable, from other dates specified in 45 CFR 75.361 for different situations. V. Enforcement Mechanisms and Remedies and Noncompliance
NDT shall 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.).
NDT shall complete a retrospective review (see FAQs in Section I) within 120 days of the institution’s determination of noncompliance when an SFI is not disclosed timely or previously reviewed or whenever and FCOI is not identified or managed in a timely manner, including:
(i) Failure by the Investigator to disclose an SFI that is determined by the Institution to constitute a financial conflict of interest; (ii) Failure by the Institution to review or manage such a financial conflict of interest; (iii) Failure by the Investigator to comply with the financial conflict of interest management plan.
NDT shall 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
Conclusions of the review
NDT ensures 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:
(i) Disclose the FCOI in each public presentation of the results of the research, and (ii)Request an addendum to previously published presentations. VI. Subrecipient Requirements NDT shall:
Address FCOI subrecipient requirements (See FAQ K.1) 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.
Make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation, not the NIH Grants Policy Statement), publicly accessible prior to the expenditure of funds. This publicly accessible information will include:
Be posted on a Public Website or before the policy is available on NDT’s website, NDT will make it available within five (5) business days of a written request.
Be updated, at least annually (Web site only but any response to a written request should include the updated information.
Be updated, within sixty (60) days of a newly identified FCOI (Web site only but any response to a written request should include the updated information).
Remain available for three (3) years from the date the information was most recently updated.
Point of Contact If you have a conflict of interest or if you have a question to discuss, contact the NDT’s Signing Official Dr. Sri Muthialu at sri.muthialu@nanodiagtech.com and Principal Investigator Dr. Jun Wang at jun.wang@nanodiagtech.com.
Part IV, Department of Health and Human Services, 42 CFR Part 50, 45 CFR Part 94, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors
Check list for policy development related to the 2011 financial conflict of interest regulation, promoting objectivity in research (42 CFR part 50 Subpart F)