FINANCIAL CONFLICT OF INTEREST POLICY

  1. Purpose

Theranano LLC is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal Financial Conflict of Interest (FCOI). The Federal Government requires that the entities engaged in research funded by the PHS maintain a Financial Conflict of Interest (FCOI) policy which is consistent with 42 CFR. 50 entitled “Responsibility of Applicants for Promoting Objectivity in Research.” The purpose of this FCOI policy is to identify, manage, reduce, or eliminate Financial Conflicts of Interest.

  1. Scope

This policy applies to all Project Directors (PDs), Principal Investigators (PIs), Project Manager (PMs) and Key Personnel who are planning to participate in or is participating in PHS funded research. Theranano LLC requires on a sponsored project to disclose a listing of Significant Financial Interest (SFI) (and those of their spouse or partner and dependent children) that could be reasonably expected to bias the design, conduct, or reporting of research.

3.            Definitions

  1. Institution means any domestic or foreign, public, or private, entity or organization (excluding a Federal agency) that is applying for or receives PHS research funding. Theranano LLC is considered an "Institution" for purposes of this policy.

  2. Investigator means the Project Director (PD), Principal Investigator (PI), Project Manager (PM) 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. Investigator also includes the investigator’s spouse or partner and dependent children.

  3. 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 NIH.

  4. PHS Awarding Component means the organizational unit of the PHS that funds the research.

  5. Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health. 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).

  6. Financial conflict of interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

  7. Significant Financial Interest (SFI) means anything of monetary value, whether or not the value is readily ascertainable.

  1.  Disclosure of FCOI

    1. Significant Financial Interests must be disclosed by all key research personnel involved in clinical research:

  • FCOI Disclosure Form must be completed annually.

  • Investigators must notify the Designated Research Official within 30 days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) any new Significant Financial Interest.

  1.  Training

5.1. All key research personnel will receive training on this material at time of implementation and    whenever this policy is updated.

 

6.     Significant Financial Interest (SFI)

6.1.             The following Significant Financial Interests must be disclosed:

  • With regard to any publicly traded entity, 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.

  • With regard to any non-publicly traded entity, 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).

  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

  • 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. Such disclosure shell include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Institutional official(s) 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.

  • An investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest.

6.2.  Significant Financial Interests do not include:

  • The financial interest does not exceed $5000 in value as determined through reference to public prices or other reasonable measures of fair market value.

  • The financial interest does not represent more than a five percent ownership interest in any single entity.

  • Salary, royalties, stocks, or other remuneration from Theranano LLC.

  • Salary, royalties, or other payments that, when aggregated for the investigator and his/her immediate family, are not expected to exceed $5000 during the next 12 month period.

  • 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.

  • 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.

  • 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.

7.          Disclosure Review

7.1.  Disclosures will be managed by a Designated Institutional Official, who will determine whether financial relationships present a source of potential conflict with PHS-sponsored research.

7.2.  The Designated Institutional Official will review the SFI Disclosure Form, determine whether the SFI is related to NIH- funded research, determine whether a FCOI exists, and if so, implement a management plan and submit an FCOI report to NIH within 60 days of disclosure.

 

 

 

8.   Management Plan

8.1.  Should management of a potential or actual Significant Financial Conflict of Interest be required,  the Designated Institutional Official will draft a management plan.

8.2. Such plans will be designed to facilitate the local resolution or management of any conflict, minimize administrative burden, and protect the confidentiality of disclosed information.

9.          Non- Compliance

9.1. If the Department of Health and Human Services determines that an FCOI was not managed or reported as required by the regulation, the Investigator involved must disclose the FCOI in each public presentation of the results of the research and request an addendum to previously published presentations.

9.2.  If an Investigator fails to comply with the Financial Conflict of Interest policy or the Management Plan, the Designated Research Official shall within 120 days:

  • Complete a retrospective review of the Investigator’s activities and the NIH-funded research project to determine any bias in the design, conduct or reporting of research.

  • Non-compliance will result initially in re-training, then in disciplinary action if there are further occurrences.

10.   Retrospective Review and Mitigation Report

 10.1.  A retrospective review will be conducted within 120 days when there is:

  • A failure by the Investigator to disclose a Significant Financial Interest that is determined by the Designated Institutional Official to constitute a Financial Conflict of Interest.

  • A failure by the Investigator to comply with a Financial Conflict of Interest management plan.

10.2.  If bias is found during the review, the Designated Institutional Official shall notify the NIH       promptly and submit a mitigation report.

11.   Sub-recipients

11.1.  Consortium agreements of the sub-recipients will be modified to accept this policy or to reference an institutional FCOI policy that will be maintained and enforced, and that meets the most recent regulatory requirements.

11.2.  If the subrecipient chooses to accept this policy, the amendment to the Consortium Agreement will include a requirement to solicit and review subrecipient Investigator disclosures that enable Theranano LLC to identify, manage and report identified FCOIs to the NIH.

11.3.  If the subrecipient chooses to use its institutional FCOI policy, the subrecipient will provide a certification that its FCOI policy complies with the regulation. In addition, the institutional FCOI policy will be modified to report identified FCOIs for its Investigators in a time frame that allows Theranano LLC to report identified FCOIs to the NIH as required by the regulation.

12.   Records

12.1.  The Designated Institutional Official will maintain records of all disclosures and associated activities securely and confidentially in a secured office.

12.2.   All records will be maintained for at least three years from the date of submission of the final expenditures report.

13.    FCOI Reporting

13.1.  All FCOI reports will be submitted to the NIH through the electronic Research  Administration (eRA) commons.

14.   Public Accessibility

14.1.  This policy will be publicly available via the Theranano LLC website, www.theranano.com