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NYTRICX, INC.

 

FINANCIAL CONFLICT OF INTEREST POLICY

Policy Statement

Nytricx is fully committed to the Public Health Service of the U.S. Department of Health and Human Services (PHS) including the National Institutes of Health (NIH) standards in promoting objectivity in research, and 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 prejudiced by a personal financial conflict of interest (FCI).

 

Definitions

For purposes of this policy, the following definitions shall apply:

  • Designated Official is the individual designated by Nytricx to oversee the financial conflicts of interest (FCOI) process, including solicitation and review of disclosures of significant financial interests.

  • Equity Interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.

  • Financial Conflict of Interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research as determined by Nytricx through the Designated Official.

  • Financial interest means anything of monetary value, whether the value is readily ascertainable.

  • Institutional responsibilities mean an Investigator’s professional activities on behalf of Nytricx. Specifically, these include:

  • Investigator means the Project Director or Principal Investigator and any other person, 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. Nytricx’s 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.

  • Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

  • Research means an 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).

  • Significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s Nytricx project responsibilities, including:

  • Interests in any publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure and any equity interest (e.g., stock, stock option, or other ownership interest) in the entity as of the date of disclosure, in which the value when aggregated exceeds $5,000;

  • Interests in any non-publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure, in which the value when aggregated exceeds $5,000, or when the Investigator or his/her immediate family 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;

  • Royalties paid to the Investigator by a third party of greater than $5,000, must be disclosed to Nytricx senior management and Nytricx Designated Official. Royalties or agreement to share in royalties related to intellectual property owned by Nytricx, and not personally owned by the Investigator, are considered remuneration from the Institution, and would not be considered a Significant Financial Interest; 

  • Travel, reimbursed or sponsored by a third party of greater than $5,000, must be disclosed to Nytricx senior management and Nytricx Designated Official. The details of this disclosure will include, the purpose of the trip, the identity of the sponsor/organizer, and the travel duration and destination. This disclosure requirement excludes travel paid for by Nytricx and does not apply to travel that is reimbursed or sponsored by an 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.

 

Significant financial interest does not include the following:

  • Salary, royalties, or other remuneration paid by Nytricx (or a subrecipient as applicable) to the Investigator if the Investigator is currently employed or otherwise appointed by Nytricx, including that paid for intellectual property rights assigned or licensed to Nytricx and agreements to share in royalties related to such rights;

  • Any ownership interest in Nytricx (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);

  • 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.

 

Responsibilities of Nytricx’s Designated Official

 

The Designated Official or his/her designee shall be responsible for the following:

  • Informing Nytricx Investigators of their obligations under this policy and any related regulations;

  • Reviewing disclosures of significant financial interest with Nytricx’s senior management to determine whether they are related to the subject research and, if so, whether they constitute FCOI;

  • Screening and managing potential FCOI;

  • Maintaining all records relating to disclosures of financial interests, Nytricx’s review of and response to such disclosures, and any related actions under this policy;

  • Ensuring inclusion of any required certifications in applications for funding or contract proposals; and

  • Reporting and disclosure as required under this policy and applicable regulations.

Responsibilities of Nytricx’s PHS-funded research PD/PI, have the following responsibility:

  • Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Nytricx with sufficient assurances to enable Nytricx’s compliance with all applicable laws or regulations. To this end, the written agreement between Nytricx and the subrecipient will specify whether Nytricx’s or the subrecipient’s FCOI policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply;

  • If Nytricx’s policy applies to the subrecipient Investigators, Nytricx will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.

 

Clinical Research Requirements

If a PHS-funded clinical research project, designed to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted, or reported by an Investigator with a FCI that was not managed or reported by Nytricx; the Investigator involved is required to disclose the FCI in each public presentation of the research results, and to request an addendum to any previously published presentations.

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Training and Education

NIH necessitates compliance (except for Phase I SBIR/STTRs) with PHS FCOI requirements, and Nytricx will train its investigators on the Company’s policy and disclosure responsibilities.  Nytricx Investigators will receive training to promote objectivity in research and to ensure Investigator compliance regarding the applicable regulations and significant financial interest disclosure obligations. A NIH website is available at https://grants.nih.gov/grants/policy/coi/fcoi-training.htm with a training module on the FCOI regulation for institution officials and Investigators.

Nytricx requires Investigators to complete such training annually, and when any of the following occurs:

  • Nytricx revises its FOIC policy or procedures in any manner that affects the Investigator’s obligations;

  • An Investigator is new to Nytricx; or

  • Nytricx finds that an Investigator is not in compliance with this policy or a FOIC management plan.

 

Internal Reporting Requirements

For any PHS-funded research, each Investigator who is planning to participate in the research is required by regulation to complete a Significant Financial Interest Disclosure (SFID) Form and submit the SFID Form to Nytricx’s Administrator. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. SFID Forms will be provided to Investigators in conjunction with the annual training and will be otherwise made available. Nytricx’s Administrator will review SFID submissions with the Designated Official. The information reported on the SFID Form includes a listing of the Investigator’s known significant financial interests and those of his/her immediate family that reasonably appear to be related to the research or that are in entities whose financial interests could be affected by the research. Nytricx Investigators in non-PHS-funded research who have any significant financial interest that may reasonably appear to be affected by the research are also expected to complete the SFID Form and submit it to Nytricx’s Administrator.  Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research).

 

Review Requirements and Determination / Management of Financial Conflicts of Interest

The Designated Official will solicit and review SFIDs of the Investigator and following policy guidelines, determine whether it falls under PHS-funded research FCOI requirements.  If the SFID could directly and significantly affect the design, conduct, or reporting of the NIH-funded research), the Designated Official, working with senor Company management, will develop and implement plans to address any FCOIs. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A FCI exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research. If Nytricx determines that a FCI exists, a FCOI management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict.

In addition to the conditions or restrictions described above, Nytricx may require the management of conflicting financial interests in other ways as it deems appropriate.

 

External Reporting Requirements

Nytricx will disclose FCOI as required by applicable laws or regulations. Before expending any funds under a PHS award, Nytricx will ensure public accessibility by posting FCOI information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any FCI that has not been eliminated and will ensure that Nytricx has implemented a plan to manage the conflict.

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FCOI Retrospective Review

 

Nytricx will undertake a retrospective review whenever a FCI is not identified in a timely manner including:

  • Failure by the Investigator to disclose a SFID that is determined by Nytricx to constitute a FCOI;

  • Failure by the Institution to review or manage such a FCOI; or

  • Failure by the Investigator to comply with a FCOI management plan;

 

The retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict.

 

Nytricx will document the retrospective review which will include: 

  • Project number and title

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

  • Name of the Investigator with the FCOI;

  • Name of the entity with which the Investigator has a FCI

  • Reason(s) for the retrospective review;

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

  • Findings of the review; and

  • Conclusions of the review.

 

Nytricx will notify the PHS/NIH of an identified conflict, complete a retrospective review, and submit a mitigation report within 120 days of its determination of noncompliance.

 

The mitigation report will include:  

  • Key elements documented in the retrospective review;

  • Description of the impact of the bias on the research project;

  • A plan of action to eliminate or mitigate the effect of the bias on the research project;

  • Extent of harm done, including any qualitative and quantitative data to support any actual or future harm; and

  • An analysis of whether the research project is salvageable. 

Thereafter Nytricx will submit FCOI reports annually as prescribed by the regulation.

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Retention of Records

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The Designated Official will retain FOIC disclosure forms and other supporting information consistent with Nytricx’s Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by Nytricx with respect to each FCI will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 75.361 or 48 CFR Part 4, Subpart 4.7.

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Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact the Nytricx Designated Official at FCOI at Nytricx.com.

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