Financial Conflicts of Interest (FCOI) Policy

Institution. Trig Innovation (the “Institution”) has taken steps to inform each Investigator (e.g., employee or subcontractor participating in a Public Health Service(PHS)-funded project) of the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of applicable Federal regulations. Each Investigator has been required to complete training 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:

(1)    The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

(2)    An Investigator is new to an Institution; or

(3)    The Institution finds that an Investigator is not in compliance with the Institution’s financial conflict of interest policy or management plan.

The Institution agrees to make information available, promptly upon request, to the Health and Human Services relating to any Investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of a financial conflict of interest.

 

Official. Ty Hagler has been designated the Institution’s Official to solicit and review disclosures of significant financial interests from each Investigator. Ty Hagler may assign other Officials as he sees fit.

Official(s) are responsible for providing any initial and ongoing FCOI reports, as well as maintain records relating to all Investigator disclosures and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted.

 

Each Investigator shall disclose to an Official the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.

Each Investigator shall submit an updated disclosure of significant financial interests at least annually, every January if not otherwise stated, during the period of the award. Such disclosure shall include any information that was not disclosed initially or previously disclosed to an Official, and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

Each Investigator shall submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

Guidelines for determining whether an Investigator’s significant financial interest is related to PHS-funded research is when an Official 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.

 

A financial conflict of interest exists when an Official reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. Upon identification of a financial conflict of interest, an Official shall take such actions as necessary to manage the financial conflict of interest, including development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report.

Adequate enforcement mechanisms and/or employee sanctions or other administrative actions are enforceable to ensure Investigator compliance, as appropriate. Further, based on such disclosures, an Official shall, within 30 days of such disclosure: review the disclosure; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan.

 

Retrospective Review. Whenever a financial conflict of interest is not identified or managed in a timely manner, the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to

determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. The Institution shall document the retrospective review, including a detailed methodology used for the review and findings of the review. Based on the results of the retrospective review, if appropriate, the Institution

shall update the previously submitted FCOI report, specifying the actions that will be taken to manage

the financial conflict of interest going forward.

 

Mitigation Report. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and 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. Thereafter, the Institution will submit FCOI reports annually.

 

Public Disclosure. Prior to the Institution’s expenditure of any funds under a PHS-funded research project, the Institution shall ensure public accessibility, via a publicly accessible website or written

response to any requestor within five business days of a request, of information concerning any significant financial  interest disclosed to the Institution that meets the following three criteria:

(1)     The significant financial interest was disclosed and is still held by senior/key personnel;

(2)    The Institution determines that the significant financial interest is related to the PHS-funded research; and

(3)    The Institution determines that the significant financial interest is a financial conflict of interest.

 

FCOI Reporting. The Institution 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 the Institution has implemented a management plan. In cases in which the Institution identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI Report to the PHS Awarding Component. Any FCOI report required under 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.

 

Annual Report. For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. 

 

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. Details of this disclosure include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

(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.