A virtual pharmaceutical company developing systems pharmacology therapies with a focus on neurological and pulmonary disease indications.

ReNeuroGen Financial Conflict of Interest (FCOI) Policy

 

Purpose

This Financial Conflict of Interest Policy (Policy) describes certain legal obligations applicable to Investigators’ disclosure of potential Financial Conflict(s) of Interest (FCOI). The purpose of this Policy is to comply with applicable law and to ensure the objectivity of the research conducted by ReNeuroGen LLC and its subsidiaries, and their respective employees, contractors, and consultants.

Investigators applying for and working on Public Health Services (PHS), National Institutes of Health (NIH), or National Science Foundation (NSF) funded research must disclose significant financial interests that are related to the Investigator’s institutional responsibilities. Investigators are all persons, regardless of title or position, who are responsible for the design, conduct, or reporting of research proposed for funding by the PHS, NIH, or NSF (together with any other organizations providing funding through grant or contract to which the regulations contemplated herein apply, collectively, the Funding Agencies), including collaborators or consultants. This Policy provides the framework to identify, evaluate and correct or remove real, apparent and potential conflicts of interest.

This Policy requires that each Investigator, subrecipient, subgrantee and collaborator affiliated with ReNeuroGen on a Funding Agency project complies with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). In addition, these regulations describe NIH’s commitment to preserving the public’s trust that the research supported by the NIH is conducted without bias and with the highest scientific and ethical standards. ReNeuroGen intends to comply with these regulations for all other Federal agency grant and contract efforts, as tailored or amended accordingly.

 

Abbreviations and Definitions

The following abbreviations and definitions are used in this Policy:

CFR Code of Federal Regulations
FCOI Financial Conflict of Interest
NIH National Institutes of Health
NSF National Science Foundation
PHS Public Health Services
SBIR Small Business Innovation Research
SFI Significant Financial Interest
STTR Small Business Technology Transfer
USC United States Code

 

An FCOI exists when ReNeuroGen reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of Funded Research.

Funded Research means any research funded by a Funding Agency but excludes applications for Phase I support under the SBIR and STTR programs.

Investigator means any person (including subrecipients, subgrantees, and collaborators) who is responsible for the design, conduct, or reporting of Funded Research.

Management of an FCOI means taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of Funded Research will be free from bias.

Policy Coordinator is the ReNeuroGen FCOI Policy Coordinator.

SFI means a financial interest of the Investigator consisting of one or more of the interests described below (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.

An SFI Disclosure is a report that each Investigator shall submit to the Policy Coordinator: (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds therefor; (b) annually thereafter; (b) in the event of certain sponsored travel, as set forth below; and (c) within thirty (30) days of the discovery or acquisition by an Investigator of any SFI.

 

What is an SFI?

• With regard to any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) 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.

• With regard to any privately held company, a SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) 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 in the entity (e.g., stock, stock options, or other ownership interest).

• For purposes of the definition of an SFI, remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and equity interest includes stock, stock options, or other ownership interest, as valued through reference to the public trading price or other reasonable measures of fair market value.

• An SFI exists with respect to intellectual property rights and interests (e.g. patents, trademarks, copyrights) upon receipt of (or right to receive) any income or other value related to such intellectual property rights and interests.

• With respect to a SFI, Investigators also must disclose (and such disclosure shall constitute an SFI Disclosure) any reimbursed or sponsored travel (i.e., travel 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 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Upon receipt of this disclosure, the Policy Coordinator will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI.

 

What is not an SFI?

An SFI does not include the following types of financial interests:

• salaries, royalties, or other remuneration paid by ReNeuroGen to the Investigator if the Investigator is currently employed or otherwise appointed by ReNeuroGen, including with respect to intellectual property rights assigned to ReNeuroGen and agreements to share in royalties related to such rights;

• any ownership interest in ReNeuroGen held by the Investigator;

• income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made by 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 USC 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 USC001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

 

SFI Disclosures and Reporting Process

Each Investigator shall submit SFI Disclosures to the Policy Coordinator as follows:

• at the time of hire or engagement of such Investigator with respect to any Funded Research on which such Investigator shall be working;

• at the time of application for Funded Research on which such Investigator shall be working and prior to the expenditure of any Funding Agency funds therefor;

• annually on or before the anniversary date of such Investigator’s initial SFI Disclosure;

• promptly in the event of certain sponsored travel, as set forth above; and

• within thirty (30) days of the discovery or acquisition of any SFI by such Investigator.

 

The Policy Coordinator will review each SFI Disclosure and evaluate whether any such SFI Disclosure has given rise to an FCOI. If it is determined that there is no FCOI, the SFI Disclosure will be filed with the Policy Coordinator’s SFI Disclosure records. If a FCOI is identified, it will be included in ReNeuroGen’s FCOI report submitted via the online eRA Commons FCOI module (or, where ReNeuroGen is a subgrantee or subawardee, then ReNeuroGen will report the FCOI as required under the applicable subgrant or subaward agreement) prior to the expenditure of any Funding Agency funds therefor. ReNeuroGen will then report any newly identified FCOIs to the applicable Funding Agency within 60 days of ReNeuroGen’s determination thereof. If an Investigator with an FCOI conducts any Funded Research, ReNeuroGen shall disclose the FCOI in each public presentation related to the results of the Funded Research.

 

Training

All Investigators are required to complete training related to this Policy and applicable law as follows:

• Upon joining ReNeuroGen;

• Prior to engaging in Funded Research;

• At least once every four years;

• In the event of any modifications to this Policy that affects an Investigator’s obligations hereunder; and

• In the event ReNeuroGen determines that an Investigator is not in compliance with this Policy or any FCOI management plan. NIH web-based training can be accessed through the NIH website at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html, and participants are required to provide ReNeuroGen with proof of completion.

 

Public Disclosure and Records Management

This policy will be publicly available on ReNeuroGen’s website at www.rngen.com, and certain information regarding FCOIs will be available within five days of a qualified written request. ReNeuroGen will maintain records of all SFI disclosures, and records of resulting ReNeuroGen management or other action with respect to the respective FCOI, for at least three years from the date of submission of the final expenditures report for the applicable Funded Research.

 

Compliance and Penalties for Non-Performance

Within 120 days of any determination by ReNeuroGen that an Investigator has failed to comply with this Policy, ReNeuroGen shall complete a retrospective review of such Investigator’s activities to determine the possibility of any bias in such Investigator’s research activities. If ReNeuroGen determines that there has been any such bias, ReNeuroGen shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the Funded Research and the actions ReNeuroGen has taken to mitigate the bias and manage the FCOI. ReNeuroGen will work with the Investigator to establish an FCOI management plan, and the Investigator shall disclose the FCOI in each public presentation related to the results of the applicable Funded Research if not previously disclosed. In certain instances, the Investigator may be prohibited from continuing to work on the project or receiving any NIH funding in the future.

 

Policy Coordinator

If you believe you have a conflict of interest or if you have any questions, please contact the Policy Coordinator, by email info@rngen.com.