Renovion 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. Renovion has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.
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The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for US Public Health Service (PHS)-sponsored research and are intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to Renovion's research activities.
Policy Background
This policy and related procedures have been developed to identify, manage, mitigate, neutralize, or eliminate actual, apparent, and potential financial conflicts of interest. The policy was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought[1] and 45 CFR Part 94, Responsible Prospective Contractors.
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42 CFR 50 outlines the NIH's commitment to preserving the public's trust that NIH-supported research is conducted without bias and with the highest scientific and ethical standards. Renovion is committed to using this same FCOI standard for all grant- and non-grant-funded research.
Key Terms
Investigator
Any person, including subrecipients, subgrantees and collaborators, who is responsible for the design, conduct, or reporting of research funded by PHS.
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Research
PHS research is any project governed by PHS regulation, but excluding applications for Phase ! support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
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Training Requirements
Renovion and all defined sub-level vendors are required to complete training related to FCOI. If any conflicts of interest are found, they must be disclosed. The training must be updated no less than every four years or as designated based on grant or role circumstances. Information and other resources developed by the NIH will be updated as appropriate and can be accessed through the NIH website.
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Financial Conflict of Interest (FCOI)
FCOI exists when Renovion reasonably determines that a significant financial interest (SFI) could directly and significantly affect the design, conduct, or reporting of NIH-funded research.
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Managing FCOI
Taking action to address a FCOI that can include reducing or eliminating the FCOI to ensure (to the extent possible) that the design, conduct, and reporting of the research will be free from bias.
Significant Financial Interest
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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 Investigators institutional responsibilities:
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Regarding 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value;
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Regarding any non-publicly traded entity: a significant financial interest exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or Investigator's spouse or dependent children) holds any equity interests (e.g., stock, stock options, or other ownership interest) or
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Upon receipt of income related to intellectual property rights and interests (e.g., patents, copyrights)
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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, medical center, or 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(s) 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 with the PHS-funded research.
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The term significant financial interest does not include the following types of financial interests: salaries, 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 retirements 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, 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.
Disclosure Process
Disclosure Reporting
Renovion's designated official(s) will review all disclosure(s) and evaluate for any FCOI.
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If no FCOI is found, the disclosure forms will be filed.
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If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds.
If any interests are identified as conflicting subsequent to the initial report, they must be reported to Renovion within 30 days. Renovion will then report it to the PHS awarding component that has issued the award within 60 days.
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Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator with a conflict that was not disclosed or managed, Renovion is required to disclose the conflict in each public presentation related to the results of the research.
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Records Management
The records of all financial disclosures and all actions taken by Renovion will be maintained for at least three years from the date of submission of the final expenditures report.