IstosVisio Inc. Company Policy

Financial Conflict of Interest (FCOI) Policy

Purpose and Guiding Documents

The appropriate conduct of research activities is essential to the principles and mission of IstosVisio, Inc. The company grew from innovation grants awarded by the National Institutes of Health (NIH), and it is paramount for IstosVisio to maintain the highest standards of objective research, as stipulated by the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS). Management of Financial Conflicts of Interest (FCOI) by employees of IstosVisio is an important process to help ensure the objectivity and reliability of research conducted by the company. We therefore require that each investigator at IstosVisio and collaborators affiliated with IstosVisio research activities be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). IstosVisio monitors compliance by affiliated research collaborators. IstosVisio uses this same FCOI standard, to which the NIH is committed, for all other Federal agency grant and contract efforts, as tailored or amended accordingly.

Definitions and Procedures

The following paragraphs provide key definitions and policies that describe IstosVisio’s FCOI policy guidance, which is also available at https://www.syglass.io/fcoipolicy for public access.

Investigator

An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct or reporting of research funded by the PHS.

Research

PHS research is any project governed by PHS regulation but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Training Procedures

IstosVisio and all defined sub-level vendors are required to complete training related to Financial Conflict of Interest (FCOI), at the time of implementation of the policy or at the initiation of employment. The training must be updated no-less than every four years, and verified at the time of award of PHS funding. The signing official for IstosVisio will verify compliance and indicate to investigators when they must complete or renew training. Information and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site. (https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html).

Significant Financial Interest (SFI)

Significant Financial Interest includes financial remuneration and travel, as defined by the regulations. A significant financial interest exists if the value of any remuneration received from a publicly traded 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. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship), ownership interest that includes but is not limited to equity interest in stock or stock options. The value of ownership interest is determined through reference to public prices and other reasonable measures of fair market value. A significant financial interest exists if the value of any remuneration received from a nonpublicly traded entity 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 the Investigator’s spouse or dependent children) holds any equity interests (e.g. stock, stock options, or other ownership interest) or Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests. A significant financial interest exists if 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 in the twelve months preceding the disclosure if the value of such travel, when aggregated from all sources, exceeds $5,000. 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. Disclosures relating to travel expenses must specify the purpose, duration and destination of the trip, and the identity of the sponsor. Certain financial interests do not constitute a significant financial interest, including salaries, royalties or other remuneration paid by IstosVisio to the Investigator if the Investigator is currently employed or otherwise appointed by IstosVisio, including intellectual property rights assigned to IstosVisio and agreements to share in royalties related to such rights; any ownership interest in IstosVisio 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 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.

Financial Conflict of Interest (FCOI)

A Financial conflict of interest exists when IstosVisio reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct or reporting of NIH-funded research.

Disclosures/Reporting Process

The Signing Official will ensure that each investigator submits a listing of his/her known significant financial interests and evaluate whether they contain any FCOI. If no FCOI is found the disclosure forms will be stored electronically. If a FCOI is identified, it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. All disclosures are updated annually during participation in a PHS-funded research award or, if any interests are identified as conflicting subsequent to the initial report, they must be reported to IstosVisio within 30 days. IstosVisio will then report it to the PHS awarding component that has issued the award within 60 days. Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, IstosVisio is required to disclose the conflict in each public presentation related to the results of the research.

Records Management

The records of all financial disclosures and all actions taken by IstosVisio will be maintained for at least three years from the date of submission of the final expenditures report.

Compliance and Penalties for Non-Performance

If an investigator fails to comply with IstosVisio’s FCOI policy, within 120 days, IstosVisio shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, IstosVisio shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. Sanctions on the employee may be imposed and may include suspension or dismissal, denial of eligibility to engage in the research at issue or other appropriate penalties. IstosVisio is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.