Financial Conflict of Interest

This policy details the proper controls and measures in place to manage, identify, and neutralize any deliberate, materialized, or potential forms of financial conflicts of interest concerning investigators and their activity within RealizedCare.

1. Background

For any research or cooperative agreement funded by the US Public Health Service (PHS), government regulations (42 CFR Part 50 Subpart F) require that objectivity in research is promoted by having an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest (FCOI).

  • PHS agencies include FDA, SAMHSA, NIH, CDC, AHRQ, HRSA and IHS

  • Research includes basic and applied research, as well as research relevant to product development.

  • The FCOI Management policy applies to each RealizedCare investigator involved in the research (primary investigators, co-investigators, and sub-investigators), as well as any sub-grantees, contractors or collaborators who carry out PHS-funded research activities on behalf of RealizedCare.

RealizedCare’s FCOI Policy Contents:

2. Purpose & Guidelines

RealizedCare operates and strives to provide quality immersive experiences via research, development, and modernized healthcare in the form of virtual reality, all contributing to the betterment of the individual. As members of RealizedCare work within these vessels of productivity and contribution, individual financial conflicts of interest may arise with the natural possibility to impact/impair the judgment and decision making driving related to RealizedCare’s work product.

The policy below describes the processes and actions leveraged within RealizedCare to evaluate, mitigate, and determine when financial conflicts of interest for its individuals exist, while avoiding violation of RealizedCare’s values and code of conduct. Disclosure is utilized to identify and present financial conflicts of interests for thorough review. The policy additionally defines those financial conflicts of interests that are legal violations or directly violate RealizedCare’s values and ethics.

This policy and its regulations are intended to comply with, and implement, the requirements of applicable federal regulations for federally funded Research, and shall be formed in accordance with such federal regulations and shall be deemed to include any requirements imposed by such federal regulations that are not otherwise expressly set forth in this policy. This policy is applicable to all RealizedCare employees, and all sub-grantees, contractors or collaborators involved in design, conduct, or reporting of NIH-funded research.

2.1 Definitions

Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Investigator: PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of NIH-funded research, including sub-grantees, contractors, consortium participants, collaborators, or consultants.

Institutions: Refers to any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, NIH research funding.

Regulation/FCOI Regulation: Refers to 42 CFR Part 50 Subpart F Promoting Objectivity in Research, which applies to both grants and cooperative agreements.

Disclosure: Refers to the investigator’s disclosure of Significant Financial Interests (SFIs) to their institution.

Report: Refers to the institution’s report of identified FCOIs to the NIH.

Significant Financial Interest (SFI): A financial interest, domestic AND foreign, 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:

  • With regards to publicly traded entities, significant financial interest exists if the the value of any remuneration received from the entity in the 12 months prior to disclosure in addition to the value of equity interest in the entity as of date of disclosure has an aggregate value exceeding $5,000.

  • 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

    • Intellectual Property rights and interests (patents, copyrights) upon receipt of income related to the above interests

SFI Exceptions:

  1. Salary, royalties, or other remuneration paid from RealizedCare to the investigator

  2. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization

  3. 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

  4. 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

    a. This specifically refers to Institutions of higher education located in the United States (domestic) and the federal, state or local government agency located in the United States, as defined in 20 U.S.C. 1001(a) mentioned above.

  5. Income from teaching at a public or nonprofit institution;

  6. Income from serving as an advisor to a public or nonprofit institution;

  7. Equity in external companies (aggregated across the RealizedCare investigator and as applicable, their spouse and dependent children) that:

    a. Is worth less than $5,000

3. Procedure

3.1 Submissions of Financial Disclosures

By the time an application is submitted for PHS research funding, each RealizedCare Employee investigator and Non-Employee sub-grantee, contractor or collaborator will submit a list of SFIs for themselves and as applicable, for their spouse and dependent children, to the Financial Analyst/Head of Compliance/CEO of RealizedCare, as outlined below in the next two sections.

  • Financial disclosures will be updated annually and within 30 days of any new reportable SFI being obtained by an investigator.

3.2 FCOI Determinations

Prior to RealizedCare receipt of research funds from a PHS Agency, the CEO along with the Head of Compliance of RealizedCare will:

  • Review all investigators

  • Determine if FCOI exists and create a mitigation plan via FCOI Management Procedure/Plan

  • SFI disclosure also includes all externally funded travel (reimbursed or sponsored) for the RealizedCare investigator and as applicable, their spouse and dependent children. Such travel must be disclosed, no matter the amount, except when the expenses are covered by SFI Exceptions.

3.3 Employee Procedure for Submission of SFIs/NIH Training

To ensure compliant operations, research, and activity on behalf of all investigators and those overseeing the investigator activity within RealizedCare, employees, sub-grantees, contractors, and collaborators involved in NIH funded research will be required to complete and pass NIH Financial Conflict of Interest Training in accordance with (42 CFR Part 50 Subpart F). In addition to the form submissions associated with compliant disclosure of RealizedCare, investigators and institution managing personnel will be required to achieve the following:

  • At the time of onboarding,

  • At the time of any change in this policy that impacts investigator responsibilities,

  • Prior to engaging in PHS-funded research, and

  • At least every 4 years.

If there is a conflict between this policy, each such employee must:

  • Disclose his or her significant financial interests (SFI) that would appear to be related to the employee’s professional responsibilities on behalf of RealizedCare via the SFI Reporting Form

  • Comply with a FCOI management plan, if a FCOI is identified; and undergo FCOI training, at least once every four years.

3.4 Non-Employee Procedure for Submission of SFI

All RealizedCare sub-grantees, contractors or collaborators involved in PHS-funded research will be provided with this policy prior to initiation of the research study, and will be asked to provide written assurance via the FCOI Adherence Form that they will adhere to all provisions of 42 CFR Part 50, including timely reporting of identified FCOIs to RealizedCare.

  • Disclosure of SFI is essential for RealizedCare to determine if a FCOI exists, and in cases of FCOI, determine how it will be managed and reported in full compliance with government regulation. For failure to report SFI, appropriate disciplinary action will be made on a case by case basis, and include factors such as number of offenses, whether the non-disclosure was an error of commission or omission, and amount of compensation received above thresholds.

  • For employees, non-disclosure of SFI or non-compliance with a FCOI management plan may subject an employee to disciplinary procedures including, without limitation, suspension or termination of employment and disqualification from participating in PHS-funded research for at least 6 months from the date the noncompliance is determined.

3.5 Enforcement of Policy Compliance

  • RealizedCare management will conduct and complete retrospective reviews within 120 days of the date noncompliance if SFI disclosure is determined.

Any RealizedCare investigator who designed, conducted, or reported research into the safety or effectiveness of prescription digital therapeutics with an unreported or unmanaged FCOI will be required to:

  • Disclose the FCOI in any public presentation of the research

    • Request an addendum to any previously published presentations

3.6 Reporting

All financial disclosures and actions recorded by RealizedCare regarding identified FCOIs will be kept for at least 3 years from the date of submission for the final expenditures report. Additionally, should an FCOIs occur, appropriate RealizedCare personnel will submit the FCOI Report Form to the relevant PHS agency:

  • Prior to expenditure of funds,

  • Within 60 days of FCOI identification for new investigators,

  • Within 60 days of newly identified FCOI for existing investigators,

  • Annually, and

  • Following a retrospective review to correct a previously submitted report, as needed.

RealizedCare management will promptly notify the relevant PHS Agency if:

  • Bias is found in the reporting, conduct, or design components of PHS-funded research, or

  • A RealizedCare investigator fails to comply with this policy, or if a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research.

3.7 Public Accessibility Requirements

Per NIH guidelines, RealizedCare will make the above FCOI Policy and information concerning FCOI’s held by key personnel (defined in regulation) publicly accessible prior to the expenditure of funds. This will include the following:

  • Public access/disclosure of FCOI’s on RealizedCare’s website (to be determined at later time per our discussion)

  • Annual updates to the information publicly available

  • Availability of information for 3 years from date of update

  • Updated within 60 days of newly identified FCOIs