NGZ AI, Inc. – Financial Conflict of Interest (FCOI) Policy
1. Purpose
The purpose of this policy is to promote objectivity in research conducted by NGZ AI, Inc. (“NGZ AI”) by establishing standards to ensure that the design, conduct, and reporting of research funded under Public Health Service (PHS), including National Institutes of Health (NIH), grants or cooperative agreements are free from bias resulting from Investigators’ financial conflicts of interest (FCOIs).
2. Scope
This policy applies to all Investigators (as defined below) who are responsible for the design, conduct, or reporting of research funded by NIH or other PHS agencies, including collaborators, consultants, or subcontractors.
3. Definitions
• Investigator: Any project director or principal investigator, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH.
• Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.
• Significant Financial Interest (SFI): 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 related to the Investigator’s institutional responsibilities:
(a) With a publicly traded entity: remuneration and equity interests exceeding $5,000 in the preceding 12 months.
(b) With a non-publicly traded entity: any remuneration exceeding $5,000 or any equity interest.
(c) Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income.
• Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS/NIH-funded research.
4. Investigator Responsibilities
Investigators must:
1. Disclose all SFIs related to their institutional responsibilities:
• At time of application for PHS/NIH funding.
• Annually thereafter.
• Within 30 days of acquiring or discovering a new SFI.
2. Complete FCOI training:
• Prior to engaging in NIH-funded research.
• At least every four years.
• Immediately if NGZ AI revises this policy or finds noncompliance.
5. Review and Management
The FCOI Designated Official (appointed by NGZ AI’s CEO) will:
• Review all SFI disclosures.
• Determine whether SFIs are related to PHS/NIH-funded research.
• Determine whether an FCOI exists.
If an FCOI is identified, NGZ AI will develop and implement a management plan, which may include:
• Public disclosure of FCOIs.
• Modification of the research plan.
• Monitoring of the research by independent reviewers.
• Disqualification from participation in the portion of research affected by the FCOI.
• Divestiture of financial interests.
6. Reporting to NIH
NGZ AI will:
• Report any identified FCOI to NIH prior to expenditure of funds.
• Submit annual FCOI updates.
• Notify NIH within 60 days of identifying new FCOIs.
Reports will include:
• Investigator name.
• Nature and value of the financial interest.
• Description of the management plan.
7. Noncompliance and Remedies
If an Investigator fails to comply, NGZ AI will complete a retrospective review within 120 days to determine if bias occurred.
If bias is found, NGZ AI will develop a mitigation report for NIH.
8. Records Retention
NGZ AI will maintain records of all disclosures and actions taken for at least three years after the final expenditure report is submitted to NIH.
9. Public Accessibility
This policy and FCOI reports related to PHS/NIH-funded research will be made publicly accessible within five business days of a written request or posted on NGZ AI’s website at www.ngz.ai/fcoi
10. Contact
Questions or disclosures should be directed to:
FCOI Designated Official
NGZ AI, Inc.
Email: compliance@ngz.ai
Phone: 888.249.8932