TruDiagnostic Financial Conflict of Interest (FCOI) Policy
Effective Date: July 3rd, 2025
Last Revised: July 2nd, 2025
1. Purpose
This policy is established to comply with the NIH regulation 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research,” and applies to all Investigators involved in NIH-funded research at TruDiagnostic.
2. Applicability
This policy applies to all Investigators (as defined by NIH) who are responsible for the design, conduct, or reporting of research funded by the Public Health Service (PHS), including NIH. This includes any person working under a subaward, if applicable.
3. Training
Investigators must complete FCOI training:
- Prior to engaging in NIH-funded research,
- At least every four years,
- Immediately if this policy is revised, or if an Investigator is new to the organization, or found noncompliant.
TruDiagnostic will use NIH’s FCOI Training Module to meet training requirements.
4. Disclosure of Significant Financial Interests (SFIs)
Investigators must disclose:
- All SFIs (foreign and domestic) related to their institutional responsibilities,
- At the time of application,
- Annually,
- Within 30 days of discovering or acquiring a new SFI.
Disclosures must include SFIs of spouses and dependent children.
5. Review and Management of FCOIs
A designated FCOI Official will:
- Review disclosures of SFIs,
- Determine whether an SFI is related to NIH-funded research,
- Determine if it constitutes a Financial Conflict of Interest (FCOI),
- Implement a written management plan, if needed.
Management strategies may include public disclosure, monitoring plans, modification of research, or reduction of SFI.
6. Reporting to NIH
TruDiagnostic will report:
- Any FCOI prior to the expenditure of NIH funds,
- Within 60 days of discovering a new FCOI,
- Annually, and
- After retrospective reviews, if bias is found, a mitigation report will also be submitted.
Reports are submitted via the NIH eRA Commons FCOI Module.
7. Retrospective Review
If an FCOI was not disclosed or reviewed timely, a retrospective review will be completed within 120 days, documenting:
- Investigator name, SFI, project number/title, timeline, and conclusions.
8. Record Retention
All records relating to Investigator disclosures of financial interests and the management of financial conflicts of interest (including any retrospective reviews) will be maintained for at least three years from the date of the final expenditure report submitted to the NIH, or longer if required by applicable law or agreement.
9. Enforcement and Sanctions
Failure to comply with this policy may result in disciplinary action, up to and including termination or restrictions on participation in research.
10. Subrecipients
If NIH funds are passed to subrecipients, written agreements will specify whether the subrecipient will follow TruDiagnostic’s FCOI policy or their own. In either case, reporting obligations must enable timely NIH reporting.
11. Public Accessibility
This policy is publicly available at: https://www.trudiagnostic.com/?variation=1
Information about identified FCOIs for senior/key personnel will be available upon request or posted online within 5 business days, updated annually and within 60 days of identifying new FCOIs.