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FCOI Policy for Principled Research Resources L3C

Compliant with 42 CFR Part 50 Subpart F – Promoting Objectivity in Research

In accordance with NIH Grants Policy Statement Section 4.1.10, this policy is reviewed annually and updated as needed to ensure compliance with 42 CFR Part 50 Subpart F. 

Effective Date: May 9, 2024
Review Cycle: Annually, or as required by regulatory changes
Public Access URL: https://www.principledresearch.org/fcoi-policy

  1. Purpose

This policy establishes standards to ensure that the design, conduct, and reporting of research funded by the Public Health Service (PHS), including the National Institutes of Health (NIH), is free from bias resulting from financial conflicts of interest.

  1. Applicability

This policy applies to all Investigators at Principled Research Resources who are responsible for the design, conduct, or reporting of PHS-funded research, including grants and cooperative agreements.

  1. Definitions
  • Investigator: Any individual, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research.
  • Significant Financial Interest (SFI): A financial interest that reasonably appears to be related to the Investigator’s institutional responsibilities and meets the thresholds defined in 42 CFR §50.603.
  • Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  1. Institutional Responsibilities

4.1 Written Policy and Public Access

Principled Research Resources maintains this written, enforced FCOI policy in compliance with 42 CFR Part 50 Subpart F. The policy is publicly accessible at https://www.principledresearch.org/fcoi-policy and is submitted to NIH via the eRA Commons Institution Profile (IPF) Module.

4.2 Designated Official

The Managing Director serves as the designated official responsible for soliciting and reviewing disclosures of SFIs, determining the existence of FCOIs, and implementing management plans.

4.3 Subrecipient Compliance

Principled Research Resources ensures that subrecipients comply with this policy or maintain their own FCOI policy consistent with 42 CFR Part 50 Subpart F. Written agreements will specify applicable responsibilities.

4.4 Enforcement and Sanctions

Noncompliance with this policy may result in administrative actions, including suspension of research activities, reporting to NIH, and other corrective measures as determined by the Managing Director.

  1. Investigator Responsibilities

5.1 Disclosure Requirements

Investigators are required to disclose SFIs:

  • At the time of application for PHS funding
  • Annually during the award period
  • Within 30 days of acquiring or discovering a new SFI

Disclosures must include relevant financial interests of the Investigator, their spouse, and dependent children.

5.2 Training

All Investigators must complete FCOI training:

  • Prior to engaging in PHS-funded research
  • At least once every four years
  • Immediately upon policy revisions or identified noncompliance

Training is provided via the NIH FCOI tutorial.

  1. Review and Management of FCOIs

6.1 Review Process

The designated official shall review all disclosures to determine whether an SFI constitutes an FCOI. Determinations will be documented and retained.

6.2 Management Plans

If an FCOI is identified, a written management plan shall be implemented prior to the expenditure of funds. Management strategies may include:

  • Public disclosure of the FCOI
  • Appointment of an independent monitor
  • Modification of the research plan
  • Disqualification from participation in the research
  • Divestiture of financial interests
  1. Reporting to PHS/NIH

Principled Research Resources shall report FCOIs to NIH via the eRA Commons FCOI Module:

  • Prior to the expenditure of funds
  • Within 60 days of identifying a new FCOI
  • Annually, at the same time as the annual progress report
  • Following a retrospective review, if applicable
  1. Retrospective Review and Mitigation

If an FCOI is not identified or managed in a timely manner, the institution shall complete a retrospective review within 120 days to determine whether the research was biased. If bias is found, a mitigation report will be submitted to NIH.

  1. Record Retention

All records related to Investigator disclosures, FCOI determinations, and management plans shall be maintained for at least three years from the date of the final expenditure report or as otherwise required by law.

  1. Public Accessibility and Requests

This policy is publicly accessible at https://www.principledresearch.org/fcoi-policy.
Upon written request, Principled Research Resources will provide information concerning identified FCOIs held by senior/key personnel within five business days, in accordance with NIH requirements.