Financial Conflicts of Interest

This policy implements the financial-conflict-of-interest disclosure requirements in 42 CFR Part 50, Subpart F and 45 CFR Part 94 for research funded by the U.S. Public Health Service. It applies to GNT’s PHS-funded research other than Phase I SBIR or STTR projects and establishes disclosure, independent review, management, and mitigation processes intended to protect research objectivity.

Every investigator participating in covered research must follow this policy and complete required training. Covered investigators include personnel, consultants, and subcontractors responsible for the design, conduct, or reporting of research. The policy defines GNT’s Institutional Official, financial conflict of interest, institutional responsibilities, PD/PI, PHS Awarding Component, research, senior/key personnel, significant financial interest, and the SBIR/STTR programs.

Investigators must complete approved FCOI training before engaging in PHS-funded research and at least once every four years. Retraining is also required when the policy changes in a way that affects investigator responsibilities, when an investigator is new to GNT, or when GNT determines that an investigator is not complying with this policy or a management plan.

Investigators must disclose significant financial interests—including relevant interests held by a spouse or dependent child—no later than submission of an application for PHS funding, at least annually during the award, and within 30 days of discovering or acquiring a new SFI. An investigator with no reportable SFI must still complete the disclosure form. The GNT Institutional Official solicits and reviews disclosures and determines whether an SFI is a financial conflict of interest.

Before covered funds are spent, the Institutional Official reviews disclosed SFIs for relationship to the research and determines whether a conflict exists. When needed, GNT develops a management plan. Measures may include public or participant disclosure, independent monitoring, modification of the research plan, changes in personnel or responsibilities, reduction or elimination of the financial interest, or severance of the relationship creating the conflict. Newly disclosed or previously unreviewed SFIs are reviewed within 60 days. Untimely identification or management may require a retrospective review within 120 days, documentation of findings, and a mitigation report when bias is found.

GNT reports identified FCOIs to the appropriate PHS Awarding Component before spending covered funds and within 60 days for subsequently identified conflicts. Reports identify the project, investigator, outside entity, nature and value of the financial interest, its relationship to the research, and the management plan. Annual reports address the status of each continuing conflict and any changes to its management.

Failure to comply may lead to corrective or disciplinary action. If noncompliance appears to have biased the design, conduct, or reporting of research, GNT promptly notifies the PHS Awarding Component and describes corrective action. When HHS determines that clinical research was conducted or reported by an investigator with an unmanaged or unreported FCOI, GNT requires disclosure in public presentations and requests an addendum to prior presentations.

Disclosure forms, determinations, and management records are retained for three years beyond the final expenditure report under the award, or for another period required by 45 CFR 75.361.

Covered subcontractors and consultants must maintain a compliant FCOI policy or follow GNT’s policy. Applicable agreements require compliance with federal rules, prompt reporting of identified conflicts, submission of management or mitigation plans for GNT review, and equivalent obligations for lower-tier subcontractors and consultants. Noncompliance is a material breach.

Before covered funds are spent, GNT makes required information about qualifying FCOIs held by senior/key personnel publicly accessible or responds in writing within five business days. Information includes the project, investigator and role, outside entity, nature of the interest, and its value or an explanation that value cannot readily be determined. Information is updated at least annually and within 60 days of identifying additional qualifying interests and remains available for at least three years after its most recent update.