PHIG Policy Framework v1.2 · Policy 47 · Adopted 1 September 2026 · References: 42 CFR Part 50 Subpart F (Responsibility of Applicants for Promoting Objectivity in Research, PHS/NIH); 45 CFR Part 94; NIH Grants Policy Statement; complements Policy 01
1. Purpose and scope
US Public Health Service agencies (NIH, CDC, FDA, HRSA, SAMHSA) require institutions receiving their research funding to maintain and enforce a written policy on financial conflicts of interest in research that meets 42 CFR 50 Subpart F. This policy supplements the general Conflict of Interest Policy for PHS-funded research. Applies to the Board, the Director, staff, consultants, volunteers, experts, partners and suppliers of PHIG and all platforms of its network.
2. Policy
- Every Investigator (anyone responsible for the design, conduct or reporting of PHS-funded research, including sub-recipients and collaborators) discloses to PHIG, before application and at least annually, all Significant Financial Interests related to their institutional responsibilities: remuneration and equity from a single entity exceeding USD 5,000 in the previous 12 months (any equity in a non-public company), intellectual-property income exceeding USD 5,000, and reimbursed or sponsored travel (except from government, higher-education and research institutions); updates within 30 days of acquiring a new interest.
- The Director (as designated official) reviews each disclosure and determines whether it is a Financial Conflict of Interest — one that could directly and significantly affect the design, conduct or reporting of the research — and if so, develops and implements a management plan (disclosure in publications, independent monitoring, modification of the research plan, change of personnel, divestiture, severance of the relationship).
- PHIG reports identified FCOIs to the PHS awarding component before expenditure of funds and within 60 days of any new FCOI, with the elements the rule requires, and makes FCOI information for senior/key personnel publicly accessible on request within five business days.
- Investigators complete FCOI training before engaging in PHS-funded research, every four years, and when the policy changes or non-compliance is found.
- Non-compliance is reviewed retrospectively within 120 days; a mitigation report is submitted where bias is found; sub-recipient compliance is ensured by written agreement.
- Records are retained for at least three years after the final expenditure report.
3. Procedures
- Disclosure form; management plan template; FCOI report template; training record.
Responsibilities
Director as designated official; Board for cases involving the Director.
Review
Annually and when the rule changes.
Part of the PHIG Policy Framework. Breaches and concerns may be reported under the Whistleblowing Procedure to info@accreditation.ge (subject “Confidential — integrity”).