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THW FCOI Form_27May2025.docx (66.1 KB)
Purpose
- Ensures compliance with PHS regulations (42 CFR Part 50 & 45 CFR Part 94) on promoting objectivity in research.
- Requires disclosure of Significant Financial Interests (SFIs) related to research responsibilities.
Who Must Complete
- All personnel responsible for design, conduct, or reporting of research, regardless of funding source.
- Includes PIs, Co-PIs, research staff, collaborators, and consultants.
Key Requirements
- Review Trinity Health–West Region’s Objectivity in Research policy.
- Complete FCOI training every 4 years.
- Submit disclosure for:
- Initial, Annual, or New/Updated situations.
- Disclose SFIs related to:
- Publicly traded and non-publicly traded entities.
- Non-profit entities.
- Travel reimbursements.
- Intellectual property rights.
- Foreign components and other support.
Form Sections
- Investigator & Research Information
- Full name, title, hospital, department, contact info.
- Type of Disclosure
- Initial / Annual / Updated.
- Role in Clinical Research
- PI, Co-PI, Coordinator, Biostatistician, etc.
- Funding Source
- Identify if research is funded by PHS agencies (e.g., NIH).
Process
- Submit completed form to Research Compliance Department.
- Conflict of Interest Committee reviews and manages any identified FCOIs.