FCOI Regulations and Compliance Overview
Information on Financial Conflict of Interest (FCOI) regulations under 45 CFR Part 94 regarding contractors, institutions, and NIH-funded research. Covers policy implementation, evaluation of significant financial interests, transparency, reporting requirements, and compliance details since 2011.
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Presentation Transcript
Financial Conflict of Interest (FCOI) Revised CFR Regulations 45 CFR Part 94 Responsible Prospective Contractors Office of Acquisition and Logistics Management (OAMP) 1
FCOI Regulatory Purpose Contractors/Subcontractors/Institutions Role: To eliminate biased objectivity or the public perception of bias in the design, conduct and reporting of research acquired in support of the NIH mission 2
45 CFR 94 Responsible Prospective Contractor Applicability All NIH Funded Research NIH Research and Development Contracts Academic institutions, Non-Profit & Commercial Organizations Contracts & Subcontracts Task orders, Delivery orders, BPAs Competitively solicited and sole sourced Does not apply to: SBIR Phase I/ STTR Contracts 3
Overview 45 CFR 94 Contractor/ Institutional Requirements: FCOI Policy Implementation Evaluation of Significant Financial Interest (SFI) FCOI Identification FCOI Management / Mitigation Plans FCOI Public Transparency FCOI Reporting requirements to NIH/ COs 4
2011 FCOI Regulation Comprehensive Changes Definition and Evaluation of Significant Financial Interest Extent of Investigators disclosure of information to Institutions regarding their Significant Financial Interests Institutions management of identified FCOIs Information reported to the NIH/COs Information made accessible to the public (i.e., Institutional FCOI policy and identified FCOIs of senior/key personnel) Investigator training 5
Compliance Final Notice was published in the Federal Register on August 25, 2011 (FCOI Final Rule 8/25/11) All Contractors applying for/or receiving NIH funding for research are required to have FCOI compliant policies Compliance date for contractors and institutions is August 24, 2012 CFR Mandated Subcontractor flow down required Applicable to all NIH Research and Development Contracts to academic institutions, non-profit & commercial organizations 6
Certification Requirement Contractors/ Institutions are required to certify in each contract proposal submission: Has in effect an up-to-date written and enforced administrative process to identify and manage FCOI Promotes and enforces Investigator compliance with the FCOI regulation Manages FCOI, and provide initial and ongoing FCOI reports to Contracting Officers Agrees to make FCOI and SFI information (including related Contractor/ Institutional reviews and determinations available to NIH upon request) Shall fully comply with the regulations requirements 7
