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Information on the Revised PHS COI Regulations
The revised Public Health Service (PHS) regulations went into effect on August 24, 2012. These regulations established new standards designed to increase accountability, add transparency, and enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest. The primary goal is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research will be free from bias resulting from Investigator financial conflicts of interest.
- 2011 Public Health Service (PHS) Regulations
- Informational Sessions on the Revised PHS Objectivity in Research Regulations
- FAQs: Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F) applicable to grants and cooperative agreements (2011 Revised Regulations)
- Yale University’s Conflict of Interest FAQs:
Highlights of PHS COI Changes:
- General disclosure threshold of >$5,000 for PAST 12 months only
- Disclose any equity interest in a privately-held company
- Disclose third party reimbursed or paid travel >$5,000 for any travel related to institutional responsibilities (i.e., administrative, teaching, research or clinical activities) EXCLUDING travel paid by sponsored awards to Yale and travel paid by the US government and US institutions of higher education
- Disclose non-Yale Intellectual property rights and interests >$5,000 (e.g. patents, copyrights) upon receipt of income related to such rights and interests
- Update new SFIs (including travel) within 30 days
- Mandated training requirement for investigators (built into the Yale disclosure form for PHS funded investigators)
- As in the past, financial conflicts of interest (FCOIs) must be managed, reduced or eliminated before expenditure of any funds