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PHS Federal Conflict of Interest Regulations

Summary

The U.S. Department of Health and Human Services (HHS) has amended the Public Health Service (PHS) regulations related to the disclosure of investigator financial interests, review, management and reporting financial conflicts of interest associated with research projects funded by NIH and Public Health Service Agencies (PHS).

Full Description

The U.S. Department of Health and Human Services is committed to preserving the public trust in the objectivity of biomedical and behavioral research.  The HHS believes it is vital that all research be conducted with the highest scientific and ethical standards.  In 1995, HHS promulgated the current PHS regulations, "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Services Funding is Sought" and "Responsible Prospective Contractors." These are also known as the financial conflict of interest, or FCOI, regluations (42 CFR Part 50 Subpart F and 45 CFR Part 94).

Agencies under the operating division of the Public Health Service include the following:

Agency for Healthcare Research and Quality (AHRQ)

Agency for Toxic Substances and Disease Registry (ATSDR)

Centers for Disease Control and Prevention(CDC)

Food and Drug Administration (FDA)

Health Resources and Services Administration (HRSA)

Indian Health Service(IHS)

National Institutes of Health (NIH)

Substance Abuse and Mental Health Services Administration (SAMHSA)

The College of William & Mary procedure for implementation of PHS , Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors (according to 42 CFR 50)

NIH FCOI

NIH FAQ

NIH Tutorial on FCOI