Financial conflict of Interest. Policy changes for PHS funding. What is this?.
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Policy changes for PHS funding
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).
An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012.
Institutions must require that each “Investigator” complete
The project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding.
Public Health Service (PHS)
Means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to:
Whenever an FCOI is not identified or managed in a timely manner, including:
the institution shall within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the project to determine bias in the design, conduct or reporting of such research.
(will be available 8/24)
Dr. Morris Foster
Associate Vice President for Research
Associate Vice President for Research and Executive Director, [email protected]
Research Information Services Coordinator