HHS Proposes New Rules Regarding PHS-Funded Research and Financial Conflicts of Interest


On May 21, 2010, the Department of Health and Human Services (HHS) published proposed revisions to the rules regarding the identification and management of financial conflicts of interest that apply to institutions that seek or receive Public Health Service (PHS) funding for research. With this notice, the Department intends to revise the regulatory framework governing investigator conflicts of interest, which has been in place since 1995, to respond to the scope and complexity of biomedical research and changes in financial relationships between research institutions and industry sponsors of research. The proposed rule addresses some, but not all, of the issues raised by the Department’s May 9, 2009 solicitation of public comments regarding the revision of 42 CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought” and 45 CFR Part 94, “Responsible Prospective Contractors.” Public comments on the proposed rule will be accepted until July 20, 2010.

The proposed revisions contain a number of noteworthy changes to the current regulations, including the following...

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