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U.S. Department of Health and Human Services Issues Proposed Rule on Investigator Conflicts of Interest in Federally Funded Research

07 June 2010

Federal Research Alert

On 21 May the Public Health Service of the U.S. Department of Health and Human Services (PHS) issued proposed amendments to its regulations on the "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought." For many institutions that conduct PHS-sponsored research, such as under National Institutes of Health (NIH) grants and contracts, the proposed changes if adopted will entail amendment of institutional conflict of interest policy and disclosure forms. The proposed changes also will increase the burden associated with administration of conflict of interest policy, including posting of the policy on a website, more disclosure by investigators, more institutional reporting to PHS, public posting of information about certain managed conflicts, investigator training, attention to sub-award agreements, records maintenance, and other administrative steps outlined below. Comments to the proposed rule are due on or before 20 July, and officials have said a final rule will issue later this year.

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