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

On May 21, 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 universities, hospitals, companies, and other organizations that conduct PHS-sponsored research, such as under National Institutes of Health (NIH) grants and contracts, the proposed amendments if adopted will entail a host of changes in oversight of investigator financial interests, such as payments received from or investment interests in companies. For such organizations, the proposed changes would require public posting of their conflict of interest policies and of information about certain managed conflicts, more disclosure by investigators, more institutional reporting to PHS, investigator training, attention to sub-award agreements, records maintenance, and other administrative steps outlined below. Companies that have financial relationships with academic researchers should be aware of the new proposed requirements to which investigators and institutions would become subject. In addition, companies that receive funds through the Small Business Innovation Research and Small Business Technology Transfer programs, which had previously been exempt in part, would now be covered by the regulations. Comments to the proposed rule are due on or before July 20, and officials have said a final rule will issue later this year.

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