HHS Proposes Rule to Modernize Regulations for Human Subjects Research

September 16, 2015 | Strategic Insights for Health System


The U.S. Department of Health and Human Services (HHS) has issued a proposed rule to revise its regulations concerning individuals who participate in research involving human subjects. Originally enacted in 1991, the regulatory framework has not been updated to reflect the expansion of research into new scientific disciplines, the increase in multisite studies, or significant advances in technology.

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