In DepthU.S. Policy

Regulators drop controversial biospecimen consent proposal

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Science  27 Jan 2017:
Vol. 355, Issue 6323, pp. 335
DOI: 10.1126/science.355.6323.335

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U.S. biomedical researchers have fought off a feared rule change that would have made it more difficult and expensive to study anonymous blood and tissue samples taken from patients. Proposed in 2015, the controversial change was dropped 2 days before former President Barack Obama left office, when federal officials released a long-awaited update to the so-called Common Rule that protects human participants in studies. The update also hands scientists a second victory, by blunting a 2014 law that researchers say had hamstrung studies using blood spots obtained from newborns. The 543-page rule, released 18 January, does include other changes, including lighter ethics reviews for certain studies, that scientists welcome.