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Obama Administration changes U.S. rules for human test subjects

by Andrea Widener
January 23, 2017 | A version of this story appeared in Volume 95, Issue 4

In its waning hours, the Obama Administration made major changes to federal rules for protecting people who participate in research studies. A proposed version of the changes faced almost universal criticism over provisions that would have prevented researchers from using historical biological specimens for which patients did not give consent. The final rules, released on Jan. 18, will allow those samples to continue to be used in research. The Common Rule, as it is called, had not been revised since the 1970s. In September 2015, the Department of Health & Human Services and 15 other agencies proposed changes including the sample ban, tighter informed consent requirements to ensure that study participants understand the scope of the research, and narrowing the number of institutional review boards that examine multisite studies. A flurry of criticism followed, primarily from universities and other research organizations whose scientists fear their research would be curtailed. More significantly, the National Academy of Sciences recommended that HHS scrap the rule and start over with a committee to examine the rule. Instead, the Obama Administration pushed forward with its version of the Common Rule.


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