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Thursday, Jun 30 2016

Full Issue

Panel Blasts Revised Proposal Protecting Medical Research Volunteers

The National Academies of Sciences says the Obama administration's proposed overhaul to the so-called Common Rule is "marred by omissions." The panel says a national commission should be created and it should start from scratch on a new plan.

An influential federal panel has taken the unusual step of telling the Obama administration to withdraw a controversial proposal to revise regulations that protect people who volunteer for medical research. The proposal is "marred by omissions, the absence of essential elements, and a lack of clarity," according to the National Academies of Sciences, Engineering and Medicine. The conclusions are part of a 283-page report released Wednesday. (Stein, 6/29)

The federal government should withdraw its proposed update of a rule governing human research and appoint an independent commission to undertake a sweeping reexamination of the ethical and practical questions involved, according to a new report from the National Academies of Sciences. Last fall鈥檚 proposed overhaul of the so-called Common Rule 鈥渄oes not adequately or effectively address the breadth, depth and import of unanswered questions,鈥 concludes the report, which was requested by the NIH and Department of Education. 鈥淸R]ather, its inadequacies signal a pressing need for a comprehensive review of the nation鈥檚 ethical, legal, regulatory and institutional frameworks for protecting human research subjects.鈥 (Norman, 6/29)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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