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.
NPR:
Heat On White House To Scrap Redo Of Human Research Rules
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)
Politico Pro:
National Academies Report: Drop The Proposed 'Common Rule'
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’s proposed overhaul of the so-called Common Rule “does not adequately or effectively address the breadth, depth and import of unanswered questions,” concludes the report, which was requested by the NIH and Department of Education. “[R]ather, its inadequacies signal a pressing need for a comprehensive review of the nation’s ethical, legal, regulatory and institutional frameworks for protecting human research subjects.” (Norman, 6/29)
