The National Academies of Sciences, Engineering, and Medicine (NASEM) have issued a call for the withdrawal of the Notice of Proposed Rulemaking (NPRM), which is intended to update the federal guidelines for research with human participants, also known as the Common Rule. In the view of the National Academies, the NPRM "is marred by omissions, the absence of essential elements, and a lack of clarity," an opinion shared by many scientific groups. In its place, NASEM suggests a national commission be appointed to issue a "course correction" that will update the rules without increasing regulatory burdens or diminishing the effectiveness of human subjects research. An article in Science describes the debate and the initial response by a Department of Health and Human Services spokesperson, who notes they've "received more than 2,100 public comments" on the NPRM and will "take all public comments seriously" as they develop the final rule.
Wednesday, June 29, 2016