A Flawed Revision of the Common Rule.

Abstract

Ideas and Opinions19 July 2016A Flawed Revision of the Common RuleSteven Joffe, MD, MPH and David C. Magnus, PhDSteven Joffe, MD, MPHFrom University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, and Stanford Center for Biomedical Ethics, Stanford University, Stanford, California.Search for more papers by this author and David C. Magnus, PhDFrom University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, and Stanford Center for Biomedical Ethics, Stanford University, Stanford, California.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-0119 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In September 2015, sixteen federal agencies released a Notice of Proposed Rulemaking (NPRM) that outlined far-reaching changes to the Common Rule. The Common Rule is the regulatory framework for all federally funded human subjects research; many U.S. institutions extend it to nonfederally funded research as well. There have been increasing calls for revising the Rule, which has been essentially unchanged since 1991. In responding to these calls, the NPRM aims to “modernize, simplify and enhance the current system of oversight” and “strengthen protections for human research subjects while facilitating important research” (1). Laudable changes include moving much minimal-risk sociobehavioral research ...