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April 18, 2012

Addressing Low-Risk Comparative Effectiveness Research in Proposed Changes to US Federal Regulations Governing Research

Author Affiliations

Author Affiliations: Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health (Dr Kass); Johns Hopkins Berman Institute of Bioethics (Dr Faden); and Center for Medical Technology Policy (Dr Tunis), Baltimore, Maryland.

JAMA. 2012;307(15):1589-1590. doi:10.1001/jama.2012.491

On July 25, 2011, the Department of Health and Human Services published an advance notice of proposed rule making, outlining potential changes to the federal regulations overseeing human subjects research.1 These regulations, known since 1991 as “the Common Rule,” have been effective in ensuring that most human research in this country is reviewed prospectively by an institutional review board (IRB) charged with determining that risks of proposed research are minimized and acceptable and also ensuring that individual participants provide informed consent for most types of research before participation.