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

• Published in: JAMA : the journal of the American Medical Association Vol. 307; no. 15; pp. 1589 - 1590
• Main Authors: Kass, Nancy, Faden, Ruth, Tunis, Sean
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 18.04.2012
• Subjects: Biomedical Research - legislation & jurisprudence; Biomedical Research - standards; Changes; Comparative Effectiveness Research - legislation & jurisprudence; Comparative Effectiveness Research - standards; Ethics Committees, Research; Federal regulation; Human Experimentation - legislation & jurisprudence; Human subjects; Humans; Informed Consent; Legislation as Topic; Patient Protection and Affordable Care Act; Patient safety; Prospective Studies; Randomized Controlled Trials as Topic; Regulatory agencies; Risk; United States; United States; United States > US
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2012.491

On Jul 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. 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. Some of the proposed changes suggested in the Advance Notice of Proposed Rulemaking (ANPRM) are designed to expand or deepen federal protections, whereas others are intended to reduce the oversight burden on investigators and IRBs for lower-risk research. Here, Kass et al address low-risk comparative effectiveness research in proposed changes to US federal regulations governing research.