Bringing the Common Rule into the 21st Century

• Published in: The New England journal of medicine Vol. 373; no. 24; pp. 2293 - 2296
• Main Authors: Hudson, Kathy L, Collins, Francis S
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 10.12.2015
• Subjects: Codes of Ethics; Ethics Committees, Research - legislation & jurisprudence; Federal regulation; Government Regulation; Human Experimentation - ethics; Human Experimentation - legislation & jurisprudence; Human subjects; Humans; Informed consent; Informed Consent - legislation & jurisprudence; Medical research; Privacy; Research Subjects - legislation & jurisprudence; Specimen Handling - ethics; United States; United States Government Agencies; United States; United States > US
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMp1512205

Proposed revisions to the rules governing the ethical conduct of research involving humans aim to enhance respect and safeguards for research participants and to increase research efficiency by reducing unnecessary burdens and calibrating oversight to the level of risk. On September 8, 2015, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a proposal to revise the regulations governing the ethical conduct of research involving humans. 1 The current regulations were adopted by HHS in 1981 to implement the landmark 1979 Belmont Report. Adopted by other agencies throughout government in 1991, the regulations, informally known as the Common Rule, have changed little since their inception, while the research landscape has changed radically. In addition to revolutionary advances in scientific knowledge and technologies, society has undergone tremendous shifts in recent decades that are highly . . .