Bringing the Common Rule into the 21st Century

Abstract

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.