Sweeping Proposal to Improve Rules Protecting Human Research Subjects Announced

Late last week, a wide-ranging initiative to update federal human research protection regulations was announced by the U.S. Department of Health and Human Services (HHS) and the White House Office for Science & Technology Policy (OSTP) through issuance of an Advance Notice of Proposed Rulemaking (ANPRM), which aims to catch the regulations up to technological advances and developments in the research enterprise. This is the first attempt to significantly revise these regulations, known collectively as the Common Rule, since their enactment in 1991.1  As with many undertakings of this scope, there is some good news and some bad news for those individuals and institutions involved in human subjects research governed by the Common Rule.  While the ANPRM does seek to reduce administrative burden that does not translate to enhanced human research protections, there are also changes proposed that are likely to, if adopted, increase the burden on researchers and may make it more difficult to conduct research involving human subjects.