HHS publishes Notice of Proposed Rulemaking seeking input on updates to the Common Rule

On September 8, 2015, the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) seeking input on potential updates to the Common Rule. The Common Rule, enacted in 1991, is a set of regulations that protect individuals who participate in federally-funded or supported research.  According to HHS, the proposed changes to the Common Rule are intended to better protect human subjects while reducing burden on researchers.  Proposed changes include:  streamlining the process and requirements for informed consent to make it more meaningful, allowing levels of review to be adjusted for proportionality to the risk of research, modifying IRB requirements, and allowing exemptions for some areas of research.  Read HHS' press release here. View the NPRM or submit comments to the address listed here.