Header graphic for print
Focus on Regulation

Tag Archives: Common Rule

FDA aims to harmonize its human subject protection regulations with Common Rule

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January

Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects

Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects.  As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research