Common Rule changes will impact informed consent, IRBs, and more

On January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common...

NPRM released outlines changes to Common Rule

A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...