Kelly M. Willenberg (kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg LLC in Greenville, SC.
The revised Common Rule[1] goes into effect on January 21, 2020, for general compliance. It is intended to reduce administrative burden on a research site so that an Institutional Review Board (IRB) can better serve the role they have in the research process. Another goal is to better protect human subjects. These are the first significant changes to human subjects research regulations since the Common Rule was established in 1991.