The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). These revisions became effective in 2018, so although the general compliance date was advanced to January 21, 2019, the regulations are referred to as the "Pre-2018 Requirements" and the "2018 Requirements."
As the Food and Drug Administration (FDA) has not yet revised its regulations, and the Department of Justice (DOJ) has not signed onto the revised Common Rule, the Pre-2018 Requirements currently apply to research that is FDA-regulated or DOJ-supported.
The general compliance date for the Revised Common Rule is January 21, 2019.
The FDA provides a Comparison of FDA and HHS Human Subject Protection Regulations side-by-side for ease of comparison.
