Human Subjects Protection in the Era of the Revised Common Rule

In January 2017, the first major revisions to the Federal Policy for the Protection of Human Subjects—known as the Common Rule—were signed into law. The Common Rule governs federally funded clinical research involving human subjects and formally defines the requirements for institutional review board (IRB) membership, functions and operations, and review of research, as well as the requirements for obtaining informed consent from research participants.

The revisions to the Common Rule became effective in January 2019, and active review is underway at US IRBs and human research protection programs about how the new regulations should be understood, implemented, and operationalized.

The spring edition of the Ochsner Journal focuses on these changes, and we hope that the explanations and examples in the articles in this edition will assist others as they tackle the various issues raised by these changes. The Journal welcomes letters to the editor about the articles in this issue to provide additional examples, perspectives, and information.