Revised Common Rule

The federal government recently made extensive revisions to the Federal Regulations that govern all human subjects research, otherwise known as the Common Rule. Many of these revisions took effect on Jan. 21, 2019.

As a result, all protocols approved by the Institutional Review Board after Jan. 21, 2019, are subject to these new regulations. Protocols approved prior to that date are still subject to the old rules and must abide by these.

Important distinction: Whether or not your research is bound by the new regulations is determined by the approval deadline, not the submission deadline, of your protocol. Hence, any research submitted prior to Jan. 21, 2019, but not approved until after Jan. 20, 2019, is subject to the new regulations.

Protocols approved prior to Jan. 21, 2019, while subject to the old rules at the time of approval, may be transitioned to the new rules at a future time at the discretion of the Institutional Review Board.

Revisions at a Glance