The Final Rule: When the Rubber Meets the Road

Abstract

The Common Rule originally issued in 1991 and last amended in 2005 is scheduled to be replaced on January 19, 2018 by a revised Common Rule (the final rule). The goal of the revisions is to modernize and improve applicability of the rule to a research landscape that has dramatically changed since 1991. Translating these changes into action will require comprehensive understanding of the final rule and detailed implementation planning by Human Research Protection Programs. This paper presents select changes that require substantial attention; including for example: expansion of the exempt category, changes to continuing review requirements, changes to the informed consent form and the use of single IRBs for domestic multi-site research. In addition, myriad policies, procedures and workflows will have to be developed, drastically rewritten, or just mildly tweaked.

Keywords: Common rule; Final Rule; Human subjects protection; Implementation.