Reducing Regulatory Burdens on Research with Human Subjects: A Case Study of the Transition to the Final Common Rule at Boston Medical Center and Boston University Medical Campus

Abstract

Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and expedited categories, approval periods, ceding review, Quality Improvement/Quality Assessment activities, and some requirements for pregnant women, prisoners, and children. This case study may assist other institutions in responding to the Final Common Rule.