‘Common Rule’ Human Research Regulation Delayed to 2019 (1)

An overhaul of regulations to protect research volunteers will officially be postponed a full year to Jan. 21, 2019.

The latest development, issued as a final rule from the Department of Health and Human Services and nearly 15 other federal agencies, provides direction to hundreds of research institutions and administrators after months of uncertainty about how to proceed with the human subject protection regulations known as the Common Rule (45 C.F.R. 46).

“This has been so open-ended with such uncertainly for so long,” Elisa A. Hurley, executive director of Public Responsibility in Medicine & Research, told Bloomberg Law ...