Pharmaceutical & Life Sciences News

Help on Research Reg Changes May Be on the Way From HHS

June 29, 2018, 8:07 PM

Research institutions may finally get some clarity on the overhaul to regulations designed to protect research volunteers—more than a year and a half after those changes came out.

A draft guidance document related to the “three burden-reducing provisions” of the revised human subjects protection regulations known as the Common Rule (45 C.F.R. 46) appears on an agenda for a July 11 meeting of a federal research advisory panel. While no such draft document publicly exists, groups representing research institutions have been clamoring for help on how to carry out the first modernization of the Common Rule since the...

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