Common Rule Changes Still on Radar For HHS, Updated Agenda Indicates

The nearly three-year effort to modernize human subject protection regulations (45 C.F.R. 46) is still an item on the Department of Health and Human Services’ rule list, according to an updated semiannual regulatory agenda released June 13.

The agenda is the twice-yearly publication of the rulemaking activities that the HHS “expects to undertake in the foreseeable future,” a Federal Register notice announcing the agenda’s availability said (79 Fed. Reg. 34,051).

The agenda lists several research-related items, including the proposed changes to the Common Rule, formally known as “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, ...