The Revised Common Rule: What Happens Now After the Compliance Date?
The revised Common Rule, released by the U.S. Department of Health and Human Services (DHHS), is the first major change to these regulations in more than 25 years. Human research protection professionals are subject to following the revised Common Rule provisions, with a compliance deadline of January 21, 2019.
This report provides a summary of major changes, reviews the complexity of the changes and gives examples of implementation approaches. It also provides considerations for working with both sets of regulations (pre-2018 and 2018) and transitioning studies.
This material was presented by Philip A. Cola, PhD, director of CTSC Regulatory Knowledge and Madeleine Williams, MA, Senior Director of Huron Consulting Group as part of a presentation for the April 2019 Midwest/Northeast Section meeting of the Society for Research Administrators International (SRAI).