Final Rule Issued to Delay the Revised Common Rule for an Additional 6 Months:
The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule).
This Final Rule delays the general compliance date for the 2018 Requirements (aka, Revised Common Rule) with a new effective date of January 21, 2019.
The transition provision in the Final Rule is structured so that regulated entities cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019. As a result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019. The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:
(1) The revised definition of “research,” which deems certain activities not to be research;
(2) The allowance for no annual continuing review of certain categories of research; and
(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
Stay tuned to our website as further updates from the HRPP Office will be posted here in the coming weeks.