Revisions to the Federal Policy for the Protection of Human Subjects delayed until January 21, 2019

Revisions to the Federal Policy for the Protection of Human Subjects delayed until January 21, 2019

On June 19th, the Department of Health and Human Services (DHHS) and 16 other federal departments and agencies announced an additional six-month delay in the general compliance date for changes made to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule). The general compliance date of the revised Common Rule (known as the “2018 Requirements”) is now January 21, 2019.

During the delay period (July 19, 2018, through January 20, 2019), regulated entities are

required to continue to comply with the requirements of the current Common Rule (“pre-2018 Requirements”) with the following exception. Institutions have the option to implement three burden-reducing provisions of the revised Common Rule during the six-month delay:

  1. The revised definition of “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.

Institutions who choose to implement these burden-reducing provisions for particular studies, must assure that these studies also meet all 2018 Requirements beginning January 21, 2019. Given this complication, UCI IRB will implement one of the three provisions.

Effective July 19, 2018, UCI IRB will no longer conduct federal award-to-protocol congruence reviews. Principal Investigators supported by a federal award to conduct Human Subjects Research will be required to assure that their IRB protocol matches the federal award scope of work.                                                                                             

Prior to January 21, 2019, the IRB will continue to implement pre-2018 requirements for two of the burden-reducing provisions – annual continuing review of DHHS-sponsored minimal risk research and the definition of research.