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

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). This final rule was published to the Federal Register on June 19 and will delay the general compliance date of the revised Common Rule (known as the “2018 Requirements”) to January 21, 2019.

During the delay period, regulated entities will be required, with the exceptions below, to continue to comply with the requirements of the current Common Rule (“pre-2018 Requirements”) until January 21, 2019. Institutions will have the option during the delay period (July 19, 2018, through January 20, 2019) to implement three burden-reducing provisions of the revised Common Rule:

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.

If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the 2018 Requirements beginning on January 21, 2019.

The Final Rule has been put on public display by the Office of the Federal Register and can be accessed here.

To speak to a Huron expert regarding ways to prepare for the Revised Common Rule or how to implement the 3 burden-reducing provisions, contact Huron.

Huron’s higher education research practice will continue to monitor and report additional developments on this topic in our weekly Clinical Research Management Briefing newsletter, monthly Future of Higher Education newsletter and on our website.