The Department of Health and Human Services (DHHS) and other federal departments and agencies announced that there will be an additional six-month delay in the general compliance date for changes made to the Federal Policy for the Protection of Human Subjects, reported Huron. The final rule was published in the Federal Register on June 19.
The rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. Because of this, regulated entities will be required to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects. Institutions have the options, during the delay period to implement three burden-reducing provisions.
The three burden reducing provisions are the following:
- The revised definition of “research,” which deems certain activities not to be research;
- The allowance for no annual continuing review of certain categories of research; and
- The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
Check out Pearl IRB’s comprehensive guide to the Common Rule changes to ensure your clinical research program undergoes a seamless transition to the new standards on January 21, 2019.
1https://www.huronconsultinggroup.com/resources/higher-education/six-month-delay-general-compliance