On January 17, 2018, the U.S. Department of Health Human Services and fifteen other federal departments and agencies announced that both the effective date and compliance date of the new “Federal Policy for the Protection of Human Subjects” (the 2018 Common Rule) is being delayed from January 19, 2018 to July 19, 2018. Read the announcement.
The new common rule will take effect for studies approved on or after July 19, 2018. The new regulations include the following changes:
- New exempt categories and changes to existing exempt categories
- New definition of Human Subjects Research
- Changes to informed consent
- Elimination of the requirement for continuing review for certain studies
See this slide deck for a detailed description of the changes. Note: this is based on the January effective date, not the new July effective date.
View the video presentation of the upcoming changes. Note: this is based on the January effective date, not the new July effective date.
This website is being updated continually with details on CMU's implementation of the new regulations.