Published January 23, 2019
The new regulations for human subjects research are now in effect. Referred to as the “2018 Common Rule,” these new regulations went into effect on January 21, 2019.
- All New Projects approved by the IRB ON or AFTER January 21, 2019, must comply with these new requirements.
- Studies that are regulated ONLY by the FDA (no federal funding or support) do not fall under these new regulations because the FDA has not yet harmonized with the 2018 Common Rule.
- All studies that were approved PRIOR to this date may choose to transition to the 2018 Common Rule regulations at the time of their continuing review.
For more information on what has changed and how it may impact your research, go to the HRPO 2018 Common Rule website.
As always, if you need help with your submissions or have questions, call SWAT! at 314.747.6800, or stop by during office hours. See the HRPO SWAT! website for more information.