Human Subjects Research (HSR) Regulations Updated for 2020
In January 2019, the federal government implemented new regulations that govern human subjects research (HSR) - referred to as the 2018 New Common Rule.
These regulations became effective for all new IRB protocols approved on or after January 21, 2019, except for federally-funded cooperative research which relies upon approval by a single IRB (sIRB). The rule cites an implementation date for these new cooperative research regulations for January 20, 2020.
The sIRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
To accommodate the transition to the new regulations, the following is planned for IRB protocol submission via SPARCS:
- Protocols approved prior to January 20, 2019, continue to be governed by the “pre-2018” HSR regulations for an undetermined period of time. This is also true for studies that are cooperative in nature but were approved prior to January 20, 2020.
See this slide deck for a detailed description of the changes and a description of the new sIRB pathway in SPARCS IRB.
Please contact the IRB Office at sirb@andrew.cmu.edu to discuss any sIRB questions.