In June 2018, a Final Rule in the Code of Federal Regulations set new effective dates for changes to the Common Rule, originally announced in early 2017. Under this latest Final Rule, most of the 2018 requirements become effective in January 2019, but three provisions that could save researchers, IRBs, and research institutions time and effort become available as options in July 2018. Use this handy infographic to track your route through the regulatory pipeline:
Each valve of the Common Rule Implementation Pipeline represents a transition stage, such as dates of announcement or when provisions become available. The space between two valves represents what regulatory possibilities exist at that time. Between January 19, 2017 and July 19, for example, any ongoing or new research must follow the Pre-2018 Requirements. Between July 2018 and January 2019, however, new and ongoing research may follow the Pre-2018 Requirements as they exist, or it may incorporate the 3 Burden-Reducing Provisions. After January 2019, ongoing research may follow either 2018 Requirements or pre-2018 Requirements, depending on circumstances, but all new research must follow the 2018 Requirements*. (Please see the specific text of the Final Rule for details, and visit our Knowledge Center).
*One provision of the revised Common Rule does not need to be implemented in January 2019. This is the requirement that multisite research undergo cooperative IRB review (also known as single IRB, or sIRB, review). This requirement becomes effective in January 2020.