FDA long awaited proposed rules for IRBs
Wednesday, September 28, 2022, the FDA issued proposed rules for the long-awaited harmonization of FDA regulations for IRBs and human subject protections with the revised Common Rule.
One proposed rule amends sections of 21 CFR 50 and 56 to harmonize language, requirements for informed consent, and provisions for continuing review and recordkeeping—find further analysis from PRIM&R here.
The other amends 21 CFR 56 to adopt the 2018 Common Rule’s single IRB requirement for cooperative research in the US, with additional exceptions—find further analysis from PRIM&R here.
The comment period for both proposed rules close 12/28/2022.