Biden Administration Lays Out Goals for Potential FDA Regulations
The Biden administration has released its first unified agenda of proposed regulatory actions, a set of goals that include rules to synchronize FDA regulations with requirements of the Common Rule.
The unified agenda, which is published twice annually and is by no means set in stone, features three rules that involve IRB regulations.
One proposed rule would require any institution doing multisite cooperative research in the U.S. to get approval by a single IRB for research conducted in the country, though it notes there are some exceptions. The proposed rule would also require IRBs to keep records of research that takes place at an institution where IRB oversight is conducted by an IRB not run by that institution. The rule, which has a notice of proposed rulemaking set for December, represents the FDA’s harmonizing with requirements of the Common Rule, which was last updated in 2018.
Another proposed rule, vaguely described, looks to harmonize other certain provisions of the FDA’s regulations on human subject protections and IRBs with the Common Rule. It would also make minor amendments to “related regulatory provisions,” though the rule does not give any detail on which provisions it would target. It also has a December target deadline.
The third, a final rule with a February 2022 target date, would establish an FDA regulation allowing IRBs to waive or alter certain informed consent elements or to waive requirements to obtain informed consent under limited conditions, though only for “certain minimal risk” clinical trials. Its goal is to facilitate certain minimal risk trials to support the development of new medical products. The regulation had already been mandated by the FDA through a guidance issued after the Common Rule was updated.
Read the entire FDA/HHS rulemaking agenda here: https://bit.ly/3iSLg5Z.