Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December

Nov 29, 2022 | News |

On September 28, 2022, FDA released two proposed rules aimed at amending some sections of its current regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Federal Policy for the Protection of Human Subjects—also known as the Common Rule.

FDA’s guidelines on human subject protections regulate clinical investigations, as well as studies used to support applications for research or marketing applications for FDA-regulated products. The Common Rule, on the other hand, applies to research supported by the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH).

In October 2018, FDA released a guidance on how to handle differences in the revised Common Rule and rules on FDA-regulated research. This guidance stated that research subject to FDA rules must continue to abide by FDA’s regulations, even when they are more restrictive than the Common Rule. At that time, FDA expressed its plans to propose human subject protection rules and IRB guidelines to align FDA’s human subject protection regulations with the now-revised Common Rule. Four years later, FDA has followed through.

The first proposed rule released by FDA this September identifies specific provisions relating to IRB review and informed consent, while the second focuses on cooperative research and a single IRB review process for multisite research conducted in the U.S. (with some exceptions).

The proposed rule “Protection of Human Subjects and Institutional Review Boards” seeks to revise, where possible, its guidelines related to informed consent, expedited IRB review, and continuing review of research. FDA has proposed that this will “reduce regulatory burden on IRBs, sponsors, and investigators.” While the proposed revisions address most of the differences between the revised Common Rule and FDA regulations, there are still some exceptions, which will be discussed in Part 2 of this series. Read the rule by clicking the link below.

2022-21088.pdf (

The second proposed rule, “Institutional Review Boards; Cooperative Research,” proposes to require any U.S.-located institution conducting cooperative research to rely on single Institutional Review Board (sIRB) oversight for the research being conducted in the U.S. This would also include an IRB recordkeeping requirement to necessitate documentation of an institution’s reliance on an external IRB for oversight of research. If finalized, this proposal would align requirements for cooperative research and IRB records with the Common Rule, which will be discussed in more detail in Part 3 of this series. Read the rule by clicking the link below.

2022-21089.pdf (

FDA is requesting comments on the two proposed rules and has extended the comment period until 11:59 p.m. ET on December 28, 2022. Comments on these proposed rules will inform FDA on how to proceed with these potential changes for regulations of human subject protections and Institutional Review Boards. Comments can be submitted electronically at Note that these comments will be posted to the docket unchanged, so you are solely responsible for making sure that your comment does not include any confidential information. If you want to submit a comment that you do not wish to be made available to the public, you can submit the comment as a written submission and mark it as confidential. Written comments can be mailed or hand delivered and will be accepted so long as they are received on or before December 28.

Have questions or want to learn more? Visit or email us at And make sure to stay tuned for Part 2 of the series, which will break down the proposed rule on “Protection of Human Subjects and Institutional Review Boards.”