> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Not Consistent with ‘Common Rule’: Attorneys
- URL: https://www.fdaweb.com/fda-not-consistent-with-common-rule-attorneys/
- Published: 2019-01-29T12:00:00.000Z
- Updated: 2026-09-15T00:58:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143252

FDA has yet to propose regulations to align its regulations on protection of human subjects with the revised Federal Policy for the Protection of Human Subjects (known as the Common Rule). Three Morgan Lewis attorneys write in an online blog [post](https://www.morganlewis.com/blogs/asprescribed/2019/01/what-does-fda-not-have-in-common-with-the-common-rule?ref=fdaweb.com) that the agency is aware of new inconsistencies between its human subject regulations and the revised Common Rule, and has advised that when a given study is subject to both sets of regulations, the rule that offers greater human subject protection should be applied.

The attorneys write that the agency said it will issue rules in the future to harmonize, to the extent applicable, its regulations with the new Common Rule, as required by the 21st Century Cures Act.

“Until FDA harmonizes its rules,” the post concludes, “clinical investigations for FDA-regulated products will continue to be subject to differing and sometimes inconsistent obligations for the protection of human subjects. Sponsors, investigators, and institutional review boards should ensure that they understand what regulations apply to their clinical investigations and, if both apply, follow the regulations that offer greater human subject protection.”