FDA Guidance Addresses Impact of Revised Common Rule on FDA-Regulated Clinical Trials
On Friday, October 12, FDA released the guidance Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations. In this document, the agency states that it plans to harmonize FDA regulations with the revised Common Rule to the extent applicable. However, since FDA has not yet revised its regulations, this guidance seeks to “reduce confusion and burden associated with complying with two different sets of human subject protection regulations.”
In the guidance, FDA states that:
- Sponsors can implement the updated consent provisions of the revised Common Rule as they do not conflict with FDA regulations.
- There has been no change to the expedited review list used by FDA, and that list must continue to be followed for FDA-regulated research.
- There has been no change to continuing review requirements for any FDA-regulated research that has been deemed to be minimal risk.
Additionally, for studies that fall under the purview of both regulations (e.g., the trial is supported by HHS and involves an FDA-regulated product), the agency states that, “where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.”
Advarra is prepared to comply with the revised Common Rule requirements and will notify clients of any policy and/or process changes necessary for compliance.
For more information, read the entire FDA guidance here.