On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January 2019. FDA’s rules on human subject protection govern clinical investigations regulated by FDA under sections 505(i) and 520(j) of the FDCA, as well as studies used to support applications for research or marketing permits for products regulated by FDA, while the DHHS Common Rule covers DHHS federally funded research. FDA’s recent guidance discusses informed consent requirements, expedited review procedures, and IRB continuing review.
Importantly, this guidance makes clear that research subject to FDA rules must continue to abide by those regulations, even when they are more restrictive than the Common Rule. For instance, FDA maintains the requirement, eliminated in the revised Common Rule, that some low-risk studies undergo an annual check-up known as “continuing review.” However, IRBs should apply Common Rule measures governing structure and content of informed consent documents, which do not conflict with any FDA regulations. As one example, the revised Common Rule includes a new requirement that all the key information in informed consent forms be at the top of the form; FDA does not yet require this.
In order to harmonize FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards (IRBs) with the recently revised final HHS Common Rule, FDA plans to issue three more guidances. The White House’s fall 2018 regulatory agenda, released October 17, indicated FDA plans to go through the formal proposed rulemaking process to finalize these rules, meaning the agency will accept and consider public comments before issuing the guidances in final form. The three planned FDA guidances are:
HHS’ Office for Human Research Protections (OHRP) has also separately issued three draft guidances on the Common Rule revisions on July 20, titled: