FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule

The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter than Health and Human Services’ (HHS) Common Rule which applies to research supported by federal agencies. To address the discrepancies, in October 2018, FDA published a guidance document for those parties subject to both FDA regulations and the Common Rule; the document clarified that these parties would be required to follow the stricter FDA regulations rather that the more lenient Common Rule.

In September 2022, FDA proposed two new rules for which HHS sought comments through November 28, 2022. The first proposed rule, Institutional Review Boards: Cooperative Research puts forth a single IRB review for studies conducted within the US, that take place at multiple research sites. The FDA hopes that this rule will “streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protections”. This rule would also help research commence earlier.

The second proposed rule, Protection of Human Subjects and Institutional Review Boards would enhance the informed consent process by revising the requirements for content and organization. Informed consent documents would be required to include[1]:

· A description of how information or biospecimens may be used for future research or distributed for future research.

· A statement that private information or biospecimens collected during research may be used for commercial profit, and a notification of whether the research subject would share in the profit.

· A statement of whether clinically relevant results will be disclosed to study subjects and under what circumstances.

· A notification of whether the research involves whole genome sequencing (for research involving biospecimens).

In addition to the content changes in the informed consent document, the new rule would also change the organization of the information such that key information must be presented to the study participants first before other information. This second proposed rule would also create changes in the criteria for IRB approval for research and in investigational device exemption (IDE) reporting requirements. The FDA hopes that this new rule will “reduce regulatory burden for IRBs, sponsors, and investigators.”

It will be important for interested stakeholders to keep a close eye on these new proposed rules. Although these rules will hopefully create an easier path for those conducting clinical trials while further protecting clinical trial participants, nonetheless, it will also mean that interested stakeholders need to review these rules upon finalization to ensure compliance. Ensuring that the informed consent document complies with all applicable regulations is important for compliance but also for products liability risk management. A document that is not compliant can contribute to the difficulty of defending a sponsor that is involved in litigation.

[1] https://www.raps.org/news-and-articles/news-articles/2022/9/fda-seek-to-harmonize-human-subject-protections-wi