Differences Between HHS and FDA Clinical Trial Rules Spark New Guidance
With an eye to reducing confusion between the revised Common Rule from the Department of Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) regulations, FDA on Friday issued new guidance to help researchers comply with the two different sets of human subject protection regulations.The six-page guidance focuses on informed consent, expedited review procedures and institutional review board (IRB) continuing review.
Background
According to FDA, the purposes of the Common Rule are to promote uniformity, understanding and compliance with human subject protections and to create a uniform body of regulations across the federal departments and agencies.
The Common Rule has been adopted by 16 other federal departments and agencies, and in 1991, FDA amended its regulations to conform to the Common Rule, with a few exceptions because of differences in FDA’s mission or statute.
Section 3023 of the 21st Century Cures Act directs the Secretary of HHS to harmonize differences between HHS’ human subject regulations and FDA’s human subject regulations.
But last January, HHS published a final rule revising the Common Rule, creating further differences between HHS and FDA regulations. FDA said it intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule but because FDA has not revised its regulations, and the general compliance date for the revised Common Rule is 21 January 2019, FDA is issuing this guidance.
Guidance
Since stakeholders have questioned FDA on the updated Common Rule and its containing several new informed consent requirements, FDA is clarifying that the provisions “related to the content, organization, and presentation of information included in the consent form and process as well as the basic and additional elements of informed consent are not inconsistent with FDA’s current policies and guidances.”
In addition, FDA said it recognizes that under the revised Common Rule, an IRB may use expedited procedures for research appearing on an expedited review list, unless the IRB reviewer determines that the study involves more than minimal risk. But because FDA has not revised its regulations, “IRBs must continue to comply with FDA’s regulation at 21 CFR 56.110(b) and use the 1998 list for FDA-regulated clinical investigations, including those that are subject to both HHS and FDA regulations,” the guidance says.
Meanwhile, the revised Common Rule eliminated the requirement to conduct continuing review in certain circumstances, but because FDA has not revised its regulations, “IRBs must continue to comply with our current requirements for IRB continuing review at 21 CFR 56.109(f), including for clinical investigations that are subject to both HHS and FDA jurisdiction. IRBs are required to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year,” FDA says.
Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations