Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for Protection of Human Research Subjects (“Common Rule”) affect FDA-regulated clinical investigations.  In 2017, the U.S. Department of Health and Human Services (“HHS”) and other federal departments and agencies published a final rule overhauling the Common Rule (“2018 Requirements”).  The 2018 Requirements became effective in July 2018 and have a compliance date of January 21, 2019.  The 21st Century Cures Act (“Cures Act”) simultaneously required the Secretary of HHS to harmonize differences between the Common Rule and FDA human subjects protection regulations, to the extent practicable and consistent with other statutory provisions, by December 2019.  The goals of both the 2018 Requirements and of the Cures Act harmonization mandate are to facilitate research and minimize regulatory burden, duplication, and delay.

Given the impending Cures Act deadline, it is expected that within the next year, FDA will propose revisions to its own human subjects protection regulations that will mirror, at least in part, the changes to the Common Rule made in the 2018 Requirements.  In the meantime, the Guidance explains the FDA’s position on how to ensure compliance for FDA-regulated clinical investigations that are federally funded (and thus subject to both sets of regulations) and seeks to reduce confusion for stakeholders who are faced with inconsistent or conflicting regulatory requirements.  Although the FDA’s human subjects protection regulations and the Common Rule are similar in many respects, certain differences exist, largely as a result of specific requirements or restrictions in the FDA’s governing statute.  The 2018 Requirements increase the number of differences between the two sets of regulations.  Below, we highlight the Guidance’s take-aways as to how provisions in the 2018 Requirements affect FDA-regulated clinical investigations.

Informed Consent

The 2018 Requirements contain new obligations regarding the content and organization of informed consent processes and forms, including changes to the elements of consent and a new requirement that key information about a study be presented at the beginning of the consent form.  The Guidance clarifies that these new consent requirements are “not inconsistent with” the FDA’s current policies or guidance on informed consent.  Therefore, there is no need for sponsors and investigators to develop separate consent forms for Common Rule- and FDA-regulated studies.

Expedited Review Procedures and List

FDA’s human subjects protection regulations and the Common Rule both allow an IRB to use expedited review procedures for certain types of research that are identified on agency-published expedited review lists and that involve no more than minimal risk.  The 2018 Requirements removed the obligation for an IRB to determine that research on the expedited review list for federally funded studies involves no more than minimal risk; instead, research on this list can be presumed to be minimal risk, and expedited review procedures can be used to review the research unless the IRB reviewer determines that the study involves greater than minimal risk.  The Guidance clarifies that because FDA’s IRB regulations have not been similarly revised, for FDA-regulated clinical investigations, an IRB must still find that a study on FDA’s expedited review list involves no more than minimal risk in order to use expedited review procedures.

IRB Continuing Review

For federally funded research, the 2018 Requirements remove the obligation for an IRB to perform continuing review of (i) research that was initially approved using expedited review procedures and (ii) research that has proceeded to the stage of clinical follow-up (retrieving follow-up clinical data from procedures that patients undergo as part of regular care) and/or data analysis.  Because the FDA has not changed its IRB regulations with respect to continuing review, IRBs must still conduct review of FDA-regulated clinical investigations at least once a year, even for studies that were approved by expedited review or that are in clinical follow-up and/or data analysis.

In sum, requirements for FDA-regulated clinical investigations will not change when the 2018 Requirements come into effect in January 2019.  FDA does not indicate in the Guidance the extent to which it will revise its own human subjects protection regulations to mirror the 2018 Requirements.  Verrill Dana will follow the FDA’s rulemaking process and will continue to bring you updates on this matter.