Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

October 31, 2018 Alerts and Newsletters

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. For assistance with questions regarding the Guidance, the FDA regulations, or the 2018 Requirements, please reach out to Emily Fogler, Andrew Rusczek, or your regular Verrill Dana attorney.

Firm Highlights

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Matter

European Union GDPR—Pharmaceutical Company

Advised pharmaceutical company on all aspects of compliance with the European Union General Data Protection Regulation (GDPR), including gap analysis, policy and procedure development, and vendor and other third party contract revisions.

Matter

CAN-SPAM/E-Sign Act

Acted as the go-to advisor for a pharmaceutical company for advice on CAN-SPAM and E-Sign Act.

Matter

FDA Advertising/Promotion

Presented to senior executives and other management of a start-up pharmaceutical company on complying with U.S. Department of Food and Drug Administration (FDA) advertising and promotion requirements pre- and post-launch.

Matter

International Clinical Trials

Advised various pharmaceutical companies on the implementation of international clinical trials and related U.S. and ex-U.S. legal issues, including under FDA regulations, Health Insurance Portability and Accountability Act of 1996 (HIPAA), the GDPR, and...

Publication/Podcast

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory...

Matter

Informed Consent Form Templates

Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.

Publication/Podcast

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines...

Publication/Podcast

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency ” with new information...

Matter

On-Site Counsel

Served as on-site, long-term legal counsel for various pharmaceutical and device companies during times of staffing shortage at the companies.

Contact Verrill at (855) 307 0700