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

Publication/Podcast

Maine PUC Clarifies Ability of Level 2 Projects to “Leapfrog” Level 4 Projects in Interconnection Queue

After months of uncertainty over the issue of whether Level 2 renewable energy projects can “leapfrog” Level 4 projects in the queue, the Maine PUC clarified one of the ambiguities. Specifically, in response to...

Event

Annual Update: Part 1 - 2022 Legal Year in Review (1st Session)

Blog

IRS Guidance Expands Access to ACA Premium Tax Credit, Allows Cafeteria Plan Sponsors to Permit Employees to Revoke Family Coverage Mid-year

Final Regulations under Section 36B of the Internal Revenue Code On October 11, 2022, the Internal Revenue Service (IRS) issued Final Regulations under Code Section 36B relating to eligibility for the Affordable Care Act’s...

Blog

New IRS Determination Letter Program for 403(b) and 401(a) Plans

On November 7, 2022, the IRS issued Revenue Procedure 2022-40 , which allows certain tax-exempt employers (such as schools, charities, and churches) to apply for IRS determination letters on their individually designed section 403(b...

News

Verrill Welcomes Associates Brody Haverly-Johndro, Maye Emlein, Victoria Larson, Chris Petronio, Abby Plummer, and Alexander Read

Matter

Advised Fortune 500 Company on Group Health and Welfare Benefit Plans

We were engaged by a Fortune 500 manufacturing company to provide legal and compliance services regarding its group health and welfare benefit plans. During the course of our representation, we have advised the company...

News

Ruth Mattson quoted in Law360 article regarding new Massachusetts surtax

Event

Annual Update: Part 1 - 2022 Legal Year in Review (2nd Session)

Matter

Elections and Constitutional Law: Successfully Challenged Certification of Initiative Petition

In a victory for consumers and the ride-hailing public, the Massachusetts Supreme Judicial Court recently barred the Secretary of State from placing on the November ballot initiative petitions proposed by companies such as Uber...

Publication/Podcast

The PHE is Ending: Do You Know Where Your Waivers Are?

While the pandemic is not over, the COVID-19 public health emergency (PHE) is expected to expire soon, which means that a number of operational, safety, and billing standards that were waived at the beginning...

Contact Verrill at (855) 307 0700