Just Under the Wire: The Final Common Rule is Here

January 19, 2017 Alerts and Newsletters

(January 19, 2017) As many of you know, the long-awaited final rule updating the Common Rule ("Final Rule") was issued officially today (after an unofficial release to the public yesterday). Like many of you, we are in the process of digesting and analyzing the new regulations and how they alter the current Common Rule, as well as how they differ from the Notice of Proposed Rulemaking ("NPRM") for the Common Rule that was published sixteen months ago.

As Verrill Dana did with the NPRM, we have created a redline of HHS's current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the Final Rule. You can find and download a copy of this redline here.

By way of brief recap, in September 2015 the U.S. Department of Health and Human Services ("HHS"), along with fifteen other federal departments and agencies, published a NPRM for the Federal Policy for the Protection of Human Subjects, known as the Common Rule. (HHS's Common Rule regulations are found at 45 C.F.R. Part 46, Subpart A.) The NPRM proposed a number of significant changes to the rules for oversight and conduct of human subjects research, including certain requirements concerning the use of non-identified biospecimens in research and IRB review for multi-site studies. HHS received over 2,100 comments in response.

The Final Rule implements some, but not all, of the proposed changes, walking back some of the more controversial proposals. Notably, the full scope of changes proposed with respect to biospecimens was not implemented, and non-identified biospecimens remain outside the regulation's reach. The Final Rule also declined to extend the Common Rule to all clinical trials regardless of funding source. Preserved, with some tweaks, is the mandate for single IRB review for multi-site studies, and the Final Rule also permits future research on identifiable biospecimens based on broad consent. The Final Rule is slated to go into effect on January 19, 2018. However, the compliance date for the provisions regarding single IRB review is January 20, 2020.

It remains to be seen whether the Final Rule will be affected by any efforts under the Congressional Review Act to dismantle regulations issued ahead of the change in presidential administrations. However, regardless of its fate, the research community is examining it with great interest.

___________________________________________________________________
This communication is intended for general information purposes and as a service to clients and friends of Verrill Dana, LLP. This publication, which may be considered advertising under the ethical rules of certain jurisdictions, should not be construed as legal advice or a legal opinion on any specific facts or circumstances, nor does it create attorney-client privilege.

Firm Highlights

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...

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...

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...

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...

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

Responsible Research During the COVID-19 Pandemic

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Matter

Research Non-Compliance Investigations

Test Tubes
Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

Publication/Podcast

COVID-19 Expanded Access Template

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...

Contact Verrill at (855) 307 0700