The 2018 Common Rule: Implementation Checklist

May 31, 2017 Alerts and Newsletters

As many of you know, most of the provisions of the Final Rule updating the Common Rule ("2018 Common Rule") will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to the current Administration's regulatory plans, as of now institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations.

To assist clients and friends in assessing high priority areas for compliance preparedness, we have attached a 2018 Common Rule Implementation Checklist here.

Also, in case you missed it, 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.

Members of our Academic and Clinical Research Group (ACRG) have been busy presenting on the 2018 Common Rule and its practical implications at various conferences and webinars. Stay tuned for additional ACRG commentary on the 2018 Common Rule in the coming weeks. Be sure to follow the ACRG on our blog, Endpoints (http://clinicalresearchlawblog.com), and on Twitter (@clinicalreslaw) for additional updates.

___________________________________________________________________
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

Publication/Podcast

Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...

Matter

Conflicts of Interest

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

Publication/Podcast

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...

Publication/Podcast

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...

News

Verrill Ranked in American Bar Association’s Health Law Top 10 in the Northeast

(January 19, 2021) – Verrill was recently ranked third in the American Bar Association (ABA) Health Law Section's Eighth Annual Top 10 Recognition for the Northeast Region. This is the sixth consecutive year that...

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...

Publication/Podcast

Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

News

Verrill Welcomes Health Care Attorney Alicia Siani

(February 2, 2021) – Verrill is pleased to welcome health care attorney Alicia Siani to the firm’s Boston, Massachusetts office. Siani represents clients in a wide range of regulatory issues, including HIPAA privacy matters...

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...

News

Verrill Welcomes Jeffrey A. Smagula, Experienced Health Care and Life Sciences Attorney, Former Health Plan Compliance Executive

(May 12, 2021) – Verrill is pleased to welcome Jeffrey A. Smagula to the firm’s Boston office as Counsel in its nationally recognized Health Care & Life Sciences Group. Jeff Smagula brings to Verrill...

Contact Verrill at (855) 307 0700