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.
Resources
ExperienceFirm Highlights
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
“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments
News
Nearly 80 Verrill Attorneys Recognized by Best Lawyers® 2021, Including a Dozen Named Lawyers of the Year
(August 24, 2020) – Nearly 80 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2021 , including 12 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer...
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
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...
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.
News
Michael K. Fee to Lead Verrill’s Nationally-Recognized Health Care and Life Sciences Practice Amidst Recent Changes
(August 31, 2020) – Verrill is pleased to announce Michael K. Fee as the new leader of Verrill’s nationally-recognized Health Care & Life Sciences Group. The Group has a long history of representing a...
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
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
340B Providers Get Partial Relief from New Dispute Resolution Regulation
1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...
