Resources
Experience

Institutional Review Board

Assisted a prominent university with the development of a NIH-funded national IRB reliance model in facilitation of NIH's Single IRB Review Policy.

Firm Highlights

Matter

On-Site Counsel

Provided coverage to in-house research counsel and the research compliance department at various institutions during times of staffing transitions, working hand-in-hand with the client to manage daily legal needs related to research compliance.

Matter

Research Biorepository/Database

Analyzed and advised on various legal, regulatory, and ethical factors related to the development of a health system's centralized research biorepository and database and the migration of existing local repositories and databases, including potential...

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...

Matter

Secondary Research With Clinical Specimens

Advised various medical centers on the implications of clinical consent language related to the repurposing of excess clinical specimens for research purposes.

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

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.

Matter

Research Non-Compliance Investigations

Test Tubes
Matter

Research Misconduct

Represented various hospital systems in connection with research misconduct investigations, including advising on the internal investigation, assisting with the drafting of required reports, and communicating with federal regulators and respondents' legal counsel.

Matter

Conflicts of Interest

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

Contact Verrill at (855) 307 0700