Resources
Experience

Research Non-Compliance Investigations

clinical research test tubes

Assisted various hospital systems and research institutes with the investigation of alleged non-compliance with applicable U.S. Department of Health and Human Services (HHS) and U.S. Department of Food and Drug Administration regulations in connection with the operations of their respective institutional review boards (IRBs) and the conduct of specific research studies, including the development of corrective actions, reporting the matter to federal agencies, and implementing the agreed-upon corrective action plan.

Firm Highlights

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

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 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...

Matter

Conflicts of Interest

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

Matter

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.

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

Responsible Research During the COVID-19 Pandemic

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...

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...