Institutional Review Board

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.

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...

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...

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...

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

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.

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.

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