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

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

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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.

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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.

Publication/Podcast

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to...

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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.

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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...

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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.

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Conflicts of Interest

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

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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

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...