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Wake-Up Call for Research Compliance

March 28, 2019 Media Mentions

On March 28, Bloomberg Law published an article entitled, "Duke's Fraud Trouble Is a Wake-Up Call for Research Compliance." The article covered Duke University's $112.5 million settlement for faking research data and discusses how the case is a warning for other companies to ensure their data complies. In the article, health care attorney Kate Heffernan notes, "the most important take-away from this settlement for institutions is that the potential for liability under the False Claims Act in the context of research misconduct cases cannot be ignored."

For the full article, log-in to Bloomberg Law's website here.

Firm Highlights

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Research Non-Compliance Investigations

Publication/Podcast

One Month Left to Submit Comments on HIPAA Request For Information

Last month, the Office for Civil Rights (“OCR”) within the U.S. Department of Health and Human Services (“HHS”) published a   Request for Information   (“RFI”) looking for recommendations and public input regarding the...

Publication/Podcast

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new  guidance  (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for Protection of Human...

Publication/Podcast

Is Cybersecurity on Your 2019 Work Plan?

On December 28, 2018, the U.S. Department of Health and Human Services (“HHS”) closed out the year by releasing long-awaited voluntary  cybersecurity guidelines  for the health care industry.[ 1 ] The four-volume publication, developed...

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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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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...

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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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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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Conflicts of Interest

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