Tag: R3 Meeting

Research that is executed in part or in whole through remote modalities, such as telemedicine and health care providers who visit participant homes, is increasingly commonplace yet complicated. Decentralized research raises novel questions regarding whether and which institutions are engaged in research under the Common Rule and who is a subinvestigator according to United States Food and Drug Administration (FDA) regulations. Mark Barnes, MRCT Center Faculty Director, overviewed the concept of engagement in research subject to the Common Rule and proposed a model to redefine the concept of engagement. David Peloquin, MRCT Center Senior Advisor, overviewed the investigator and subinvestigator designations in research subject to FDA regulations.

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The European Union (“EU”) General Data Protection Regulation (“GDPR”) and its effect on research activities was the first topic addressed by the R3 at its initial meetings in 2018. In the four years since those meetings, there have been many developments that have continued to cause complications for trans-Atlantic research. These have included, among others, the invalidation of the EU-U.S. Privacy Shield in June 2020 by the Schrems II decision, Brexit, the release in 2021 of new Standard Contractual Clauses by the European Commission, and the introduction of data transfer impact assessments as a prerequisite for many cross-border transfers of personal data.

On March 25, 2022, the European Commission and the United States announced that they have agreed in principle on a new Trans-Atlantic Data Privacy Framework, intended to foster trans-Atlantic data flows and address the concerns raised by the Court of Justice of the European Union in the Schrems II decision. The discussion at the convened R3 considered these recent developments and identified potential solutions to ease trans-Atlantic research while complying with GDPR.

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The core activities of clinical trials are typically conducted at physical locations referred to as “sites.” Traditionally, these sites are hospitals or academic medical centers. While these traditional sites remain important fixtures in the clinical trial landscape, new models including “decentralized” or even “site-less” clinical trials have emerged. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of the clinical trial site landscape and how it has changed over time, with a particular focus on the emergence of stand-alone sites, as such sites present unique regulatory issues. He then provided several examples of these stand-alone sites and presented a handful of recent regulatory enforcement cases before moving into a discussion of the relevant legal risks and considerations.

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In an increasingly connected world, clinical trials and other research activities are no longer state- or country-specific. Not surprisingly, the globalization of research activities creates any number of legal and compliance challenges for stakeholders involved in the development, authorization, and commercialization of medicinal products, including under data privacy regulations that continue to evolve.

This hybrid meeting addressed some of the most pressing of these challenges. We addressed issues that go to the heart of the General Data Protection Regulation (“GDPR”) of the European Union (“EU”), such as what constitutes a restricted international data transfer, the appropriate lawful basis to legitimize the processing of personal data in the context of clinical trials and secondary research, and the designations of parties participating in research as controllers and processors. We also discussed potential solutions to problems that continue to challenge the research community. The research community has been awaiting further guidance on the topic of the GDPR and research from the European Data Protection Board (“EDPB”) for several years. The research community must thus navigate several complex issues in the absence of relevant regulatory guidance.

This meeting consisted of a series of panels made up of experts from the life sciences industry, government, and academia to address key challenges faced by the research sector under the GDPR and data privacy regulations in other geographies, including the Personal Information Protection Law of the People’s Republic of China (“PIPL”).

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Some state privacy laws apply to specific types of data that might be used in research. Other state privacy laws, sometimes referred to as omnibus privacy laws, regulate the collection and use of personal data throughout the economy. Meeting attendees reviewed and discussed both types of laws in several states, including their applicability to organizations involved in research, exemptions for research activities, and overall impact on research.

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There has been an increase in sustained interactions between sponsors of clinical research or their designees and potential and enrolled study participants and their families. Sponsor interactions with study participants and their families raise certain legal and regulatory concerns when sponsors perform the functions of investigators, such as taking medical histories or securing records from third-party health care providers, or when interactions contribute to inaccurate participant perceptions regarding who is responsible for their participation in a study, among other things.

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Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070

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Research Collaboration with China: Where are we now with Data Privacy, Export Controls, and Foreign Influence?

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The Revolution in Online Behavioral Advertising – What it Means for the Research Enterprise

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