Norton Rose Fulbright Head of Data and Information Risk David Kessler, CIPP/E, Partner Christoph Ritzer, Senior Associate Anna Rudawski, CIPP/US, Senior Associate Sven Jacobs, and Law Clerk Max Kellogg wrote an analysis on the European Data Protection Board’s opinion on the interplay between the Clinical Trials Regulation and the EU General Data Protection Regulation. The analysis covers the EDPB’s differentiation of informed consent and consent as a legal basis under the CTR and GDPR and the board’s views on the use of clinical trial data outside of clinical trial protocols. The privacy professionals also raised concerns about the imbalance of power between clinical trial operators and participants under the CTR and GDPR and potential confusion patients may face should they need to consent multiple times to appease different laws.
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