The document provides an in-depth overview of the European Union's General Data Protection Regulation (GDPR) as it pertains to research, with a particular focus on implications for U.S.-based organizations involved in multi-regional research activities. It outlines the GDPR’s jurisdiction, extending its reach beyond entities established within the European Economic Area (EEA) to include those offering goods or services to, or monitoring the behavior of, individuals located in the EEA. The regulation defines personal data broadly, covers special categories of sensitive data, and demands a specific legal basis for processing such information, such as consent, contractual necessity, public interest, or legitimate interests—subject to strict safeguards, especially for special categories like health or genetic data.
The summary also details the roles of controllers and processors, highlighting their corresponding contractual and operational obligations under GDPR. Transferring personal data outside the EEA, notably to the United States, requires explicit legal mechanisms, including model contractual clauses or obtaining explicit consent after informing data subjects of associated risks. The GDPR’s requirements for consent in research are stringent, emphasizing it must be freely given, specific, informed, and easily withdrawn, with further guidance suggesting “rolling consent” for evolving research aims. The document further discusses the challenges and practicalities of secondary data use, data sharing across entities, and biospecimen banking under GDPR, emphasizing the vital need for careful alignment with both legal and ethical standards. Hypotheticals illustrated within the document serve to contextualize application of the GDPR’s provisions in real-world research scenarios, underscoring the regulation’s broad and complex impact on international research collaborations.
