European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data.

By Gail E. Crawford, Frances Stocks Allen, and Mihail Krepchev

In January, the European Data Protection Board (EDPB) issued an opinion (Opinion) on the interplay between the General Data Protection Regulation (GDPR) and the Clinical Trials Regulation (CTR), which: (1) confirms that consent under the GDPR and CTR are different concepts; and (2) sets out the EDPB’s recommendations on the appropriate legal basis required for processing personal data in connection with clinical trials conducted in the EEA (which is unlikely to be consent).

Practical Takeaways

While the Opinion brings some much-needed certainty to the area of consent and other legal grounds for clinical trials, challenges remain. Outlined below are the key challenges and the steps that sponsors of clinical trials in the EEA (Sponsors) should take when designing their research activities: