For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council¹ should apply.
¹ Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
* This title is an unofficial description.
Why Recital 161 Matters for GDPR Compliance?
Recital 161 explains that when individuals consent to participate in clinical trials or scientific research, specific EU regulations such as Regulation (EU) No 536/2014 must also be followed alongside GDPR. This ensures that participants’ rights, safety, and personal data are properly protected. It highlights the importance of combining data protection rules with sector-specific laws to maintain ethical standards in medical and scientific research.