Criminal Liability for Conducting a Clinical Trial Without the Informed Consent of the Participant or His/Her Legal Representative

On 14 April 2023, the Act of 9 March 2023 on clinical trials of medicinal products for human use entered into force, with certain exceptions. The criminal provisions of this Act include Article 77 point 1, which provides the offence of conducting a clinical trial without the informed consent of the participant in such a trial or his/her legal representative, which is carried out contrary to the provisions of Article 28 paragraph 1 letters b and c, paragraphs 2 and 3, Articles 29–32 or Article 35 of 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. This criminal regulation is analysed in this paper. Among other things, attention was drawn to the blanket nature of the analyzed criminal provision, and findings were made regarding its subject, the subject of protection, and the manner of capturing the causative act of the offense regulated in this provision. The concept of informed consent to a clinical trial was also analyzed, establishing that not every failure to comply with the information obligations under Article 29 paragraphs 2–6 of Regulation (EU) No 536/2014 should be treated as an offence.