Odpowiedzialność karna za prowadzenie badania klinicznego bez świadomej zgody uczestnika lub jego przedstawiciela ustawowego

Białostockie Studia Prawnicze 2025, t. 30, nr 2, s. 95-110.

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.

Podanie wyroku do publicznej wiadomości w ustawie o odpowiedzialności podmiotów zbiorowych za czyny zabronione pod groźbą kary

Prawo karne na przełomie wieków : księga jubileuszowa profesora Ryszarda A. Stefańskiego / redakcja naukowa Maciej Rogalski, Jacek Kosonoga, Jacek A. Dąbrowski. Warszawa : Wolters Kluwer, 2025, s. 1114-1126.

Wyłączenie odpowiedzialności karnej

Kodeks karny : komentarz / redaktor prof. dr hab. Ryszard A. Stefański. Warszawa : Wydawnictwo C. H. Beck, 2025, s. 258-311.

Objaśnienie wyrażeń ustawowych

Kodeks karny : komentarz / redaktor prof. dr hab. Ryszard A. Stefański. Warszawa : Wydawnictwo C. H. Beck, 2025, s. 778-845.

Stosunek do ustaw szczególnych

Kodeks karny : komentarz / redaktor prof. dr hab. Ryszard A. Stefański. Warszawa : Wydawnictwo C. H. Beck, 2025, s. 846-849.

Przestępstwa przeciwko prawom osób wykonujących pracę zarobkową

Kodeks karny : komentarz / redaktor prof. dr hab. Ryszard A. Stefański. Warszawa : Wydawnictwo C. H. Beck, 2025, s. 1607-1633.

Dwukrotne egzekwowanie odpowiedzialności karnej za ten sam czyn a zasada ne bis in idem : glosa do postanowienia Sądu Najwyższego – Izba Karna z dnia 10 września 2024 r., IV KK 145/24

Orzecznictwo Sądów Polskich 2025, nr 3, s. 58-84.

This decision raised a number of important issues regarding the broadly understood field of criminal law and procedure, including those related to the constitutional and international standards of these branches of law. Attention should be drawn to the qualification of liability for committing a petty crime as criminal liability within the meaning of the Constitution of the Republic of Poland, the reconstruction of the constitutional and conventional sources of the principle of ne bis in idem and the determination that this principle is breached by the legal situation created by Article 12 § 2 of the Penal Code and Article 10a § 1 of the Petty Crimes Code. However, the Supreme Court’s efforts to find a procedural instrument that would prevent the unconstitutional and unconventional consequences of these provisions seem problematic. In particular, it seems that the Supreme Court hastily used the so-called dispersed control of the constitutionality of statutes, breaching the subsidiarity of this type of control.