Human studies other than clinical trials: the role of a medical
therapeutic experiment in the Polish legal system

Beata Świątkowska-Flis; Wojciech Statowski; Małgorzata Wójcicka; Michał Flis

doi:10.5114/ms.2026.161807

eISSN: 2300-6722
ISSN: 1899-1874

Medical Studies/Studia Medyczne

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abstract:

Human studies other than clinical trials: the role of a medical therapeutic experiment in the Polish legal system

Beata Świątkowska-Flis

^{1, 2}

,

Wojciech Statowski

^{2, 3}

,

Małgorzata Wójcicka

^{2, 4}

,

Michał Flis

⁵

Clinical Department of Cardiovascular Diseases, Władyslaw Biegański Collegium Medicum, Jan Długosz University, Czestochowa, Poland
Klara Medical Center, Czestochowa, Poland
Institute of Physical Culture Sciences, Władyslaw Biegański Collegium Medicum, Jan Długosz University, Czestochowa, Poland
Provincial Specialist Hospital Blessed Virgin Mary, Czestochowa, Poland
Student Scientific Society of Cardiovascular Diseases Władyslaw Biegański Collegium Medicum, Jan Długosz University, Czestochowa, Poland

DOI: https://doi.org/10.5114/ms.2026.161807

Online publish date: 2026/05/14

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In accordance with Polish law, doctors are entitled to conduct two types of medical experiments: research and therapeutic. The research experiment focuses on expanding medical knowledge, and it can be carried out in patients or healthy subjects. The participants in these experiments are not exposed to risk, or the risk is small and proportionate to the effects. By contrast, therapeutic experiments involve the use of new or only partially tested diagnostic, therapeutic, or prophylactic methods that can only be used if the existing methods are ineffective or provide insufficient efficacy. The aim of a therapeutic experiment

is to improve the health of a patient, and it may offer the only chance to improve or maintain the patient’s condition. A medical experiment must be approved by an independent bioethics committee. Herein, we provide an analysis of Polish legal documents and their relevance to medical experiments.

keywords:

Human studies other than clinical trials: the role of a medical therapeutic experiment in the Polish legal system

Beata Świątkowska-Flis 1, 2 , Wojciech Statowski 2, 3 , Małgorzata Wójcicka 2, 4 , Michał Flis 5

medical experiment, therapeutic experiment, bioethical committee, drug testing, clinical trials

Beata Świątkowska-Flis

^{1, 2}

,

Wojciech Statowski

^{2, 3}

,

Małgorzata Wójcicka

^{2, 4}

,

Michał Flis

⁵