Human studies other than clinical trials: the role of a medical therapeutic experiment in the Polish legal system
- 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
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
medical experiment, therapeutic experiment, bioethical committee, drug testing, clinical trials
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