Legal Aspects of Bioethics Committees Functioning in the Context of Freedom to Experiment on Human Beings
The purpose of the article is to examine the legal status of bioethics committees as well as opinions produced thereby. The author’s analysis is based on provisions of international statutory material (beginning from the Nuremberg Code to Regulation (EU) No 536/2014 of the Parliament and of the Council of 15 April 2014 on clinical trials of medicinal products for human use, and repealing Directive 2001/20/EC) and domestic legal acts in the view of divergent case law of administrative courts (inter alia the Supreme Administrative Court) on that issue. The article contains several recommendations which should be taken into consideration during the implementation process of the abovementioned regulation into the Polish legal system.
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