Legal Regulations of Clinical Trials in the Polish Legal System

The article deals with the issue of regulation of clinical trials against the background of the Polish legal system. The starting point is the analysis of the institution of medical experimentation in the context of clinical trials on humans. The paper pays particular attention to the informed and voluntary consent of the participant in a clinical trial, taking into account the current case-law of the Supreme Court. Drafts of future legislative changes concerning clinical trials have been announced recently.