Therapeutic trial, clinical research and therapeutic freedom--legal boundaries
Deutsch, E.
Zeitschrift für Arztliche Fortbildung und Qualitatssicherung 91(7): 698-700; Discussion 701
1997
ISSN/ISBN: 1431-7621 PMID: 9527472 Document Number: 474931
Clinical research can be therapeutic or purely scientific. The therapeutic trial is usually chosen to obtain treatment liberty. On the other hand, the physicians in controlled clinical trials have relatively little choice of treatments. In Germany, special statutes and the general law limit clinical trials. The sec. 41 AMG, 18 MPG allow therapeutical trials under special circumstances. There are requirements for clinically controlled trials, especially the provision to seek the approval of an ethic commission.
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