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Clinical trials of medicinal products on human subjects are a balancing act between the protection of the study participant and the preservation of his dignity on the one hand and the constant striving for medical progress on the other hand. This applies likewise to the control group as an essential part of every clinical testing of pharmaceuticals without which no drug will receive marketing authorisation in Germany by the competent authorities. Nevertheless, significant gaps in the German legislation concerning this matter still remain as the German legislator has yet to implement any specific rules with regard to the handling and management of the control group in clinical trials. In view of this unsettled legal situation, the author critically analyses the core of the problem areas in this field’s current research practice and creates solutions reflecting the interests of the study participant as well as the practical needs of medical research. Only legal clarity regarding the control group can provide for the safety that is crucial in this field of tension between ethics, medicine and the law.Die klinische Prüfung von Arzneimitteln am Menschen bedeutet eine Gratwanderung zwischen dem Schutz des Studienteilnehmers und der Wahrung seiner Würde auf der einen sowie dem Streben nach medizinischem Fortschritt auf der anderen Seite. Dies gilt ebenso für die Kontrolle der Studie. Denn zu Recht wird in Deutschland kein Medikament ohne die Testung in einer kontrollierten Studie zugelassen. Gleichzeitig bestehen hier bedenkliche Regelungslücken, hat doch der Gesetzgeber den Umgang mit der Kontrollgruppe in der Humanforschung bisher gesetzlich nicht reglementiert. Vor dem Hintergrund dieser ungeklärten Rechtslage werden die sich ergebenden Problemfelder in der aktuellen Forschungspraxis grundlegend wie kritisch analysiert und interessengerechte Lösungsvorschläge entwickelt. Denn nur die Schaffung rechtlicher Klarheit über den Umgang mit der Kontrollgruppe vermag in diesem Spannungsfeld aus Ethik, Medizin und Recht Sicherheit für Ärzte und Studienteilnehmer zu gewährleisten. Ebendiese Schaffung von rechtlicher Sicherheit und Angemessenheit muss in einem solchen Bereich, der als medizinrechtliche Thematik die Grundfesten von Persönlichkeits- und Selbstbestimmungsrecht berührt, als höchste Priorität gelten.

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