Zusammenfassung
Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können.
Abstract
Definition of the Problem:
The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo is still missing. The central issue in the ongoing controversy is the justification of placebo-use if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions justifying placebo-use according to each guideline are in the focus of our attention.
Arguments:
First, we will first present a formalized general principle that defines the ethical acceptability of placebo use in all regulations. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow to expose the participants of clinical trials to be exposed to a risk of serious harm, while others do not.
Conclusion:
The normative difference of each guideline could influence strongly the decision of researchers or IRBs concerning the ethical acceptability of placebo use.
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Ehni, HJ., Wiesing, U. Placebos in klinischen Versuchsreihen. Ethik Med 18, 223–237 (2006). https://doi.org/10.1007/s00481-006-0439-5
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DOI: https://doi.org/10.1007/s00481-006-0439-5
Schlüsselwörter
- Placebo
- Klinische Versuchsreihen
- internationale Richtlinien
- Deklaration von Helsinki
- internationale Forschung