Ethik in der Medizin

, Volume 24, Issue 4, pp 313–322 | Cite as

Sowohl als auch? Zur Koppelung des Informed Consent und des Community Consent Prinzips in kulturübergreifenden klinischen Forschungsvorhaben

Originalarbeit

Zusammenfassung

In den westlichen Industrienationen gilt das Prinzip der informierten Einwilligung als das Zentralelement medizinischer Forschungsethik. In anderen, stärker die Relationalität als die Individualität von Personen betonenden Kulturen hingegen werden medizinische Entscheidungen traditionell eher durch die Gemeinschaft bzw. ihr Oberhaupt getroffen. Um verschiedenen kulturellen Normen gerecht zu werden, wird international tätigen Forschungsteams häufig empfohlen, den Community Consent und den Informed Consent einzuholen. Ausschlaggebend soll dabei letztlich der Informed Consent des Individuums sein. Es soll die Teilnahme auch dann verweigern können, wenn die Gemeinschaft bzw. ihr Repräsentant dem Vorhaben zugestimmt hat. Der Beitrag diskutiert, ob eine solche Kopplung von Community Consent und Informed Consent tatsächlich geeignet ist, den Ansprüchen beider Prinzipien gerecht zu werden. Es wird argumentiert, dass die Kopplung von Community Consent und Informed Consent ethisch problematisch ist, wenn der Gemeinschaft hierbei ein Vetorecht eingeräumt wird, das geeignet ist, die Realisation konträrer individueller Interessen und damit das Selbstbestimmungsrecht der Betroffenen zu unterlaufen. Um zu gewährleisten, dass in interkulturellen Forschungszusammenhängen sowohl der individuellen als auch der relationalen Autonomie von Personen angemessener Raum gewährt wird, wäre es empfehlenswert, den Informed Consent ausdrücklich mit einer Community Consultation zu koppeln. Hier käme die Entscheidung gegen, aber auch für eine Studienteilnahme in letzter Instanz klar dem Individuum zu, während die Vorzüge einer Einbeziehung der Gemeinschaft in den Entscheidungsfindungsprozess anerkannt und genutzt werden könnten.

Schlüsselwörter

Forschung in Entwicklungsländern Kulturelle Normen Forschungsethik Informierte Einwilligung Community Consent Community Consultation 

And/and, rather than either/or? On combining Informed Consent and Community Consent in trans-cultural clinical research settings

Abstract

Definition of the problem Obtaining Informed Consent is a central requirement of western medical research ethics. Other cultures, however, regard it as an alien concept, based on an individualistic culture of rights, and consider personal relations to be normatively superior. Here, medical decisions are not to be taken by individuals but by their community or their community’s representatives, respectively. In order to respect different cultural norms, researchers working in transcultural settings are often advised to obtain both Community Consent and Informed Consent. The balance shall be turned, however, by the Informed Consent. Even if a community leader agreed to recruiting research subjects, individuals shall still have the right to turn down a researcher’s request. Arguments The article argues that combining Community Consent and Informed Consent is ethically problematic if an individual’s potential Informed Consent may be trumped by a community’s veto. While this policy warrants a certain degree of protection against recruitment of research participants against their will, it fails to appropriately handle the possibility that a person may legitimately wish to participate in a research project in spite of a community’s or community representative’s misgivings. Conclusion A combination of Community Consultation and Informed Consent is better suited to allow protecting the rights of individuals and their relational embeddedness as it emphasizes that no one but the individual has the final say on whether or not he or she participates in a clinical trial, while acknowledging important potential benefits of community involvement in decision-making processes.

Keywords

Research in developing countries Cultural norms Research ethics Informed consent Community consent Community consultation 

Notes

Interessenkonflikt

Die Autorin gibt an, dass keine Interessenkonflikte bestehen.

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Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  1. 1.Institut für Wissenschaft und Ethik (IWE)BonnDeutschland

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