Zusammenfassung
Die Globalisierung der klinischen Forschung gewinnt zusehends an Dynamik. Insbesondere Schwellenländer wie Brasilien, Indien, Russland und China verzeichnen ein deutliches Wachstum bei klinischen Studien. Dieser Trend erzeugt unterschiedliche ethische Probleme, die wir im vorliegenden Artikel untersuchen werden. Teils werden allgemein akzeptierte ethische Regeln wie die Begutachtung von Studien durch Ethikkommissionen nicht eingehalten, teils entstehen schwer zu lösende Konfliktsituationen. Umstritten ist etwa, welchen Behandlungsstandard Forscher und Sponsoren bei internationalen Studien zur Verfügung stellen müssen. Erschwert werden diese Konflikte noch durch ein grundlegendes Dilemma: Mehr Forschung in Entwicklungs- und Schwellenländern zu den dort vorherrschenden Erkrankungen ist notwendig. Gleichzeitig stellt der Schutz der dortigen Studienteilnehmer eine besondere Herausforderung dar. Internationale Kommissionen und Richtlinien haben in den letzten Jahren deutliche Fortschritte erzielt, um diese Konflikte zu lösen. Dennoch muss die weitere Entwicklung sorgfältig untersucht werden. Anreize müssen geschaffen werden, um bisher vernachlässigte Erkrankungen besser zu erforschen. Fehlentwicklungen und Missbrauch müssen durch angemessene internationale ethische Standards verhindert werden.
Abstract
The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.
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H.-J. Ehni und U. Wiesing geben an, dass kein Interessenkonflikt besteht.
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Ehni, HJ., Wiesing, U. Globalisierung in der medizinischen Forschung. Chirurg 89, 178–184 (2018). https://doi.org/10.1007/s00104-017-0570-5
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DOI: https://doi.org/10.1007/s00104-017-0570-5
Schlüsselwörter
- Entwicklungsländer
- Forschungsethik
- Internationale Richtlinien
- Behandlungsstandard
- Gerecht geteilter Nutzen