Die erneut überarbeitete Deklaration von Helsinki

Zusammenfassung

Die Deklaration von Helsinki des Weltärztebundes ist eines der einflussreichsten Dokumente der Forschungsethik. Im Oktober 2008 wurde eine überarbeitete Fassung der Deklaration verabschiedet. Dieser Beitrag stellt ausgewählte Änderungen zur normativen Stellung der Deklaration, zum Schutz von Forschungsteilnehmern und zu Aspekten internationaler Forschung in den Zusammenhang aktueller forschungsethischer Debatten.

Summary

The World Medical Association’s Declaration of Helsinki is one of the most influential documents in research ethics. A revised version of the Declaration was adopted in October 2008. This paper discusses selected changes regarding the Declaration’s normative status, subject protection and issues in international research in light of current debates in research ethics.

Schlüsselwörter

Forschungsethik - Deklaration von Helsinki - Internationale Forschung

Keywords

research ethics - Declaration of Helsinki - international research

Literatur

• 1 Ashcroft R. The Declaration of Helsinki. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D The Oxford Textbook of Clinical Research Ethics. New York; Oxford University Press 2008: 141-148
• 2 Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva; CIOMS 2002
• 3 Emanuel E J. Finding New Ethical Conceptions through Practical Ethics: Global Justice and the „Standard of Care” Debates. Erhältlich unter: http://www.ethics.utoronto.ca/pdf/events/Paper-EzekielEmanuel.pdf (abgerufen 19. November 2009). 
• 4 Food and Drug Administration, Department of Health and Human Services. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule.  Fed Regist. 2008;  73 (82) 22800-16
• 5 Forster H P, Emanuel E J, Grady C. The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?.  Lancet. 2001;  358 (9291) 1449-53
• 6 Lie R K, Emanuel E J, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion.  J Med Ethics. 2004;  30 (2) 190-3
• 7 London A J. The ambiguity and the exigency: clarifying ‘standard of care’ arguments in international research.  J Med Philos. 2000;  25 (4) 379-97
• 8 London A J, Kimmelman J. Justice in translation: from bench to bedside in the developing world.  Lancet. 2008;  372 (9632) 82-5
• 9 Miller F G. Research ethics and misguided moral intuition.  J Law Med Ethics. 2004;  32 (1) 111-6
• 10 Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London; Nuffield Council 2002
• 11 Wendler D, Emanuel E J, Lie R K. The standard of care debate: can research in developing countries be both ethical and responsive to those countries’ health needs?.  Am J Public Health. 2004;  94 (6) 923-8
• 12 Wendler D, Miller F G. Assessing research risks systematically: the net risks test.  J Med Ethics. 2007;  33 (8) 481-6
• 13 Wolinsky H. The battle of Helsinki: two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics.  EMBO Rep. 2006;  7 (7) 670-2
• 14 Wolitz R, Emanuel E J, Shah S. Rethinking the responsiveness requirement for international research. Lancet 2009 374 9692 847-849
• 15 World Medical Association .World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. verabschiedet vom 59th WMA General Assembly Seoul; October 2008 Erhältlich unter: http://www.wma.net/e/policy/b3.htm (abgerufen 19. November 2009)