Biomedical Research and Human Research Subject Protection: Is There Need for Action in Germany and Austria?

Biomedical Research and Human Research Subject Protection: Is There Need for Action in Germany... © Koninklijke Brill NV, Leiden, 2009 DOI: 10.1163/157180909X400222 European Journal of Health Law 16 (2009) 45-68 www.brill.nl/ejhl News and Views Biomedical Research and Human Research Subject Protection: Is Th ere Need for Action in Germany and Austria? 1 Verena Stühlinger a , Gerhard Fortwengel b , Magdalena Th oeni a , Roland Staudinger a a Department of Human and Economic Sciences, UMIT, Hall in Tyrol, Austria b Actelion Pharmaceuticals Ltd., Allschwil, Switzerland Abstract Biomedical research and international collaborations in biomedical research become more and more impor- tant — economically and politically, making harmonised legislation for human research subject protection indispensible. Th e European Convention on Human Rights and Biomedicine is the fi rst binding contract under international law to protect human rights in the fi eld of biomedical research. Almost 10 years after its entry into force neither Germany nor Austria have signed or ratifi ed the Convention. Research involving incapacitated adults is one of the key issues in this context. Th is paper analyses the Convention and other European, US and international legislation, focusing on research involving incapacitated adults in “non- therapeutic” trials. It shows that a ban of “non-therapeutic” research involving incapacitated adults leads to an http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Health Law Brill

Biomedical Research and Human Research Subject Protection: Is There Need for Action in Germany and Austria?

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Publisher
Martinus Nijhoff
Copyright
© 2009 Koninklijke Brill NV, Leiden, The Netherlands
ISSN
0929-0273
eISSN
1571-8093
D.O.I.
10.1163/157180909X400222
Publisher site
See Article on Publisher Site

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