© 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
European Journal of Health Law – Brill
Published: Jan 1, 2009
Keywords: UNIVERSAL DECLARATION ON BIOETHICS AND HUMAN RIGHTS; BELMONT REPORT; EC GCP DIRECTIVE; INCAPACITATED ADULTS; NON-THERAPEUTIC RESEARCH; EUROPEAN CONVENTION ON HUMAN RIGHTS AND BIOMEDICINE
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