Biomedical research and human research subject protection: is there need for action in Germany and Austria?

Biomedical research and international collaborations in biomedical research become more and more important--economically and politically, making harmonised legislation for human research subject protection indispensible. The European Convention on Human Rights and Biomedicine is the first binding contract under international law to protect human rights in the field of biomedical research. Almost 10 years after its entry into force neither Germany nor Austria have signed or ratified the Convention. Research involving incapacitated adults is one of the key issues in this context. This paper analyses the Convention and other European, US and international legislation, focusing on research involving incapacitated adults in "nontherapeutic" trials. It shows that a ban of "non-therapeutic" research involving incapacitated adults leads to an unjust exclusion of this patient group, leading to uncertainty and disadvantages in medical treatment.