ABSTRACT

The system for ethical review in Austria was initiated by few medical faculties in the early 1980s with the establishment of research ethics committees (RECs) to evaluate clinical research projects on a voluntary basis. In 1993, a major amendment to the Drug Act foresaw implementation of Directive 91/507/EEC, the EU-GCP, and the establishment of ethics committees by the federal states for the evaluation of research on medicinal products outside of hospitals. The ethical review system in Austria is well regulated. The review of medical research on medicinal products and on medical devices is covered by law for research in and outside of hospitals. Thus, the ethical review of the vast majority of research projects on human subjects is regulated by law. RECs consider that DNA samples and genetic information are covered by data protection rights insofar as they are not covered by the law on genetic engineering.