Research Ethics Committees in the field of health-related human research--a European perspective and the case of Austria.

Abstract

Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (IRBs or Research Ethics Committees (RECS)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of EU Member States; and European laws differ widely. The article gives an overview of European regulations in the field of REC review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria--the Research Committee for Scientific and Ethical Questions (RCSEQ). Finally, important European initiatives for the future are pointed out.