ABSTRACT

The general rules for conducting biomedical research were laid down in the Health Care Act of 1997, while conditions for research on human beings were specified in a Ministry Decree issued in 2002. The main task of local research ethics committees is to check whether the personal and technological conditions at the health institution are adequate for organizing and conducting research and to monitor the research procedure once research protocol is approved. The research ethics committees operate on few levels in Hungary: on the national level, the regional level, and the level of healthcare institutions. Ethics committees at the national level have a high prestige and they are often considered as the bearer of ultimate knowledge on almost any issue. Although ethics committees, even at national level, may provide only scientific and ethical opinions on implementation of new research projects, their opinions are often regarded as ultimate decisions in administrative licensing of the various new medical procedures and research protocols.