Abstract

Definition of the problem. In the field of biomedical research on humans, ethical committees have an important role. They ensure the necessary protection of the subjects and contribute to quality assurance in medical research. Originally established as an instrument of ethical self-regulation in the medical profession, the ethical committee soon advanced to a statutory institution and is now on the way to becoming the body charged with judicial control in medical research. This development implies the need for changes in both position and function of the ethical committee, but these have not been made with due consideration for all the developments there have been. Arguments and conclusion. The existing uncertainties are hampering medical research, which is in the interests of neither the public nor the actual medical research. Owing to the different and obscure legal arguments used, it has not been possible to make any definitive decision on the legal standing of decisions made by ethical committees. It seems obvious that these problems cannot be solved unless the work of ethical committees can be based on a clear and reliable legal basis regulating the judicial nature of the committees’ decisions, the composition of the actual committees and the procedures they are to follow in reaching their decisions. With regard to the existing regulations, this might be best achieved by integrating the work of the ethical committees into the approval procedures of an administrative authority