Institutionalisierte Sachverständige in Wissenschaft und Medizin?: Zur rechtlichen Bewertung von Ethikkommissionen

In Germany, as well as in other industrialised countries, ethics commissions play a central role for medical research. These panels have developed out of the Declaration of Helsinki which was adopted in 1967 by the World Medical Association. It provided for an inspection of experiments on human beings based on self-assessments enacted by a professional code of conduct. Since then, ethics commissions have increasingly developed from means of scientific self-assessment into institutionalised arenas of co-operation between science and public administration. As to the clinical assessment of drug tests on adult human beings, this outcome has been given a legal foundation by the Law on the Dealings with Medicaments (Arzneimittelgesetz) or the Medical Products Act (Medizinproduktegesetz). On the grounds of the Ordinance on Good Clinical Practice in the Performance of Clinical Tests Involving Drugs for the Treatment of Human Beings (GCP-Verordnung) which, in turn, is based on the amended Medical Products Act, and under the influence of European law, ethics commissions are adjucated increasingly far-reaching competencies as to the shaping of procedures.Seen from the viewpoints of legal theory and of democracy theory, the role of ethics commissions is somewhat problematic. The higher the extent to which these commissions can affect the design of procedures, the more the boundary between counsel and decision-making is blurred. The legal qualification of the votes made by ethics commissions, as well as their implications for the possibility of legal action, are therefore issues of high importance. These concerns, along with general questions on the role of governments in the ethical assessment of scientific research in the age of biotechnology, are dealt with in this paper.