[Clinical research studies from the ethical and legal point of view]

Relevant cases that had come to public knowledge and critical analysis of medical research on human beings prompted the USA to introduce the provision of approval by a committee and other forms of administrative control. In the 70's, ethics commissions were set up in Central Europe in compliance with the recommendations of the revised Helsinki-Tokyo Declaration. In Austria, the guiding principles are now legally safeguarded by the Pharmaceuticals Act, whereby general principles of research on human beings such as benefit-risk calculation and consent of the test person are laid down by statute. The risks involved in a novel method of treatment must nowadays be shared by the patient, which presupposes that the patient must be adequately informed. Notwithstanding the patient's consent, however, the risk must be socially acceptable, meaning that the experiment must be scientifically relevant and carried out in compliance with accepted methods and rules. The concept of cumulative justification is demanded today; it consists of the scientist's freedom of research, the test person's right to self-determination and the benefit-risk calculation. Ethics commissions composed of researchers themselves are invaluable consultant bodies for the scientist when soberly viewing his own particular project and who must himself undertake to observe the generally accepted principles regulating research on human beings. Only positive control by the medical profession itself will, in the long run, be able to effectively stave off an ever increasing encroachment of legislative and state control upon medical research.