[Clinical research in critically ill patients]

Some of the ethical and legal problems raised by medical research involving critical care patients are analysed and discussed. Particular attention is given to the difficulties of obtaining informed consent from patients that most of the times are not considered competent from the legal point of view to give it. Careful thought must also be given to the weighting of risks of the procedures against the expected benefits. Finally attention is drawn to ethical dilemmas raised by exclusion criteria or placebo use in clinical trials that preclude critical patients from benefitting of some very promising new treatment.