ABSTRACT
In the Netherlands, as in many other countries, the law nowadays requires that researchers and doctors need to obtain the informed consent of subjects or patients before involving them in an experiment or initiating a medical plan. In case of medical experiments the informed consent has often to be given by signing a form. The requirement to obtain informed consent is based on the principle of respect for the autonomy of persons. In the analysis by Faden & Beauchamp (1986), informed consent is an autonomous action by a subject or a patient that authorises a professional to involve the subject in research or to execute a medical plan. The most important condition for giving informed consent is substantial understanding. A patient who is asked to participate in a phase 11-study, e.g. to test a new drug, needs to understand the information about the risks, burdens and benefits of the use not only of the experimental drug, but also about the risks etc. of the standard treatment-if such a treatment is available. However, medical experiments are often very complicated. That is why patients sometimes are overloaded with information which precludes substantial understanding. Moreover, they often have to decide under stress. In many cases patients tend to overestimate the possible benefits for themselves of participating in an experiment. Empirical researches show that the conditions for informed consent are often not met and are also very difficult to fulfil in practice. This raises the question whether the doctrine of informed consent has to be rejected because of the shallowness of its empirical presuppositions about patients' actual capacity to understand information.
