Myth and reality of informed consent in clinical trials.

Informed consent is a prerequisite for any medical intervention or for participation in scientific research. Legal requirements in health care towards informed consent provide qualifications of information disclosure and focus on procedures to obtain a valid consent. The premise of informed consent as a rational decision making process implies an informed consideration, assessment and patient choice and may be perceived as an ideal in the nature of a myth. These principles and assumptions will be discussed to obtain more insight into informed consent in clinical trials. A cogent model of informed consent is presented, which could be useful in clinical trials. We suggest a gradual distinction between informed consent in regular treatment vs. clinical trials, based on concepts like achievable benefits and risk disclosure. Suggestions are made for further empirical research, to obtain more insight into the myth and reality of informed consent in clinical trials.