Understanding informed consent

Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to doc ument the informed consent discussion. The pines ui informed consent in lea ding international codes of research ethics is reviewed. Some prominent exa mples of past violations of informed consent are discussed. Even when prope rly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information mu st be given to research subjects, and how much is too much; and how io ensu re the full voluntariness of subjects' consent, especially when the researc her is also the patient's physician. An ongoing problem is the 'therapeutic misconception' ' the belief that proposed research is a promising treatmen t intended to benefit the subjects. The complexity of the technical languag e in which consent forms are written remains a problem, though this can eas ily be remedied.