Understanding informed consent.

Abstract

Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to document the informed consent discussion. The place of informed consent in leading international codes of research ethics is reviewed. Some prominent examples of past violations of informed consent are discussed. Even when properly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information must be given to research subjects, and how much is too much; and how to ensure the full voluntariness of subjects' consent, especially when the researcher is also the patient's physician. An ongoing problem is the 'therapeutic misconception'--the belief that proposed research is a promising treatment intended to benefit the subjects. The complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied.