Approaches to informed consent.

Informed consent (IC) is an indicator, or a pivotal point, in broader and more fundamental questions dealing with the way clinical experimentation and, more specifically, randomized controlled trials (RCTs) relate to routine clinical practice; the rules that characterize the doctor-patient relationship; the self-perception of medicine with respect to its capacity, duty, and autonomy in the production of new knowledge; and the role of medicine in society. The asymmetry of knowledge and power that characterizes the usual relationship between care providers and patients does not resolve when something experimental enters the relationship. The real world of clinical investigation is not uniformly distinct from clinical practice. Experimentation is more appropriately considered a continuum with respect to appropriate or recommended care. Fundamental patient rights come first and are more binding than compliance with procedures and regulations. The view that IC is the most important component of the "ethical" aspects of experimentation is highly misleading. The responsibility to foster well-informed decisions shapes the contents, the timing, the validity, and the credibility of IC. Documented, evaluable decisions are the natural substitute for individual IC when the patient is not able to handle information autonomously. Positive examples of IC practices and approaches suggest that IC may be important in improving the way medicine responds to its responsibilities and communicates with society.