Valid informed consent: a process, not a signature.

Abstract

Surgeons have dutifully used "consent forms" for most of the last century. But only in the last two decades have we begun to understand the difference between a patient's legalistically signed form and the meaningful process of communicating the reasons for considering surgical or other invasive intervention. Furthermore, we must be reasonably assured that the patient is legally competent, understands the situation and alternatives, and is not coerced (by family or medical professionals) in the decision-making. To accomplish this, time-consuming patient education and negotiation are necessary. To limit this process to a brief agreement that the procedure should be done and the patient is willing (as evidenced by a signature) is to return to paternalism. Little evidence suggests that such signing is valid. Of more importance, patients want and are owed a clear understanding of what is probably ahead including risks and preventive measures to limit complications. This article analyzes the components of "consent," suggests methods to ensure the validity of the agreement, and proposes that an educated patient benefits greatly by an appropriate process.