Obtaining Informed Consent From Patients: Brief Update Review

Introduction In health care, informed consent refers to the process whereby the patient and the health care practitioner engage in a dialogue about a proposed medical treatment’s nature, consequences, harms, benefits, risks, and alternatives. Informed consent is a fundamental principle of health care. The process of informed consent can be considered a patient safety issue from several perspectives. At the extreme, performing a procedure on a patient without his or her consent has been considered by the courts to be a form of battery. Informed consent may also be indirectly related to patient safety in that, when done well, it opens a dialogue between the patient and provider so that the patient can ask questions, knows what to expect during and after procedure, and can at least theoretically help to avert medical errors. In general, studies have shown improved patient outcomes with effective physician-patient communication and increased patient empowerment. Patient education has also been associated with preventing medical errors. A review on this topic conducted in 2001 found few studies linking informed consent with health outcomes and few studies on the impact of procedures used to obtain informed consent on the quality of consent obtained; studies suggested that the value of informed consent might be modestly enhanced by augmenting standard patient provider discussions with additional learning and retention aids and that the process of consent can be modestly enhanced by using structured interviews and asking patients to recall and restate the key elements of the discussion. This update review focuses on what we have learned about the informed consent process and the effectiveness of interventions that have been implemented to try to improve it. We conducted a search of the health care and health services literature for the time interval 2001 to present and reviewed all studies relevant to informed consent in the clinical setting.