Informed Consent and Medical Law

Abstract

Informed consent is the dominant doctrine in the modern physician-patient relationship. It is based on the ethical principle of autonomy, rooted in Western culture. In the twentieth century, it was set up by the American courts with precedents and was spread worldwide after the 1970s. It greatly changed the traditional paternalism model of the physician-patient relationship and established a new model encapsulating the notion that every competent person controls his or her own fate in medical affairs. The informed consent principle consists of the patient’s right to make medical choices and the corresponding obligation of the physician to deliver sufficient and proper information. The physician has the duty to give information, such as the nature of the illness, the benefits and risks of proposed treatment, alternatives, and other information necessary to the patient. The informing process shall be performed in a manner that the patient can understand. A consent form may be needed in case of operation or other invasive treatment. To tell whether the physician’s informing meets the requirement, the American courts developed three deferent standards: the physician standard, the objective patient standard, and the subjective patient standard. In case of therapeutic privilege, emergency, or waiver, the physician is exempt from the duty of informing. Supported by the physician’s information, the patient has the absolute right to make a voluntary choice. The patient must be competent when he or she does so. If the patient is incapable of consenting, his or her family or the next to kin should make the decision on his or her behalf. The informed consent doctrine was introduce to China in the early 1990s and reaffirmed in the recently promulgated Tort Law. It has to face the conflicts of tradition and culture between China and the West in the way of making medical decisions and also the reality of limited medical access to the large population in China.