Informed consent to medical treatment is premised upon the ethical principle of personal autonomy. (1) Although the notion of informed consent originated from Western liberal culture, it has gradually become a popular doctrine adopted by many countries of the world, and China is no exception. (2) Chinese law not only established the rule of consent to medical treatment as early as 1982, but has also widely incorporated the rule of informed consent since the new century. (3) However, as the notion of informed consent was imported from the West into China, three questions are worthy of consideration. First, is there any difference between the Chinese rules of informed consent to medical treatment and its dominant theory accepted in Western society? Second, what is the rationale for the difference? Third, can the difference be justified given the value of informed consent in promoting patient autonomy?
According to the prevailing theory and practice of informed consent in Western jurisdictions, a competent patient has an absolute right to make his own medical decisions and his family members have no right to interfere. However, the most prominent difference between Chinese laws of informed consent and Western ones is that although a patient is fully competent to make medical decisions, his family members have the right to make medical decisions on his behalf under Chinese law. It is even widely agreed in practice that family members' informed consent to medical treatment on behalf of a competent patient is more important than the patient's own. (4)
This article opens with a review of the development of the Chinese regulations relevant to the family members' consent since the early 1980s. The next sections briefly describe the current practice regarding family members' consent and analyse the three main arguments of the proponents for the requirement of family members' consent. Part Four explores the real reasons underlying such a requirement and Part Five discusses its negative impact on patient rights. The conclusion provides a proposal for abandoning the requirement of family members' informed consent to medical treatment for competent patients, thus promoting full patient autonomy.
Regulations Regarding Family Members' Consent
The first piece of the national enactments pertinent to consent to medical treatment is Yiyuan gongzuo zhidu (the Working System of Hospitals) made by the Ministry of Health in 1982. (5) According to Rule 6 of the collateral rules titled Shixing shoushu de jixiang guize (the Rules of Performing Operation) set forth in Section 40 of the Working System of Hospitals, written consent with the signature of a family member or danwei (6) (work unit) of the patient, either competent or incompetent, is a prerequisite for surgery.
12 years later, the State Council promulgated Yiliao jigou guanli tiaoli (Regulations on Administration of Health Care Institutions) in 1994. Its Section 33 introduces the rule of "dual consent", namely, both the patient and his family member (7) or Guanxiren (the Related Party) (8) shall grant written consent with signature prior to medical intervention. When it is impossible to obtain the patient's decision, his family member or the related party's written consent with signature will be sufficient.
In 1998, the Standing Committee of National People's Congress released Zhiyeyishi fa (the Practising Physicians Law), introducing the rule of "optional consent" under Section 26. It provides that physicians shall honestly disclose to a patient or his family member all the information about the disease unless the disclosure may have a negative influence upon the patient's health. In addition, experimental clinical treatment shall be performed only with the approval of the hospital and the consent of patients or their family members. It is worth noting that the Practicing Physicians Law expressly applies the requirement of optional consent to experimental clinical treatment, and keeps silent about whether this requirement is also applicable to non-experimental medical treatment. …