A brief review on informed consent laws in China.

• Author: Du, Li

Introduction

Informed consent, as one of the first principles of medical law, (1) requires physicians to obtain a patient's informed consent before undertaking medical treatment. (2) In Canada, courts have established comprehensive rules for the application of the principle of informed consent through sophisticated analyses in cases such as Hopp v. Lepp (3) and particularly in Reibl v. Hughes. (4) In China, (5) informed consent was not asserted within Chinese laws until the 1980s. Although there is no legislation specifically explaining the principle of informed consent, its requirement has been embodied in a series of legal documents. For example, Article 40 of the 1982 Regulations on Medical Work (6) and Article 33 of the 1994 Managerial Regulations of Medical Institutions (7) require physicians to gain consent from their patients before providing medical treatments. Article 26 of the 1998 Law on Medical Practitioners (8) and Article 11 of the 2002 Regulations on Handling Medical Accidents (9) require that physicians should inform their patients about planned treatments. In 2009, the National People's Congress promulgated the Tort Law of the People's Republic of China. (10) Chapter 7 of the Tort Law regulates the liability of medical malpractice. It explicitly states that medical staff must explain the diagnosis and relevant medical measures to their patients. Where any medical staff member fails to fulfill the duties of informed consent and causes harm to a patient, the medical institution shall assume liability for compensation.

In clinical practice, the last decade in China has witnessed patients' growing awareness of health care rights protection. (11) Doctors and patients have gradually begun to understand the principle of informed consent. A 2009 survey indicated that doctors and patients were relatively clear about the content of informed consent, especially that patients have the right to know about their illnesses, relevant medical measures, risks and effects of medical measures, and expense of diagnoses and treatments. (12) On the other hand, the survey also demonstrated that doctors and patients did not fully understand the principle of informed consent. For instance, they knew very little about a patient's right to choose and deny medical measures and a patient's right to choose their health care providers. (13) Also, most doctors and patients believed that both patients and their relatives give informed consent. (14) The sensational Xiao Zhijun case in 2007 (15) revealed misunderstandings about informed consent in practice. The following sections of this paper explore problems with the relevant Chinese laws and regulations and suggest improvements to provide clearer guidelines for informed consent in China. It examines four aspects of China's current informed consent protocols. They include who shall inform, who shall be informed, what they shall be informed about, and exceptions to disclosure.

Key Consent Issues

(1) Who shall inform?

In China, according to Article 55 of the 2009 Tort Law (16) and Article 26 of the 1998 Law on Medical Practitioners, (17) during diagnosis and treatment, medical staff are responsible for informing patients about their condition, treatment measures, medical risks and other related matters. (18) "Medical staff" mainly refers to doctors and, in China, three or four doctors of different levels take charge of one patient in a department. Medical personnel are divided into four types, namely, resident, attending, associate chief physician and chief physician. (19) Generally, a more senior doctor supervises a lower level doctor in a department. The residents are the primary level medical staff and they are the doctors, in most medical institutes, who directly deal with patients. (20) This system was designed to achieve a better quality of health care and to protect a patient's right to make decisions.

Residents are the medical staff members who most often carry out the duty to inform a patient. (21) Yet, as residents have the least amount of direct patient care experience, they may not be well equipped to answer patients' questions effectively and comprehensively. (22) In situations where the patient's medical condition is complex and multiple treatment options with differing potential harms and benefits must be considered, a senior doctor may be better equipped to address informed consent. Doctors should be aware, however, that every doctor in charge of a patient's care is responsible for meeting the informed consent obligation. By having more senior doctors inform patients directly when their illnesses are complex, unsatisfactory informed consent processes are minimized.

Another controversial issue is whether doctors in continuing medical education ("refresher") training and interns ought to handle informed consent. Refresher programs for doctors in China aim to further educate medical staff at all levels. Physicians are able to maintain their competence by learning new medical theory and technology, improving their clinical care, and learning new clinical techniques. (23) Usually, refresher doctors come from other hospitals and receive training at higher level hospitals. (24) Interns are medical trainees and include fourth year medical undergraduates and graduate students. Although refresher doctors and interns do not have employment contracts with hospitals where they receive their specialty education, they participate in the actual processes of medical treatments. (25) Refresher doctors already possess licenses to practice and are legally competent to fulfill the obligation of informing a patient, however, because they do not have employment contracts with the training hospitals, they should not be independently responsible for seeking informed consent from patients. They should be either accompanied by a staff doctor when seeking informed consent from patients or ask a staff doctor to approve informed consent documentation after information has been disclosed to patients. With regard to interns, those who have licenses can seek informed consent from patients independently, but interns who have not acquired licenses should not be permitted to seek informed consent from patients.

(2) Who shall be informed?

The applicable...