Article Title


Abstract 摘要

Understanding, being closely associated with the context, is the basis of realization of informed consent. Physician often complains that patients cannot well comprehend medical information, while patients are often unsatisfied with the explanatory statements and technical terms given by physicians. Since 1980s the emphasis in the studies of informed consent has shifted from what should be presented to patient to how to present the related information to patients. Besides being concerned with the meaning of the narratives of patients, physician should pay close attention to the connection of the medical facts or information and the everyday language, to maintain the norms of the syntax, and to understand the real goal and intention of the patients. This paper aims to approach the context of informed consent by semantic analysis, syntax and pragmatics.

Informed consent involves much more than merely reading and signing a paper. It normally has two essential parts: a document and a process. The document of informed consent should be understandable to any ordinary patient in the local population. It should be written in such a way that anyone with an education level of the ninth grade or lower can read it. To make the document of informed consent easy-to-read, the following requirements should be met. First, the language is everyday language and familiar to the readers. Any scientific, medical, or legal terms should be defined clearly. Second, terms and key concepts should be consistent throughout the document. Third, sentences should be short, direct, and easy to comprehend. Fourth, the paragraph should be short too. Each paragraph coveys one major idea only. Fifth, every idea should be clear and logically sequenced. Last but not least important, readability analysis should be to determine the reading level of the document.

The process of informed con sent process requires physicians to provide the patient with ongoing explanations so that patients can make his or her informed decisions. This is to say, before the patient makes his or her decisions, the physician should fully discuss related issues with the patient. Of course, the physician's communications kills are usually difficult to change. However, physicians can improve their communication skills through learning and practicing.

Of course, in China, not only researchers and physicians, but patients and research participants, including the public who can be regarded as the potential subjects, lack the full understanding of the principle of informed consent. It is thus important to improve the nationwide level of education, for it is only by doing that the principle of informed consent can be carried out in reality. The current level of education of the nation is not high yet, and many people even cannot fully understand some basic terms in medical and life sciences. There is s till a still considerable amount of illiterates in China. In medical education, especially in the educating of medical ethics, we have not paid enough attention to on the principle of informed consent so that some medical students even never heard the term" informed consent." As a result, there is still a long way for us to go.

Informed consent, serving as an effective measure to protect the subjects and patients, has enjoyed the wide recognition in the fields of medical and related laws. It has become the paradigm of consent in medical research and clinical practice internationally. Many international relative organization s have regarded informed consent a basic ethical requirement. Legally speaking, physicians and patients are equal. But in reality they are not equal. There is an imbalance of medical knowledge between doctors and patients. Although the patient has the right to make his or her own decision, he or she is often not capable of deciding and choosing. It is necessary to establish the law in order to guarantee the realization of the patient's rights such as informed consent.