How much is known about informed medical consent?

This is the 3611st article of Da Medical Care

With the transformation of the medical model from the traditional "bio-medical model" to the modern "social-psychological-medical model", the transformation of the doctor-patient model from the "doctor-master power model" to the "doctor-patient contract model", and the medical decision-making model from "patient authorized medical treatment" to "patient participation in medical treatment", the patient's independent decision-making power has been paid more and more attention.

The current laws and regulations have specific provisions on the obligation to inform and explain medical treatment. Article 32 of the Basic Medical Care and Health Promotion Law stipulates that citizens who receive medical and health services enjoy the right to informed consent in accordance with the law on matters such as medical conditions, diagnosis and treatment plans, medical risks, and medical expenses. Where surgery, special examinations, or special treatments need to be carried out, medical and health personnel shall promptly explain to the patient the medical risks, alternative medical plans, and other circumstances, and obtain their consent; where it is not possible or inappropriate to explain to the patient, they shall explain it to the patient's close relatives and obtain their consent. Where the law provides otherwise, follow those provisions. Carrying out clinical trials of drugs, medical devices, and other medical research shall comply with medical ethics norms, pass ethical reviews in accordance with law, and obtain informed consent.

Article 1219 of the Civil Code stipulates that medical personnel shall explain their condition and medical measures to patients during diagnosis and treatment activities. Where surgery, special examinations, or special treatment needs to be carried out, the medical personnel shall promptly explain to the patient specifically the medical risks, alternative medical plans, and other circumstances, and obtain their explicit consent; where it is not possible or inappropriate to explain to the patient, it shall be explained to the patient's close relatives and their explicit consent shall be obtained.

The medical informed consent form is not only a proof that the hospital has fulfilled its obligation to inform the patient and the patient has effectively known the relevant medical situation, but also a major communication method between the doctor and the patient on the diagnosis and treatment plan. Next, let's talk about how to sign the informed consent form.

Medical staff have a mantra, especially surgeons, that is, in the preoperative informed consent process, they will casually say "notify the family and let the family sign it." Here to remind, please remember that the person who should sign the informed consent form is not someone else, but - "the patient himself". As far as jurisprudence is concerned, under the premise that the patient himself has the ability to sign, his signature alone already has full legal effect, and the law does not require his family to sign.

So, is there a situation where it is not signed by the patient himself? Yes, there are two main situations. First, the patient himself signed a "Power of Attorney" authorizing others to sign on his behalf, which is the most common situation in clinical practice in which the patient himself does not sign, because the patient himself has the right to authorize his or her legal rights to be exercised by others. Two points need to be reminded: 1. Once the patient himself has signed the Power of Attorney, then the informed consent form can only be signed by the patient himself or the authorized person to have legal effect, and the signature of others even if it is a close relative is invalid. 2. If it is authorized by multiple people, pay attention to the use of the conjunction "or" between multiple authorized persons, and do not use the conjunction "and", it is best to add this sentence to the authorization document: "The signature of any one or more of the above authorized persons on the informed consent document can represent my own intention and have the same legal effect as my signature."

Second, because the patient is not yet a minor or suffers from mental illness and does not have full legal capacity, he does not have the qualification to sign, including the patient's own loss of consciousness or confusion due to the cause of the injury, resulting in the objective possibility of signing. In this case, do not draw a snake and sign any power of attorney, but the patient's close relatives can sign the informed consent form directly. Of course, the informed consent form should list the kinship and identity information. It is important to recall here which persons are close relatives, the Civil Code clearly stipulates that spouses, parents, children, siblings, grandparents, maternal grandparents, grandchildren and maternal grandchildren are close relatives.

In addition, there is a special situation that needs to be explained. In the case where the patient needs emergency treatment, the patient himself or herself is unconscious or confused due to the disease, and cannot contact close relatives, the treating physician should propose a medical disposal plan, fill in the relevant informed consent form, and after the department director or superior physician signs the opinion, report to the medical department or the general duty, and implement it after approval by the hospital leader or authorized person in charge.

The Regulations on the Prevention and Handling of Medical Disputes and other provisions on the obligation to inform and explain require medical institutions to obtain "written consent" from the patient, and the Civil Code is amended to "express consent". The explicit consent here contains two meanings, one is to require the patient's "consent" to express the meaning should be specific, clear, clear, clear, it is recommended that when signing the informed consent form, the patient should write "the doctor has been clearly informed in detail, I have known, I choose xxxx plan" and other content. Second, "consent" is no longer limited to written signature, audio and video recordings and other audio-visual materials can be used as evidence of the patient's intention, alleviating the dilemma that the patient cannot sign in writing in some special circumstances, such as the family of the affected party in a different place, can not rush to the hospital immediately or in a short time. However, in non-emergency situations, it is recommended that the medical staff obtain the written consent of the affected party.

I said how to sign the informed consent form earlier, and then I will talk about the legal effect of the informed consent form. The first is the probative effect in procedural law. Only when the patient signs the medical informed consent form on the premise of specific understanding of the disease information and the treatment plan and the true expression of meaning, can the medical staff prove that the medical staff has fulfilled the obligations and effectively protect the legitimate rights of the patient in this process. If the patient does not have this signing procedure, it will be determined that the medical staff is at fault in the medical act, and the medical party will bear the resulting tort liability. Second, informed consent does not have the effect of exoneration in substantive law. The signing of the medical informed consent form only indicates that the medical staff fulfills the obligation to inform the medical staff of the risks that may occur in the process of medical diagnosis and treatment, and the patient expresses that he is aware of these risks and is willing to bear them, and does not indicate the exemption from the medical institution from damages due to fault. Therefore, the signing of the patient's medical informed consent only indicates that the risks inherent in the medical treatment, the accident, the responsibility for the losses that should be incurred, whether the medical behavior is subjectively faulty, whether it conforms to medical routines, etc., are not within the scope of the patient's self-acceptance exemption in the medical informed consent.

In today's diversified diagnosis and treatment technology and methods, medical risks and diagnosis and treatment activities go hand in hand, there is no best diagnosis and treatment plan, only a more suitable diagnosis and treatment plan for patients. The obligation to explain to doctors is the premise of protecting the patient's right to make independent decisions, the concrete manifestation of the principle of autonomy of will, and the need for the organic distribution of medical risks between doctors and patients and the balance of interests of both parties. Therefore, the doctor should fully respect the patient's right to informed consent, properly fulfill its obligation to inform, and better avoid medical legal risks.

Author: Shanghai Boss & Young Zhongjian Zhonghui Law Firm

Zheng Jun, lawyer