知情同意管理制度

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1 知情同意包含下列两方面内容：Informed consent includes two aspects:
1.1 知情：患者对病情、医疗措施、见习生、实习生和研究生参与的治疗范
围、风险、备用治疗方案、费用开支、临床试验、治疗方案、治疗结果
(包括意外情况)等真实情况的了解、被告知的权利。

Informed: the patient knows or is informed of such facts as present illness, medical measures, treatment scope of trainee,
intern and postgraduate, risks, alternate treatment plan,
medical expenses, clinical trial, treatment regimen and results
(including unexpected conditions)
1.2 同意：患者在知情的前提下有选择、接受或拒绝的权利。

Consent: having been informed, the patient has the right to select, accept or reject.
2 知情同意的范围Scope of informed consent
2.1 所有手术all operations；
2.2. 有创检查和治疗，如胸穿、腰穿、骨穿、腹穿、深静脉置管、胃肠镜、
支气管镜、血管造影、穿刺活检等
Invasive examination and treatment, such as thoracentesis, lumbar puncture, bone marrow aspiration, peritoneocentesis, deep
vein intubation, gastrointestinalscopy, bronchoscopy,
angiography, puncture and biopsy；
2.3 麻醉（局部麻醉除外） anesthesia (except local anesthesia)；
2.4 使用特殊药物，如化疗、抗结核、大剂量免疫抑制治疗等
Use special drugs, such as chemotherapy, tuberculostatic agents and large dose of immunosupressive agent；
2.5 特殊治疗，如放疗等；special treatment, for example, radiotherapy
2.6 输血及血液制品blood transfusion and blood products；
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2.7 实践性医疗行为practical medical behavior；
2.8 临床试验Clinical trial.
3 知情同意内容Contents of informed consent
3.1 采取诊疗措施的目的purpose of treatment measures；
3.2 诊疗方法、具体操作流程及操作者
Methods of diagnosis and treatment, operation process and operator
3.3 预期的效果、副作用、风险及防范预案
Expected effect, side effect, risks and prevention plan
3.4 备选治疗方案alternate treatment plan
3.5 相关费用等related expenses
4 知情同意履行Carry out informed consent
4.1 医务人员须以简明易懂的语言、图表或照片等方式告知患者或家属，并
确认患者或家属是否已理解。

Medical staff shall use simple and understandable language, charts or photos to tell the patient or family members the
contents of informed consent, and confirm comprehension.
4.2 患者或家属在确认理解的基础上签署知情同意书。

The patient or family members shall sign on the informed consent based on understanding of the contents.
4.2.1 由患者本人、其监护人或授权委托人行使患者知情权。

The patient himself, his guardian or authorized consignee Shall execute the right of informed consent.
4.2.2 患者具有完全民事行为能力的，在不违反保护性医疗制度的前
提下，可将告知内容直接告知其本人，须履行书面签字手续的
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由其本人签字。

The patients who possess full capacity for civil acts, under the prerequisite of not violating the protective medical system, can be directly informed of the contents; the patient shall sign on written document personally.
4.2.3 患者虽具有完全民事行为能力，但如实告知病情、医疗措施、
医疗风险后可能造成患者不安，进而影响医务人员开展诊疗工
作的，由其授权委托人代为行使知情同意权。

Sometimes the patient possesses full capacity for civil acts , however, in certain circumstance, knowing the facts
of his illness, treatment risks may cause unnecessary
negative feelings and affect the treatment, then the
authorized consignee shall exercise the right of informed
consent instead.
4.2.4 患者虽具有完全民事行为能力，但不能理解或不愿了解各项诊
疗措施，由其授权委托人代为行使知情同意权。

When the patient possesses full capacity of civil acts, but fails to understand or refuses to know treatment
measures, the authorized consignee shall exercise the
right of informed consent instead.
4.2.5 授权委托人由患者在法律法规所规定的近亲属或代理人中选
择，按照患者配偶、父母、成年子女、其他近亲属的先后循序
依次担任。

无直系或近亲属的患者，可由其所在单位、街道办
事处或村民委员会指定人员担任。

Patients may designate the authorized consignee from his close relatives or agent specified by laws and regulations
as follows (according to priority): spouse, parents,
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grown-up son or daughter and other close relatives. If the
patient has no direct relatives, other organizations such
as the unit he serves, subdistrict office or villager
committee in charge of his community may designate one.
4.2.6 患者以授权的方式指定委托代理人，并由双方(患者和其授权委
托人)按医院规定在授权书上签名，并将授权委托书和双方身份
证复印件保存在病历中。

In case the patient wish to designate an authorized agent, both of them are required to sign on the written
authorization paper according to hospital regulations,
the document and copies of their ID cards will be kept in
case record.
4.2.7 对急诊、危重患者以及拟实施抢救性手术、有创检查、治疗、
输注血液及血液制品、实施麻醉等情况下，如在患者本人无法
履行知情同意又无法与家属取得联系，或其家属短时间内不能
来院履行有关手续，且病情又不允许等待时，应由主管医生提
出医疗处置方案，由主诊医生和主管医生共同签字，报医务处
批准、备案；夜间和节假日，由两位值班医生签字，报行政总
值班批准、备案。

For emergency patients or critically ill patients, sometimes urgent operations/invasive examination and
treatment/transfusion of blood or blood
products/anesthesia may be needed, however, sometimes
those patients are unable to sign informed consent and
his/her family members may not be available or couldn’t
arrive at the hospital quickly enough. In this setting,
the attending doctor shall propose a treatment plan.
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Should the plan being approved by both the attending
doctor and responsible doctor, dept. of medical
administration will be informed for further approval and
documentation. Should this happened on holidays or night
shift, two doctors on duty shall sign and report to general
duty office for further approval and documentation.
4.2.8特殊情况如患者或家属仅叩痛同意或拒绝，据不签署知情同意
书的情况，主管医生应汇报科主任，进行再次沟通。

仍不签署
的，应汇报医务处，并在病历记录中记录谈话时间、地址、内
容、双方参加人员，医方参加谈话人员均要签字。

必要时录音，
并保留资料。

When the patient or his family members just orally agree or disagree with certain therapy and refuse to sign on the
informed consent without proper reasons, the attending
doctor shall report to chief of the dept. and try to
communicate with them again; should fail again, the dept.
of medical administration will be informed and details
including time, place, contents, participants of
communication will be recorded in case history, attached
with staff signatures. Make and keep sound recording when
necessary.
获经批准Approved by
院长Hospital director 日期Date。