Voluntary informed consent to medical intervention: sample and example

Any person who has applied to a medical organization will necessarily be asked to fill out a voluntary informed consent to medical intervention. Patients do not always understand why it is required to fill out and sign this form, indicating in it their personal data. In addition, health professionals are not always available to explain what exactly a person who has signed a voluntary informed consent to medical intervention (DIS) agrees. What rights does this document give to the attending physician? This issue of the parents of minor children is especially worrisome: filling out and signing a voluntary consent for medical intervention for their child is often offered not only in the precinct pediatric clinic, but also in the educational institution. Is it necessary to sign the DIS or better to issue a refusal? Why do I need to fill out this document? What are the consequences of consenting and refusing medical intervention?

What is medical intervention?

By the term "medical intervention" is meant any kind of examinations, procedures and manipulations that are performed by medical personnel in relation to the patient. Thus, medical intervention is treated equally both by the simplest medical examination and questions about the patient's complaints, and transplantation of donor organs.

Form DIS

Consent to medical intervention, and with it the refusal of medical intervention or consent to specific types of procedures should be made in writing. Typical forms and the order of their filling are approved by the order of the Ministry of Health of Russia No. 1177n of December 20, 2012.

What medical intervention involves DIS?

Voluntary informed consent is a document confirming that the patient's right to receive reliable, understandable, complete information about the provided medical services is observed. A typical DIS (Appendix 2 to Order No. 1177n) is filled out and signed by the patient (patient's representative) and the medical worker before the provision of primary medical care, in accordance with the list approved by the order of the Ministry of Health and Social Development No. 309n of 23.04.2012).

The patient's medical card in a polyclinic, a child's medical card in an educational institution, a contract for the provision of paid medical services and other documents related to the provision of this type of services must necessarily contain a voluntary informed consent to medical intervention.

Important! Before filling in the DIS form, the attending physician (medical worker) must inform the patient in an accessible form in detail about the forthcoming intervention, including the goals, methods and possible consequences of the forthcoming procedures.

By signing voluntary informed consent to medical intervention in school or kindergarten, the parent also gives permission only for the procedures listed in the law. The standard letterhead form always specifies in detail the list of proposed procedures conducted in accordance with the age of the minor child. In the event that the parent causes this doubt on the list, it will be superfluous before examining the form to read the DIS at home, in a relaxed atmosphere. If the question is in the consent form, the parent (the child's representative) can specify the list of prospective procedures in the current order of the Ministry of Health of the Russian Federation No. 1346n of December 21, 2012 "On the procedure for passing medical examinations by minors ...", and the order and types of vaccination - in the official vaccination calendar.

How to fill in: instruction, sample

How should voluntary informed consent be filled in for medical intervention? The DIS form is prepared and signed by the patient and the treating doctor only before the beginning of all medical examinations and manipulations. Obligatory condition of filling - all information is filled by the patient (the legal representative of the minor patient) with his own hand. An exception to this rule is that if the patient is unable to fill out the form on his own due to his state of health. In this case, an authorized officer of the medical organization will do it for him.

What information should I specify in completing consent for medical intervention? (For a sample of filling see below in the article.)

According to the officially approved Instruction for completing the forms of DIS (hereinafter referred to as the instruction), the annex to the order of the Federal Medical and Biological Agency of Russia No. 88 of 30.03.2008, the patient must indicate on the form:

• Your personal data: name, address of registration (residence), year of birth, information about the passport (identity card).

• Data of a medical worker (doctor) who conducted information about medical intervention.

• List of persons who are allowed to provide information about the diagnosis and health status of the patient.

• When registering DIS before inpatient treatment: information about the medical institution where the hospitalization is planned.

• Date of signing DIS.

When the legal representative fills in a minor patient:

• At the beginning of the form (first lines), the personal data of the parent (representative) and the address of his registration (residence) and information about the passport (identity card) are indicated.

• In the text of the DIS, I should emphasize the words "whose legal representative I am ...".

• The personal data of the child (FI, year of birth) are indicated.

At the end of the text of the form, voluntary informed consent to medical intervention is certified by the signature of the medical officer (doctor).

Consent to certain types of medical procedures

Specific types of medical intervention require obtaining a DIS in addition to standard consent. For example, vaccination (vaccination) of a minor patient with a patient (his legal representative) requires voluntary informed consent for medical intervention (sample see below in the article).

For DIS for specific types of medical intervention, similar filling rules apply. Before signing the consent of the patient must inform in detail both the procedure itself and the expected consequences. Each form of DIS filled in by the patient or his legal representative is also pasted into the medical record.

What should I look for? The form must contain the name of the specific procedure to which the patient (representative) will give consent. Any common notations and phrases are inadmissible. For example, with consent to vaccination, the DIS should include not only the procedure, but also the name of the vaccine used.

Is it possible to specify additional information in the form?

In the standard letterhead of the DIS, the section "Additional information" can be filled out by the attending physician, if necessary, which provides information on obtaining the DIS of the patient and the forthcoming medical intervention.

The introduction of any additional information into the standard consent or refusal form is not provided for by law, but it is not prohibited.

Is it possible to formulate consent or refusal in free form?

Instructions also provide for cases when the patient for some reason does not want to fill the DIS on the approved form. In such a situation, voluntary informed consent to medical intervention can be written by hand or printed in free written form. However, there is a clarification that if the DIA is written independently, the patient should still adhere to all the legal requirements established for DIS for medical intervention.

Medical intervention without the consent of the patient

In exceptional cases, the law allows the provision of necessary medical assistance or medical procedures without receiving a DIS:

• If urgent measures are required to eliminate the threat to the life of the patient, but he is in a state that does not allow the identification of his decision, and his legal representatives are absent.

• For persons:

1) presenting a danger to others due to existing diseases;

2) having mental disorders in severe form;

3) those who committed crimes;

4) in respect of which forensic examination or forensic psychiatric examination is carried out.

How to refuse: we fill out the refusal of medical intervention

Refusal from medical intervention is the legal right of the patient (legal representative of a minor patient). The patient can issue a refusal either on a special form (appendix 3 to order No. 1177n) or by writing it on a standard sheet by hand.

Before drawing up this document, the attending physician (medical worker) is obliged to tell the patient about all possible consequences of signing the refusal of medical intervention or from the "refusal" part of the medical procedures.

To do this, the upper "passport" part of the DIS form is filled in the same order as the consent, in accordance with the instruction. Further, there should be a disagreement on the intervention, a record certifying that an explanation has been given about the consequences of the refusal by medical workers. In the standard denial form there is a section for filling in by the attending physician, where possible consequences of an informed refusal are introduced.

Refusal of the patient from medical intervention is pasted into his card or, in case of refusal from hospitalization, is pasted to the discharge documents of the patient.

How to partially abandon the procedures specified in the consent?

Separately, we should consider the situation when the rejection is not in general from medical intervention, but from one or several procedures. In this situation it is necessary to arrange it on a special type letterhead indicating the specific procedure from which the patient refused (Appendix 3 to Order No. 1177n).

The form is filled in completely, according to the established order of filling and instructions. The attending physician shall indicate the expected consequences of the refusal of this procedure.

At what age can a child sign the DIS himself?

A person who has reached the age of 15 may give informed consent to medical intervention. But from this rule there are exceptions established by laws and acting normative acts. Consent to certain categories of medical intervention can be signed only fully capable - an adult, that is, a citizen over the age of eighteen years or a person who has received legal capacity ahead of schedule in the manner prescribed by law. Such exceptions include:

• Consent to any medical manipulation regarding donation (seizures for donor purposes) of organs or blood and transplanting donor organs to the patient.

• Consent to carry out an examination on suspicion of a drug (alcohol) intoxication.

• DIS for providing narcological assistance to a citizen who is ill with drug addiction. At the same time, for a medical intervention that is not connected with drug treatment, a patient with drug dependence can consent to sixteen years.

Important! A citizen recognized as legally incompetent in the manner prescribed by law does not have the right to give DIS himself. For him to make a decision on the consent or refusal of medical intervention should be his legal representative.

Validity of the DIC

Strictly established terms of validity of the DIS are not established by law. The only definition in this regard is that the consent is valid for the entire period of treatment (medical care). In practice, this means that informed consent to medical intervention will be valid for the entire time that the patient is assigned to a medical organization. That is, it is on inpatient, sanatorium treatment or, as for additional paid medical services, for the entire duration of the contract with the clinic.

However, the patient who gave informed consent for medical intervention has the right to withdraw it completely or partially before the expiration date. To refuse medical intervention or from a part of procedures it is necessary in writing, having filled the corresponding form of the medical organization or having written in the free form the application addressed to the head physician. The patient may indicate in the application (denial form) the reason for the withdrawal of the DIS, but this is an optional condition.

Responsibility for providing medical intervention without DIC

Informing the patient about upcoming medical procedures and their possible consequences is the obligation of the medical organization established by the current legislation and the condition of the license (authorization) for rendering this type of services. The attending physician or medical organization that did not properly register the voluntary informed consent for medical intervention shall be held administratively liable in accordance with Article 14.1 (item 3.4) of the CoaP, in the form of a fine or temporary suspension of professional activity.

If the patient was provided with medical services for a fee under the contract, then the above penalty will be added to the responsibility under Art. 14.8 Coap RF for the fact that the patient did not receive reliable information on the services provided.

The situation is much more complicated if the patient's health or life has been harmed. If the victim was not given full and reliable information about the upcoming medical procedures and their possible consequences, the patient (or his relatives) has the right to receive full compensation for harm in accordance with the Law on Protection of Consumer Rights (Article 12) and the Civil Code of the Russian Federation (Article 1095). It should be noted that in the absence of DIS, the patient can claim compensation for the harm received, regardless of whether there is a fault of the medical organization in the incident.