Any person who has contacted a medical organization will be asked to fill out a voluntary informed consent for medical intervention. Patients are not always clear why they need to fill out and sign this form, indicating their personal data in it. In addition, healthcare providers do not always readily explain what exactly the person who signed the voluntary informed consent to medical intervention (DIS) agrees to. What rights does this document give to the attending physician? This question is especially worrying for parents of minor children: they often offer to fill out and sign a voluntary consent to medical intervention for their child not only in the district children's polyclinic, but also in the educational institution. Is it necessary to sign a DIS or is it better to issue a refusal? Why do I need to fill out this document? What are the consequences of consenting to and refusing medical intervention?
What is medical intervention?
The term "medical intervention" refers to any types of examinations, procedures and procedures that are performed by medical personnel in relation to the patient. Thus, a simple medical examination and questions about a patient’s complaints, as well as transplantation of donor organs, are equally related to medical intervention.
DIS form
Consent to medical intervention, and with it the refusal of medical intervention or consent to specific types of procedures must be made in writing. Typical forms and the procedure for filling them out are approved by order of the Ministry of Health of Russia No. 1177n of December 20, 2012.
What kind of medical intervention involves a DIS?
Voluntary informed consent is a document confirming that the patient’s right to receive reliable, understandable, complete information about the medical services provided is respected. A typical DIS (Appendix 2 to Order No. 1177n) is filled out and signed by the patient (patient representative) and the medical professional before providing primary medical care, in accordance with the list approved by order of the Ministry of Health and Social Development No. 309n of 04/23/2012).
The patient’s medical records in the clinic, the child’s medical records in the educational institution, the contract for the provision of paid medical services and other documents related to the provision of this type of service must necessarily contain voluntary informed consent for medical intervention.
Important! Before filling out the DIS form, the attending physician (medical worker) is obliged to inform the patient in detail about the upcoming intervention, including goals, methods and possible consequences of the forthcoming procedures.
By signing a voluntary informed consent for medical intervention at school or in kindergarten, the parent also gives permission only for the procedures listed in the law. In the standard form of the DIS, a list of proposed procedures is always indicated in detail in accordance with the age of the minor child. In the event that the parent has any doubts about this list, it would be worthwhile to study the DIS form at home in a calm environment before signing. If it is a question of medical examination in the consent form, the parent (representative of the child) can clarify the list of proposed procedures in the order of the Ministry of Health of the Russian Federation currently in force No. 1346n dated 12/21/2012 “On the procedure for minors to undergo medical examinations ...”, and the procedure and types of vaccination - in the official vaccination calendar.
How to fill in correctly: instructions, sample
How should I fill out a voluntary informed consent for a medical intervention? The DIS form is executed and signed by the patient and the attending physician exclusively prior to the start of all medical examinations and manipulations. Mandatory condition for filling in - all information is filled in by the patient (legal representative of the minor patient) with his own hand. An exception to this rule is if the patient is unable to fill out the form on his own for health reasons. In this case, an authorized employee of the medical organization will do it for him.
What information should be provided when filling out a consent to a medical intervention? (See the article below for a sample fill.)
According to the officially approved Instructions for filling out DIS forms (hereinafter referred to as the instruction), the annex to the order of the Federal Medical and Biological Agency of Russia No. 88 dated March 30, 2008, the patient must indicate on the form:
• Your personal data: full name, address of registration (residence), year of birth, passport information (identity card).
• Data from the health worker (doctor) who provided information on the medical intervention.
• A list of people who are allowed to provide information about the diagnosis and health status of the patient.
• When applying for pre-hospital inpatient care: information about the medical institution where hospitalization is planned.
• Date of signing of the DIS.
When filling in the legal representative of 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 passport information (identity card) are indicated.
• The words “whose legal representative I am ...” should be emphasized in the text of the DIS.
• The personal data of the child is indicated (full name, year of birth).
At the end of the text of the form, voluntary informed consent for medical intervention is certified by the signature of the medical worker (doctor).
Consent to certain types of medical procedures
For specific types of medical interventions, it is required to obtain a DIS in addition to standard consent. For example, to vaccinate (vaccinate) a patient (his legal representative) of a minor patient, it is necessary to give voluntary informed consent for medical intervention (for a sample, see the article below).
For DIS, similar filling rules apply for specific types of medical interventions. Before signing the consent of the patient, they are obliged to inform in detail both about the procedure itself and about the expected consequences. Each DIS form filled out by the patient or his legal representative is also pasted onto the medical record.
What should I look for? The form must contain the name of a specific procedure for which the patient (representative) will give consent. Any general designations and phrases are not allowed. For example, with consent to vaccination, the DIS should indicate not only the procedure, but also the name of the vaccine used.
Can additional information be indicated on the form?
In the typical DIS form, the “Additional Information” section may, if necessary, be filled in by the attending physician, who will enter information regarding the receipt of the DIS from the patient and upcoming medical intervention.
The introduction of any additional information into the standard consent or refusal form is not provided for by law, but is also not prohibited.
Is it possible to draw up consent or refusal in free form?
The instruction also provides for cases when the patient for some reason does not want to fill out the DIS on the approved form. In such a situation, voluntary informed consent for medical intervention can be written by hand or printed in free written form. However, there is a clarification that when independently compiling a DIS, the patient should always adhere to all the requirements of the legislation established for the DIS for medical intervention.
Medical intervention without patient consent
In exceptional cases, the law allows the provision of necessary medical care or medical procedures without obtaining a DIS:
• If you need to take urgent measures to eliminate the threat to the life of the patient, but at the same time he is in a state that does not allow his decision to be indicated, and his legal representatives are absent.
• For persons:
1) representing a danger to others due to existing diseases;
2) with severe mental disorders;
3) committed a crime;
4) in relation to which a forensic medical examination or forensic psychiatric examination is carried out.
How to refuse: fill out the refusal of medical intervention
Refusal of 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 compiling this document, the attending physician (medical worker) is obliged to tell the patient about all the possible consequences of signing a refusal of medical intervention or from the “refusal” part of medical procedures.
For this, the upper “passport” part of the DIS form is filled out in the same manner as the consent, in accordance with the instructions. Further, disagreement on the intervention should be indicated, a record certifying that the consequences of the refusal by the medical staff were clarified. The typical refusal form has a section for filling in by the attending physician, where the possible consequences of the informed refusal are entered.
The patient’s refusal of medical intervention is pasted into his card or, in case of refusal of hospitalization, is pasted to the patient’s discharge documents.
How to partially abandon the procedures specified in the consent?
A separate consideration should be given to a situation where a rejection is not intended as a whole of medical intervention, but of one or more procedures. In this situation, it should be issued on a special standard form indicating the specific procedure that the patient refused to provide (Appendix 3 to Order No. 1177n).
The form is filled in completely, in accordance with the established procedure for filling and instructions. The attending physician indicates the expected consequences of refusing this procedure.
At what age can a child independently sign a DIS?
A person who has reached the age of 15 years can give informed consent to medical intervention. But there are exceptions to this rule established by laws and applicable regulations. Consent to certain categories of medical intervention can only be signed by a fully competent person - an adult, that is, a citizen over eighteen years old or a person who has received legal capacity ahead of schedule in the manner prescribed by law. These exceptions include:
• Consent to any medical manipulations regarding donation (removal for donor purposes) of organs or blood and transplantation of donor organs to a patient.
• Consent to conduct an examination on suspicion of drug (alcohol) intoxication.
• Disabilities in the provision of narcological assistance to a citizen who is addicted to drugs. At the same time, for a medical intervention not related to drug treatment, a drug addict can give consent from sixteen years of age.
Important! A citizen recognized as legally incompetent in the manner prescribed by law shall also not have the right to independently provide DIS. For him, a decision should be made on his consent or refusal of medical intervention by his legal representative.
Dis validity period
Strictly established periods of validity of the DIS are not established by law. The only definition in this regard is that consent is valid for the entire period of treatment (medical care). In practice, this means that informed consent to a medical intervention will be valid for as long as the patient is assigned to a medical organization. That is, he is on inpatient, sanatorium treatment or, as for the additional paid provision of medical services, for the entire duration of the contract with the clinic.
However, a patient who has given informed consent for a medical intervention has the right to withdraw it, in whole or in part, before the expiration date. Refuse medical intervention or part of the procedures in writing by filling out the appropriate form of the medical organization or by writing in a free form a statement addressed to the head physician. The patient may indicate in the application (refusal form) the reason for the revocation of the DIS, but this is an optional condition.
Responsibility for providing medical interventions without DIS
Informing the patient about upcoming medical procedures and their possible consequences is the obligation of the medical organization established by applicable law and the condition of a license (permit) for the provision of this type of service. The attending physician or medical organization that has not duly obtained the voluntary informed consent for medical intervention shall be held administratively liable, in accordance with Article 14.1 (clause 3.4) of the Administrative Code, 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 liability under Art. 14.8 Coap of the Russian Federation for the fact that the patient did not receive reliable information about the services provided.
The situation is much more complicated if the health or life of the patient has been harmed. If the victim has not been provided with a signature with complete and reliable information about 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 the Protection of Consumer Rights (Article 12) and the Civil Code of the Russian Federation (v. 1095). It should be noted that in the absence of a DIS, the patient may claim compensation for the harm received, regardless of whether the incident was the fault of the medical organization.