Informed voluntary consent

There is an opinion that the requirement for patient consent for medical intervention was first formulated in the 18th century in the UK . The concept of “voluntary consent” was first formulated in the second half of the 1940s after the end of the Nuremberg trials , when emphasis was placed on the voluntary participation of subjects in medical experiments ^[1] . Many authors attribute the emergence of the concept of “informed consent” to 1957, when in the USA after transluminal patient was immobilized, he went to court and won a lawsuit against doctors: it was found out that if he had been notified of this complication, he would not have given consent , thus his consent was not informed ^[4] .

• Getting before medical intervention;
• Voluntary receipt and the ability to withdraw consent at any time and without explanation
• Comprehensive awareness
• A prerequisite for medical intervention ^[2] .

The fact that informed consent was given can only be said if there is a clear understanding of the facts, consequences and consequences of the action. In order to provide informed consent, the patient must have sufficient competence and legal capacity (legal capacity in this context means, according to the WHO formulation, the presence of “physical, emotional and cognitive abilities to make decisions or perform targeted actions”, and competency refers to the mental ability to “process and understand the essence of information for making clearly formulated decisions on this basis ”) ^[5] .

Some scholars have disputed the legitimacy of obtaining consent from people with severe mental disorders (such as schizophrenia , severe depression ), since these disorders significantly affect cognitive functions. However, it was shown that when changing the form of presenting the information necessary for making a decision (for example, repeating it repeatedly, providing more time for reflection), the percentage of its assimilation practically does not differ from that of healthy people. Only in very severe cases ( states of altered consciousness , acute psychoses with severe confusion or extreme congestion with psychotic experiences, states of deep dementia ) is it practically impossible to establish the patient’s attitude to the provision of psychiatric care, so obtaining consent in such cases should be considered illegal ^[6] .

In a number of countries, patients hospitalized in an involuntary manner have a statutory right to refuse treatment ^[6] . According to the standards of the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment , “the forced placement of a person in a psychiatric institution should not be construed as authorization to receive treatment without his consent” ^[7] . In accordance with WHO principles, legislation should provide for all types of treatment based on voluntary and informed consent; involuntary hospitalization and involuntary treatment should be used only in exceptional cases and in special circumstances ^[8] .

According to the Principles for the Protection of Mentally Sick Persons and Improvement of Mental Health Care ( UN document), treatment without informed consent, even in the most severe cases where the patient is not able to give informed consent, should not be prescribed if the patient has a personal representative authorized by law to give consent to treatment for the patient. However, the personal representative cannot consent to the use of measures such as sterilization , serious surgical intervention, psychosurgery and other types of invasive and irreversible treatment of mental illness, clinical trials and experimental treatment methods. These measures can only be applied voluntarily ^[9] .

In cases where the person is not provided with enough information to make an informed decision, serious ethical issues arise. Such cases in clinical trials are identified and prevented by the Ethics Committee or a panel of specialists.

Informed consent templates for use in practice can be found on the World Health Organization website ^[10] .

In the Russian Federation

The concept of informed voluntary consent for the first time in the Russian Federation is legislatively enshrined in the adoption of the "Fundamentals of the legislation of the Russian Federation on the protection of public health" dated July 22, 1993 No. 5487-1 ^{[11] [12]} . At present, informed voluntary consent in the Russian Federation “is a necessary condition for the provision of medical care”, which is enshrined in Art. 20 of the Federal Law of November 21, 2011 No. 323-ФЗ “On the Basics of Protecting the Health of Citizens in the Russian Federation” ^[13] , and the procedure for obtaining it is established by Order of the Ministry of Health of the Russian Federation of December 20, 2012 No. 1177n ^{[4] [12] [ 14]} .

Cases of medical intervention are regulated without the consent of the patient, they include emergency indications of eliminating a threat to a person’s life, a danger to other people as a disease — in this case, the decision is made by the consultation of doctors or the attending physician with the obligatory subsequent informing the administration of the medical institution and the citizen; this type also includes urgent actions in relation to persons suffering from severe mental disorders, persons who have committed socially dangerous acts by a court decision and during forensic psychiatric and forensic examinations ^[4] .

Age and other characteristics

The right to consent is directly related to legal capacity :

• children under 6 years of age are completely incompetent (Article 28 of the Civil Code of the Russian Federation ^[15] ), legal representatives give their consent;
• minors from 6 to 18 years of age are of limited legal capacity (Articles 26, 28 of the Civil Code of the Russian Federation ^[15] ), however, from the age of 15, according to the Federal Law “On the Basics of Protecting the Health of Citizens in the Russian Federation”, they have the right to voluntary informed consent to medical intervention thus, from 6 to 15 years old, legal representatives give consent for a minor, from 15 years to 18 years - minors independently, although they can also use the help of parents or legal representatives, nevertheless sign the form on their own;
• adult citizens give voluntary informed consent on their own;
• adult citizens recognized legally incompetent by court give informed voluntary consent through guardians ^[16] .

In case of refusal of legal representatives of a minor (up to 15 years old) about medical intervention upon request of a medical institution, the question of it is decided in court ^[2] .

When issuing informed voluntary consent, legally capable elderly people often involve proxies (Articles 182, 185 of the Civil Code of the Russian Federation ^[15] ) or trustees (assistants) acting in the form of patronage (Article 41 of the Civil Code of the Russian Federation ^[15] ), but only for help , the patient has no right to concede it to them ^[16] .

EU

In accordance with the provisions of the Convention for the Protection of Human Rights and the Dignity of the Human Being in connection with the use of the achievements of biology and medicine ^{[17], an} intervention in health can be carried out only after obtaining free, informed consent based on the knowledge of the person undergoing such an intervention (Art. 5-10), he is informed in advance about the purpose and nature of the intervention, possible consequences and the risks associated with it, the patient can also refuse his consent at any time ^[3] . The same Convention provides for the indispensability of medical professionals to comply with professional norms and duties in order to fully observe the rights of patients and protect their legitimate interests ^[3] .

Other contradictions that have arisen a long time ago point to conflicts of interest among the medical faculty and researchers. For example, information about employees of the University of California contains data on constant corporate payments to researchers and practitioners by companies that sell and manufacture advertisements and produce exactly the devices and drugs that these practitioners and researchers further recommend to patients ^[18] . Robert Pedowitz, a former chairman of the Department of Orthopedic Surgery at the University of California, Los Angeles, expressed concern that financial conflicts of interest for his colleagues could adversely affect patient care or research on new treatments ^[19] . In a subsequent lawsuit by the University against Pedowitz, who divulged this information, the university paid, by agreement of the parties, $ 10 million, while refusing to admit violations ^[19] . The Consumer Watchdog stated that the policy of the University of California “is either inadequate or insufficient ... Patients at hospitals at the University of California deserve the most reliable surgical devices and medicines ... and should not be considered subjects in expensive medical experiments” ^[18] .

Other cases with the University of California include the removal of female eggs for implantation to other women without the consent of the patient ^[20] , the illegal sale of donated corpses ^[21] , injections of live bacteria into the human brain, leading to premature deaths ^[22] .

• Medical law
• Informed voluntary consent in psychiatry
• Antipsychiatry
• Helsinki Declaration
• Adulthood

• Universal Declaration on Bioethics and Human Rights (2005)
• Ethical principles for conducting medical research involving a person as a subject // Helsinki Declaration of the World Medical Association, ed. 2008

• Bazhanov, N. Informed voluntary consent of the patient to medical intervention: age-related aspects / N. Bazhanov, N. Ivanenko // Doctor. - 2011. - No. 10. - S. 73—75. - ISSN 0236-3054 . (unavailable link from 10-07-2018 [396 days])
• Bazhanov, N. O. Medical and legal aspects of informed voluntary consent / N. O. Bazhanov, N. S. Ivanenko // Health of the Russian Federation. - 2012. - No. 6.
• Pishchita, A. N. Informed voluntary consent in medicine (legal aspect) / A. N. Pishchnt, A. E. Klimov // Bulletin of the Peoples' Friendship University of Russia. - 2006. - T. 33, No. 1. - (Medicine).
• Pogodina, T. G. On the issue of voluntary informed consent to medical intervention as an inalienable right of a patient // Jurisprudence and Practice: Bulletin of the Nizhny Novgorod Academy of the Ministry of Internal Affairs of Russia. - 2015. - T. 30, No. 2. - ISSN 2078-5356 .
• Filippov, Yu. N. The history of the formation of informed voluntary consent of a patient in Russia / Yu. N. Filippov, O. P. Abaeva, A. Yu. Filippov // Medical almanac. - 2013. - T. 25, No. 1.
• A.N. Food. Consent to medical intervention. - M .: Center. wedge. hospital Ros. Acad. Sciences, 2006. - 84 p.