Free and informed consent: when and how to elaborate

By: Tertius Rebelo
Tertius Rebelo

Prevention of forensic complications

Strategies for the prevention of medical-legal complications are based precisely on three bases: 1) quality of the services provided, 2) effective communication and 3) medical-legal care with the documentation of medical acts.

The quality of the services provided refers not only to the promptness of the assistance, but also to its technical and personal aspectsincluding the necessary and appropriate preoperative and postoperative follow-up / procedure / consultation.

Communication is related to the information transmitted to patients, which must be understandable and address the benefits, risks and possible inconveniences that may occur, prognoses, among others. In addition, the documentation can be divided into two levels: the medical record (patient's set of medical documents) and the informed consent form.

The medical record is one of the main documentary evidence of the technical correctness of the medical care provided. Because of this, the complete and readable completion of the medical record is of fundamental importance for the greater safety of the physician and the patient.

Já a importância do termo de consentimento livre e esclarecido advém da capacidade do médico em provar o cumprimento de seu dever legal de bem informar o paciente a respeito do diagnóstico, prognóstico, da possibilidade de tratamento ou de não tratamento e de seus riscos. Ao esclarecer o paciente, o médico permite que esse manifeste seu consentimento com segurança e autonomia, que é o requisito fundamental para o aperfeiçoamento contratual com o médico assistente.

Validity of Informed Consent

The free and informed consent term has been considered an instrument of manifestation of the patient's self-determination and protection for the physician.

É óbvio que cada processo judicial tem características próprias e o valor probante que o documento terá dentro do processo dependerá do caso concreto que está sob a análise do Poder Judiciário. Entretanto, não ter o documento assinado não representa uma infração ética,  mas é, sem sombras de dúvida, um grande risco jurídico para quem não tem o cuidado de colher o consentimento escrito do paciente.

Failure to provide the patient with the necessary information is understood as negligence (for justice: informational negligence), liable to civil liability and indemnity to the patient.

On the other hand, a standardized document risks losing evidence within a process or being too general and not sufficient to demonstrate that adequate and sufficient information has been provided to the patient.

Thus, when making informed consent, the physician should, on the date on which the consent is obtained, make clear all that, in a competent and coherent manner, tried to achieve.

It should also be noted that, as a rule, the medical professional is not committed to giving a right result, but is committed to dedicating the best of his or her technical and scientific capacity to healing or better patient care. Moreover, it should be noted that the correct completion of the form does not guarantee the absolute protection of the professional against ethical-professional and judicial processes and does not exempt him from liability, but it is certainly an instrument of great value from the legal probative point of view and closer doctor-patient relationship.

Thus, informed consent properly obtained legitimates and grounds the medical or research act as fair and well performed.

Characteristics of informed consent

The informed consent process consists of three steps: the patient's preconditionsthe information elements it's the consent itself.

O paciente deve ter duas condições prévias: a capacidade para entender e decidir e a voluntariedade. A voluntariedade é a possibilidade de o paciente escolher uma das alternativas propostas, livre de pressões externas.

The information elements are the information about the procedures, risks, discomfort, benefits, alternatives, etc.& #8230; Consent itself occurs when the patient makes the decision for one of the alternatives presented. The signing of the consent form is the last step of the process, when the patient gives his / her consent to perform the proposed procedures.

How to prepare a free and informed consent form

A term of Informed Consent Form elaborated, should address the following items: Patient ID; b- Written consent, being the most recommended form; c- If it is impossible to obtain consent from children, adults with difficulties in understanding or to express understanding of the procedure / treatment, informed consent must be given by a family member of the hotline or legal guardian. In the case of an experiment, the research protocol must be approved by the Institution's Research Ethics Committee; d- Coercion: There can be no coercion, the decision must be the result of freedom / autonomy of the individual; e- Refusal or interruption: the patient has the right to refuse or discontinue treatment or experimentation; f- The doctor has the duty to provide the necessary information, describing in accessible and understandable language: f.1- The diagnosis; f.2- Therapeutic alternatives; f.3- The alternative chosen and why. f.4- The expected benefits; f.5- The risks and possible complications; g- To finalize the document, it must be stated that: g.1- The patient requested and obtained clarification; g.2- Understood the explanations provided; g.3- Accordingly, you consent to the informed procedure; g.4- Informed consent must also be signed by the patient, the physician and witnesses.

Finalizando, não há dúvidas que o exercício da medicina, nos dias de hoje, oferece maior risco de contestação e de processos. Assim, a preocupação do médico em se defender é perfeitamente compreensível. Entretanto, a melhor defesa é o exercício profissional realizado com conhecimento competente e uma atitude respeitosa com o paciente, o que resultará numa boa relação médico-paciente, fundamental na prática médica. Após toda a análise acima, conclui-se é necessário buscar uma nova prática na obtenção do consentimento informado, na qual seja possível o compartilhamento de informações suficientes e claras ao paciente.

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Tertius Rebelo

Specialist in Medical and Health Law.
Specialist in Medical and Health Law. Postgraduate in Civil and Business Law. Experience in civil and criminal actions and administrative procedures involving health professionals and companies. Member of the Special Committee on Medical and Health Law of the Federal Council of the Brazilian Bar (2016-2019); Member of the Commission on the Right to Health of OAB / RN (2012-2019); Member of the TJRN Executive Health Committee (2016-2019); Member of the Medical and Health Law Commission of ABA - Brazilian Association of Lawyers (RN); Member of the Review Committee of the Code of Medical Ethics in RN; Member of the World Association for Medical Law; Member of the Association of Lawyers of RN - AARN; Speaker on Medical Law, Health Law and Bioethics; Invited Professor of the Medicine courses at UFRN and UnP (RN); Professor of Specialization in Medical and Health Law at UNI-RN, UNIFACISA (Campina Grande / PB) and Julio Cesar Sanches Institute (Tocantins).