Free and informed consent: when and how to elaborate

By: Tertius Rebelo
Tertius Rebelo, proteção de dados

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.

The importance of free and informed consent comes from the physician's ability to prove compliance with his legal duty to inform the patient about the diagnosis, prognosis, the possibility of treatment or non-treatment and its risks. By clarifying the patient, the doctor allows the patient to express his consent with security and autonomy, which is the fundamental requirement for contractual improvement with the attending physician.

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.

It is obvious that each judicial process has its own characteristics and the probative value that the document will have within the process will depend on the specific case that is under the analysis of the Judiciary. However, not having the document signed does not represent an ethical violation, but it is undoubtedly a major legal risk for those who are not careful to seek written consent from the patient.

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.

The patient must have two preconditions: the ability to understand and decide and the willingness. Willingness is the possibility for the patient to choose one of the proposed alternatives, free of external pressure.

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.

In conclusion, there is no doubt that the practice of medicine today presents a greater risk of contestation and prosecution. Thus, the physician's concern with defending himself is perfectly understandable. However, the best defense is professional practice performed with competent knowledge and a respectful attitude towards the patient, which will result in a good doctor-patient relationship, fundamental in medical practice. After all the above analysis, it is concluded that it is necessary to seek a new practice in obtaining informed consent, in which it is possible to share sufficient and clear information to the patient.

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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).