Letter of informed consent in medical practice

Informed consent has become an almost essential aspect in medical practice, being one of the pillars of the legality, trust and legitimacy of the doctor-patient relationship.

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This is not a mere formalism or a doctor's habit, but it is even a requirement to carry out medical activity, whose non-compliance can have serious consequences for the professional.

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The Official Mexican Standard NOM-004-SSA3-2012, on the clinical record, defines the letter of informed consent as that written document, signed by the patient or their legal representative or closest relative in connection, through which a medical or surgical procedure is accepted for diagnostic, therapeutic, rehabilitative, palliative or research purposes, once information has been received about the expected risks and benefits for the patient.

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Definition that brings us to an extremely important point and without which such a document would not make sense, that is, the expected risks and benefits. The doctor must make the patient aware of the expected benefits and risks of the procedure, without it being advisable to insure one or the other, since very variable and incidental issues also affect, which it is also advisable to report.

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There are different factors that must be considered when determining the content of the physician's duty to inform: some of a subjective nature and others of an objective nature.

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The first group should consider, among others, the patient's cultural level, age and personal, family, social and professional situation.

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Among the objective factors, the following must be evaluated: urgency of the case, need for treatment, dangerousness of the intervention, novelty of the treatment, severity of the disease and the patient's possible refusal to receive information.

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In this regard, the more urgent a medical intervention is, the less precision is required in the information to be provided to the patient. The same is predicable of the need for treatment, so that the less treatment is necessary, the more rigorous the information must be, and it must be extreme in aesthetic interventions and, in general, in so-called voluntary or satisfactory surgery (vasectomies, tubal ligations, rhinoplasty, mammoplasty, dermolipectomies, among others), unlike curative or assistive surgery where the information may be less rigorous.

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It should be noted that the more dangerous and novel an intervention is, the more comprehensive the information provided to the patient should be.

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Some of the elements that make up this authorization are the following:

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• Name of the institution to which the hospital belongs.
• Name, reason or company name of the hospital.
• Title of the document.
• Place and date.
• Name and signature of the person granting the authorization.
• Concept by which authorization is given.
• Name and signature of witnesses.

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A personal recommendation is that, as far as possible, the patient should sign the letter of informed consent before any procedure, since the consequences that may be incurred due to medical malpractice or improper integration of the clinical record, are quite burdensome; in addition, this gives the patient security and confidence, in terms of the professionalism of the doctor who will treat him, as well as the procedure to which he will undergo.

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The consequences to which you are subject for not seeking informed consent are not limited to the medical field, but they escalate to civil, administrative and even criminal penalties that can definitely ruin the doctor's professional career.

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That is why it is essential to comply with their obligations in terms of health and the provision of health care services, so as to avoid any sanction that could jeopardize the continuation of their professional practice, as well as to strengthen their reputation and trust with their patients.