May 7, 2020 / COVID-19 / Health
Currently in medical practice and in accordance with MEXICAN OFFICIAL STANDARD NOM-004-SSA3-2012 OF THE CLINICAL RECORD (hereinafter, the “Standard”), it is a requirement that for the proper integration of the clinical record, the medical, technical, or administrative staff of the hospital must obtain the Informed Consent from the patient when any medical or surgical procedure is required to be performed. The Informed Consent must be expressed and verified in writing by means of a document signed by the patient, their legal representative, or their closest kin.
The National Commission of Bioethics (CONBIOÉTICA) establishes that Informed Consent is
“…the tangible expression of respect for the autonomy of individuals in the field of medical care and health research. An informed consent is not a document, but it is a continuous and gradual process that takes place between the health personnel and the patient, and it is consolidated in a document.
In the informed consent, the health personnel informs the competent patient, in enough quality and quantity, about the nature of the disease and the diagnostic or therapeutic procedure proposed to be used, the risks and benefits involved, and the possible alternatives. The written document is only proof that the medical staff has informed the patient and that the patient has understood the information. Therefore, informed consent is the representation of the responsible and bioethical attitude of medical or health research personnel, which enhances the quality of services and ensures respect for the dignity and autonomy of individuals…”.
In what cases must the medical staff obtain an Informed Consent?
In accordance with the Standard, medical, technical, or administrative personnel must obtain the Informed Consent in the following situations:
- Patient Admission;
- Major surgical procedures;
- Procedures requiring general or regional anesthesia;
- Tubal ligation and vasectomy;
- Organ, tissue, and transplant donation;
- Clinical research in human beings;
- In-hospital autopsy;
- Diagnostic and therapeutic procedures deemed as high risk by the physician;
- Any procedure involving mutilation.
What are the minimum requirements that the Informed Consent must contain?
Within the guidelines established by the Standard, it is mentioned that the Informed Consent must contain at least the following:
- Name of the institution to which the medical establishment belongs, if applicable;
- Name or corporate name of the establishment;
- Document title;
- Issuance place and date;
- Authorized Act;
- Indication of the expected risks and benefits of the authorized medical act;
- Authorization to health personnel for the attention of contingencies and emergencies derived from the authorized act, in accordance with the principle of prescriptive freedom; and
- Full name and signature of the patient if their health condition allows them. In case the health condition of the patient does not allow them to sign and give their consent, the full name and signature of the closest kin, guardian, or legal representative present must be recorded;
- as well as the data of the treating physician: full name and signature of who provides the information and collects the consent for the specific act that was granted, if applicable.
- Full name and signature of 2 (two) witnesses.
Informed Consent during the health emergency period due to COVID-19.
If the health personnel had to perform any medical intervention during this health emergency period, in addition to mentioning the inherent risks of the procedure to be performed in the patient, it is important that the Informed Consent clearly explains the risk of contagion to which the patient will be exposed when the surgical intervention is performed within the hospital facilities. The foregoing so that both the patient and the physician may determine if the performance of such intervention or procedure during the health emergency period entails more benefits than the risk to which the patient is exposed.
In which cases will it not be required to obtain an Informed Consent?
In accordance with the General Health Law in Health Care Service Provision matters, it is established that in case of emergencies in which there is no chance to obtain the written authorization from the patient or their closest kin or legal representative, the authorized physicians of the relevant hospital, after evaluating the case and with upon agreement of at least 2 physicians, will carry out the therapeutic procedure required by the case, leaving a written record in the clinical file.
Sources:
–http://www.conbioetica-mexico.salud.gob.mx/interior/temasgeneral/consentimiento_informado.html
General Health Law in Health Care Service Provision matters, Article 81.
-MEXICAN OFFICIAL STANDARD NOM-004-SSA3-2012 OF THE CLINICAL RECORD, provisions 10.1, 10.1.2, 10.1.3, and 10.1.4
