- Both Conamed and NOM-004-SSA3-2012 establish the cases in which this legal document must be prepared.
- If you do not meet all the requirements, the document loses validity.
- There are 9 specific cases in which an Informed Consent Letter must be drawn up.
The legal aspect is fundamental in all health professionals. Due to the nature of the work, it is an activity in which a lot of attention must be paid because it can have various consequences. It is not only about the integrity of the patients but your prestige is also at stake. In this sense, something that seems simple like write an Informed Consent Letter It is not something that everyone masters.
What does this document consist of?
First of all it is necessary to explain this term. Based on the National Medical Arbitration Commission (Conamed) is the act of free and voluntary decision made by a competent person, by which he accepts the diagnostic or therapeutic actions suggested by his doctors, based on the understanding of the information revealed regarding the risks and benefits that they can cause .
For its part, informed consent is based on the principle of patient autonomy, considering for its existence three basic requirements necessary for it to be valid: freedom of decision, sufficient explanation and competence to decide.
For its part, the NOM-004-SSA3-2012 defines the informed consent letter as the written document, signed by the patient or their legal representative or closest relative, through which a medical or surgical procedure is accepted for diagnostic, therapeutic, rehabilitative, palliative or research purposes, once information has been received on the expected risks and benefits for the patient.
Consent is intimately related to information. Patients have the right to be informed, in a clear, complete, truthful, timely and qualified manner, regarding their health status, treatment alternatives, benefits and reasonably foreseeable risks according to medical practice. In such a way, that they have all the elements that allow them to make a rational and conscious decision.
How should an Informed Consent Letter be written?
As with other legal documents, there are some minimum elements that it must contain or else it will not be valid. For its part, through social networks Conamed published a guide with the elements that must contain an Informed Consent Letter.
- Name of the institution to which the establishment belongs.
- Name, reason or corporate name of the establishment.
- Document title.
- Place and date of issue.
- authorized act.
- Pointing out the expected risks and benefits of the authorized medical act.
- Authorization to health personnel for the care of contingencies and emergencies derived from the authorized act, in accordance with the principle of prescriptive freedom.
- Full name and signature of the patient, if his state of health allows it, in case his state of health does not allow him to sign and issue his consent, the full name and signature of the closest relative who is present must be entered, guardian or legal representative.
- Full name and signature of the doctor who provides the information and obtains the consent for the specific act that was granted, where appropriate, the data of the treating doctor will be recorded.
- Full name and signature of two witnesses.
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Validly informed consent letter
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Cases in which an Informed Consent Letter must be drawn up
Conamed itself points out that the minimum events that require a letter of informed consent are the following:
- Hospitalization.
- Major surgical procedures.
- Procedures that require general or regional anesthesia.
- Salpingoclasia and vasectomy.
- Donation of organs, tissues and transplants.
- Clinical research in humans.
- Hospital necropsy.
- Diagnostic and therapeutic procedures considered by the doctor as high risk.
- Any procedure involving mutilation.