What Informed Consent Is and What Information the Patient Must Receive
Informed consent is a foundational institution of health law. Under the law, it is the consent of the patient — or, where the patient is a minor, of the patient's legal representative — to the provision of a particular medical service, given after the patient received information on the essence and necessity of the service; its expected results; the expected risk to the patient's health and life; alternative options for the intended service, their accompanying risks and possible effectiveness; the expected consequences of refusing the service; and the financial and social issues connected with all of the above.
This definition is a practical checklist for clinics as well: a consent form works only where every one of these blocks has been explained to the patient. The terminology itself is fixed by law — patient, provider of medical services, medical records — and in a dispute it is precisely the content of these concepts that comes under examination.
Consent Precedes the Intervention, and When Writing Is Required
The law sets a clear priority: informed consent of the patient — or, where the patient is a minor or unable to make a conscious decision, of the patient's relative or legal representative — is a necessary condition for providing a medical service, and obtaining informed consent precedes the provision of the service. An intervention without consent is therefore not merely defective — it is a violation of the law.
Written informed consent is mandatory for interventions carrying special risk: any surgical operation except minor surgical manipulations; abortion; surgical contraception — sterilization; catheterization of major blood vessels; hemodialysis and peritoneal dialysis; in vitro fertilization; genetic testing; gene therapy; radiation therapy; chemotherapy for malignant tumors; and in all other cases where the provider considers written consent necessary. Written form is also required when serving a minor or a patient unable to make a conscious decision.
Use as a Teaching Object and Its Exceptions
A separate field is the use of a patient as an object of teaching: the patient's informed consent is required for this too, and it precedes such use. The law defines exceptions: consent is not necessary where the teaching purpose uses information from the patient's medical documentation that does not allow identification of the patient, or material obtained in the course of treatment and diagnostics in which the patient's anonymity is ensured. Organising the teaching process must stay within precisely these boundaries.