Introduction:

According to The Patient's Rights Law, care providers must obtain patients' free and voluntary informed consent for all medical treatments (with the exception of certain circumstances listed below)
Care providers are required to provide patients with the medical information necessary to make a decision regarding proposed treatment
No medical treatment may be performed on a patient without obtaining informed consent or with providing the information required by law.
If medical treatment was performed without informed consent or without the provision of the medical information as required, the patient may file a monetary suit against the relevant care provider and the medical facility.
For more information see sections 13 - 16a of the Patient's Rights Law.

Section 13 of The Patient's Rights Law establishes that care providers must obtain patients' free and voluntary informed consent for any medical treatment.

  • No medical treatment may be provided to a patient without first obtaining informed consent.
  • Care providers are required to provide patients with the medical information necessary to make a decision regarding proposed treatment.
  • Care providers should provide relevant medical information to patients as early as possible and in a manner that enables them to make an unconditional decision of their own free will.
  • The more complex or risky a treatment, the more detailed information patients are entitled to receive.
  • In special and exceptional cases (see more details below, treatment may be provided without obtaining informed consent, or even against the patient's will.
  • For some specific types of treatments, the law requires that informed consent be provided in writing (on an informed consent form) that includes a summary of the information provided to the patient.

Who is Eligible?

  • All patients.

Which Treatments Require Informed Consent?

  • The requirement to obtain informed consent applies to any medical treatment, including:
  • Procedures performed to diagnose a patient's medical condition (for example blood tests)
  • Preventative treatments (for example vaccinations)
  • Treatments intended to maintain a patient's current medical state (for example nursing care)
  • Treatments that do not involve physical action on a patient's body such as psychological treatments; decisions to cease medical treatment; decisions to not give a patient any active medical treatment, (for example telling a patient to rest).

Disclosure of Information for Purposes of Informed Consent

Giving Informed Consent

  • In general, a patient's consent to treatment may be given in one of the following ways:
  1. Written consent
  2. Verbal consent
  3. Behavioral consent (for example a nod of the head)
  • In the following cases, written consent on an informed consent form must be obtained:
  1. Surgeries (except minor surgery)
  2. Blood vessel catheterizations
  3. Dialysis
  4. Radiation Therapy (Radiotherapy)
  5. In vitro fertilization (IVF)
  6. Chemotherapy for malignancies
  7. Hypnosis
  8. Egg donations
  9. Abortions
  10. Amniocentesis

Timing of Informed Consent

  • Care providers must request informed consent and provide all required medical information to the patient within a reasonable amount of time before the treatment.
  • A "reasonable amount of time" depends on each individual case and circumstances (such as the type of treatment and the patient's medical condition), while giving consideration to enabling the patient to understand the medical information that was provided and make an independent decision.
Example
Patient consent should not be obtained immediately prior to an invasive procedure unless medical necessity justifies it. If possible, the patient's consent should be obtained before hospitalization or before coming to the clinic.
  • When the treatment is composed of a number of identical repeated treatments (such as chemotherapy), informed consent may be obtained before beginning the treatment series, and this consent will be valid as long as there is no change in the medical circumstances which would justify a reevaluation of the treatment (such as if the patient developed severe adverse reactions to the treatment, and a decision has to be made whether or not to continue treatment).

Free and Voluntary Consent

  • Informed consent must be free and voluntary in order to be valid, meaning it has to be given while the patient is not under undue pressure or influence.
  • Care providers must take all reasonable steps to allow patients to make a decision of their own free will.
  • Informed consent may not be obtained while a patient is on the treatment table.
  • Patients may not be strongly pressured to accept a proposed treatment, either directly by the care provider or through family members.
Example
If a patient agreed to a proposed treatment after the care provider threatened that the continuation of treatment with him/her was contingent on undergoing the proposed procedure, the patient's consent was not given of free will and is not valid.
Example
If a patient agreed to a proposed treatment after his/her family threatened that their ties would be severed otherwise, the patient's consent was not given of free will and is not valid.
  • Patients may not be offered gifts, rewards or benefits of any significant value in exchange for agreeing to treatment.
  • Care providers must refrain from exploiting patients' dependence on them to obtain consent for proposed treatment.

Informed Consent for Medical Treatment of a Minor

  • Generally, consent of both parents or Legal Guardian is required prior to medical treatment of a minor.
  • For urgent medical care, minor's can be treated with the consent of one parent only
  • In addition to what is written above, there are certain cases that need the consent of minor in addition to the consent of his/her parents. There are also cases that the consent of the minor is sufficient without the consent of his/her parents as detailed below.

Medical Treatment of a Minor who's Parent has been Accused or Convicted of a Violent or Sexual Offence Against Them

Routine Examinations and Medical Treatments of Minors Over the Age of 14

  • A care provider may perform a routine test or treatment on a minor who is over the age of 14 without parental consent and without accompaniment, on condition that the minor him/herself gives informed consent for the medical procedure.
  • Care should be taken to make sure that the prognosis and suggested treatment are given and explained to the minor in a language that he/she can understand and a letter should be given to the minor to give to the parents.
  • Despite this, before any additional tests or treatments that are not routine or in a situation that there is concern for a serious medical issue, or something that will need follow-up and/or additional treatments; the care provider must invite the parents or speak with them on the phone in order to give them this information and get their consent. If the minor is against informing his/her parents or if there is concern that telling the parents may harm the child, or the response to the treatment, or will interfere with the child's well being, a social worker should be brought in accordance with the Youth Law.

Medical Treatment of a Minor without Parental Knowledge and Consent

Medical Treatments that Require the Minor's Consent in Addition Parental Consent

  • There are certain procedures for which the minor's consent is required in addition to the consent of his/her parents. There are also cases in which the minor is given the right to veto despite his/her parents' consent.
Example
A person who is considered intersex
  • When a minor is diagnosed as an intersex and is at least 14 years old, the minor's consent for medical treatment is needed in addition to parental consent. The exception to this is if refusing the treatment can harm the minor and the parents have given their consent.
  • If the minor is under 14, only parental consent is needed but the minor has the right to veto so long as there is no danger to his health.
  • For more information see Rights of People with Different Sexual Development (DSD)-Intersex.

Cases When Treatment May Be Provided Without Informed Consent

  • Section 15 of The Patient's Rights Law details a number of cases in which a care provider is permitted to provide treatment even without the patient's informed consent:
    • Under the following circumstances, where there is determined to be no serious risk to the patient, all of the following criteria must be met:
      1. The patient's physical or mental state does not allow for the provision of informed consent.
      2. The care provider does not know of any opposition on the part of the patient or legal guardian to the proposed medical treatment.
      3. It is impossible to obtain informed consent from the patient's power of attorney, or it is impossible to obtain informed consent from the patient's legal guardian if the patient is a minor or legally incompetent.
    • In circumstances where there is determined to be serious risk to the patient and he/she opposes medical treatment (which must be provided immediately), ethics committee approval is required and all of the following criteria must be met:
      1. The patient is determined to be at severe risk, meaning his/her life is in danger or there is a risk that severe, irreversible disability will be caused if medical treatment is not provided.
      2. The proposed medical treatment must be given immediately in order to save the patient's life or prevent irreversible disability. Any treatment that does not have to be performed immediately does not fulfill this criterion.
      3. It is predicted that the medical treatment will significantly improve the patient's medical condition. Thus, for example, medical treatment cannot be performed against the will of a terminally ill patient, as it will not significantly improve the patient's medical condition.
      4. The ethics committee has been convinced that the patient has been given the information required to give informed consent.
      5. There are reasonable grounds to assume that after the medical treatment is provided, the patient will give consent in retrospect.
    • In a medical emergency in which it is not possible to obtain informed consent from the patient, or there is no time to do so, medical treatment may be provided even without the patient's consent as long as all of the following conditions are met:
      1. There is an immediate risk to the patients life or severe, irreversible disability will be caused if urgent medical treatment is not provided.
      2. It is not possible to obtain informed consent from the patient (i.e. if the patient is unconscious, if the patient is unable to express consent due to severe pain, or if the treatment is so urgent that it is not possible to wait to obtain consent).
Example
  • In the following cases, medical treatment may be provided without patient consent:
    • Someone who has suffered a heart attack and must undergo immediate life-saving resuscitation.
    • Hip fractures in the elderly are considered to be a "medical emergency" and performing surgery to fix such a fracture is thus considered to be an emergency medical procedure which may be performed without patient consent (according to Medical Administration Circular 30/2004).
    • A car accident victim who has lost consciousness and requires immediate life-saving medical treatment.
    • A patient undergoing surgery under full anesthesia whose condition deteriorates during the course of the surgery requiring life-saving medical actions to be taken.
    • A burn victim requiring emergency medical care who is suffering from pain so severe that it is not possible to obtain consent.
    • Someone suffering from a heart condition who is conscious and capable of interacting with his/her immediate surroundings, but requires immediate catheterization.
  • The treating physician may make the decision to provide medical treatment without patient consent in an emergency medical situation.
  • The following medical procedures require approval of three doctors, unless the circumstances of the emergency do not allow for it:
    1. Surgeries (except minor surgery)
    2. Blood vessel catheterizations
    3. Dialysis
    4. Radiation Therapy (Radiotherapy)
    5. In vitro fertilization (IVF)
    6. Chemotherapy
  • If the criteria for providing treatment without consent have been met, the care provider is only permitted to provide the required emergency medical treatment. Section 15(3) of the law does not permit the care provider to perform any additional medical treatments on the patient.

Please Note

  • If the care provider imposed medical treatment on the patient, performed medical treatment without patient consent, or performed medical treatment with patient consent but without disclosing relevant information regarding the patient's medical condition or the proposed treatment, the patient may sue the care provider and medical facility where the treatment was provided for damages (a claim for monetary compensation).

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