The Knesset enacted the Patient's Rights Law in 1996. The Law aims to offer solutions to many difficult issues facing patients prior to and during treatment. Among these issues, that of informed consent to receive treatment, received particular attention during the legislation process, and is dealt with in Part D of the Law.
The Society for Patient's Rights in Israel has prepared this information as a companion to their brochure the "12 Principles of the Patient's Rights Law". Here, we aim to clarify the topic of informed consent.
What is informed consent?
The consent of the patient is a prerequisite to receiving medical treatment. Every adult is entitled to decide what is or is not performed on his/her body, therefore any procedure done without his/her explicit consent, or with a fraudulently obtained consent, may be construed as "bodily assault" and is therefore illegal.
Informed consent is consent given by a patient only after having received detailed explanation regarding the proposed medical treatment.
The purpose of informed consent
- Maintaining trust between medical practitioner (clinician) and patients.
- Enabling the patient to participate in the decision making process.
- Averting patronizing attitudes by the medical practitioner.
- Minimizing doubt by maximizing information.
- Assuring control against impingement of privacy.
Who is bound by the Patient's Rights Law?
Part D of The Patient's Rights Law is about informed consent. The requirement to administer medical treatment only after obtaining informed consent applies to all clinicians. A clinician is defined in the Law as "a physician, dentist, intern, nurse, midwife, psychologist or any other practitioner recognized by the Director General of the Ministry of Health as a clinician. At present 20 such professions are recognized and are thus subject to The Patient's Rights Law. The Law applies to any treatment performed in a clinic, dental clinic, institute, laboratory, emergency room or hospital, both public or private.
What is the Law's contribution?
Until the Law's enactment, practitioners were not particular about fully informing the patient regarding the proposed treatment, in order to enable him/her to participate in the decision making process. This caused needless frustration among patients who were kept ignorant as to the nature of the proposed treatment and its effects on their health. Information was given shortly before an operation and there were many instances when the patients received only partial and hasty explanations.
What explanations are to be given before informed consent is obtained?
- Diagnosis of disease.
- A detailed explanation of the nature of the proposed treatment, its purpose, anticipated benefit and chances of success.
- Risks associated with the treatment, including potential side effects such as pain and discomfort.
- Chances and risks associated with alternative therapies or lack of treatment.
- Imparting information regarding novelty of treatment or procedure.
Who takes the initiative?
The initiative to impart information is the responsibility of the practitioner not the patient. The patient usually does not know what to ask or may hesitate to request information. The information should be complete, clear, in plain understandable language, and should be given as early as possible so as to allow the patient ample time to contemplate the proposed treatment with less pressure and to make a free choice.
How may the patient give informed consent?
After having received the explanations required by the Law, the patient may give his/her consent in three ways:
- By behavior - i.e. offering his/her arm for an injection.
- Verbally - "I agree" or "O.K".
- By signing an informed consent document.
Consent by written document should always be obtained for special treatments such as surgery, vascular catheterization, dialysis, radiotherapy, chemotherapy, IVF, etc.
Can treatment be given without the patient's consent?
Unauthorized medical treatment may be given under several conditions:
- When the patient needs any of the treatments mentioned in the Supplement to the Law, and his/her condition precludes his/her giving a signed consent. In this case, the patient's verbal consent should be obtained in the presence of two witnesses.
- In the case of a medical emergency, which is defined as "a situation threatening immediate danger to life or severe, irreversible disability, if medical care is not given urgently", treatment may be given without the patient's consent under the following conditions:
- The patient's physical or mental condition precludes him from giving his/her informed consent.
- The practitioner is not aware of any objection to treatment voiced by the patient or his/her legal representative. This rule applies when the patient is a minor or legally incompetent and it is physically impossible to obtain the consent of his/her guardian. When a patient is in grave danger but rejects medical treatment, "which in the circumstances must be given soon", the clinician may perform the treatment against the patient's will, if an Ethics Committee has confirmed that all of the following conditions have been met:
- The patient has received all of the information required to make an informed choice;
- The treatment is anticipated to significantly improve the patient's medical condition;
- There are reasonable grounds to suppose that after receiving the treatment, the patient will give his retroactive consent.
The difference between representatives and guardians
The patient has a legal right to appoint a representative to act on his/her behalf and give or deny informed consent. In such a case the patient chooses his/her representative and gives him/her power of attorney to consent to treatment. A legal guardian may be appointed by a court of law when it is evident that the patient is unable to act responsibly on his/her own behalf. A legal guardian may be appointed even without the patient's consent. Parents are natural guardians to children under 18.
Ethics committees and informed consent
The Law stipulates the appointment of an Ethics Committee in every medical institution. The committee shall consist of five members: A senior legal expert, two specialist physicians (from different disciplines), a psychologist or social worker, and representative of the public or person of religious authority.
Among the committee's duties: To grant permission for medical treatment in the absence of the patient's informed consent, when his/her life is in grave danger if he/she does not receive the treatment.
Written by Dr. Nili Tabak
Translated by Prof. Moshe Many
In light of this issue’s importance, please see the following detailed explanations on our Hebrew site
Editing and formatting provided by The Shira Pransky Project