Informed consent is essentially defined as a legal condition whereby a person can be said to have given a formal consent based upon an appreciation and understanding of the facts and implications of an action.
In specific medical jargon, informed consent is a patient’s right to be presented with sufficient information, by either the physician or their representative, allowing the patient to make an informed decision regarding whether or not to consent to a treatment or procedure.
In other words, informed consent is the process in which a fully informed patient can participate in choices about his/her health care.
Informed consent is primarily of two types .i.e. Express Consent and Implied Consent.
Historical background of Informed Consent
Reportedly, ‘consent’ was officially turned into ‘informed consent’ in a landmark case in 1957 in the US. The verdict in this case declared that doctors have a duty to disclose any facts, which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.
Prior to giving an informed consent, an individual is required to be in possession of all his faculties. This includes mental stability and not being under any influence of intoxication, alcohol, drugs, insufficient sleep or other health complications.
Elements of Informed Consent
The most crucial goal of informed consent is that the patient should have an opportunity to be an informed participant in decisions regarding his/her healthcare.
A complete informed consent should involve a discussion on the following elements:
- patient’s diagnosis, if known
- nature of the decision/procedure
- reasonable alternatives to the proposed intervention
- relevant risks, benefits and uncertainties related to each alternative
- risks and benefits of not receiving any treatment or procedure
- detailed assessment of patient’s understanding
- acceptance of the patient’s intervention
When is Informed Consent required?
Most healthcare institutions have clearly established policies that list the health procedures, which require a consent form to be signed. For instance, the most common procedures requiring consent include surgery, anesthesia and other invasive procedures.
A signed consent form stands as evidence that a patient has been informed about and has given permission for the treatment described in the form.
Also known as an implied consent, presumed consent is awarded in special cases where the patient is unable to give or refuse consent. This includes the following situations:
- when the patient is incapacitated/incompetent or mentally unstable
- when the patient is a minor
- in case of an emergency
There are also situations where in spite of the patient being unable to award informed consent, there is no surrogate decision maker who can give consent. In such cases, the physician is expected to act in the best interest of the patient until a surrogate is found or appointed.