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Informed consent may be defined as the process whereby a patient is provided with sufficient and accurate information about the benefits and risks of a proposed course of therapy or procedure, to equip such individuals with the knowledge as a basis on which they have a right to reject or accept therapy. In more direct terms, informed consent is formulated on the legal and moral grounds of patient autonomy.
In most, if not all, countries, all adult and mentally competent patients have the right to make autonomous decisions concerning their medical and health conditions. This right is reserved so long as the patient has the ability or capacity to voluntarily make and comprehend the decision in the presence of full disclosure with regard to the therapy in question.
Failure of a healthcare provider to adhere to the principles of informed consent may result in litigation, because it is punishable by law in many jurisdictions.
However, there are exceptions in cases such as emergency situations, where medical aid must be provided to avoid irreversible morbidity or mortality. Another example of an exception would be an adult who is mentally-incompetent and not capable of understanding the situation.
In contrast to informed consent, there is implied consent, which is applicable for simple interactions, such as inspection or auscultation during a physical examination. More invasive interactions, such as administering anesthesia, which is associated with adverse effects in some patients, explicitly require informed consent.
It is imperative that the specifics of the anesthetic agents that will be used and the risks unique to the patient, as well as those that are common to all patients undergoing the treatment or procedure in question, are discussed and documented in detail.
Patient as well as family history, with co-existing morbidities and/or past allergic reactions, are critical elements that should be documented as evidence that the discussion took place.
If the important parts of a discussion are not written down, then that discussion is legally non-existent (even if it did happen) and this opens the door to liability.
Some proponents note that a list or statement encompassing the common risk factors can be made generically, while the risks unique to the patient may be written in as an appendix. This suggestion may be quite useful in busy clinics.
However, opponents to this suggestion claim that patients seldom take the time to read preprinted text.
Moreover, it is crucial that the informed consent for the anesthesia is taken by the anesthesiologist and not the surgeon, because anesthesia is not within the scope of the surgeon’s medical and legal domain.
Some anesthesia associations recommend separate forms of informed consent for anesthesia and the actual surgical procedure.
This recommendation is made on the observation that combining these two distinct branches of medical procedures (i.e. anesthesia and surgery) on one consent form, significantly de-emphasizes the role of anesthesia. This lowering of the significance of anesthesia in a surgical setting increases the potential for lawsuits.
While a patient may have the capacity to give informed consent for the surgery, the same may not have been applicable to the anesthesia, especially if an anesthesiologist was not present.