I am frequently asked by my residents, “What elements are needed for informed consent?” The first place to start is the definition of informed consent. Applebaum defined informed consent as “the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment.”[1] This concept derives from a patient’s right to self-determination and the physician’s duty to involve the patient in his/her health care. An important part of this definition is the assessment by the physician that the patient has the capacity to make an informed decision. Decision-making capacity is not to be confused with the legal concept of “competence.” “Incompetence” is a legal definition that is made in the court of law.
A patient has decision-making capacity if they possess four factors:
- Understanding
- – Understands their medical condition and prognosis
- – Understands the purpose and potential benefits of the bedside procedure
- – Understands the risks of the procedure
- – Understands any alternatives for care
- Appreciation
- – The patient appreciates the consequences of their decisions
- – They appreciate what will likely happen if they do not have a procedure
- Reasoning
- – Patient can use reason to explain their decision
- – Can ask the question, “Help me understand how you came to decide not to have a “name of procedure”?
- – Can ask the question, “Tell me how you reached your decision?”
- Absence of active psychosis
- – The decision is not based on delusions
- – The patient does not have psychotic symptoms
Having assessed that a patient has decision-making capacity, informed consent for a bedside procedure has the following elements:
- 1. Explain the nature of the procedure in the patient’s preferred language and using simplistic terms that the
- patient can understand
- 2. Understands the potential risks/complications of the procedure
- 3. Understands any alternatives to having the procedure
- 4. Understands the likely outcome if he/she does not have the procedure
- 5. The patient can recite this information and explain their acceptance or refusal of the procedure
[1] Applebaum PS. Assessment of patient’s competence to consent to treatment. N Engl J Med. 2007; 357: 1834-1840.