Informed Consent/Assent and Refusal

History of Medical Ethics

Hippocrates: reveal nothing of patient’s future or present condition→prevent refusal of future care

thomas percival: coined expression medical ethics
encourage witholding medical information
incorporated into the AMA code of ethics 1847

legal cases early 20th centure: voluntary consent

nazi/tuskegee medical experiments: nuremberg/belmont report→consent in research

AMA revision 1957

council on ethical and judicial affairs (1992) right of patients to “receive information from the physician about risks/benefits/alternatives to any medical treatment”
term informed consent

Capacity

a person’s ability to make a decision (their knowledge)

the ability to utilize information about an illness and proposed treatment options to make a choice that is congruent with one’s own values and preferences

individual/informal

Informed Consent

the process by which competent adults make voluntary decisisons folowign adequate disclosure of the relevant information

allows a clinician to achieve a balance between respecting patient autonomy vs. exercising beneficent on behalf of a pt

lack of capacity→can’t consent

Competency

legal judgement informed by an assessment of capacity

legal right to make their own decisions

Surrogate Decision Maker

legally allowed to make healthcare decisions for others

chosen by patient in advance

selected by law (spouse/adult children/parents/siblings/other relatives)

SDM steps in to grant informed consent or refusal when physician determines when pt. lacks capacity

formal guardianship not required

Risk Factors for Impaired Capacity

1) Acknowledged fear or discomfort with health

care settings

2) Age < 18 or > 85

3) Chronic neurologic condition

4) Chronic psychiatric condition

5) Low educational level

6) Significant cultural or language barrier

Four Component Model of Decisional Capacity

Understanding: the ability of the individual to comprehend the information being disclosed along risks and benefits of treatments and alternatives (+no treatment)

appreciation: the ability to apply the relevant information to one’s self and own situation (understanding the personal risks of medical decisions)

reasoning: the ability of the person to make decisions with a coherent thought process

expression of a choice: the ability of the pt to communicate a decision

Questions to Ask During an Evaluation of Medical Decision-Making Capacity

Questions to determine the patient’s ability to understand treat-

ment and care options:

What is your understanding of your condition?

What are the options for your situation?

What is your understanding of the benefits of treatment, and what are

the odds that the treatment will work for you?

What are the risks of treatment, and what are the odds that you may

have a side effect or bad outcome?

What is your understanding of what will happen if nothing is done?

Questions to determine the patient’s ability to appreciate how that

information applies to his or her own situation:

Tell me what you really believe about your medical condition.

Why do you think your doctor has recommended (specific treatment/

test) for you?

Do you think (specific treatment/test) is best for you? Why or why not?

What do you think will actually happen to you if you accept this treat-

ment? If you don’t accept it?

Questions to determine the patient’s ability to reason with that

information in a manner supported by the facts and the patient’s

own values:

What factors/issues are most important to you in deciding about your

treatment? What are you thinking about as you consider your decision?

How are you balancing the pluses and minuses of the treatments?

Do you trust your doctor? Why or why not?

What do you think will happen to you now?

Questions to determine the patient’s ability to communicate and

express a choice clearly:

You have been given a lot of information about your condition. Have

you decided what medical option is best for you right now?

We have discussed several choices. What do you want to do?