1. Autonomy, Informed Consent, and Refusal of Treatment

2. The notion of informed consent is a recent one.
Prior to the 1950’s, there was no firm ground in which a commitment to informed consent could be grounded.
It is important that we work to understand exactly what it means to make an informed decision, so that we can be certain that our patients are able to act autonomously.

3. Canterbury v. Spence (1972)
The first and most influential decision on the issue.
The court recognizes that, given the unequal nature of the medical professional and the patient, it is essential that the doctor disclose the given risks of a procedure.

4. What is legally required?
Certainly not full disclosure. It seems unreasonable to require that every risk be fully explained.
The court argues that the need to disclose arises from concerns external to the medical profession; that is, it arises from the rights of the patient.
Instead, the duty to reveal arises out of the patient’s right to self- decision, or, as we have been saying, the patient’s autonomy.

5. How do we decide what is material to making an informed decision?
“a risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy” (73).

6. Exceptions:
the patient is unconscious (then consult a relative when possible)
disclosure would subvert autonomy, though this must not be used as an excuse for paternalism.

7. Physicians and Patients: A History of Silence Jay Katz
“Life is short, the Art long, Opportunity fleeting, Experiment treacherous, Judgment difficult. The physician must be ready, not only to do his duty himself, but also to secure the cooperation of the patient, of the attendants and of externals.” --Hippocrates

8. Katz claims:
• that the courts have not appreciated how deeply the tradition of silence is rooted in medical practice, and that their appeals to self- determination were radically foreign to the standards of medical practice.
• that it was this fact that contributed to the physician’s construing these rulings as being more far-reaching than the courts intended them to be.

9. • Medical silence had been almost a necessity, especially during the time that medical practices were less than scientific. • The courts have made impassioned pleas for more patient self-determination while at the same time undercutting those pleas by giving physicians considerable latitude to practice according to their own lights, telling them to “treat each patient with the utmost care.”

10. Katz’s Criticisms of Canterbury v. Spence
• It results in MUCH wiggle room for the medical practitioner. The case says: “When medical judgment enters the picture and for that reason the special standard controls, prevailing medical practice must be given its just due” (76). What is “just due?”
• The difference between the objective standard and the subjective standard, and the short shrift given the latter.
• What does a patient need to know in order to make a decision, and what does a medical practitioner need to know in order to fully inform the patient? How can the doctor know exactly what is material to that patient?

11. Katz argues that informed consent and shared decision making are synonymous and that the current state of case law and current medical practices are not fulfilling the ideals of informed consent.

12. The Concept of Informed Consent Faden and Beauchamp
They distinguish between two senses of informed consent, sense1 and sense2.
Sense 1 informed consent: An informed consent is an autonomous action by a subject or patient that authorizes a professional either to involve the subject in research or to initiate a medical plan for the patient (or both).

13. More technically:
An informed consent in sense1 is given if a patient or subject with:
1) substantial understanding and
2) in substantial absence of control by others
3) Intentionally
4) authorizes a professional
to do intervention I. All substantially autonomous acts fulfill 1-3, but such acts may not fulfill 4 if indeed the patient refuses such authorization. In that case, we have not informed consent, but informed refusal.

14. Thus:
• Katz’s equating of informed consent with shared decision making is a mistake. While indeed such a process may represent the medical ideal, it doesn’t exhaust the notion of autonomy.
• While the patient and the doctor may well reach a treatment decision in a shared fashion, it needs not in order to fulfill sense1 of informed consent. I may willingly and consciously put those decisions in the hands of the professionals.
• In other words, I can give informed consent without engaging the process of shared decision making. I can authorize the other to make decisions for me.

15. Sense2 informed consent: Sense2 is procedural. It is effective consent
Sense2 informed consent: Sense2 is procedural. It is effective consent. It is policy oriented and is obtained by following a particular procedure that is put in place. It does not refer to autonomy, but neither does it rule it out. Note that I can have informed consent in sense1 without having it in sense2. Note that sense2 may well require disclosure of risks, while sense1 does not require it. Note that informed consent in sense1 need not conform to sense2, and that consent in sense2 need not conform to sense1. So, what do we have? What do we want?