Informed Consent l l What is it Why

Informed Consent l l What is it? Why is it important? Is the concept different in ethics and in law? What practical approach is best?

Some History (Law) l l l “Right to determine…” NY, 1914 Salgo v Stanford, CA, 1957: Modern idea (lawyer for surgeons) BUT: Mary Dixon Jones case, Brooklyn, 1890’s-- claim was that surgeon did not get informed consent before procedures

Some History (Ethics) l l Hippocratic Ethic: do no harm; try to benefit the patient; no autonomy or duty to disclose info Gregory, Percival, AMA code (1770 -1848): code of honor of a gentleman; sympathy and compassion

Ethics Today l If respect for autonomy (antipaternalism) is the “centerpiece” of modern US medical ethics, then informed consent as a concrete expression of autonomy is the most important medical practice

Today’s Practice? l l l “Did you consent the patient? ” (Did you get the patient’s signature on a form? ) Is the best trained or least trained person sent in to “get the consent”?

Today’s Practice? l l Is there a mismatch between ethical ideal and real practice? Is real practice ethically lacking? Is the ethical ideal simply unrealistic? Both?

What Is Informed Consent? l l A medical choice is going to be made list of options (including “no treatment”) pros and cons of each option answers to questions about options, pros and cons

Levels of Consent? l l Consent to this particular medical decision Consent to the consent process as a whole

Levels of Consent? l Is it consistent with IC for a physician to administer treatment when a patient has been minimally informed and does not explicitly consent? • NO-- standard consent model • YES-- If patient has indicated preference for this method

Spectrum of Consent l l l How much information patient wishes to receive (especially risks) How involved in decision patient wishes to be How much patients want others involved and who the others are

Spectrum? l Can one autonomously give up autonomy? • Not an all or nothing question • Frequently delegate authority for decisions • Sick may have many rational reasons for not wishing to exercise full autonomy (Schneider)

Conversation l l l Katz: IC as a type of conversation between provider and patient Could occur at either level Schneider: cannot guess who wants what level of autonomy without asking first

Arato case l l l Was patient adequately informed about the risks of treatment? Did physicians facilitate an unhealthy state of denial? Did the patient suffer harm as the result of a bad decision?

Arato Case l l Did physicians disclose basic aspects of treatment plan, including low chance of success? Did the physicians treat Mr. Arato as a person and try to design their conversation for him individually?

Arato Case l l Did the physicians listen and pick up cues as to what Mr. Arato did or did not wish to be told? If physicians now wish they could have done otherwise-- is this negligence or honest mistake in judgment?

Katz’s Criticism l l CA Appeals Court: right to be informed includes the right to be informed of one’s dire prognosis Supreme Court: rejected expansion; more concerned to protect “therapeutic privilege”

Therapeutic Privilege l Physician’s normal duty to disclose information is overridden by well grounded professional judgment that such disclosure would be harmful to patient’s well-being

Katz’s Key Metaphors l. Silence l. Conversation

Conversation “Rules” l How do you decide what to say next in a conversation? • Do you consult a prepared script? • Or do you take your cues by listening to the other party and decide what he/she wants to talk about?

Possible Defense l l “I did not get Mr. Arato’s fully informed consent at the lower level because he denied his consent at the higher level for the full disclosure of how bad his prognosis was. ” Does this violate or respect Mr. Arato’s autonomy?

Transparency Standard l l l What is the key idea? Under what circumstances will this lead to ideally informed consent? Under what circumstances will this lead to inadequate consent?