Unit 2 Stuff: Chapter 5

Informed consent

Action of an autonomous, informed person agreeing to submit to medical treatment or experimentation; the ethical ideal in which physicians are obligated to tell patients about possible medical interventions and to respect their choices regarding them

Informed consent appeals to the principles of ___

* Autonomy: respect people’s capacity for self-determination
* Beneficence: informed consent promotes the good for patients because knowledgeable, autonomous patients who choose for themselves will advance their own best interests as they themselves conceive them

Is the idea of informed consent old or young?

Young

Schloendorff v. Society of New York Hospital

* Justice Cardozo underscored the value of patient self-determination and voluntary consent, declaring that “every human being of adult years and sound mind has a right to determine what shall be done with his body.”
* Simple consent (not yet informed consent)

Salgo v. Leland Stanford Junior University Board of Trustees

1st time a physician’s disclosure of information was firmly tied to patient’s consent

* The California Supreme Court found that physicians “have the duty to disclose any facts which are necessary to form the basis of an intelligent consent by the patient to proposed treatment.”

Canterbury v. Spence

* Canterbury went to the hospital for pain
* Dr. Spence recommended surgery for his spinal cord
* Canterbury consented
* After the operation, he became paralyzed from the waist down and only later learned that paralysis was a possible risk of his surgery, which Dr. Spence did not tell him about
* Canterbury sued Dr. Spence for failure to tell him of the risks
* Ruling
* The U.S. Court of Appeals ruled that the adequacy of disclosure by a physician should not be judged by what the medical profession thinks is appropriate but by what information the patient finds relevant to his or her decision

Informed consent exists if…

(1) the patient is *competent* to decide

(2) she gets an adequate *disclosure* of information

(3) she *understands* the information

(4) she decides about the treatment *voluntarily*

(5) she *consents* to the treatment

Competence

The ability to render decisions about medical interventions

Disclosure involves

1. The nature of the procedure


1. E.g. Whether it is a test or treatment
2. E.g. Whether it is invasive
3. E.g. How long it will take to perform
2. The risks of the procedure


1. E.g. What kind of risks are involved
2. E.g. Their seriousness
3. E.g. Their probability of occurring
4. E.g. When they might happen
3. The alternatives to the proposed procedure—including the option of no treatment


1. Includes information on the options’ nature, risks, and benefits
4. The expected benefits of the proposed treatment—including their extent and their likelihood of being achieved

Waiver

The patient’s voluntary and deliberate giving up of the right to informed consent, an exercise in autonomous choice- the choice not to choose or decide

Therapeutic privilege

The withholding of relevant information from a patient when the physician believes disclosure would likely do harm

* E.g. When a patient is so depressed, weak, distraught, etc. that disclosing would make their condition worse

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Possess decision-making capacity if:

* The patient makes and communicates a choice regarding medical treatment/course of action
* The patient appreciates the following information regarding medical care:
* Medical diagnosis and prognosis
* Nature of the recommended care
* Alternative courses of care
* Risks, benefits, and consequences of each alternative
* The patient makes decisions that are consistent with his/her values and goals
* The decision is not the result of delusions
* The patient uses logical reasoning to make a decision

Catalano v. Moreland

* The Supreme Court of New York held that the adequacy of informed consent cannot be ascertained by merely applying a hospital’s bylaws


* The court declared, “Thus . . . the reasonableness of defendant’s conduct will be measured, not against the Hospital bylaws, but rather against what would have been disclosed by a reasonable medical practitioner.”

Natanson v. Kline and Mitchell v. Robinson

These decisions further specified the information to be conveyed to patients, insisting that the risks involved in a medical procedure should be disclosed

Cobb v. Grant

The California Supreme Court held that disclosure must consist of “all information relevant to a meaningful

decisional process.”

Shinal v. Toms

The Pennsylvania Supreme Count ruled, in a 4–3 decision, that informed- consent information that surgeons must provide to their patients about surgical procedures must be delivered to patients in person, not through a nurse or other intermediary

Informed consent and utilitarianism

* Judge actions involving informed consent by the overall good they would produce, everyone considered.
* Act-utilitarianism
* This standard must be applied to each individual case (case-by-case), and whether a physician should try to obtain informed consent depends on the benefits generated for all parties concerned (patient, medical providers, family, and others)
* In some instances, a physician may be obliged to obtain informed consent, but in others she may be justified in ignoring it, even invoking therapeutic privilege
* Rule-utilitarianism
* The best overall consequences would be achieved if physicians consistently followed a rule requiring informed consent (except in a few extraordinary circumstances)
* Rule-based, depending on the rule being used to determine justification

Informed consent and Kantian

* As autonomous beings, people are entitled to respect, to be treated as ends in themselves, never merely as a means to an end
* They therefore cannot be subjected to medical treatment just because physicians believe it is in their best interests
* They must voluntarily consent to be treated, and for the choice to be fully autonomous, they must be informed truthfully about what is involved
* Therapeutic privilege is never permissible, but waiver is allowed because it represents an autonomous choice not to choose

Informed consent and Rawl’s contract theory

* Calls for equal liberties for all, a demand that seems to support the doctrine of informed consent
* Treating people without their informed authorization would be a violation of such liberties, and manipulation and coercion to obtain consent would be impermissible
* Would be the case even if treating a few patients without informed consent would somehow benefit all of society

Incompetent patients

Cannot give their informed consent and must rely on surrogates

\*\*\*Informed consent- Must it Remain a Fairy Tale

1. The Pre-History of Informed Consent in Medicine

* Hallmark of the past was that physicians were not obligated to share decision-making authority with their patients
* Believed physicians themselves should make treatment decisions for their patients
* That they have competence and knowledge that a simple layman doesn’t have
* Believed cheerfulness and peace of the patient was more important, revealing nothing about their future or present condition
* 3 claims supporting why physicians only should have authority
* (1) Patients wouldn’t even be able to comprehend whatever knowledge they received
* (2) The anxiety that comes with being ill makes them incapable of making decisions on their own behalf
* (3) Physician’s commitment to altruism is a sufficient safeguard for preventing abuses of their professional authority


2. The Age of Medical Science and Informed Consent

* Perspective changed with the introduction of scientific reasoning
* Recognized there are a variety of treatments available to choose from
* Recognized, depending on their lifestyle, patients may have different choices on the great benefits or harms that come with each treatment


3. The Impact of Law

* California and Kansas cases recognized that without any disclosure of risks, new technologies had been employed, which promised great benefits but also exposed patients to formidable and uncontrollable harm
* Faultlines in American legal doctrine
* (1) The common law judges who promulgated the doctrine restricted their task to articulating new and more stringent standards of liability whenever physicians withheld material information that patients should known, particularly in light of the harm that the spectacular advances in medical technology could inflict
* Court’s ruling constituted that patients have the right to make decisions not only about the fate of their bodies but about the fate of their lives as well
* There is a duty to inform patients of their dire prognosis
* (2) The doctrine of informed consent was not designed to serve as a medical blueprint for interactions between physicians and patients
* Thus, disclosure practices only changed to the extent of physicians disclosing more about the risks of a proposed intervention in order to escape legal liability
* (3) Underlying the legal doctrine there lurks a broader assumption which has neither been given full recognition: that from now on patients and physicians must make decisions jointly, with patients ultimately deciding whether to accede to doctor’s recommendations
* (4) The idea of joint decision-making is 1 thing and its application in practice another
* Informed consent is nothing without taking many more things into account (e.g. reassessment of the limits of medical knowledge, professional authority to make decisions for patients, limits of patients’ capacities to assume responsibility for choice in light of their ignorance on medical matters and their anxieties when ill, etc.)


4. Barriers to Joint Decisionmaking

* (A). Medical Uncertainty
* Clinicians are still uncertain about the best means of treatment, even for the most routine things
* Medical uncertainty is a formidable obstacle to joint decision-making, as physicians are not able to communicate/explain to patients the benefits and risks
* This could further prevent doctor’s authority and sense of superiority
* (B). Patient Incompetence
* Illness and medicine’s eosteric knowledge robs patients the capacity to participate in decisionmaking
* (C). Patient Autonomy
* Patient autonomy and beneficence can clash; where is the balance for both


5. Respect for Autonomy

* Informed consent misleads patients into thinking they are making decisions when indeed they are likely lead a certain way by doctors who present disclosures in a certain way


6. The Current State of Physician-Patient Decisionmaking

* Physician-patient relationship in the past: patients have been viewed as passive, ignorant persons whose welfare was best protected by doctor’s orders
* Dictated by the doctor’s inability to explain to themselves what was therapeutic and what was not in the practice in medicine
* Physician-patient relationship now: doctors now can distinguish better between knowledge, ignorance, and conjecture; in turn, this permits physicians to take patients into their confidence

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Reason for this essay


1. To argue that patients must ultimately be given the deciding vote in matters that effect their lives
2. To suggest that informed consent will remain a fairy tale as long as the idea of joint decision-making, based on a commitment to patient autonomy and self-determination does not become an integral aspect of the ethos of medicine and the law of informed consent


1. Until then, physicians, patients, and judges can only deceive themselves or be deceived about patients having a vital voice in the decision-making process