Informed Consent

Philosophy 2803

Lecture IV

Feb. 5, 2003

Issues

Why does informed consent matter?

How should we understand the idea of informed consent?

How should the issue of consent be dealt with when a patient is incompetent?

The distinction between legal and moral versions of informed consent

Case 1

A 2001 study surveyed 108 4th year med students at U of T about their experiences as clinical clerks

– See Hicks et al, British Medical Journal March 24, 2001

Several students reported being asked to perform pelvic examinations on patients under general anesthesia without the patients’ knowledge

Case 2

“Once, when I was on call, there was a patient who was palliative, in a vegetative state. The resident I was working with decided that this would be a good opportunity for me to learn how to do a femoral stab, even though it was not medically required. The patient was not expected to [recover] from his current condition, and wasn’t in a position to argue … we don’t really get a lot opportunity to practise those types of procedures.” (Hicks et al, 2001)

The Importance of Informed Consent

“every human being of adult years and sound mind has a right to determine what shall be done with his own body” (Justice Cardozo, p. 159)

“all of medical ethics is but a footnote to informed consent” (Mark Kuczewski, 1996)

“Our common view of informed consent is that, when at all relevant, it represents a minimum condition which ethics imposes upon the physician” (p. 169)

– But why is informed consent so important?

Resources

Deontology

– Respect for persons

Consequentialism

– Promoting good outcomes

Principilism

– Autonomy, Beneficence, Non-maleficence, Justice

Why Value Informed Consent?

Justification #1: via The Principle of Autonomy (self-rule)

– Control typically requires consent – Very deontological– Today, thought of as the main reason for requiring

consent– “our capacities for personhood ought to be

recognized by all – these capacities including the capacity for rational decision” (Freedman, 170)

Why Value Informed Consent?

Justification #2

– via The Principles of Beneficence and Non-maleficence

We're generally thought to be the best judges of our own best interest

As such, obtaining consent is an effective way of doing good and avoiding harm.

Very consequentialist Today, usually thought of as a secondary reason for

consent, although this might be a mistake

Potential for Conflict

Notice the potential for conflict between the two justifications

– What if we don’t think you know your best interest in a particular case?

– Some might say this means you’re incompetent but best interest is a slippery notion

– Also perhaps: best interest medical best interest

Research Subject vs. Patient

Generally, it is thought that requirements for consent should be stronger in ‘pure’ research contexts than therapeutic contexts.

– Why? Because generally in research, the beneficence justification isn’t available to us

The Nuremburg Code (1947) “The voluntary consent of the human subject is absolutely essential.”

We’ll talk more about this in a future class (Lecture 6)

Elements of Informed Consent*

I Information Elements

1. Disclosure of Information2. Comprehension of Information

II Consent Elements

3. Voluntary Consent 4. Competence to Consent

* follows Beauchamp & Childress, Principles of Biomedical Ethics

4. Competence

No competence, no consent

– We often talk about parents or guardians consenting for you, but we need to remember this is really a very different thing.

Competence is not all or nothing

– Perhaps I am competent to drive a car, but not to make complicated medical decisions about myself

What is Competence?

Being rational?

– i.e., using reason to pursue your own goals? – What about the person who carefully figures out how to

pursue his project of dismembering himself?

Having the right goals?

– A competent person reaches reasonable conclusions based on reasonable goals?

– There’s a danger of paternalism here

Incompetence

What if the patient isn’t competent?

– How can we treat the patient in such a case?

We’ll discuss this at length later on

3. Voluntariness

Consent must be free of corercion or undue influence from others

Simple in theory although often trickier in practice

– Pressure from family– Health care providers

2 & 1. Disclosure & Comprehension

Disclosure: How much information must be given?

– “Full disclosure is impossible” (Freedman, p. 171)– Remember that how information is presented is crucial– An overload of information can actually hamper informed

consent– Patients may decide they want only limited disclosure

Comprehension: What must you do to ensure the patient has consented?

Disclosure & Comprehension

Disclosure must:

– Be specific to the intervention – Explain alternatives– Explain prognosis with and without treatment– Explain risks and benefits of treatment and

alternatives– Involve an opportunity for questions form patient

What is adequate disclosure?

3 Standards:

1. Medical Community: What a typical physician/researcher would disclose

2. Subjective: What the patient wanted to know

3. Objective: What a reasonable person would want to know

Reibl v. Hughes (S.C.C. 1980)

Sets Canadian standard on disclosure Reibl - 44 year old man with a history of severe migraines Dr. Hughes – removes blockage in left internal carotid

artery– Surgery is “competently performed” (p. 157)

Reibl suffers a stroke which leaves him impotent and paralyzed on right side

Reibl had not been warned about this specific risk– Sues Hughes claiming he had not given an informed

consent

Reibl v. Hughes

“in obtaining consent … a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation.” (p. 158)

“even if a certain risk is a mere possibility…, yet if its occurrence carries serious consequences, as for example, paralysis or even death, it should be regarded as … requiring disclosure.” (p. 158)

Reibl v. Hughes

Significant here is the fact that Reibl was 1.5 years away from qualifying for a lifetime pension for Ford

Reibl claimed he would at least have delayed the surgery if he had fully understood its risks

Are these specific facts about Reibl relevant to whether he was fully informed about the surgery?

Reibl v. Hughes

Court rules that the appropriate standard of disclosure is what a reasonable person in the patient’s position would want to know

Dr. Hughes was found guilty of negligence by the Supreme Court of Canada

Compromise between objective and subjective view

Ciarlariello v. Schacter (S.C.C., 1993)

Case involves a patient who asked to have an angiogram stopped mid-way through and then gave verbal go ahead to start up again (“Please go ahead”)

Question of the Case: How much did C’s physician have to do to ‘re-consent’ her? Did they have to go through a process of full disclosure?

Ciarlariello v. Schacter

Central element of the verdict is reminiscent of Reibl v. Hughes although perhaps more subjective

“The appropriate approach is … to focus on what the patient would like to know concerning the continuation of the process once the consent has been withdrawn.” (p. 180)

“Changes may arise during the procedure which are not at all relevant to the issue of consent. Yet, the critical question will always be whether the patient would want to have the information…” (p. 180)

Group Work

S, a severely brain damaged 9 year old child has had a series of heart surgeries since age 1 in order to save her life

S’s doctors say that she will die very soon unless another heart surgery is performed

S is clearly not capable of consenting to the surgery

– How should the decision about whether to carry out the surgery be made?

– On what basis?– What factors should be considered?

Results of Group Work Who should decide?

– Decision should be made by parents (most)– Decision should be shared by parents & doctors (some)

What should be factored in?

– Assessment of likely quality of life after surgery– Parent’s reasons for accepting/rejecting surgery– Likelihood of death without surgery– Impact on health care system – time, use of resources, cost– Emotional impact on family– Expenses for family

What if the Patient Isn’t Competent?

“a proxy consent ought to be obtained on behalf of the incompetent subject.” (p. 169)

– Who?  Parents? Doctors? Courts?

Living wills

Newfoundland: Advance Health Care Directives Act

Advance Health Care Directives Act

Sets out conditions for setting up an advance health care directive.

If no directive in place, it sets out the rules for proxy decision making– Spouse– Children– Parents– Siblings …

Majority rules One decision maker may be designated In case of a tie, the decision goes to the next place

on the list (See section 10)

On What Basis Should Substitute Decisions Be Made?

3 Possibilities

– Best Interests of the Incompetent Person– Substituted Judgment– Interests of the Substitute Decision Maker

Eve vs. Mrs E. & Re. S.D. illustrate that the Canadian legal standard is ‘best interests’

The NL Advance Health Care Directives Act shares this approach

Re. S.D. (B.C.S.C., 1983)

B.C. Supreme Court S.D. was a 7 year old boy with profound brain

damage “no control over his faculties, limbs or bodily

functions.” (p. 184) At 5 months, had a shunt (i.e., plastic tube) installed

to draw excess cerebro-spinal fluid from the head Shunt became blocked Parents at first consented to having the blockage

cleared, then withdrew consent “on the ground that the boy should be allowed to die with dignity” (p. 184)

Verdict in Re. S.D.

Family and Child Services assumed custody of S.D.

A B.C. provincial court judge returned custody to the parents

The B.C.S.C. reversed this decision:

– “I do not think that it lies within the prerogative of any parent or of this court to look down upon a disadvantaged person and judge the quality of that person’s life to be so low as not to be deserving of continuance.” (p. 185)

Eve vs. Mrs. E. (S.C.C. 1987)

Eve = 24, extreme expressive aphasia

“at least mildly to moderately mentally retarded”

Incapable of being a mother other than ‘physically’

Mother sought to have her daughter sterilized by tubal ligation

Mother feared her daughter would become pregnant and that the child would become her responsibility

Eve vs. Mrs. E

Lower court (in PEI) rules Eve cannot be sterilized for non-therapeutic reasons

PEI Supreme Court reversed this decision, ordered a hysterectomy

Supreme Court of Canada reinstated original court’s order– Very clear: no non-therapeutic sterilization of incompetent

patients– A controversial ruling, both legally and morally

S.C.C. Verdict

“The grave intrusion on a person’s rights and the certain physical damage that ensues from non-therapeutic sterilization without consent, when compared to the highly questionable advantages that can result from it, have persuaded me that it can never safely be determined that such a procedure is for the benefit of that person.” (La Forest, p. 418)

– Clear reliance on the best interests standard

Advance Health Care Directives Act

12.1c “when the substitute decision maker has no knowledge of the maker’s wishes, [the substitute decision maker shall act] in accordance with what … [he or she]… reasonably believes to be in the best interests of the maker.”

A Last Point: Moral vs. Legal Consent

Moral informed consent– patient actually having made an informed voluntary decision

with an appropriate level of disclosure

Legal informed consent– having gone through appropriate steps so that consent will be

considered legally valid (e.g., signing documents)

Remember contrast between intrinsic and instrumental value– Sometimes things that are initially perceived as instrumentally

valuable come to be mistaken for having intrinsic value

Moral vs. Legal Consent

Legal consent requirements started out as means of ensuring moral consent had actually been sort

Today, we often pay more attention to legal consent than moral consent

– Conversations are often about whether forms were signed

Sometimes seeking legal consent actually gets in the way of achieving moral consent

– E.g., overly complicated consent forms