Informed Consent

Did John Williamson give informed consent for his surgery?

“The ambiguities in communication and the unspoken motives of all participants is, current research suggests, common to the medical setting”

Informed consent

•Legal requirements

•Ethical doctrine (respect for autonomy)

•Interpersonal process

–Consent vs. choice

Legal issues

•What does the law require of physicians and other health care providers?

•Risk of legal action by patients: protection runs both ways

Ethical issues

•Respect for autonomy

•Free consent (no coercion)

•Information required

–Deliberate partial disclosure

–More subtle problems about information provided

Conceptual questions

•How informed is “informed”?

–misunderstandings

–partial disclosure

–variations in patients’ abilities to understand technical information

•Consent to treatment vs consent to research

•“Informed consent or refusal”

Practical questions

•How effective are attempts to communicate with patients?

•risk perception

•How can health care providers better ensure that a patient is truly informed?

•Purpose of consent forms?

•Why do patients consent to or refuse treatment: how does the information provided influence their decision?

Freedman: informed consent

•Appelbaum et al. just “frame the issues” but do not provide an in-depth analysis

•Freedman provides a deeper analysis of issues important in informed consent

Consent and capacity

•Some people are not able to give informed consent, even when information is given to them

•Thus, one important aspect of informed consent is that patients must be capable of giving informed consent (i.e. they must be competent to consent, have the capacity to consent)

The right to consent

•“A person who has the capacity to give valid consent, and who has, in fact, consented to the procedure in question, has a right to have that fact recognized by us.”

•Refusal to accept consent casts doubts on the capacity of the patient/research subject giving consent

•Note: the right to give informed consent is not the same as a right to treatment (or to be a research subject)

•Increased emphasis on patient choice (rather than simply consent) – patient as consumer

Research vs. treatment

•It is generally accepted that informed consent is even more important in a research context than it is in a clinical context

•This is because the purpose of research is not to benefit individual research subjects

•The process of informed consent involves telling patients about the balance of benefits and harms that they can expect from the treatment/experiment

•Research settings generally have fewer benefits, so it’s even more important to understand potential harms

•But this means that we require more discussion, not different standards not that we’re more conservative about whose consent is acceptable

The right to consent (again)

•Freedman: most ethics literature assumes that, in cases where it is doubtful that informed consent has been given, we should err on the side of caution and refrain from experimentation

•But this may violate the subject’s right to give informed consent (paternalism?)

Rights and duties

•If we take seriously a patient’s/subject’s right to give informed consent, then it turns out that the physician/investigator has a duty to recognize this consent

•If it’s doubtful that the consent is valid, then there is a conflict of duties...

“Informed” consent revisited

“The claim has been made…that ‘fully informed consent’ is a goal which we can never achieve, but towards which we must strive”

•only graduate/medical students as research subjects?

Reductio ad absurdum

•“Reduction to the absurd”

•An argument strategy that proves a point by:

1) assuming that the point is false and

2) showing that this assumption leads to a contradiction

e.g.the computer that plays perfect chess and always wins

(From Andreas Teuber)

Reductio ad absurdum

•Freedman’s argument is not strictly a reductio

•The phrase is, however, sometimes used to refer to a similar argument strategy, in which an assumption leads to a conclusion that we would find absurd.

Freedman on “fully informed” consent

•The absurd result here is that fully informed consent would require consent forms to be infinitely long….

–e.g. to insert a catheter, must a doctor inform a patient by showing him an anatomy text? Ensuring that he understands the text? Must he tell the patient the chemical formula of the catheter? Its melting point?

One possible response

“…it is not surprising to find doctors who claim that since they cannot fully inform patients, they will tell them nothing, but instead will personally assume the responsibility for assuring the subject’s safety”

Freedman’s response

•It is a mistake to talk about “information” in the abstract, without reference to human purpose

–relevant “information” about clouds is different for an artist, a meteorologist, a sooth-sayer

•Depending on what we want to use it for, different sorts of information about a topic are relevant

•The first thing we need to do, then, in deciding what information is required for informed consent is to determine why the patient must be informed (i.e. what is the purpose of getting consent

•The answer to this question: the patient must be informed so that he can make a decision about whether to undergo the procedure

•So, the patient will need to know:

–what to expect from the procedure/treatment

–possible outcomes (good and bad) and their likelihood of occurring

–alternatives to the procedure/treatment

“The proper test of whether a given piece of information needs to be given, then, is whether the physician, knowing what he does about the patient/subject, feels that the patient/subject would want to know this before making up his mind.”

•We must know “what is necessary to make meaningful the power to decide”

•What information is relevant might depend on the patient

–Impotence example

Therapy vs. research

•In a therapeutic context, a patient will often allow a physician to act as his/her agent

•In a research context, it is less likely that this sort of carte blanche consent will be acceptable

•Two reasons for this difference:

–in a therapeutic setting, the physician is more likely to know what the outcome(s) will be

–the goals of therapy and of research are different

Challenging the difference between research and therapy

•Some settings are partly therapeutic and partly experimental (e.g. when no traditional therapy is available)

•Patients/subjects sometimes do benefit from participating in research

Must the patient be informed?

•Freedman concludes that this is not a fundamental requirement of valid consent: what matters is that “the consent [is] the expression of a responsible choice”

John Williamson, again

•Was Williamson’s consent to pancreatic surgery the expression of a responsible choice?

What is a responsible choice?

•Freedman’s views on informed consent make clear that there is an important relationship between consent and capacity

•This does not mean that the decision about whether a choice is responsible is ultimately the physician’s

–this would defeat the whole purpose of informed consent

Some choices are clearly not responsible...

•Small children

–can make choices

–but cannot make what we would generally consider to be responsible choices

•would we hold them responsible for the outcome of their choice?

Dilemma

•A dilemma is a situation or question that leads to a choice between two undesirable alternatives

The dilemma of informed consent

1) We must require that a choice is responsible for consent to be valid

2) But if we require that a choice is responsible, this presupposes a set of standards by which the responsibility of a choice is to be judged

So, who sets the standards? (paternalism)

Between the horns of the dilemma

•The “responsibility” required should not be taken to mean that the choice is responsible, but that the person doing the choosing is responsible

Responsibility: a dispositional characteristic

•Someone is responsible when she

–makes choices on the basis of reasons, arguments

–remains open to the claims of reason

–is capable of making and carrying out a life-plan

–can live with/take responsibility for the outcomes of her choices

Consent must also be voluntary

•Consent given under duress or coercion is not voluntary

–E.g. threat (but a threat need not be overt)

–Power imbalance

•Even without coercion, consent may be “unfree” à motivated by reward

Degrees of reward

•Prisoner example – how much reward is enough to interfere with the voluntariness of consent?

•Where we set the cutoff can be too high or too low

Is the problem actually reward?

•How persuasive reward is depends on the specific circumstances and the individual making the decision

–3 examples

2 distinctions

•Acts of God vs. acts of human beings

•Response to “natural contingencies” does not make us unfree

Reward that brings us up to a minimum standard of living vs. reward that supplies “luxuries” above this standard

Consent and the Incompetent

•Age of consent is determined by a society; may vary for different activities

•But reaching the age of consent is neither necessary nor sufficient for competence

Proxy Consent

•“is consent given on behalf of an individual who is himself incapable of granting consent”

–e.g. children, the insane, the unconscious

A Note on Method

•Freedman uses a method that “involves an interplay between cases and principles, such that each influences the other”

–principles alone may not be readily applicable

–cases alone may lead to ad hoc results

•Freedman also stresses the similarity between the therapeutic and the experimental contexts