1. Informed Choice

2. Overview Brief introduction to cases (ours, yours) Elements of informed choice Capacity Informed choice for research Return to cases

3. Cases 1.Informed choice for chemotherapy for breast cancer (primary and adjuvunct) 2.Informed choice for retreatment radiotherapy 3.Informed choice for BRCA testing 4.Informed choice for clinical trials

4. Elements of Informed Choice

5. Informed consent/informed choice Consent/refusal of recommended therapy – informed consent requires that a patient (1) has sufficient information and (2) makes a voluntary choice Increasing emphasis on patient involvement, shared decision-making has prompted a shift to discussion of “informed choice”

6. What does it mean to be informed? “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?

7. Freedman on “fully informed” consent “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?

8. 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”

9. 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

10. Freedman’s response 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

11. Freedman’s response 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 (and their possible outcomes) Informed consent/informed choice

12. Freedman’s response “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”

13. Capacity

14. Consent and Capacity We must know “what is necessary to make meaningful the power to decide” What matters is that “the consent [is] the expression of a responsible choice”

15. What is a responsible choice? Some choices are clearly not responsible –E.g. 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?

16. What is a responsible choice? Distinction between a responsible choice and a “good” choice We also know that people who are generally responsible can make bad choices At what point do we say that a choice is not responsible?

17. What is a responsible choice? Trying to determine when a choice is responsible leads to a dilemma –A dilemma is a situation or question that leads to a choice between two undesirable alternatives

18. 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?

19. 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

20. 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

21. Capacity Shifting the focus from responsible choice to responsible persons means that giving valid consent means that a person must be competent to give informed consent -The test for capacity is described in legislation at Section 4(1) of the Health Care Consent Act (HCCA).

22. Capacity s.4.(1) Capacity: A person is capable with respect to a treatment, admission to a care facility or a personal assistance service if the person is able to understand the information that is relevant to making a decision about the treatment, admission or personal assistance service as the case may be and able to appreciate the reasonable foreseeable consequences of a decision or lack of a decision as the case may be.

23. Capacity A patient is assumed to be capable unless proven otherwise. Sec. 4(2) Presumption of Capacity: A person is presumed to be capable with respect to treatment, admission to a care facility and personal assistance services What Does This Imply? The onus is on the doctor to prove that the patient is not capable. He/She must prove this using the criteria of Sec.4(1), and provide clear and cogent evidence to demonstrate that this criteria is not fulfilled.

24. Consent and Capacity Presumption of capacity: addresses our general belief that adults are responsible individuals (who may occasionally make bad choices) Capacity as decision-specific: addresses our belief that making a responsible decision requires understanding the information relevant to that decision

25. Informed Choice for Research

26. Informed choice for research Considerations are similar to those in informed choice for treatment, but we may “set the bar higher” for capacity to consent to research –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

27. Challenging the difference between research and therapy Some settings are partly therapeutic and partly experimental (e.g. when no traditional therapy is available, or when adding an experimental therapy to an established treatment regimen) Patients/subjects sometimes do benefit from participating in research

28. What is different about research? Goals are different (benefit to participants is incidental) But it is true that some research protocols involve interventions that would also occur during therapy. They may also involve non-experimental procedures that serve the purpose of research, not of clinical care.

29. Choice 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”  motivated by reward

30. Freedman: 2 distinctions 1.Acts of God vs. acts of human beings Response to “natural contingencies” does not make us unfree 2.Reward that brings us up to a minimum standard of living vs. reward that supplies “luxuries” above this standard

31. Summary of problems Distinction between research and treatment may appear to be blurred Possibility that patients may view their treatment as depending on acquiescence to research participation

32. Weijer’s solution Make clear what parts of a protocol are (1) established therapies vs. experimental interventions and (2) required by the protocol but not part of standard care –This approach fits neatly into Freedman’s discussion of what is required for informed consent –Also, specifying alternatives helps to address problems raised by power differential

33. Cases 1.Informed choice for chemotherapy for breast cancer (primary and adjuvunct) 2.Informed choice for retreatment radiotherapy 3.Informed choice for BRCA testing 4.Informed choice for clinical trials