1. Informed Consent Andrew Latus E/H/HL Course Oct. 28/02

2. Schedule  Today –Informed Consent and Due Care  Thursday, 11-11:50 –Physician as Healer – Some Historical Perspectives  Updated Course Outline at http://www.ucs.mun.ca/~alatus/BSM1 http://www.ucs.mun.ca/~alatus/BSM1  Case study in mailbox soon

3. Why Value Informed Consent?  “No medical intervention done for any purpose— whether diagnostic, investigational, cosmetic, palliative, or therapeutic—should take place unless the patient has consented to it.” (Doing Good, 84) –Note the emphatic tone –Later qualified: “in the case of an incompetent patient, someone else who is authorized to do so has agreed to do it.” (84) –Emergencies  Why is informed consent important?

4. Resources  Deontology –Respect for persons  Consequentialism –Promoting good outcomes  Principilism –Autonomy, Beneficence, Non-maleficence, Justice

5. 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

6. 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  Doing Right misses this  Today, usually thought of as a secondary reason for consent

7. 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 –Also perhaps: best interest medical best interest  In a later session, we will focus on conflict cases

8. 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.”  WMA Helsinki Declarations (1964, 1975, 1983, 1989, 1996, 2000)

9. Elements of Informed Consent*  I Information Elements 1. Disclosure of Information 2. Comprehension of Information  II Consent Elements 3. Voluntary Consent 4. Competence to Consent * follows Beauchamp & Childress, Principles of Biomedical Ethics

10. 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

11. 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

12. What if the Patient Isn’t Competent?  Substituted Judgment - Someone else can decide for the patient. –Who? Parents? Doctors? Courts?  Living wills  Newfoundland: Advance Health Care Directives Act

13. 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

14. Disclosure & Comprehension  Disclosure: How much information must be given? –Remember that how information is presented is crucial –An overload of information can actually hamper informed consent  Comprehension: What must you do to ensure the patient has consented?

15. 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

16. 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

17. Reibl vs. Hughes  Case 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  Reibl is left impotent and profoundly paralyzed on right side  Reibl had not been warned about this specific risk

18. Reibl vs. Hughes  Dr. Hughes was found guilty of negligence by the Supreme Court of Canada  Court rules that the appropriate standard of disclosure is what a reasonable person in the patient’s position would want to know  Compromise between objective and subjective view

19. 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  Remember contrast between intrinsic and instrumental value –Sometimes things that are initially perceived as instrumentally valuable come to be mistaken for having intrinsic value

20. 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

21. A Common Consent Issue for Students  Examinations on patients who have not consented to them  A number of U of T students reported encountering this (BMJ March, 2001) –Utilitarianism vs. Deontology