Ethical/Legal Aspects of Consent to Investigation or Treatment

1. Ethical/Legal Aspects of Consent to Investigation or Treatment May 21, 2003 ISD I Barbara Barrowman Andrew Latus

2. Case • On your first clerkship rotation, you encounter a patient who is in a vegetative state. • The resident you are working with tells you and the other students in your group that this would be a good chance for you to learn how to do a pelvic exam • Some uncomfortable glances are exchanged among the clerks, but the first student goes ahead as instructed. • ‘You turn,” says the resident.

3. Case: Dr. Christiaan Barnard & first human heart transplant patient “Mr. Washkansky, I have come to introduce myself [i.e., Barnard]. I believe Dr. Kaplan and Professor Schire have spoken to you about it–we intend doing a heart transplant on you, and for this you will be admitted to my ward.” “That’s fine with me—I’m ready and waiting for it.” “If you like, I can tell you what we know and what we don’t know about this.” He nodded and waited for me to go on… “We know you have a heart disease for which we can do nothing more. You have had all possible treatment, and you are getting no better. We put a normal heart into you, after taking out your heart that’s no longer any good, and there’s a chance you can get back to normal life again.” “So they told me. So I’m ready to go ahead.” He said no more… “Well, then … good-bye,” I said. “Good-bye” (from One Life by Christiaan Barnard & Curtis Bill Pepper, 1969)

4. Outline – Consent • General Significance • Forms of Consent • Elements of a Valid Consent • Exceptions to Requirement of Consent • Earlier session covered ethical aspects of consent • Primary focus will be on legal aspects of consent

5. General Considerations • A mentally competent patient has right to refuse medical treatment, regardless of consequences and how beneficial or necessary treatment may be • This is both a legal requirement as well as, to most, a moral requirement • Consent is often viewed as the single most ethically important aspect of medical ethics • “all of medical ethics is but a footnote to informed consent” (Mark Kuczewski, 1996) • But why is consent so important?

6. Consent: Moral Significance • Main reason: the requirement of consent reflects the ethical principle of patient autonomy • To some extent principles of beneficence/non-maleficence also support importance of consent • Figuring out what is in a patient’s ‘best interests’ is notoriously difficult in some cases. • Distinguish medical best interest from best interests ‘all things considered’ • Often we take the view that the patient is the best judge of what is in his own best interest ‘all things considered’

7. Consent: Legal Significance • Save in exceptional circumstances, medical treatment must not be administered without obtaining patient’s valid consent • Treatment/investigations performed without consent constitute “battery” • No liability results from decision to withhold or withdraw even life-sustaining treatment at request of competent patient

8. Forms of Consent - Written or Oral • As general rule, no legal requirement that consent be in written form • Written consent = evidence • Hospital practice to require written consent • Consent not a piece of paper, but part of a process of communication between doctor and patient • Beware of tendency to treat signs of consent as more important than consent itself

9. Forms of Consent - Express or Implied • Consent may often be implied by words or conduct e.g. holding out arm for injection • Many examinations, some procedures routinely performed with implied consent • Prudent to document for anything but the most minor interventions

10. Case • Because of a stricture detected on barium enema, it is recommended to Mr. B that he undergo a colonoscopy • The procedure is carefully explained to Mr. B and he gives a fully informed consent to the colonoscopy. • Mr. B is clearly anxious before the procedure and is given medication to sedate him. • Midway through the procedure, he cries out “Stop, it hurts. I’ve changed my mind.” • Dr. X, who is performing the colonoscopy, replies “I’m almost done here – just bear with me a little bit longer.” • Has consent been withdrawn? • What should Dr. X do?

11. Withdrawing Consent • Right to withdraw consent at any time • Doctor must stop treatment once consent withdrawn unless life-threatening or immediate serious problems to health of patient to stop • If unclear whether consent being withdrawn, doctor must stop to ascertain

12. Elements of Consent Information Elements • Comprehension • Disclosure • Consent is specific to treatment & person administering it Consent Elements 4. Capacity/Competence 5. Voluntariness

13. 5. Voluntariness • Some factors interfering with voluntariness • coercion by physician, family or others • line between coercion & legitimate influence can be tricky • pre-op sedation • misrepresentation as to nature of treatment or procedure

14. 4. Capacity/Competence • Except as defined in legislation, these terms may be used interchangeably • Presumption that adults have legal capacity • If patient has capacity, no one else’s consent required • Capacity = ability to understand and appreciate nature and purpose of treatment and consequences of giving or refusing consent • detailed discussion of capacity during Psychiatry in ISD II • Problem areas - mental disability, minors

15. Capacity - (a) Mental Disability • Impairment may be temporary or permanent • Assessment of capacity is functional - specific to issue in question • i.e., not all or nothing • Not automatically lacking capacity because of Dx of dementia, psychosis, etc. • Refusal of treatment others see as beneficial or necessary does not imply incompetence

16. Capacity - (b) Minors • Common law - regardless of age, child capable of consenting if able to appreciate nature and purpose of Rx and consequences of giving/refusing consent (“mature minor”) • Legislation in some provinces • If child has capacity, parental consent not required, nor can they override child • Common practice to get parental consent • Parental decisions can be overridden by court order if not in child’s best interests • Will be discussed in detail during Pediatrics in ISD II

17. 3. Specific to Treatment & Treating MD • Patient should only receive that treatment to which (s)he has consented, apart from emergency • importance of clear communication • Consent specific to doctor who will carry out care or treatment • presence and role of house staff should be made clear to patient

18. Treatment and Treating MD • Consent should be obtained by person who will carry out care or treatment • Role of obtaining informed consent may be delegated (e.g. resident), but before delegating, treating MD should be confident delegate has knowledge and experience to provide adequate explanations to patient • Responsibility rests with delegating MD

19. 1 & 2. Comprehension/Disclosure Four points (a) importance (b) standard of disclosure (c) research/experimental treatment (d) documentation

20. (a) Importance • Gives meaning to patient’s right to medical self-determination, profound impact on nature of doctor-patient relationship • Focus on effective communication • Frequent basis of litigation - failure to obtain informed consent may constitute “negligence” or substandard care

21. (b) Standard of Disclosure …in obtaining the consent of a patient for a surgical operation, the 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 operation, its gravity, any material risks and any special or unusual risks… (Reibl v. Hughes, S.C.C. 1980)

22. Standard of Disclosure • Professional disclosure standard vs. reasonable patient standard • Canadian Standard: what a reasonable person in the patient’s position would want to know • Reibl vs. Hughes • compromise between reasonable person standard and subjective standard • Material risks include common risks and risks which are mere possibilities but have serious consequences, e.g. death, paralysis

23. Standard of Disclosure • Insofar as possible, tell patient the diagnosis • If uncertainty, explain this • Explain nature of proposed treatment, its gravity, chances of success and risks • Give patient opportunity to ask questions • Be alert to patient’s individual concerns and circumstances and deal with them

24. Standard of Disclosure • Patient should be told consequences of non-treatment - no coercion but entitled to information • Accepted alternative forms of treatment (no obligation to discuss unconventional Rx) • Optimism should not allow misinterpretation of guaranteed results

25. Standard of Disclosure • Although patient may waive explanations, have no questions and be prepared to submit to treatment, doctors must be cautious in accepting such waivers • “therapeutic privilege” (withholding or generalizing information due to patient’s emotional condition) - use very cautiously • once much more widely accepted than today • part of shift away from paternalism

26. Standard of Disclosure • Consent for cosmetic or other “medically non-necessary” procedures - take special care re. risks and expected results • courts may impose higher standard of disclosure • Patients must be informed re. planned delegation of care • Supplements to consent explanations - pamphlets, etc.

27. (c) Research/Experimental Rx • Full disclosure required, “therapeutic privilege” not applicable • Consent requirements even stronger morally than in standard treatment situation • less possibility of appeal to beneficence if treatment is untested, so respecting patient autonomy is more important • Caution re. coercion if doctor-patient relationship with researcher • Patient must understand possibility of placebo/alternative treatment • Research and minors/incompetents

28. (d) Documentation • Consent form - identification, acknowledgement of explanations, anesthesia, added/alternative procedures, delegation, signatures, witness • Contemporaneous note - brief summary of informed consent discussion, risks discussed, any special concerns/questions

29. Exceptions to Requirement of Consent • Emergency situations • Legislation

30. Emergencies • May treat without consent if: • injury life-threatening or imminent threat to patient’s health, • patient not able to give consent, e.g., comatose, severe injuries, incompetent, and • substitute decision maker not readily available

31. Legislation • Mental health legislation - detention +/- treatment of patients with mental disorder who are danger to selves or others • Other examples of law providing for compulsory treatment • Charter of Rights issues

32. Controversies about Informed Consent • Idea of the absolute centrality of informed consent is relatively recent • Some challenge the importance of informed consent on the grounds that it reflects an unrealistic picture of patients’ ability to understand what they are consenting to

33. Informed Shared Decision-Making • Not a legal term, but in some ways a better term to describe ideal process of medical decision-making • Emphasis on discussion, working together with patients in deciding best way to proceed • “Meeting between experts” - MD expert in disease, patient expert in own experience of disease and in their preferences • emphasis placed on consent can hide the appropriately collaborative nature of medical treatment