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CONSENT

VIEWS: 62 PAGES: 33

									Ethical/Legal Aspects of Consent to
Investigation or Treatment


                                May 21, 2003
                                        ISD I
                          Barbara Barrowman
                                Andrew Latus
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.
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)
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
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?
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‘
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
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
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
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?
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
Elements of Consent
Information Elements

  1. Comprehension
  2. Disclosure
  3. Consent is specific to treatment & person
     administering it

Consent Elements

  4. Capacity/Competence
  5. Voluntariness
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
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
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
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
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
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
1 & 2. Comprehension/Disclosure

Four points

  (a) importance

  (b) standard of disclosure

  (c) research/experimental treatment

  (d) documentation
(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
(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)
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
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
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
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
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.
(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
(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
Exceptions to Requirement of
Consent

 Emergency situations

 Legislation
Emergencies

    May treat without consent if:

    1. injury life-threatening or imminent threat to
       patient‘s health,

    2. patient not able to give consent, e.g., comatose,
       severe injuries, incompetent, and

    3. substitute decision maker not readily available
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
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
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

								
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