Ethical/Legal Aspects of Consent to Investigation or Treatment

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Ethical/Legal Aspects of Consent to Investigation
or Treatment

• May 21, 2003
• ISD I
• Barbara Barrowman
• Andrew Latus

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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.

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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 itwe
  intend doing a heart transplant on you, and for
  this you will be admitted to my ward.
• Thats fine with meIm ready and waiting for
  it.
• If you like, I can tell you what we know and
  what we dont 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 thats no longer any good, and theres a
  chance you can get back to normal life again.
• So they told me. So Im 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)

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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

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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?

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Consent Moral Significance

• Main reason the requirement of consent reflects
  the ethical principle of patient autonomy
• To some extent principles of beneficence/non-malef
  icence also support importance of consent
• Figuring out what is in a patients 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

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Consent Legal Significance

• Save in exceptional circumstances, medical
  treatment must not be administered without
  obtaining patients 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

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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

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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

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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. Ive changed my mind.
• Dr. X, who is performing the colonoscopy, replies
  Im almost done here just bear with me a
  little bit longer.
• Has consent been withdrawn?
• What should Dr. X do?

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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

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Elements of Consent

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

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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

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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 elses 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

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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

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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 childs best interests
• Will be discussed in detail during Pediatrics in
  ISD II

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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

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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

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1 2. Comprehension/Disclosure

• Four points
• (a) importance
• (b) standard of disclosure
• (c) research/experimental treatment
• (d) documentation

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(a) Importance

• Gives meaning to patients 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

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(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)

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Standard of Disclosure

• Professional disclosure standard vs. reasonable
  patient standard
• Canadian Standard what a reasonable person in
  the patients 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

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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 patients individual concerns and
  circumstances and deal with them

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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

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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 patients
  emotional condition) - use very cautiously
• once much more widely accepted than today
• part of shift away from paternalism

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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.

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(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

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(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

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Exceptions to Requirement of Consent

• Emergency situations
• Legislation

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Emergencies

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

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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

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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

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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