Post on 23-Jan-2016
description
Ethical/Legal Aspects of Consent to Investigation or Treatment
May 21, 2003ISD I
Barbara BarrowmanAndrew 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. Disclosure3. 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