Mednotes

L2 Ethics Informed Consent

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tagsethics, lecture
aliasesL2 Ethics Informed Consent

9 min read

Overview

This lecture sets out why informed consent matters in medical practice and gives a four-criterion framework (disclosure, comprehension, competence, voluntariness) for analysing it, drawn from Beauchamp and Childress and grounded in the NZ Code of Health and Disability Services Consumers’ Rights. It then works through each criterion in turn, when consent must be written, and closes by stressing that the framework is a guide for judgment, not a formula, within an ongoing doctor-patient relationship.

‘Informed consent’ is the right of every patient to make an informed decision about whether to accept or refuse treatments offered to them. This matters because it:

  • Respects patients’ autonomy, including Mana Motuhake
  • Prevents harms and promotes benefits, generally leading to better outcomes
  • Builds trust
  • Is a legal requirement

This contrasts with the older paternalistic view expressed in the 1847 Code of Medical Ethics of the American Medical Association, which held that “the obedience of a patient to the prescriptions of his physician should be prompt and implicit” and that a patient’s own opinions on the fitness of treatment should not be allowed to influence compliance with it.

The Code of Health and Disability Services Consumers’ Rights sets out relevant rights:

  • Right 5: right to effective communication, in a form, language and manner that enables the consumer to understand the information provided
  • Right 6: right to be fully informed, to the information a reasonable consumer in that consumer’s circumstances would expect to receive
  • Right 7: right to make an informed choice and give informed consent; services may be provided only if the consumer makes an informed choice and gives informed consent

The small print on the Code of Rights poster graphic (below the "It's Your Decision" heading) is illegible in the source slide.

The four-criterion framework

Based on Beauchamp and Childress’ Principles of Biomedical Ethics, informed consent requires:

  • Disclosure of information
  • Comprehension of information
  • Competence to decide
  • Voluntariness of decision

These can be organised as a two-tier hierarchy: Informed consent splits into Information and Consent. Information comprises Disclosure and Comprehension. Consent comprises Competent and Voluntary.

Disclosure

Disclosure is the provision of information to the patient. Information that should be disclosed in gaining informed consent includes:

  • Why the treatment is thought necessary (results of tests and/or procedures)
  • Benefits
  • Risks
  • Side effects (harms)
  • Costs
  • Expected timeframe of treatment
  • Possible alternatives
  • Notification of any proposed participation in teaching or research, and relevant details
  • The practitioner’s own recommendation, if the patient asks for it

When is disclosure sufficient?

  • Previous standard: when the ‘reasonable doctor’ thinks the information given is sufficient
  • Current NZ standard: when the ‘reasonable patient’ thinks the information is sufficient. More precisely, when the reasonable patient making this particular decision would think it sufficient, which requires both spontaneous disclosure (offered unprompted) and responsive disclosure (answering the patient’s questions).

Comprehension

Comprehension is the patient’s understanding of the information given. Two key factors affect it:

  1. How the information is presented
  2. The receptivity and understanding of the patient

Comprehension can be enabled by:

  • Asking questions of the patient, engaging them in discussion
  • Using simple language wherever possible, and explaining technical language when it must be used
  • Using images or written information
  • Being aware of factors that may undermine comprehension, e.g. effects of medications, time needed to process information, shock
  • Deferring the decision where necessary

Informed consent must be given in writing when:
(i) the consumer is to participate in any research;
(ii) the procedure is experimental;
(iii) the consumer will be under general anaesthetic; or
(iv) there is a significant risk of adverse effects on the consumer.

Oral consent is acceptable for minor procedures through which the patient remains conscious, but it is prudent to note in the patient’s records that it was given.

Important

Competence

Competence is the patient’s ability to make the necessary decision. Factors that may render a patient unable to decide include:

  • Unconsciousness
  • Intoxication
  • Immaturity
  • Cognitive impairment
  • Brain injury
  • Acute psychiatric condition

In NZ, a patient is presumed competent unless there are ‘reasonable grounds’ for thinking otherwise. Competence is task-specific and admits of degrees, so there are many ways a person can be incompetent and competence can often be difficult to determine. It is not objectively determinable, but thresholds and tests are used for practical and legal reasons.

If a patient is not competent to decide:

  • Parents typically decide on behalf of their children
  • The Court may appoint a ‘Welfare Guardian’
  • A patient may have legally appointed an ‘Enduring Power of Attorney’ (EPA)
  • A patient may have issued advance directives
  • Each of these mechanisms has limitations and restrictions, and together they do not cover all circumstances

Right 7 of the Code addresses diminished and absent competence:

  • (3) Where a consumer has diminished competence, they retain the right to make informed choices and give informed consent, to the extent appropriate to their level of competence.
  • (4) Where a consumer is not competent to make an informed choice and give informed consent, and no person entitled to consent on their behalf is available, the provider may provide services where (a) it is in the best interests of the consumer, and (b) reasonable steps have been taken to ascertain the views of the consumer.

Important

Voluntariness

Voluntariness concerns a person being allowed, or having the opportunity, to make their own decision. It requires that the decision be free from manipulation, pressure or coercion. Factors that may affect voluntariness include:

  • The practitioner
  • Family or friends
  • Time available
  • Undue threats or incentives

A key tension is persuasion versus manipulation/pressure: how far a doctor should go in ‘helping’ with a decision while still enabling the patient to decide voluntarily.

The framework is not a formula

The doctor-patient relationship is ideally a partnership grounded in mutual commitment to the patient’s welfare. This means:

  • Informed consent is an ongoing process, not a single event
  • Patient autonomy should not be seen as at odds with practitioner autonomy; the relationship must be grounded on trust

Each of the four criteria involves an element of judgment: the practitioner must discern whether enough information has been given, whether enough has been done to enable the patient’s understanding, whether the patient is competent to decide, and whether the decision is voluntary. These judgments are always relative to the particular treatment being offered and to the needs of the particular patient.

Self-test

  1. Define informed consent.
  2. List the four criteria for informed consent in the Beauchamp and Childress framework, and state which two sit under “Information” and which two sit under “Consent” in the hierarchy diagram.
  3. List at least five categories of information that should be disclosed to a patient when obtaining informed consent.
  4. Distinguish the previous (‘reasonable doctor’) standard for sufficient disclosure from the current NZ (‘reasonable patient’) standard, and explain what “spontaneous and responsive disclosure” means under the current standard.
  5. Describe the two key factors affecting comprehension, and list three ways a doctor can help enable it.
  6. List the four circumstances in which informed consent must be given in writing.
  7. List four factors that may make a patient unable to make a decision (i.e. affect competence).
  8. Explain the presumption of competence in NZ, and why competence can be difficult to determine.
  9. Describe four mechanisms available for decision-making when a patient is not competent, and state one limitation of these mechanisms as a group.
  10. Under Right 7(4) of the Code, what two conditions must be met for a provider to provide services to a consumer who is not competent and has no available person entitled to consent on their behalf?
  11. Define voluntariness, and list four factors that may affect it.
  12. Explain why the informed consent framework is described as “not a formula”, with reference to the ongoing nature of the process and the role of judgment.

Answers

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