204.13 Valid Consent

Front 1

Why is Consent Necessary?

Back 1

Many of the procedures that are performed in medicine would be considered highly unethical if they were performed in different circumstances.
Think for instance, of the actions involved in surgery, or the administration of highly toxic chemicals in chemotherapy: if we did these things to each other in non-treatment contexts, we could be accused of battery or assault.

Front 2

Why are potentially harmful acts in medical practice acceptable?

Back 2

1) Because these actions are in the patient’s interests: Clinician motivation- therapeutic intent/ welfare for patient and liklihood of benefit. Benefit necessary but not sufficient, wishes of patient/ respect for autonomy important
2) Because the patient has consented to them. Even if consent obtained for treatment that is not for welfare does not mean treatment can go ahead. There needs to be consent for an beneficial treatment. Eg. Just cause someone consented to enslavement does not mean it is ok. So better answer to this would be(see below)
3) Because these actions are intended to benefit the patient, because there is adequate likelihood of benefit, and because the patient consents to them

Front 3

Reasons to Seek Consent for Treatment/ components of valid consent

Back 3

• Consent shows respect for autonomy
• Consent promotes the welfare of patients
• Consent promotes trust within the doctor-patient relationship

Front 4

Two Definitions of Informed Consent

Back 4

- consent means a voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action.
(Gillon 1986: 113)
- an informed consent is an autonomous action by ... a patient that authorises a professional ... to initiate a medical plan for the patient ... an informed consent is given if a patient or subject with (1) substantial understanding and (2) in substantial absence of control by others (3) intentionally (4) authorises a professional ...
(Faden & Beauchamp 1994: 149)
- These accounts incorporate the following characteristics:
• Information and understanding
• Voluntariness
• Competence
• Deliberation

Front 5

Methods of Consent:

Back 5

Consent can be:
• written
• verbal
• implicit, implied or tacit. (the patient acts in such a way that they are assumed to have consented, eg presenting their arm in response to a suggestion the doctor takes your blood pressure,opening your mouth for a swab)

Front 6

The form of consent which is most appropriate will depend upon various factors, such as:

Back 6

• the gravity of the procedure and the risk involved
• the complexity of the information involved
• the patient’s familiarity with these procedures
• the patient’s preferences with respect to the mode of consent

Front 7

Deliberation

Back 7

Adequate deliberation typically involves:
• time to deliberate
• the opportunity to ask questions and discuss (perhaps not only with the professionals involved)

Amount of Time for sufficient deliberation involves several factors such as:
• The individual patient’s decision-making style
• The extent of involvement of third parties (spouses, family members, church groups, etc)
• The gravity of the decision
• The complexity of the information involved
• External factors (eg the nature of the situation- whether it is an emergency procedure, a routine procedure, research participation, etc)
• Opportunity to deliberate allows for consent to be truly reflective of individual, not because of insufficient understanding and behavior

Front 8

Information:

Back 8

3 standards of disclosure:
• The Professional Practice Standard
• The Reasonable Person Standard
• The Subjective Person Standard
• note: Information should be understood, not merely provided

Front 9

The Professional Practice Standard:

Back 9

• legally enshrined in the ‘Bolam Test’: ‘a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.’ That is if the doctor gave the same amount of info as another doc, or all patient in like condition will be given same info, reflects consistency- only valid for diagnosis and treatment but not for consent.
• Problems: no basis upon which to determine whether the profession in general provide a high enough standard of information to patients and there is little reason to believe that there is agreement within the profession about how much information to provide in many cases

Front 10

The Reasonable Person Standard:

Back 10

• This standard takes the patient, rather than the physician, as its guide, and seeks a level of disclosure, which would enable a hypothetical reasonable person to make an informed decision.
• Achieves consistency and flexibility eg info needs change depending on age etc.
• Problem: consistency means individual needs ignored in favor of what a fictionally ideal person would want to know

Front 11

The Subjective Person Standard:

Back 11

• This approach aims to tailor disclosure levels to the actual needs and preferences of a given patient. The level of information is appropriate if it enables the individual patient to make an informed choice.
• Most demanding as it requires doc to make accurate judgments about info needs of patient
• Problem: expensive because of time constraints of patients and difficulty in applying as doc not always in good position to assess eg language barriers
• Best standard when considering what make consent important

Front 12

What does it mean for a consent to be competent/ have capacity?

Back 12

A basic definition of competence is ‘the ability to perform a task’ .
The task we are concerned with is:
• to understand the relevant information
• to use that information in a process of reaching a decision
- competence is process based not income based- as long as there is sufficient understanding, even if outcome it against their interests
Some might require a decision to be ‘rational’ or ‘reasonable’ or to do something like advance a person’s interests, or at least not to impair their interests. Accounts of competence widely acknowledged in law tend not to require a decision to be rational or reasonable, but focus rather on whether it is made on the basis of understanding.