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  5. Informed Consent to Medical Treatment – Legal criteria under common jurisdictions

Informed Consent to Medical Treatment – Legal criteria under common jurisdictions

UK 

Criteria: For consent to be valid for medical treatment it must be voluntary and informed, and the person consenting must have the capacity to make the decision. 

Voluntary means the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family. 

Informed means the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead. 

Capacity means the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision.

Age: People aged 16 or over are entitled to consent to their own treatment. 

Exceptions to age requirement: Children under the age of 16 can consent to their own treatment if they’re believed to have enough intelligence, competence and understanding to fully appreciate what’s involved in their treatment (Gillick competent). The degree of maturity and intelligence needed depends on the gravity of the decision. Sufficient time for the assessment must be allowed by the health professional who needs to be satisfied that a child has fully understood the nature and consequences of the proposed treatment and is mature enough to take account of broader health and social factors when making their decision. 

If it is found that someone under 16 is not able to provide consent, a person with parental responsibility can consent for them if they meet the consent criteria. 

Singapore 

Criteria: Same as UK law.

Age: The age a person is legally considered an adult is 21. However, Singapore has no statute law that defines the legal age to give consent for medical treatment. 

Exceptions: Although it has not been specifically tested in Singapore Courts, it has largely been accepted that the Gillick competence applies in young persons. 

Australia 

Criteria: Same as the UK. 

Age: 18 years old. 

Exceptions: Same as the UK. 

EU Guidelines and the Oviedo Convention

Criteria: Same as UK law. 

Age: Varies in each Member State, however, the majority legal age is 16. 

Exceptions: The Oviedo Convention specifies that where, according to national law, a minor does not have the capacity to consent to an intervention, the intervention may be carried out only with the consent of parents who have custody of the minor. The Convention also states that “the opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity”. This means that in certain situations which take account of the nature and seriousness of the intervention as well as the minor’s age and ability to understand, the minor’s opinion should increasingly carry more weight in the final decision. 

USA 

Criteria: Same as UK law. 

Age: 18 years old. 

Exceptions: Each state varies depending on whether a young person can give informed consent. For example, some states allow a young person to give informed consent if they are legally emancipated. However, all states will give medical treatment to a young person if they have parental consent. 

Overall

Whilst age restrictions and their exceptions are different across each jurisdiction, the criteria of informed consent is consistent. Additionally, before any member gives their consent, it is paramount that they are given; detailed information about the medical treatment involved, how this will affect their health and social life and all other treatment options. All patients/members should give their consent in writing before medical treatment begins. 

Ethical and philosophical principles

In the clinical context, informed consent is the voluntary and autonomous authorisation of a person to receive a medical intervention. The process of obtaining informed consent is a process of mutual decision-making, whereby the healthcare professional provides sufficient information to the person to enable the development of a treatment plan that the person endorses.

The ethical basis of informed consent is respect for autonomy, which is one of the four principles of medical ethics discussed by the philosophers Tom Beauchamp and James Childress in Principles of Biomedical Ethics (1971):

  1. Beneficence — the obligation to act for the benefit of the person
  2. Nonmaleficence — the obligation to avoid harm to the person
  3. Autonomy — respect for the person’s right to self-determination
  4. Justice — ensuring fair and equitable treatment of the person

Informed consent is grounded in the principle of autonomy, insofar as it aims to facilitate the person’s decisional ability, respect the person’s values, enhance the person’s knowledge, and promote the person’s right to self-determination.

Informed consent involves the following necessary elements (Beauchamp and Childress, 1971):

  • Threshold elements
    • Competence — the person has the mental capacity to consent
    • Voluntariness — the decision is voluntary and not coerced
  • Information elements
    • Disclosure — sufficient information must be provided
    • Recommendation — a plan must be developed
    • Understanding — the person must understand the above
  • Consent elements
    • Decision — the person must communicate a decision
    • Authorisation — the person must endorse the decision

What is mental capacity?

In order for a person to give informed consent to a proposed treatment, it is a necessary condition that the person has the mental capacity to give informed consent. Mental capacity refers to the person’s ability to (1) understand the relevant information, (2) appreciate and recall the information, (3) evaluate the benefits and risks of the different options, and (4) endorse a decision.

Importantly, the assessment of mental capacity is decision-specific and time-specific. A person may lack the mental capacity to consent to one intervention but possess the mental capacity to consent to another intervention. Also, a person may lack the mental capacity to consent to the intervention at one point in time but possess the mental capacity to consent to the intervention at another point in time.

If a person is deemed to lack the mental capacity with respect to a particular decision at a particular time, then the person cannot give informed consent for that decision at that time.

How is mental capacity assessed?

A person’s mental capacity to  can be assessed the MacArthur Competence Assessment Tool for Treatment (Grisso et al., 1997)

  • Understanding — the ability to understand the information relevant to the treatment
  • Appreciation — the ability to relate the information to one’s own situation and to consider how the treatment would be beneficial
  • Reasoning — the ability to evaluate treatment alternatives by comparing risks and benefits in light of potential consequences and likely impacts on everyday living
  • Choice — the ability to communicate a decision about treatment

This is roughly analogous to the Mental Capacity Act 2005 in England and Wales, which states that mental capacity is present only if the following is demonstrated:

  • The person must understand the information relevant to the decision including the consequences of making or not making the decision.
  • The person must retain that information long enough to make the decision.
  • The person must use or weigh the information as part of the decision making process.
  • The person must communicate the decision in any recognisable way.

The Mental Capacity Act 2005 also makes the following procedural recommendations for assessing mental capacity:

  1. Always assume the person is able to make the decision until you have proof they are not.
  2. Try everything possible to support the person to make the decision.
  3. Do not assume the person does not have capacity to make a decision just because you think the decision is unwise or wrong.
  4. If you make a decision for a person who cannot make it themselves, the decision must always be in the person’s best interests.
  5. Any decisions, treatment or care for a person who lacks capacity must always follow the path that is the least restrictive of the person’s basic rights and freedoms.

How much information is deemed sufficient will partly depend on the person’s values, interests, and goals. Hence, when disclosing information, it is recommended that the healthcare professional establishes what the person wants to know, what the person takes to be important, and what concerns the person may have.

However, there are also some minimum reasonable standards for what information is necessary to disclose. These include information about the likely reversible and irreversible effects of the treatment, the intended benefits of the treatment, the potential risks and harms associated with the treatment, the limitations of the treatment, and the alternative options that are available.

What if it is still unclear whether the person really endorses the decision?

Sometimes it may still be unclear whether a person is genuinely giving informed consent to treatment even after applying the MacArthur Competence Assessment Tool for Treatment and the Mental Capacity Act 2005. For example, in the case where a person’s psychological state seems to fluctuate, there may remain some doubt about whether the person’s decision is authentic. Here, a framework developed by the philosopher Harry Frankfurt (1971) may be helpful. While this is a theoretical framework for thinking about free will rather than a practical framework for thinking about clinical decision making, it can still be helpful in the clinical setting.

The framework makes the following distinction between different sorts of desires.

  1. First-order desire — A desire relating to action (“I want to begin hormone treatment”)
  2. Second-order desire — A desire relating to desire (“I want to want to begin hormone treatment”)

A decision is free and authentic if the second-order desire endorses the motivating first-order desire. For example, a person who has a desire for hormone treatment is making this decision freely if the person wants to have this desire for hormone treatment. Such a decision is authentic because it involves the person reflecting on the desire for hormone treatment and concluding that it is a desire that is consistent with the person’s underlying values and interests.

Sometimes, an action may not be free or authentic because the second-order desire contradicts the motivating first-order desire. For example, a person with obsessive-compulsive disorder who has a desire to perform a compulsive act may not want to have this desire and would rather get rid of it. Here, the compulsive act is not consistent with the person’s underlying values and interests.

What if the person wants something that the clinician thinks is unwise?

The Mental Capacity Act 2005 specifies that we must not assume that a person lacks decisional capacity just because we think the decision is unwise.

If there is doubt about the person’s decisional capacity, then this must be assessed independently with reference to the criteria specified by the MacArthur Competence Assessment Tool for Treatment (Grisso et al., 1997) and the Mental Capacity Act 2005. If the person is able to understand and appreciate the implications of the decision, retain this information, evaluate the benefits and risks of the decision, and communicate the decision, then the person has the capacity to make the decision, even if the clinician thinks that the decision is unwise.

It can be helpful to ask why the clinician thinks that the decision is unwise. Sometimes this may not reflect a clinical concern about the harmfulness of the decision, but instead may be because the clinician and the service user have different values. For example, the clinician and the service user may prioritise different things and have different ideas about what constitutes flourishing, and so arrive at different judgements about the reasonableness of the decision.

Is there a framework for approaching a disagreement between the healthcare professional and the person?

When there is a disagreement about whether or not a given healthcare decision is reasonable, this is often because the healthcare professional and the person have different values, interests, and goals. In such a scenario, Bill Fulford’s Ten Principles of Values-Based Practice (2004) can be useful for unpacking why one person thinks the decision is reasonable and why the other person thinks the decision is unreasonable. By making the underlying values explicit, the clinician can come to a better understanding of what the decision means in the context of the service user’s goals and interests:

  1. All decisions stand on two feet, on values as well as on facts, including decisions about diagnosis (the “two feet” principle).
  2. We tend to notice values only when they are diverse or conflicting and hence are likely to be problematic (the “squeaky wheel” principle).
  3. Scientific progress, in opening up choices, is increasingly bringing the full diversity of human values into play in all areas of healthcare (the “science driven” principle).
  4. VBP’s “first call” for information is the perspective of the patient or patient group concerned in a given decision (the “patient-perspective” principle).
  5. In VBP, conflicts of values are resolved primarily, not by reference to a rule prescribing a “right” outcome, but by processes designed to support a balance of legitimately different perspectives (the “multi-perspective” principle).
  6. Careful attention to language use in a given context is one of a range of powerful methods for raising awareness of values (the “values-blindness” principle).
  7. A rich resource of both empirical and philosophical methods is available for improving our knowledge of other people’s values (the “values-myopia” principle).
  8. Ethical reasoning is employed in VBP primarily to explore differences of values, not, as in quasi-legal bioethics, to determine “what is right” (the “space of values” principle).
  9. In VBP, communication skills have a substantive rather than (as in quasi-legal ethics) a merely executive role in clinical decision-making (the “how it’s done” principle).
  10. VBP, although involving a partnership with ethicists and lawyers (equivalent to the partnership with scientists and statisticians in EBM), puts decision-making back where it belongs, with users and providers at the clinical coal-face (the “who decides” principle).

What if the person wants something that carries a risk of harm?

It is important here to ensure that the person is fully informed of the intended benefit and potential harm of the intervention so that the person can evaluate these to make an informed decision.

Again, if there is doubt about the person’s decisional capacity, then this can be assessed with reference to the criteria specified by the MacArthur Competence Assessment Tool for Treatment (Grisso et al., 1997) and the Mental Capacity Act 2005. If the person is able to understand and appreciate the implications of the decision, retain this information, evaluate the benefits and risks of the decision, and communicate the decision, then the person has the capacity to make the decision.

If the person is deemed to have decisional capacity, then it is important to consider the magnitude and likelihood of the harm. Under the Principles of Biomedical Ethics (Beauchamp and Childress, 1979), the principle of autonomy suggests that the clinician ought to respect the person’s right to self-determination. However, the principle of autonomy can be outweighed by the principle of nonmaleficence if the decision has a high likelihood of resulting in severe harm to the person without sufficient benefit.

If it is deemed that the harm from an intervention will be highly likely and severe without any associated benefit, then the clinician would be justified in withholding the requested intervention, even if the person has the capacity to consent to the intervention. Here, the principle of nonmaleficence outweighs the principle of autonomy.

If it is deemed that the intervention carries some risk of harm but that this risk is acceptable in light of the potential benefit of the intervention, then the clinician would be justified in proceeding with the requested intervention. Here, the principles of autonomy and beneficence outweigh the principle of nonmaleficence. However, in this scenario, it is important to ensure that the person is fully informed of the risk of harm and of factors that could mitigate this harm.

What if a person wants something but is struggling to articulate this?

The Mental Capacity Act 2005 states that all practical and appropriate steps must be taken to help a person make a decision. Hence, when assessing whether the person is able to understand, appreciate, retain, evaluate, and communicate a decision, it is important to enable the person’s engagement with this process by communicating in an appropriate way.

For example, could information be presented in a way that is easier for the person to understand, such as with nontechnical language and visual aids? Have different methods of communication been explored, such as nonverbal communication? Are there other people who can assist with communication, such as a family member, a carer, a support worker, or an interpreter?

The environment can also influence the person’s ability to engage with decision making. For example, are there particular times or locations where the person is more comfortable with communicating? Can the decision be postponed until a later time when the person feels more ready to engage?

Decisional capacity can only be assessed when all the appropriate steps have been taken to enable the person to engage in communication.

What if a person’s psychological state seems to fluctuate?

If there is doubt about whether or not a person has decisional capacity, then decisional capacity needs to be assessed with the appropriate frameworks, which are the MacArthur Competence Assessment Tool for Treatment (Grisso et al., 1997) and the Mental Capacity Act 2005.

The following criteria must be demonstrated for a person to have capacity to consent to a given decision. Does the person understand and appreciate the information relevant to the decision, including the intended benefits, the potential risks, and the possible alternatives? Is the person able to retain the information? Is the person able to engage in a process of reasoning that evaluates the relative weights of the benefits and risks? Is the person able to communicate the decision?

However, the assessment of decisional capacity can be more complicated if the person’s psychological state fluctuates. Given that the assessment of capacity is specific to a given decision at a given time, the outcome of such an assessment at one time may not be applicable at another time. Different things can be done to achieve more clarity in this scenario.

First, the Mental Capacity Act 2005 states that all practical and appropriate steps must be taken to help a person make a decision. For example, could information be presented in a way that is easier for the person to understand, such as with nontechnical language and visual aids? Are there other people who can assist with communication, such as a family member, a carer, a support worker, or an interpreter? Are there particular times or locations where the person is more comfortable with communicating? Addressing these could remove some of the barriers to engagement that could be associated with a fluctuating psychological state.

Second, the assessment of capacity could be undertaken more than once and at different times. This could help to establish whether the person is retaining the relevant information and whether there is consistency in the person’s understanding of the relevant information. For example, a question such as “the last time we spoke we discussed the risks and benefits of the treatment. Could you tell me what those are again?” could be helpful for assessing recall and understanding over time.

Third, the framework of first-order and second-order desires (Frankfurt, 1971) could be used to assess whether the person’s decision is consistent with the person’s authentic character and underlying values. This can be assessed by asking the person to reflect not only on the decision itself but also on how consistent the person’s attitude toward the decision is. For example, asking something like “you now say that you think this about hormone treatment, but a while ago you said something else. What led you to change your view?” can help to establish whether the person is able to engage in second-order appraisal of the first-order wish. This can provide evidence that the decision involves some deliberation about the person’s underlying values even though the psychological state may fluctuate.

What if a person wants something but a carer is preventing it?

An important consideration here is whether the person has the capacity to give informed consent to the intervention. This is assessed with the MacArthur Competence Assessment Tool for Treatment (Grisso et al., 1997) and the Mental Capacity Act 2005. If the person is able to understand and appreciate the implications of the decision, retain this information, evaluate the benefits and risks of the decision, and communicate the decision, then the person has the capacity to make the decision.

If the person is deemed to have decisional capacity, then the carer cannot override the person’s decision. Under the Four Principles of Biomedical Ethics, the principle of autonomy suggests that the clinician ought to respect the person’s right to self-determination.

The above also holds for a young person under 16. In England and Wales, the legal framework of Gillick Competence suggests that a young person who has the capacity to consent to a decision can proceed with the decision even if the parents do not agree. An important exception is where a young person is refusing treatment and such refusal could lead to death or permanent harm. Here, the treatment refusal can be overruled. Nonetheless, in other scenarios, a young person who is deemed to have decisional capacity can proceed with treatment regardless of whether the parents agree.

If there is evidence that the carer is actively obstructing the person’s healthcare, then it is prudent to consider whether this needs to be escalated and reported as a safeguarding issue.

If the person is deemed not to have decisional capacity, then the Mental Capacity Act 2005 states that any decision that is made must be in the best interests of the person. Such a decision must consider whether the person is likely to regain decisional capacity in the future, involve the person as much as possible, consult all the relevant people, consider all the relevant information, not make any assumptions without evidence, pick the least restrictive option, and consider past, present, and future wishes.

References

  • Beauchamp, T. L. and Childress, J. F. (1979). Principles of Biomedical Ethics. New York: Oxford University Press.
  • Frankfurt, H. (1971). “Freedom of the Will and the Concept of a Person”. Journal of Philosophy, 68: 5–20.
  • Fulford, K. W. M. (2004). “Ten Principles of Values-Based Medicine”. In J. Radden (ed.), The Philosophy of Psychiatry: A Companion, pp. 205–234. New York: Oxford University Press.
  • Grisso, T., Applebaum, P. S., and Hill-Fotouhi, C. (1997). “The MacCAT-T: A Clinical Tool to Assess Patients’ Capacities to Make Treatment Decisions”. Psychiatric Services, 48: 1415–1419.
  • Office of the Public Guardian (2005). Mental Capacity Act 2005 Code of Practice. London: The Stationary Office.
Updated on February 20, 2024

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