Autonomy and Informed Consent
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Autonomy takes its primary meaning from governmental theory where it refers to the status of a state or nation as being self-governing and free from control or interference from another power. When applied to individuals, the term carries the same meaning: a self-governing person – a personal rule of the self that is free from controlling interferences by others and personal limitations that prevent realization of an individual’s self-chosen plan. In this way, autonomy of individuals is regarded as analogous to the manner in which independent governments determine, implement, and manage policies and responsibilities (Beauchamp and Childress 2012).
Consent means the grant, by a person, of permission for something to take place (e.g., to receive medical treatment) or the agreement to do something (such as entering into a contract). The expression includes both the substance – the specification of what is to take place or what the consenting person agrees to do – and also the form in which consent is expressed, namely, whether in a written document or verbally or implied from conduct.
In various contexts of human interaction, different legal principles define what constitutes legally effective consent. This entry focuses on those elements widely regarded as constituting consent that is ethically sound.
For an act to be autonomous, three components are necessary: volitional, that the person’s decision is deliberate; voluntary, that the act or decision is free from compulsion, threats, or coercion; and cognitive, that the individual has the requisite knowledge to make a decision about their intention. Unless all three components are present, any decision cannot rightly be called autonomous (Beauchamp and Childress 2012).
Of these components, only the first is absolute: acts are either voluntary or not voluntary, and autonomous acts cannot be unintentional. On the other hand, the other components can be matters of degree – a person’s freedom may be limited to some degree but not so much as to prevent an act or decision being autonomous, and the amount of information a person has may not be complete but nonetheless sufficient for the decision to be regarded as autonomous. The context of participation in human research, particularly biomedical research, illustrates the acceptance of such degrees. For example, people with the medical condition in question are likely to be favorably inclined to participate in research about that condition, although the information on which they base their decisions is unlikely to contain a full account of the scientific basis of the research.
Competence or Capacity
An essential premise to assessing whether decisions merit recognition as autonomous decisions is that a decision-maker is competent or has the capacity to make that decision. The criteria for competence are similar to those for autonomy, but the two concepts are different. Autonomy means to be a self-ruling person, and competence means the ability to perform a task, for example, to make a decision.
For a person to be competent or to have capacity, the person needs to be able to take in and retain information about the decision, believe the information, weigh or use that information in reaching a decision, and express the decision.
Because competence is the ability to perform a task, legal and ethical doctrine has consistently held that competence is specific to the task to be performed or the decision to be made. The question is whether the person is or is not competent to make the decision in question – it is not whether the person is competent to make any decisions.
In medical practice, it is important to separate those patients whose decisions, legally, merit recognition from those patients whose decisions do not. The judgment that a patient is competent to make a decision is used to make this distinction. Routine presumptions assist; for example, adults are presumed to be competent unless there is reason to overturn that presumption; for example, an otherwise competent adult admitted to hospital with non-life-threatening injuries who is unconscious is not competent to decide about treatment at that time. On the other hand, children are presumed to lack competence to consent to treatment decisions unless there is reason to overturn that presumption. As children reach their mid-teens, we often refer to them as young people, in recognition of their increasing capacity and maturity. Assessment of a young person’s stage of development and maturity can overturn the presumption against competence to make a specific decision; for example, a young person who has lived with a chronic condition since birth may be competent to make a choice about accepting treatment for the condition. If it is determined that a person is not competent to make a decision, another mechanism needs to be used for that decision to be made on that person’s behalf.
Competence and Autonomy
Competence means the ability to perform a given task, and autonomy means a self-governing person. Competence is a necessary but not a sufficient condition for an autonomous decision. Some, but not all, of the criteria for an autonomous decision may have been satisfied in deciding that the decision-maker is competent.
Even if someone has been found to be competent, he or she may be so affected by external influence or coercion or so lacking in relevant information that the autonomous character of the decision is in doubt. In one case, a young woman who was, at all times, considered to be competent, gave consent to blood transfusion. However, during each of several visits from her mother, who objected to the procedure on religious grounds, the young woman withdrew her consent. Following each visit, the young woman renewed her consent. The question was whether consent or refusal was the autonomous decision of the daughter. In human research ethics, paying participants for their participation has often provoked debate whether such payments amount to “undue influence” and so compromise the autonomy of a competent participant’s choice (Largent and Lynch 2017).
Most people reach their decisions in a familial or social context. These external influences might not affect someone’s choice to the point that it is no longer autonomous. Consequently, some writers have offered an alternative model of autonomy, referred to as relational autonomy, which highlights the social context within which all individuals exist and acknowledges the emotional and embodied aspects of decision-makers (Mackenzie and Stoljar 2000).
Respect for Autonomy
In professional ethics, and particularly medical ethics, discussion of autonomy most commonly emerges as an element in the principle of respect for autonomy. In medical ethics and human research ethics, this principle requires that an autonomous decision to accept or not to accept medical treatment or to participate or not participate in a research project should be respected and followed. In medical professional ethics, increasing recognition of the principle has marked a change in medical professional practice. Of two competing ethical principles – deciding what a doctor thought was best for patients’ welfare (beneficence) and allowing patients to decide for themselves (respect for autonomy) – the latter has come to take priority in treating competent patients.
The recognition of individual choice demonstrates respect for autonomy by ensuring that persons with capacity who make autonomous decisions can express their will and expect it to be respected and acted upon.
Consent is the most common example of the acts or decisions that, when autonomous, merit respect. In the following components for an ethically sound consent, reliance on the elements of the concept of autonomy is apparent.
For an ethically and legally sound consent, the person giving that consent must be competent or have the relevant capacity to give that consent, have received sufficient information about the nature of what is to be consented to, comprehend that information, act voluntarily and freely, and give consent.
Although the principle of respect for autonomy is recognized in the requirement for consent, this application of the principle is not absolute. For example, medical professionals, including paramedics and ambulance officers as well as doctors, may legally administer treatment that is necessary to avert an imminent risk to life or health, without the patient’s consent. In these emergency situations, an ethical obligation to act for the welfare of patients by preserving their life or health outweighs respect for autonomy.
Legal standards apply in many social contexts and impose requirements of substance and process for consent to be legally effective. The most well-known example of these is “informed consent.” This expression is a product of United States jurisprudence but has become commonly used in healthcare, research, and an ever-widening number of contexts (Faden and Beauchamp 1986).
Generally speaking, informed consent means a person’s consent will be neither ethically nor legally sound if that person considers she was not informed or that the disclosed information did not meet the required standard for disclosure. The concept is not accepted in every legal jurisdiction around the world. One problem with giving prominence to “informed consent” is to suggest that being informed is all that matters or the most important test for consent. This emphasis can lead to increasing the quantity of information disclosed, without regard to whether this helps the decision-maker. In human research ethics, this emphasis on disclosure often leads to using lengthy and complex information documents that are so long and so hard to understand that they fail to inform participants effectively (Ennis and Wykes 2016).
Autonomy and Consent
Autonomy and consent are closely related. Consent by a person, of itself, marks a fundamental ethical (and legal) shift in that person’s relationships. By giving consent, a person either permits conduct on the part of others that would otherwise be both unethical and illegal, for example, consenting to a doctor conducting a physical examination, or creates a new relationship with, or a new obligation to, another person or persons, for example, consenting to sell property to another person.
The importance of this fundamental effect of consent is reflected in the ethical requirement that, for consent to be respected, it needs to be autonomous – the decision of a self-governing person.
The tests for both autonomy and consent need to be satisfied for a consent to be ethically worthy of respect because when consent is an autonomous decision, there can be no doubt that it fully expresses the will and values of the decision-maker.
- Beauchamp TL, Childress JF (2012) Principles of biomedical ethics, 7th edn. Oxford University Press, New YorkGoogle Scholar
- Faden RR, Beauchamp TL (1986) A history and theory of informed consent. Oxford University Press, New YorkGoogle Scholar
- Largent E, Lynch HF (2017) Paying research participants: the outsized influence of “undue influence”. IRB: Ethics Hum Res 39:1–9Google Scholar
- Mackenzie C, Stoljar N (2000) Relational autonomy: feminist perspectives on autonomy, agency and the social self. Oxford University Press, New YorkGoogle Scholar