Issues Magazine

Ethical Aspects of Consent

By Paul A. Komesaroff (1) and Malcolm Parker (2)

The legal and ethical nuances of consent and their applications in health care can be challenging and controversial. Determining competence is a key task.

Consent is a central topic in bioethics. It is linked to many other key areas of concern in both ethics and health care, such as competence, autonomy, privacy and confidentiality, and the nature and extent of mutual responsibility within a community.

In our society the rights of individuals to make decisions about issues relating to their personal welfare are attributed great importance. Indeed it is assumed that – at least in the setting of health care – decisions should be undertaken after consultation and with the agreement of the people concerned wherever possible. This is the essential idea underlying the concept of consent.

However, despite its apparent simplicity, in actual practice the nature and practice of consent can raise issues of significant difficulty and complexity and is subject to ongoing controversy.

Following the Nuremberg trials after World War II and subsequent revelations about unethical research practices in the United States and elsewhere, increasingly stringent consent requirements were developed for medical research. The World Medical Association’s Declaration of Helsinki (1964) was the first codification of ethical requirements for medical research, and included an explicit focus on the issue of consent.

With the social and cultural change in the western world from the 1960s, which was associated with greater attention to individual rights, decreasing deference to authority, a stronger sense of the importance of personal autonomy, better access to education for most people and so on, increasing emphasis was placed on consent, not only in the context of research but also in clinical practice. This has led to a complex array of ethical guidelines and legal requirements that define and clarify the concept and outline the ways in which it should be implemented.

It should be noted that discussions on this subject commonly speak of “informed consent”. However, this is essentially an American term that has limited application in Australia, especially from the legal standpoint. Accordingly, we will mainly just refer to “consent”, although the term is used with a more technical meaning than what is assumed in ordinary language.

Consent, Refusal and Decision-making

In our daily lives we consent to many different things. In health care we may consent to professionals receiving private information about us, to the conduct of investigations for the sake of diagnosis, and to the carrying out of treatments of various sorts, including operations and administration of medications.

The paradigm case of consent is the performance of a medical procedure or investigation, which can involve significant risk to the patient. If, in this setting, consent is the active authorisation of treatment, not merely the passive agreement to whatever a doctor or health provider advises, based on rights of self-determination we logically should also enjoy the right to refuse treatment. Indeed, this is the case in many, but not all, healthcare settings.

There is said to be a symmetry between consent and refusal. However, it should be noted that on this subject there may be differences in the views taken in different societies. For example, it is not universally accepted that an individual has a right to refuse life-saving treatment or the provision of food and drink.

Consent and the Law

Consent is both an ethical and a legal concept. However, the ways in which the term is understood in the two domains is not always identical and in any particular discussion it is important to be clear about whether the focus is on law or ethics. This itself is an important conceptual point because it is not in general the role of the law to determine the content of ethical decisions but rather to establish the social framework within which individuals and communities can decide freely and without coercion on ethical matters that affect them. This is sometimes complicated because many laws undoubtedly arise out of community concerns of an ethical nature and reflect the personal attitudes of politicians and public officials.

Requirements for Valid Consent

The general ethical requirements for consent are competence, voluntariness and being adequately informed. In the western jurisdictions these are also requirements for valid legal consent. In addition, consent must be specific for the procedure contemplated, and it can only be valid if the procedure itself is legal.

These requirements are important for both theoretical and practical reasons. To provide valid consent we clearly have to be capable of making a decision, to do so freely and to base that decision on a full and accurate understanding of the facts and any other relevant considerations. In addition, our consent applies to a specific matter at hand and usually does not apply to a general state of affairs or particular issue or principle.

Ethical beliefs and legal rights do not always coincide. We cannot legally consent to voluntary euthanasia, since it is illegal, even if we feel strongly that it should be permitted.

Furthermore, the legal response to lapses in ensuring consent may not always be consistent with intuitive expectations. Recently in Britain a surgeon mistakenly removed a transplanted kidney instead of the other, diseased, kidney from a woman. Clearly she was wronged, as she did not provide consent for the transplanted kidney to be removed, and the result was the need for dialysis following the operation. However, the legal wrong committed in this case is not, as one might assume, that of medical negligence, but another sort of wrong: medical assault or battery. These examples highlight the importance of distinguishing between ethical and legal discourses when discussing consent.

Competence

Competence or decision-making capacity is a key condition of consent. Competence traditionally refers to the ability of a patient to comprehend, believe and understand the information provided. This is conventionally construed as a cognitive ability, although this has been criticised recently as restricting the concept, and not recognising the part played by the emotions, values and intuitions in decision-making, and the importance of personal, social and other contextual factors. Certainly, both clinicians and researchers need to take these factors into account when assessing competence, which is an important but underemphasised aspect of clinical skill.

The competence of a person may vary from situation to situation and from time to time. For example, someone may be competent to authorise a simple first aid measure but not more complex treatments. While some individuals are permanently incompetent, either from congenital or acquired disease, some people’s competence may be only temporarily impaired, for example due to the effect of illness, drugs or alcohol. In many cases, the restoration of temporarily impaired competence is an important clinical responsibility.

The core abilities of comprehension and understanding form the foundation of what is termed a “functional” approach to competence, which emphasises the importance of ensuring the conditions required for free decision-making and then accepts whatever outcomes emerge as a result. This is ethically preferable to an approach that is sometimes adopted, which emphasises the nature of outcomes, basing the assessment of whether someone is competent on the reasonableness of their actual decisions. It is also preferable to relying, for such a judgement, on the person’s overall status – for example their age or whether they suffer from a mental illness – which is clearly far too general and imprecise.

In addition to comprehending, believing and understanding the information provided, to be judged competent some additional conditions must be satisfied. For example, the person concerned must be able to retain, recall and integrate the information in the light of his or her situation, goals and values, understand the consequences of any decision, including the risks of each choice, evaluate the various options, rationally manipulate the information, justify the choice made, and communicate both the decisions and process underlying it to others.

While a person’s competence may vary from situation to situation or from time to time it is a different matter to assert that there are degrees of competence. Some people have, for example, tried to categorise competence as “adequate”, “marginal” and “inadequate”.

However, this approach is problematic. For example, just what would marginal competence consist of? If it does not constitute competence but the person may in other circumstances become competent, this arguably collapses into incompetence.

Furthermore, an approach emphasising degrees of competence gives little practical help, because what we need to know is whether a particular decision satisfies the conditions of competency – that is, whether in a given case a threshold has been reached. The tensions between these and other concepts of competence become important in relation to the consideration of the risks associated with certain procedures.

Whether someone should be held to a higher standard of competency in a situation where refusal of treatment poses very high risks, including death, has also been the subject of debate. One argument is that all the conditions of competency must be fully met where a decision of grave importance is to be made, whereas less rigour is appropriate for a trivial decision. For example, a small child may be allowed to make minor decisions about how a treatment might be administered but not about whether life-saving treatment should be given or withheld.

A counter-argument is that complexity is not the same as seriousness of outcome, and if we accept that a higher level of competence is required for complex decisions, this may rule out some people from making them. The risk of death from not having a treatment may, in many cases, be a straightforward matter that is easily understood, and to require some higher degree of competence in such cases would be inappropriate and unnecessary.

In addition, it is claimed that such an approach confuses the assessment of competency with a different ethical question: that of our responsibility to prevent individuals under our care from coming to harm. This controversy is an ongoing one but may be partially resolved by the recognition that the important thing in serious cases is to take great care to communicate carefully and to assess competence, thereby maximising the chances that a competent decision will be made.

Cases Where Consent Is Not Possible

Generally speaking, no medical procedure should occur without consent, in the sense that we need a special licence to do things to other people that would, in normal circumstances, be unacceptable. Consent provides such a licence. Few circumstances now exist in which consent to medical management is not required by the common law or by specific legislation.

In situations of emergency it is generally agreed that where the potential harm associated with the withholding of treatment is significant it is ethically appropriate to treat without consent, since we would be able to avoid the greater harm by treating. In non-emergency settings, when a person is temporarily or permanently incapable of making medical decisions, consent must still be given, although by someone else. This has not always been the case, or at least not to the same extent that has developed in recent years.

As the dominance of medical paternalism has given way to an emphasis on patient autonomy, the need to act in the patient’s best medical interests, particularly in the case of incompetent patients, has been largely replaced by “substituted judgements” where someone close to the patient, usually a spouse or family member, becomes the decision-maker. Substitute decision-makers are generally charged by the law with deciding in a way in which they believe the person would have decided had he or she remained competent. Many jurisdictions now also make provision for people to write “advance health directives”, which extend directly or indirectly patients’ rights to refuse (and occasionally to consent in advance to) medical treatment.

Another important instance where special conditions for consent for medical treatment apply is when a person is assessed and admitted to a health institution as an involuntary patient under mental health legislation. The conditions under which this may occur are strictly defined, although they vary to some extent between jurisdictions.

Consent and Research

The broad ethical principles underpinning consent to medical treatment and consent to research are the same, and the need for full information to be provided to research participants is generally recognised, although it is often impossible to know in advance the risks and benefits of a particular research program. This uncertainty should be emphasised in the information provided to participants.

In Australia, the guiding document for the regulation and conduct of research involving human subjects is the “National Statement on Ethical Conduct in Human Research”. This states that obtaining consent should involve: (a) provision to participants of information about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form or publication of research results) at their level of comprehension; and (b) the exercise of a voluntary choice to participate. A person may refuse to participate in a research project and need give no reason or justification for that decision. Consent must be given for any research involving people who lack decision-making capacity but it is generally agreed that in such circumstances not only should it not be contrary to the best interests of the person but the risks of the research must be no greater than those that would be encountered in routine clinical practice, and its outcomes must potentially contribute to improvements in treatment.

There are now legal processes in most jurisdictions that determine who can consent to research involving incompetent people, often involving a guardianship authority.

Controversies and Critiques

As already indicated, the concept of consent has at times given rise to significant controversy. In addition to the issues already mentioned, it has been criticised on the basis that it involves an excessively narrow rationalistic conception of competency.

The dominance within western bioethics of the autonomy–rationality model of decision-making has in recent years been challenged on the basis that it pays insufficient attention to context, motivation and meaning and is excessively limited to cognition. According to this view, people with particular kinds of diseases, such as neurodegenerative diseases and mental illnesses, may be discriminated against by a primarily cognitive approach.

Furthermore, it is argued, this approach ignores the fact that we decide and act not only in relation to rational arguments and reasons but also according to a range of emotions, intuitions and values, often not at a conscious level. Accordingly, biographical, social and contextual factors should also be taken into account when assessing competency, and may arguably expand the idea of competence beyond a dependence on rational thinking.

Certainly, the fact that we act, as just described, on the basis of emotions, intuitions, values, and personal, social and contextual factors does not invalidate or undermine decisions we make in highly charged circumstances. Indeed, it is widely recognised that in daily life decision-making often includes the appreciation of a wide range of kinds of information and the evaluation of risks and benefits in relation to personal values and other factors.

The concept of informed consent has also been criticised on the basis that it fails to ensure that patients’ medical wishes are fulfilled because we can never be sure that the choices offered do not reflect the values and preferences of the physicians describing the possibilities. This criticism draws attention to the finely balanced relationship between clinician and patient and the complex and fragile nature of communication between them.

This relationship is no doubt partly dependent on the personal values of each participant. As with other interactions involving ethical content it also may involve a delicate, ongoing process of negotiation and compromise.

In fact, the vast majority of medical decisions are taken in an ethical environment in the absence of any obvious dilemma. They are made within an organic, ongoing relationship in the spirit of open dialogue between doctor and patient. This is precisely why the functional approach to consent and competency, which emphasises the conditions which make a free and open decision possible, is preferable to one based on a pre-existing idea of what constitutes good or appropriate outcomes.

Conclusion

We have highlighted the fundamental importance of the concept of consent in medicine and medical research, and indeed in daily life. We have sought to show that while there are some clear conditions that need to be satisfied for consent to be valid, in many cases there are also significant areas of uncertainty and doubt.

A key concept underlying consent is that of competency, and this in itself is often difficult to assess. We have also highlighted the fundamental conceptual difference and occasional practical discrepancies between the ways in which consent is understood from the points of view of ethics and law, and have adverted briefly to a number of areas in which ongoing controversies exist.

Further information about clinical aspects of bioethics, including consent and competence, can be found in the Monash University Clinical Ethics Resource http://mnhs-teaching1b.med.monash.edu.au/Public/Clinical%20Ethics