Consent and competence—the Australian, NZ and UK perspectives

Introduction

Consent is necessary for any clinical intervention performed on a patient and the higher standard of informed consent has become accepted.

Consent is an essential basis for any medical intervention and has ethical, legal and administrative elements.

Historically, the need for consent may have been applied more variably than today. The American physician, Oliver Wendell Jones said in 1871 to his students: ‘your patient has no more right to all the truth than he has to all the medicine in your saddle bags and should get only so much as is good for him’. Self-determination was addressed in 1914 by Justice Cardozo who said: ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body’. The pendulum has recently swung in the direction of person centred care, patient autonomy and informed choice to the extent that clinicians now need to go to extensive efforts to ensure that enough specific information is given to the patient prior to consent being obtained and the threat of successful litigation, although rare, serves as a potent stimulus to this.

Respect for patient autonomy is enshrined within consent law and to impose care or treatment on patients without respecting their wishes is illegal and unethical.

Consent serves to protect the patient from assault and battery, namely unwanted medical interventions. The more exacting standard of informed consent requires that the patient be given and understand adequate and appropriate information specific to the procedure or intervention to be performed. There is debate around what defines reasonable consent practice in different clinical circumstances. There is also debate around the ethical and legal interpretations of the principles underpinning informed consent, which may vary according to local jurisdiction, subjective interpretation and may, in practice, deviate from the theoretical ideal.

Legally, informed consent protects the patient from assault and protects the clinician from an allegation of assault. On an ethical level, the clinician should aim to facilitate autonomous decision making around treatment goals as jointly agreed with the patient. From an administrative point of view, consent documentation serves as proof of a systematic check that the patient received information concerning, and agreed to, the procedure undertaken. The consent form is only the documentation of consent having been obtained and should not be seen as equivalent to or a substitute for the consent process.

Consent

All medical treatment is based on legal and ethical principles. The four basic ethical principles in medicine are:

• Beneficence: the duty to do the best for the patient.

• Non-maleficence: the duty to do no harm to the patient.

• Autonomy: the right of individuals to make decisions on their own behalf.

• Justice: the fair distribution of resources, incorporating the notion of responsibility to the wider community.

Resources may need to be rationed to ensure fair and equitable distribution, and no patient has the right to demand treatment not felt to be indicated by the treating clinician.

There is a requirement that patients consent to the specific interventions proposed, provided they have sufficient information to make an informed choice and are competent to do so. It is the job of the emergency physician to ensure that the patient is sufficiently well informed to make the choices that best meet his or her own needs in the context of patient-centred care. Legal judgements have centred around the nature of the relevant material risks disclosed and whether the patient was actually given sufficient specific information to make an informed choice, in addition to the determination of whether a particular patient has competence in a specific situation.

The term ‘informed decision making’ is preferred by some to informed consent as it reflects consideration of patient autonomy and recognizes the importance of partnering with patients in making decisions about their health care. Consent should be considered as a two-way process in emergency medicine, with an exchange of adequate and relevant knowledge between a patient and the emergency physician, or nurse in some circumstances, and the end goal should be to share the aims of treatment, although it has been suggested that the means of getting to the shared end could reasonably be guided by the clinician, if acting in the patient’s best interests.

Failure to obtain informed consent can lead to prosecution. The risk of litigation is related to patient dissatisfaction due to perceived lack of clinician communication or rapport, therefore this should serve to build in good communication skills as an essential part of the consent process.

Consent requires the clinician to take an active role in giving information and choice, while respecting the patient’s wishes. The concepts of competence, provision of adequate information and the voluntariness with which consent is given are crucial in the consideration of obtaining valid consent or seeking an informed decision. In Victoria, Australia, an adult patient is competent to provide informed consent if they are able to understand, retain, use or weigh up information about the general nature and effect of the proposed medical treatment and communicate their decision to consent to the treatment. If the patient is not able to provide informed consent, his or her instructions regarding care can be communicated via a legally witnessed advance care directive. Recent legislation (Medical Treatment Planning and Decisions Act 2016) has specified two forms of statement a person may include in their advance care directive:

• An instructional directive, where a person may either consent to or refuse a particular medical treatment or form of therapy.

• A values directive, where a person may make more general statements about their preferences and values and what matters to them. If the person has not included a relevant instructional directive, then the clinician will need to obtain consent from a medical treatment decision maker to provide treatment.

Clinicians are required to make a reasonable to attempt to seek and follow the instructions in a directive. This is often difficult to validate in an emergency situation.

The recent changes to Victorian law enshrine the concept of autonomy and support of the person’s rights in the following ways:

• 1.

  A person has the right to refuse medical treatment in most circumstances.

• 2.

  The medical practitioner must usually seek the person’s consent prior to carrying out medical treatment.

• 3.

  A person’s capacity to consent is assumed unless there are indications otherwise.

• 4.

  A competent person can refuse treatment in relation to a current or future condition by completing a valid instructional directive.

• 5.

  Likewise, the person’s medical treatment decision maker can consent to or refuse treatment on their behalf if they no longer have the capacity to do so themselves.

Treatment without consent may be considered an assault, although the law is generally pragmatic, and as long as the clinician is able to demonstrate that they gave information in a manner that most reasonable patients would wish to know, acted in the best interests of the patient, and in a manner that most reasonable professionals of similar clinical background and seniority would have done. Judgements may take into account whether the treatment was carried out in an emergency rather than an elective situation, and documentation should aim to demonstrate the circumstances under which the decision was taken at the time. There has been debate in both Australian and UK law around what constitutes the reasonable standard of care around consent practices and whether the standard should be that which is thought to be reasonable by a responsible body of professional opinion, known as the Bolam standard. The Bolam ruling was challenged in the Bolitho case which ruled that even expert clinical opinion may be challenged if it was felt to be illogical and not to stand up to analysis. Legal discussion has also centred around precisely what information most patients in a particular situation would want or need to know in order to be considered adequately informed. This principle was the deciding factor in Rogers vs Whittaker, in which consent given by the patient was held to be invalid on the grounds of a ruling that insufficiently detailed disclosure by the surgeon did not allow the consent to be informed. Judgements are likely to be subject to location-specific jurisprudence and to consideration of the urgency of the situation; however, it should be emphasized that there is a strong need to demonstrate, and to document, that the decision around gaining consent was taken in good faith, with the available evidence at the time, in the patient’s best interests.

To present only a one-sided option may be seen as a form of coercion. However, there is much potential for debate on ethical and legal points of what defines full, relevant and expected. This is not surprising as the literature around informed consent comes from multiple disciplines including clinical, legal and ethical cases, and judgement is open to unique interpretation.

The clinician is encouraged to be open and transparent in their communication with patients, and that all relevant information pertinent to the procedure and outcome be disclosed in a manner that provides the patient with all the information needed to make an informed decision.

The patient has the right to self-determination. Consent lies at the heart of the medical contract between the clinician and the patient. Medical investigation and treatment are essentially voluntary acts, which the patient consents to the clinician performing.

Consent may be given in several ways: implied, verbal or written. If the patient voluntarily presents to the emergency department (ED) then some degree of consent is implied, although consent must be specific to the intervention proposed. Simply presenting to the ED with a severe headache does not automatically imply consent to lumbar puncture, for example. Such a procedure would usually need sufficient explanation in order that the patient understood what was to be done and the potential consequences of not doing the procedure, before the consent was given. One should consider the clinical context when contemplating the mode of consent. If a doctor says ‘put your arm out straight because I need to take some blood for a test’ and the patient cooperates by extending his or her arm voluntarily this can be taken as implied consent for venesection. Verbal consent is when the patient orally states agreement to the treatment or procedure (which usually does not carry a significant risk). Written consent is generally sought before more invasive, potentially complex or prolonged procedures, and where the treatment or procedure carries significant risk such as procedural sedation for hip relocation in ED and surgery under general anaesthetic. Written consent is not more valid than verbal consent that is documented, but it is easier to prove.

Adjuncts to written consent may serve to strengthen both the patient’s understanding of the procedure and to protect the clinician. These may include procedure-specific consent forms and patient information leaflets detailing what to expect after local anaesthetic or recovery from procedural sedation.

Consent must be sought after a full and relevant explanation of what is to be done and the expected results, risks and the consequences if it is not done. The explanation should, as much as possible, be balanced and realistic in describing the advantages and disadvantages of each option. Informed consent or decision making requires that clear, accurate and relevant information must be given to the patient. Legal judgements have defined the importance of considering what may be material or significant to that particular individual when disclosing information. Essentially, the patient should be provided with information regarding: (1) treatment options; (2) the foreseeable consequences and side effects of any proposed treatment or intervention; and (3) the consequences of not proceeding with the advised treatment. This information should be conveyed in unambiguous terms and in a manner that is likely to be understood by the patient. Language and other communication needs must be met and there must be an opportunity for the patient to ask questions and to reflect on the information given. It is important that the clinician is aware of their patient’s level of health literacy. Health literacy is defined as the capacity of a person to access, understand and apply information to make effective choices about health and health care. People with low levels of health literacy are one and a half to three times more likely to have an adverse health outcome, and in 2006, the Australian Bureau of Statistics identified that almost 60% of adult Australians have low health literacy. Understanding the impact of language, culture, age, socioeconomic and educational advantage is relevant to any discussion on informed consent.

The information should be given by the clinician responsible for the intervention or a delegate who is suitably qualified and has sufficient knowledge of the proposed intervention. Hence in the public hospital system interns are discouraged from obtaining consent. It is appropriate for a doctor to give advice as to the best clinical options and for the reasons for this professional opinion. Such an opinion is frequently expected and desired by patients, and it cannot be considered as coercive unless the information has been presented in a manipulative fashion in order to elicit a particular choice. It is important to avoid subtle forms of information bias, for instance, presenting the patient with only the benefits of having a fracture reduced on an operative list under general anaesthetic in order to minimize workflow disruption in ED, without the relevant statistics of complications of general anaesthetic versus those of procedural sedation in the ED.

In Australia, it is common practice for hospitals to assist staff in making their communications contextual and understanding the unique needs and preferences of indigenous patients. Indigenous peoples experience disadvantage across a number of socioeconomic indicators and English is often a second language. Therefore indigenous people are at risk of lower individual health literacy. In New Zealand, the Treaty of Waitangi creates a particular specification in relation to Maori, whereupon doctors may be expected to include the extended family in decision making and to allow the family to be present with the patient. Similarly, clinicians in Australia need to be aware of family and kinship within an indigenous community and how it may impact on the decision-making process. There are other cultures that may have similar expectations within the multicultural environments of both Australia and the UK.