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Informed Consent in the Code of Health and Disability Services Consumers' Rights

Presentation to the 8th Annual Medico-Legal Conference by:

Katharine Greig, Legal Manager

8 February 2000

1. Background

The purpose of the Health and Disability Commissioner Act 1994 ("the Act") is:

"To promote and protect the rights of health consumers and disability services consumers, and, in particular, to secure the fair, simple, speedy and efficient resolution of complaints relating to infringements of those rights."

Section 20 of the Act provides for the enactment of a Code of Rights by regulation. Under s20(a) the Code is required to contain provisions relating to the principle that:

"Exept where any enactment or any provision of the Code otherwise provides, no health care procedure shall be carried out without informed consent." (1)

Section 20 also requires the Code to provide for "the duties and obligations of health care providers" as they relate to the principle of informed consent. Further direction to ensure, as far as possible, that consent is given with full comprehension of the consumer's rights is set out in s20(1) (d) of the Act which requires that the Code contain provisions relating to the duties of health care providers and disability services providers:

" ... as they relate to the measures (including the provision of interpreters) necessary to enable health consumers and disability services consumers to communicate effectively with health care providers and disability services providers."

The Code of Health and Disability Services Consumers' Rights ("the Code") was promulgated as a regulation under the Act and came into force on 1 July 1996. The Code rights relating to informed consent (in particular, Rights 5, 6 and 7) reflect the requirements set out above.

The purpose of this paper is to examine consumer rights and provider obligations under the Code in relation to informed consent. While I am not able to give advance interpretations of the Code's application, I hope the following discussion will help to clarify the Commissioner's approach to interpretation of the Code's requirements for informed consent.

2. The Elements of Informed Consent under the Code

The Code is based upon the central right of health care consumers to be 'fully informed' in order to make an informed choice. As the Code makes clear, the requirements for informed consent are more complex than a 'one-off action' to authorise a medical intervention. Rather, informed consent is a process which comprises a number of components including competence, disclosure, understanding, voluntariness and consent.

The process of informed consent is embodied in three essential elements under the Code:

• effective communication between the parties (Right 5)
• provision of all necessary information to the consumer (including information about options, risks and benefits) (Right 6) .
• the consumer's freely given and competent consent (Right 7) .

3. Right 5 - Right to Effective Communication

Right 5 of the Code sets out the right of health and disability services consumers to effective communication from providers. It states:

1. "Every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. Where necessary and reasonably practicable, this includes the right to a competent interpreter.
2. Every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly, and effectively."

Many of the complaints the Commissioner receives are essentially about a lack of proper communication between the consumer and provider. When discussing the medical practitioner's duty to communicate in an appropriate and effective way in a paper delivered to a medical law symposium last year, Chief Justice Elias noted:

"There is something of a tightrope here. A medical practitioner cannot be made a guarantor of the patient's comprehension, any more than he can be a guarantor of the effectiveness in treatment. ... Communication however, is central to the relationship between medical practitioner and patient. The question of adequacy in communication is not able to be evaded." (2)

Effective communication is part of the process that optimises informed decision making. It is at the heart of the consumer's degree of understanding, the quality of clinical decision making and the process by which the decision making is informed. (3)

In giving a consumer information the provider should not see herself or himself as simply meeting legal requirements or institutional standards, or providing value-neutral data. Rather, the provider should see herself or himself as participating in a shared dialogue which should be responsive to the needs, wishes, capacities and expressed concerns of the particular consumer. This is in recognition of the uniqueness of the particular individual and therefore the circumstances in which they are entering into the decision.

Right 5(2) emphasises the importance of an environment that enables both the consumer and the provider to communicate openly, honestly and effectively. A number of factors may be relevant in considering how to create an environment in which effective communication can occur. These may include extending consultation times so that questions can be asked and honest and accurate answers given, using plain language rather than medical jargon or using visual or written explanations, diagrams or models. The involvement of support persons and whanau can also be of assistance. The important thing is for providers to be sensitive to the needs of the consumer and to adapt the method and form of communication accordingly. This includes being sensitive to any religious or cultural needs, values and beliefs of the consumer.

Right 5 Case Studies

Example 1: No Breach of Right 5 by an Orthopaedic Registrar 

The consumer had surgery involving exploration of the lumbar spine and a discectomy at a private hospital. Surgery was difficult and there were number of complications post operatively including the consumer suffering considerable pain and weakness in his legs. The orthopaedic surgeon who had performed the operation had to leave town unexpectedly shortly after the operation and the consumer was transferred into the care of a second orthopaedic surgeon. Due to his condition the consumer was transferred to a public hospital three days after surgery.

The consumer made a number of complaints about his care. One complaint involved the way he was told by an orthopaedic registrar about the results of an MRI (magnetic resonance imaging) scan done four days after surgery.

The consumer advised the Commissioner that he was told that he would be going to a different city later that day for an MRI scan. The consumer asked to see the orthopaedic surgeon but he was not available and instead he was seen by the orthopaedic registrar. The registrar told him that his problem could be one of three things - a blood clot, damage to the spinal cord or damage to the nerves. The consumer stated that:

"We [my family were present] asked him what the outcome of each case would be and he advised if it was a blood clot an operation would remove this but of the other two he just shrugged his shoulders and said nothing more."

The consumer went for the MRI scan and consequently returned to the public hospital. He advised the Commissioner that he "was woken about approximately 9.15pm by the orthopaedic registrar to tell me they had the report back from the MRI unit, which had been faxed through. He told me that my condition was inoperable that there was nothing more they could do".

The orthopaedic registrar advised the Commissioner that on the day the MRI scan was performed he was contacted at approximately 9.00pm by a radiologist with a verbal (preliminary) report of the MRI scan. The orthopaedic registrar stated:

"I was of the opinion that the consumer would appreciate hearing the result as soon as possible, therefore I went to the ward soon after 9.00pm and on entering his room found him to be sleeping. My presence in his room caused him to rouse. After ensuring that the consumer was fully awake I reiterated to him that there was no indication for urgent surgery and that the management team would discuss subsequent management with him in the morning. After our discussion I believed the consumer understood what was said and thought that he had no concerns which needed addressing at that time, therefore I took my leave.'"

The clinical notes made by the orthopaedic registrar the same evening record that there was to be no surgical intervention that night.

The Commissioner's opinion was that the registrar had not breached Right 5. She noted that the clinical notes made by the registrar on the evening he spoke to the consumer indicated that the registrar had advised the consumer that there was no need for surgical intervention that night, not that he had said that his condition was inoperable.

Notwithstanding that there was no breach, the above example illustrates the potential for miscommunication and the importance of the provider taking the time to ensure that the consumer understands the information provided.

Example 2: Failure to provide environment that allowed consumer to communicate openly, honestly and effectively - Breach of Right 5(2) by Massage Therapist - 98HDC14193

The consumer visited a massage therapist he had not been to before for a therapeutic massage. The therapist's office was in what the consumer described as a disused city council building. The building was full of long corridors and empty rooms. Before the massage the therapist stripped down until he was just wearing a pair of speedos. The consumer described the environment as, "[my] impression's 'X-files' ."

The consumer said that during the massage the therapist boasted that when he massaged somebody they could not resist him. The consumer took this to mean that they could not pull away. The consumer said that when he was undergoing the massage he could not breathe and could not tell the therapist to stop. He also could not tell the therapist that the technique was hurting him.

The Commissioner found that the massage therapist breached Right 5(2) of the Code. The therapist had not provided an environment where the consumer could communicate openly, honestly and effectively with the provider.

Clause 3 - Reasonable actions in the circumstances

One criticism of Right 5 raised by providers from time to time is that it simply is not always practicable to take the necessary steps to ensure effective communication. An important point to note is that applying the rights within the Code is not an 'all or nothing' matter. Clause 3 of the Code provides:

1. " A provider is not in breach of this Code if the provider has taken reasonable actions in the circumstances to give effect to the rights, and comply with the duties, in this Code.
2. The onus is on the provider to prove that it took reasonable actions.
3. For the purposes of this clause, "the circumstances" means all the relevant circumstances, including the consumer's clinical circumstances and the provider's resource constraints."

The Commissioner will take all the relevant surrounding circumstances into account when considering whether a breach of a right has occurred. However, as clause 3(2) makes clear, the onus is on the provider to prove that it took reasonable actions. If the provider can establish this to the satisfaction of the Commissioner, by pointing to established practice, guidelines, patient notes or whatever may be of assistance in clarifying the circumstances in which the act or omission by the provider was made, then the Commissioner must take this into account, as is demonstrated in example 1.

An example of the "relevant circumstances" arises in relation to interpreters. The obligation here is to have a competent interpreter "where necessary and reasonably practicable." A sole general practitioner on the West Coast is unlikely to be able to obtain a low cost Russian interpreter for the occasional Russian speaking tourist that happens to get sick. In this instance, the most reasonable step would probably be to rely on the consumer's fellow tourists, friends or family. On the other hand, it is likely to be "reasonably practicable" for a general practitioner in South Auckland servicing a largely Samoan population to arrange for interpreter services where these are needed.

4. Right 6 - The Right to be Fully Informed

Right 6 sets out the central right of health and disability services consumers to be 'fully informed' in order to make an effective choice as to consent. Valid choices cannot be made and valid consent cannot be given by someone who does not have sufficient information.

The language of Right 6 focuses on the concept of 'choice' as well as the more traditional concept of 'consent'(5) . This is to emphasise that the Code envisages consumers taking an active role in decision-making. Armed with sufficient information consumers are able to make positive choices about services, rather than simply acquiescing in decisions made on their behalf by providers.

Right 6(1) gives consumers a right to information, irrespective of whether a particular choice is being made. It sets out the types of information a consumer should expect to receive - but as the language of 6(1) makes clear this list is indicative rather than exhaustive. Right 6(2) gives every consumer a right to information that a 'reasonable consumer' in that consumer's circumstances would require to make an informed choice or give informed consent. In addition, consumers are entitled to honest and accurate answers to questions about services (Right 6(3) ) and are entitled to receive, on request, a written summary of the information provided (Right 6(4) ) .

What information should be supplied?

The test of what information should be supplied incorporates the objective element of the 'reasonable consumer' but considers this in light of the particular circumstances of the consumer whose rights are at issue, which is a subjective overlay. This test is based on the patient-focused tests developed in North American and Australian Courts in the context of negligence cases. In particular it draws on the decision of the High Court of Australia in Rogers v Whitaker(6) which has since been applied in New Zealand(7) .

In Rogers v Whitaker Mrs Whitaker had to make a decision as to whether to undergo an operation on her eye. She was almost blind in the eye which was to be operated on and was concerned not to lose her sight in her 'good eye'. According to the findings of the trial judge, Mrs Whitaker questioned the surgeon "incessantly" about possible complications. The surgeon considered that the risk that Mrs Whitaker might lose the sight in her 'good eye' was so small that he did not warn her that it was a potential complication. In considering whether the medical practitioner's general duty to advise had been breached, the High Court of Australia rejected the 'Bolam' test formulated by the House of Lords(8) . Under the 'Bolam' test (as enunciated in Sidaway v Bethlehem Royal Hospital) (9) a doctor's duty of care to inform a patient of the risks involved in any proposed procedure or treatment was discharged:

" ... if [the doctor] has acted in accordance with practice accepted as proper by a responsible body of medical men skilled in that particular art".

In Rogers v Whitaker the Court held that there is a fundamental difference between diagnosis and treatment on the one hand and the provision of advice or information to a patient on the other.

"Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often decisive role to play; whether the patient has been given the relevant information to choose between undergoing the treatment is a question of a different order. Generally speaking, it is not a question the answer to which depends upon medical standards or practices. ... Rather, the skill is in communicating the relevant information to the patient in terms which are reasonably adequate for that purpose having regard to the patient's apprehended capacity to understand that information."

The basic duty to disclose was held to be present even where a consumer makes no specific enquiry. Gauldron J stated:

"Where, for example, no specific enquiry is made the [doctor's ] duty is to provide the information that would reasonably be required by a person in the position of the patient".

She also pointed out that the duty to disclose or warn of all material risks was a minimum, not a maximum standard.

Back to the Code

Under the Code the focus is on the consumer's rights and the information the consumer needs. In practice, the obligations under Right 6 require the provider to make judgements, for example as to the 'expected risks' associated with the procedure or treatment and what the 'reasonable consumer in the consumer's circumstances' would want to know. The consensus of "a responsible body of [providers] skilled in that particular art" as to what information should responsibly be given is relevant, but is not the final determining factor in terms of the Code. In deciding what information should be given, and in what manner and form the information should be conveyed to the consumer, the provider must focus on the ability of the consumer to understand the information provided. Good communication is essential in getting the balance right.

Example 3: Failure to give information on side effects and risks and failing to enable the consumer to make an informed choice and give informed consent - Breaches of Rights 6(1) (b) and 7(1)

The consumer visited a general practitioner (out of her hometown) to have a mole on her neck checked. On examining the mole, the general practitioner noticed the consumer had a neck problem. He advised her that he was trained in neck and back manipulation techniques and could treat her problem. The general practitioner advised the consumer that if he treated her she would no longer suffer from pain in her neck, back and groin and commented to the effect that he "could not make it any worse".

After some discussion with the consumer and her husband, the general practitioner carried out the manipulation. The consumer felt dizzy at the time of the treatment and later developed pain in her neck, lower back and hips and shooting pains from her groin to knee in both legs. This required drug treatment for severe muscle spasms from another general practitioner. The consumer was still experiencing pain and discomfort eighteen months later.

The Commissioner found that the general practitioner breached Right 6(1) (b) of the Code as he did not provide the consumer with an explanation of the expected risks and side effects of the proposed manipulation, nor did he explain to the consumer her possible treatment options. The Commissioner also found a breach of Right 7(1) , stating that because insufficient information was provided to the consumer, the consumer could not make an informed choice and give informed consent to the proposed treatment.

This matter was referred by the Commissioner to the Director of Proceedings who laid a charge against the medical practitioner with the Medical Practitioners Disciplinary Tribunal. The Tribunal found the practitioner guilty of conduct unbecoming a medical practitioner and which reflects adversely on the practitioner's fitness to practice medicine.

Right 6(3) sets out providers' obligations to provide honest and accurate answers to questions relating to services. As with Right 6(1) , the language of Right 6(3) makes it clear that this list is intended to be indicative, not exhaustive. This Right recognises that consumers cannot make fully informed choices and give fully informed consent unless their questions are answered honestly and accurately by the provider.

Example 4: Failure to disclose qualifications - Breach of Right 6(1) and Right 6(3)

A mother had taken her young daughter to a general practitioner as the consumer had a weepy navel. The general practitioner sought the assistance of another general practitioner in the practice for treatment of this condition. The second general practitioner had previous experience as a dermatologist in another country, but was not registered in New Zealand as a dermatologist. The second general practitioner saw the consumer seven times over a three month period for treatment of the navel. The mother believed from the information provided by the first general practitioner that her daughter had been referred to a skin specialist.

The Commissioner's opinion was that the first general practitioner's failure to clarify to the complainant the status of the second general practitioner's qualifications was in breach of Right 6(1) and Right 6(3) of the Code.

5. Right 7 - Right to make an Informed Choice and give Informed Consent

The Code is clear that as a general rule services can be provided only if a consumer chooses and gives informed consent to those services going ahead. Right 7(1) provides that:

"Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of this Code provides otherwise."

As set out in Right 7(1) , in some situations the requirement for informed consent can be overridden. Examples of "enactments" which provide that informed consent to treatment is not required in certain defined situations include the Mental Health (Compulsory Assessment and Treatment Act) 1992 and the Tuberculosis Act 1948. "Necessity" is an example of a common law requirement which overrides the requirement for informed consent in Right 7(1) . "Necessity" allows treatment to proceed in emergency situations without the need for informed consent. However, apart from the exceptional situations provided for in Right 7(1) , the consumer's consent is always required before services can be provided.

The Code also makes clear that every consumer has the right to refuse services and to withdraw consent to services (Right 7(7) ) (10) . This is consistent with s11 of the New Zealand Bill of Rights Act 1990, which provides that everyone has the right to refuse to undergo any medical treatment.

Rights 7(1) and 7(7) recognise the autonomy and dignity of the individual and require that providers recognise the right of competent consumers to self determination. It is this right of consumers to make important decisions about their own lives that requires providers to respect, and not to interfere with, consumers' treatment choices. This is so even where providers disagree and/or consider these choices will be bad for the consumer.

Example 5 - Right to Refuse Services - Breach of Right 7(7)

The Commissioner received a complaint from the parents of a new born baby that their baby was given an intramuscular injection of Vitamin K after birth, against their wishes.

A birth plan was completed by the midwife and the consumer five months before the baby was born. It recorded the consumer's wish that no Vitamin K injection be administered to her baby. Vitamin K is an intramuscular injection routinely given to new-born babies to prevent them from developing haemorrhagic disease of the newborn. The midwife explained to the consumer the reasons vitamin K is given and the day after the birth-plan was drawn up, provided some written information on this treatment.

The baby was born with a severely bruised face and head. The midwife explained to the consumer that it was her opinion that the baby required Vitamin K because of the amount of bruising present. The midwife then gave the baby an injection of Vitamin K as she thought the consumer had indicated her consent by her body language. The consumer complained to the Commissioner that she did not consent to this procedure. In the Commissioner's opinion, the midwife breached Right 7(7) .

Written consent

Right 7(6) places a duty on providers to obtain written evidence of informed consent where:

• the consumer is to participate in research
• the procedure is experimental
• the consumer will be under general anaesthetic
• there is a significant risk of adverse effects on the consumer.

Some providers, as a matter of internal procedure, go beyond the requirement of Right 7(6) and require signed consent forms for a number of procedures. The Commissioner's approach is that a consumer's signature on a consent form is not necessarily determinative of compliance with the Code. Rather, the Commissioner looks beyond the form to determine if all the Code's requirements concerning the informed consent process have been complied with.

On occasion, consumers may choose not to give consent in writing. There are a number of reasons for this, including cultural reasons. The wording of Right 7(6) and in particular the use of the word "must" has lead some providers to refuse to provide services unless they are able to obtain consent in writing - regardless of the consumer's wishes. The Commissioner's approach is that so long as informed consent is given, a refusal to give written consent should not be used as a basis for refusing to provide a service.

The Commissioner has taken this approach because the Code is concerned with consumer rights. The requirement for consent in writing is intended to protect consumers by ensuring that providers take steps to secure informed consent and to alert consumers to the fact that some procedures are more significant than others. However, consumers may waive their right to sign a consent form. Where consumers are able to give informed consent but are unable or unwilling to sign a consent form, the Commissioner's view is that documented consent can be achieved by other means.

Research and the writing requirement

Some researchers have raised concerns about the requirement that informed consent in writing must be obtained if the consumer is to participate in research. Their criticism is that this makes the undertaking of research unworkable in some circumstances.

The Commissioner addressed this issue in the consultation document for the review of the Act and Code undertaken last year. She stated that in her view the Code is sufficiently flexible to address most of the difficulties said to be experienced with this requirement. Her reasons for this were set out in the consultation document as follows:

"Clause 3 of the Code makes it clear that providers, including researchers, will not be in breach of the Code if they have taken reasonable actions in the circumstances to give effect to it. What is reasonable is assessed on a case by case basis. For example, there may be situations where obtaining written consent is culturally inappropriate and potentially in breach of Right 1(3) . In such circumstances the obtaining of ethical approval for the research and the fact that it has a valuable public health objective are factors that may indicate the researcher acted reasonably in proceeding, even in the absence of written consent. In all cases the basic obligation to obtain informed consent remains."

A number of quite detailed submissions were received in response. As set out in the report on the review the Commissioner provided to the Minister of Health in October 1999, some submissions reiterated the practical difficulties which arise from the need for consent in writing. For example:

"The Ethics Committee almost always requires written consent but accepts that on a few occasions, written consent is not required and on even rarer occasions, is not appropriate. A very good example of the latter is where research is undertaken on health related issues where the potential research participants have broken the law. This Committee has looked at a number of research proposals into intravenous drug use and in all cases, has accepted that any requirement for written informed consent would be inappropriate. There is no way that intravenous drug users would willingly identify themselves as participating in illegal activities, yet the benefits of the research for them are potentially great. The Committee is of the view that such research should proceed and that any requirement for written consent in these cases would jeopardise the research.

Other instances where this Committee would not require written consent are: unlinked anonymous surveys where it is preferable for confidentiality to be preserved by not having written consent; retrospective studies where there is access to medical records; and the obtaining of informed consent would be a logistical nightmare making it almost impossible for the research to be carried out; finally cultural considerations where signing of one's name would be considered culturally offensive.

This Committee is aware that clause 3 states that researchers will not be in breach of the Code if they have taken reasonable actions in the circumstances to give effect to it. However, at present, when research proceeds without written consent, researchers are in breach of the Code and they can only assume or hope that should a complaint be lodged with the Commissioner, the Commissioner will agree that they have taken all the reasonable steps. That is not a comfortable or enviable position for researchers to be in as they are in breach of the Code, until deemed otherwise." - (Wellington Ethics Committee) (12)

Similar concerns were expressed with regard to HIV and AIDS research, where a potential participant may not want to sign a consent form or have their name recorded.

Having considered these submissions the Commissioner remained of the view that, as discussed in the consultation document, the need for consent in writing is a consumer right which the consumer may waive. Furthermore, she noted that the types of concerns raised appeared to be covered by Clause 3 of the Code which states that a provider is not in breach where she or he has taken "reasonable actions in the circumstances" to give effect to its rights and obligations.

The Code and competence

As already covered in this paper, Right 7(1) of the Code requires that, with some exceptions, services may be provided only if the consumer makes an informed choice and gives informed consent. An important component of this is that, to be valid, consent must be freely given by a consumer who is competent to consent.

The Code starts from a presumption of competence. Right 7(2) states:

"Every consumer must be presumed competent to make an informed choice and give informed consent, unless there are reasonable grounds for believing that the consumer is not competent."

Following on from this Right 7(3) provides:

"Where a consumer has diminished competence, that consumer retains the right to make informed choices and given informed consent, to the extent appropriate to his or her level of competence".

The fact that a consumer has, for instance, an intellectual impairment or severe behavioural problems does not necessarily mean that she or he is incompetent to consent to all health and disability services. The provider must focus on whether the consumer has the ability to understand the information necessary to give informed consent. This will depend on the individual consumer and the type of service. For example, the level of competence necessary to consent to treatment with a high degree of risk or complexity or with serious consequences for the consumer will usually be different from that required to consent to minor and low risk procedures. In assessing the consumer's competence to consent, the provider may wish to check with other experts or take into account the views of caregivers or support persons. The assessment of a person's competence is itself a health procedure which should be performed with 'reasonable care and skill' under Right 4(1) of the Code. Certainly if a decision is made that a person is not competent, that should be documented and the reasons stated.

One error which occurs when decisions as to competence are made is that some providers take an 'all or nothing' approach. People are put into categories and uniform decisions are made about competence in respect of everyone within the category. For example, a hospital might issue a policy requiring a consent form to be signed by a caregiver before any treatment is provided to a consumer with an intellectual disability. Another example is a doctor or dentist declining to provide any sort of treatment at all to children under 16 without a parent's consent. In addition to making blanket assumptions about groups of individuals, these blanket assumptions are often applied to an individual consumer's ability to consent to different types of services.

Steps to take where a consumer is not competent - Right 7(4)

If there are reasonable grounds on which to conclude the consumer is not competent to consent, then services should not be provided unless the steps specified in Right 7(4) are carried out. This requirement must be adhered to unless one of the exceptions maintained in Right 7(1) applies - for example an emergency situation exists.

The first requirement of Right 7(4) is for the provider to attempt to obtain informed consent from someone entitled to give consent on the consumer's behalf. Examples of those entitled to consent on the consumer's behalf include a parent giving consent on behalf of a child or a welfare guardian appointed by the court with authority to make health decisions on behalf of the consumer.(13) Assuming that no such person is available, the remaining steps in Right 7(4) must be followed before any service is provided

A fundamental requirement is for the proposed service to be in the best interests of the consumer (Right 7(4) (a) ) . This involves a clinical assessment by the provider of the need for treatment. However, the 'best interests' test may involve the provider not just considering what is in the best interests of the consumer with a narrow clinical focus. It may also involve looking at the consumer's needs, interests and quality of life from a wider holistic view point, as is required by Right 4(4) of the Code.(14)

To satisfy Rights 7(4) (b) and (c) , the provider must also take reasonable steps to ascertain what the consumer would have wished to happen if he or she were competent. Services should only be provided where they are consistent with the informed choice the consumer would have made if competent. Where it is not possible to ascertain this information, the views of other 's uitable persons' able to advise the provider have to be taken into account. 's uitable persons' may include family, partners, friends or caregivers who have an interest in, and a relationship with, the consumer such that it makes them suitable advisors on the type of care they believe is in the consumer's best interests. It is important to emphasise that it is not a matter of obtaining informed consent from a 's uitable person', as the procedure set out in Right 7(4) is based on the premise that no-one who is legally entitled to consent is available. Rather, it is a matter of the provider taking into account the views of 's uitable persons' in deciding whether treatment is in the consumer's best interests.

Example 6: Failure to Consult With Interested Persons - Breach of Right 7(4) - 97HDC7679

The Commissioner received a complaint from the family of the consumer that he received inappropriate treatment from a general practitioner. The consumer suffered from advanced dementia and was not competent to make an informed choice or to give informed consent. His family were interested in his state of wellbeing and had been present during previous examinations of the consumer by the general practitioner.

The consumer developed necrotic leg ulcers. The general practitioner considered admitting the consumer to hospital but decided not to do so, as he believed that the familiar surroundings of the consumer's rest home were important for the consumer because of his confusion and that surgery was not appropriate in view of the consumer's general condition. At no time did the general practitioner consult with interested family members about the consumer's care before deciding on treatment.

In the Commissioner's opinion, the general practitioner's failure to consult with the consumer's family before he decided on the consumer's treatment was a breach of Right 7(4) (c) (ii) .

Advance directives

Right 7(5) of the Code provides that consumers may use an advance directive in accordance with the common law. For the purposes of the Code, an advance directive is a written or oral directive by which a consumer makes a choice about a possible future health care procedure. This directive is intended to be effective only when he or she is not competent.(15) In simple terms, it is giving consent or refusing to consent to treatment in advance.

Children as consumers

The Code does not impose an artificial barrier on the age at which a child can validly give informed consent to services. This recognises that the ability to understand information and make informed choices about particular services is not always tied to the age of the consumer.

The Commissioner considers that all the rights in the Code, including the right to give informed consent, are applicable to consumers of health and disability services, regardless of their age. This does not mean that the age of the consumer should be ignored. Obviously, age is a relevant factor to take into account when determining a child's competence to make a particular decision. The Code simply recognises that the age of the consumer is only one of a number of factors that should be considered. Ultimately an assessment of whether a particular child is competent to give consent to a proposed procedure will depend on the understanding and maturity of the child and the gravity of that procedure.

This approach follows the leading case in this area, Gillick v Wisbech Area Health Authority, which established the "Gillick competency test' for determining when a minor is competent to consent to medical treatment.(16) In Gillick the House of Lords considered the issue of whether contraceptives could be administered to a competent child under the age of 16 years without the consent of the girl's parents. The Law Lords concluded that the provisions of s8 of the Family Law Reform Act 1969 (which is similar to s25(1) of New Zealand's Guardianship Act 1968) did not prevent a minor consenting to contraceptive treatment, providing that the minor was of sufficient understanding and intelligence to fully understand the consequences of what was proposed.

As already stated, where a consumer of any age has diminished competence, he or she retains the right to make an informed choice and give informed consent to the extent appropriate to his or her level of competence. The level of ability necessary to consent to treatment with a high degree of risk or complexity or with serious consequences for the child will usually be different from that required to consent to minor and low risk procedures. Thus, while a child of twelve may be competent to consent to the setting of a broken limb, he or she may lack the necessary maturity and understanding to consent to heart surgery. The key under the Code is to consider each case on its own facts and not to lay down inflexible rules.

Providing consent on behalf of a child

The definition of 'consumer' under the Code for the purposes of the informed consent provisions includes someone entitled to consent on behalf of the consumer. If a child is not capable of consenting, someone else will be required to do so on his or her behalf. The issue of who is legally entitled to consent on a child's behalf is not dealt with directly by the Code and other law on this matter applies. For example, s25(3) of the Guardianship Act 1968 authorises parents and legal guardians to consent to any medical, dental and surgical procedures on a child's behalf. If a parent or guardian cannot be found, this authorisation extends to persons acting in place of a parent.

While the Code gives "consumer" rights to those who are entitled to give informed consent on behalf of the consumer, it is important to remember that the child retains the rights and protections set out in the Code. For instance, where a child is unable to appreciate the consequences of a serious or complicated procedure, they must still be provided with information proportionate to his or her level of understanding. This information must be communicated in a form, language and manner that enables the child to understand it. Therefore, it may be necessary for two alternative sets of information to be provided. One set for the parent or guardian to enable them to give informed consent to the proposed treatment and one set that is appropriate for the child, to enable him or her to understand what is happening.

Informed consent and training

All the rights in the Code extend to those occasions where the consumer and the provider are participating in teaching.(18) Thus the process for obtaining informed consent from the consumer must be followed before any teaching can begin. "Teaching" includes training of providers.(19)

Training may include situations involving unqualified providers such as students. It may also include providers who are only recently qualified. For example, in hospitals junior staff members such as trainee interns and house surgeons gain experience under the supervision of more senior staff. The fact of supervision may indicate that the junior staff member is participating in training, and implies that it is necessary to combine the skills of the junior staff member and the supervisor to provide care of an appropriate legal and professional standard. In this situation it may be reasonable to conclude that the junior staff member has not yet required the necessary degree of skill to provide services to the requisite standard on his or her own. Arguably, the junior staff member is still 'in training' so specific consent is required for his or her involvement in the consumer's case.

In a teaching hospital, it may not be necessary to obtain specific informed consent for every stage of the teaching process. What is necessary is that the consumer is informed that he or she is receiving treatment in a teaching hospital and that parts of the treatment may be carried out by junior staff under supervision. The consumer should also be informed that he or she has the right to ask questions, to have those questions answered honestly and accurately, and can refuse to be involved in training at any stage.

Example 7: Informed Consent While Teaching - Breach of Right 5(1) and Right 9

The consumer was admitted to a public hospital for intensive neurological physiotherapy. The consumer was asked by the neurologist responsible for his care to be one of the subjects of a demonstration in front of a group of general practitioners who were to attend a continuing education session in neurology.

The consumer complained that he was not advised by the neurologist of the exact information about him that was to be conveyed to the general practitioners, nor was he informed of how large the group of practitioners would be. At the demonstration the consumer formed the view that the neurologist wished to show the group that the consumer's problems were psychological. The consumer felt humiliated by this.

Although the neurologist had asked the consumer to attend and had provided some information to the consumer, the Commissioner's opinion was that the neurologist had not communicated effectively enough with the consumer about the purpose of the consumer's attendance and the scale of the demonstration. In her view the neurologist breached Right 5(1) and Right 9 of the Code.

6. Summary

The function of the Code is to empower consumers by recognising that consumers have a fundamental right to self determination. The Code's provisions on informed consent are basic to the Code's cornerstone concept of individual dignity and respect.

Right 5 emphasises the importance of providers communicating effectively with consumers. This involves shared dialogue between consumers and providers in an environment where consumers feel secure enough to participate in the dialogue, to ask questions and to feel that their concerns are being addressed by the provider.

Right 6 provides that consumers should be armed with information that enables them to make positive choices about services. Consumers should be able to feel secure that they are receiving all the information that they require and that their questions are being answered honestly and accurately.

Right 7 is the culmination of the informed consent process. Providers can only provide services to consumers who have made an informed choice and who have given informed consent.

The consumer-focused approach promoted by the Code emphasises that informed consent involves a careful and thorough process leading to the empowerment of health and disability services consumers.

Reference

(1) The direction in s20(a) is limited to "health care procedures" However, acting under s(20) (2) (a) , which authorises the Commissioner to include in the Code provision "for any matter relating to the rights of disability services consumers that the Commissioner considers is of particular importance to such consumers", the Commissioner extended the right to informed choice and informed consent under the Code to disability services consumers also.

(2) "Informed consent - should we follow Rogers v Whitaker?" The Hon. Sian Elias, Brookfields' Medical Law Symposium, 11 June 1999, pp 17-18.

(3) A point noted by Prof. Gavin Kellaway in relation to the potential for successful prescribing and subsequent therapeutic response in the latest New Ethicals Journal "The Importance of Observing Therapeutic Response", January 2000, 43.

(5) The full text of Right 6 is set out in the appendix to this paper.

(6) (1992) 175 CLR 479.

(7) B v Medical Council Elias J, High Court, Auckland, HC 11/96, 8 July 1996.

(8) Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.

(9) Sidaway v Bethlehem Royal Hospital [1985] AC 871.

(10) The full text of Right 7 is set out in the appendix to this paper.

(11) Right 7(6) .

(12) "A Review of the Health and Disability Commissioner Act 1994 and Code of Rights for Consumers of Health and Disability Services Report to Minister of Health October 1999", Health and Disability Commissioner, October 1999, pp. 53-54.

(13) The definition of consumer in clause 4 includes, for the purposes of Rights 5, 6, 7(1) , 7(7) , 7(10) , and 10, a person entitled to give consent on behalf of that consumer.

(14) Right 4(4) provides "Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer". The phrase "optimises the quality of life" is defined in Clause 4 of the Code to mean "to take a holistic view of the needs of the consumer in order to achieve the best possible outcome in the circumstances."

(15) Clause 4 of the Code.

(16) [1985] 3 A11 ER 402.

(17) Clause 4 of the Code.

(18) See Rights 9 and 6(1) (d) of the Code. These Rights also extend to research.

(19) Clause 4 of the Code.