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The Informed Consent Process and the Application of the Code to Children

1. Introduction

 

No health or disability service can be provided to a consumer without his or her informed consent. The right to make an informed choice and give informed consent is fundamental to individual autonomy, and is one of the central elements in the Code of Health and Disability Services Consumers' Rights, a new part of the legislative framework regulating the provision of service. The concept of respect for the intrinsic value and uniqueness of each individual, including children, underlies all the rights within the Code.

The law relating to the ability of children to consent to medical treatment is complex. One thing which is clear is that there is no one particular age at which all children can consent to all health and disability services. Indeed, the development of the law in this area demonstrates a trend away from age-related thresholds, and instead focuses on the competence of the individual child. The Code of Rights reflects this trend. Under the Code, the relevant question is not what is the age at which a child may validly consent to services, but rather whether the level of understanding of a particular child enables him or her to consent to a particular service. There is no blanket answer to this.

This morning I would like to outline the provisions of the Code of Rights relating to informed consent, discuss their application to children and give some examples of cases considered by the Commissioner. While I cannot promise to convert what is an intrinsically complex matter into a simple checklist for providers, I do hope that discussion of the Code will give a clearer understanding of the principles underpinning the issue.

2. Elements of Informed Consent

 

In terms of the Code, informed consent is a process rather than a one-off event. The essential elements of this process are effective communication, full information, and freely given, competent consent. These three elements are represented by Rights 5, 6, and 7 respectively. While the bulk of this paper deals with Right 7 and the ability to consent, it is clear that valid consent cannot be given by someone who doesn't understand what is being consented to. I will therefore address all these rights, which under the Code operate as a group. The obligation under the Code is to take all reasonable action in the circumstances to give effect to these rights.

Effective communication

Many problems of consent arise from poor communication. Right 5 of the Code therefore entitles every consumer to effective communication in a form, language and manner that enables the consumer to understand the information provided to them. Where necessary and reasonably practicable, this includes the right to an interpreter. Further, every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly and effectively.

Depending on the circumstances, creating this environment for children might include one-on-one or group discussions in which appropriate time is allowed for questions to be asked, and honest and accurate answers given. It may also involve using culturally appropriate methods of communication, plain language rather than medical jargon, written or visual explanations, and diagrams, toys or videos. Often, family members or support persons may be involved to assist understanding.

Providing all relevant information

The second essential element of informed consent is to give all relevant information to the consumer. Right 6(2) of the Code gives every consumer a right to information that a reasonable consumer in that consumer's circumstances needs to make an informed choice or give informed consent. In addition, Right 6(1) gives consumers a right to the information they would expect to receive, irrespective of whether a particular choice is being made or consent given, and sets out a list of such information. The list is not an exhaustive one, but rather is indicative of the type of information which a provider should make available. In addition, consumers are entitled to honest and accurate answers to questions about services, and are entitled to receive, on request, a written summary of the information provided. Where the consumer is a child, in deciding what information should be given and in what form, the provider must focus on the ability of the child to understand the information provided.

3. Consent and the presumption of competence

 

Right 7(1)

The fundamental right to informed consent is embodied in Right 7(1) of the Code, which states 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 the Code provides otherwise.

The more general language of "choice" is used to reflect the Code's focus on the active involvement of the consumer in the decision-making process.

Children as consumers under the Code

In recognition that the ability to understand information and make informed choices about particular services is not always tied to the age of the consumer, the Code avoids imposing an artificial barrier on the age at which a child can validly give informed consent to services. Therefore, all the rights in the Code are applicable to consumers of health and disability services, regardless of the age of the consumer, including the right to give informed consent. 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.

The presumption of competence contained in Right 7(2) of the Code forms the basis of the Code's approach to the giving of informed consent by children. The presumption is similar to that which applies in the Protection of Personal and Property Rights Act, and provides that 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. 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.

The Code goes on to provide that where a consumer 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 12 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 blanket rules.

The common law

The approach taken by the Code to informed consent by children reflects that adopted by the courts in recent years. In a number of cases the courts have shown a willingness to give a child the right to consent to treatment or services which are relatively minor and for which the child is capable of understanding the nature and consequences. The leading case in this area is Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402, a case involving a child under sixteen who sought to give consent on matters involving contraception. The English House of Lords held that minors may authorise medical treatment if they are mature enough to understand what is proposed and are capable of expressing their own wishes.

This decision has had wide implications beyond the law relating to contraceptive advice - it also established what is known as the "cillick competency" test for determining when a minor is competent to consent to any medical treatment.

The right to refuse treatment

This test of competence is also relevant when a child seeks to exercise his or her right to refuse treatment and withdraw consent to services under Right 7(7) of the Code. However, the scope of this right as it relates to children is uncertain. The English Court of Appeal in a number of cases has sought to deny children the right to refuse consent to treatment, particularly where such refusal may result in death or severe disability, and subsequently ordered the children concerned to be treated without their consent.

I am unaware of any cases to date in New Zealand which have directly applied the decisions in these cases. It seems generally accepted that Gillick should be followed for a number of reasons, including the importance of "nature" minors being able to seek or refuse health services without fear of parental involvement. I understand that the issue of refusal of services will be addressed in more detail by a later speaker.

Providing consent on behalf of a child

The definition of "consumer" under the Code for 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, the Guardianship Act 1968 section 25(3) 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 the place of a parent.

While the Code gives rights to such persons as "consumers" for the purposes of giving informed consent, it is important to remember that the child retains all the other rights and protections 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 their level of ability to understand. Regardless of whether the child is competent to consent, providers are still obliged to supply the child with information about the procedure or service which is suitable to their age, maturity and interest, and again, this information must be communicated in a form, language and manner that enables them to understand. Therefore it may be that two alternative sets of information is provided - that which is given to the parent or guardian to enable them to consent, and that which is appropriate to the child, to enable him or her to understand what is happening.

The Code and other legislation

The Code cannot be read in isolation from other legal rules. Rather, it recognises that a consumer's ability to consent may be subject to the provisions of other enactments. In addition to the qualification contained within Right 7(1) itself, clause 5 states that the Code does not override other legislation and nothing in the Code requires a provider to act in a manner which would be a breach of any duty or obligation imposed by any enactment, or prevents a provider doing an act authorised by any enactment.

For example, providers need not obtain consent from either the child or the parent/guardian before performing services in emergency situations; or when examining a child on suspicion of child abuse or neglect under section 49 of the Children, Young Persons and their Families Act.

4. Other Code Rights

 

While this paper focuses primarily on the right of children to make informed choices and give informed consent, it is important to remember that children are entitled to all the rights in the Code whenever they receive health or disability services. The Code rights cannot be read in isolation. For this reason, I would like to briefly mention some of the other Code rights which also apply during the process of obtaining informed consent.

Respect - the "Key to the Code"

Consumers are entitled to be treated with respect, to be free from discrimination, and to have services provided in a manner that respects their dignity and independence. The Commissioner has often spoken of the importance of these first three Code rights for consumers who are vulnerable, and commonly, elderly consumers in rest homes are referred to by way of example. However, consumers at the other end of the age-spectrum, such as new-borns, infants and children who are not competent to consent for themselves are also particularly vulnerable and need to be shown particular consideration.

Right to support - Right 8

Every consumer has the right to have one or more support persons of his or her choice present. Depending on the circumstances, a child's support person may also be the person entitled to give consent on his or her behalf. In most cases the presence of a support person, parent or guardian will not be an issue. It is only when safety may be compromised or another consumer's rights unreasonably infringed that the presence of a support person may be denied. There may be situations where it would not be safe for a support person to remain with the child, for instance, during some forms of surgery. The important thing to remember with regard to this qualification, as with the rest of the Code, is that the individual circumstances of each case must always be considered and an attempt made to comply with the Code as much as possible in those circumstances - it is not an "all or nothing matter".

Right to complain - Right 10

Providers can learn from consumers' comments, complaints and suggestions and use them to improve the quality of service and care they offer. For this reason Right 10 of the Code enables consumers to complain about the service they receive, in any form appropriate to them. This includes children, although in practice complaints about service provided to a child will often be made by the child's parent or guardian. Children who exercise their right to complain must be taken seriously and have their complaint dealt with appropriately.

Clause 3

Finally, providers will not be in breach of the Code if they can show they have taken all "reasonable actions in the circumstances" The responsibility is on each provider to show this. If circumstances are difficult, the obligation as already pointed out is to take all reasonable steps to comply with the Code as much as possible in those circumstances.

5. Examples

 

Over the past two years since the Code's inception the Commissioner has investigated a variety of matters where parents have complained on behalf of their child. These have included a pharmacist dispensing an incorrect prescription medicine to a child; a GP referring a matter involving a child's broken leg to the Children, Young Persons and their Families Service; a podiatrist failing to obtain a parent's informed consent before the removal of an ingrown toenail, and a hospital's failure to provide full information to parents about a quarantined blood product administered to their son.

These examples involved situations where parents were present when their child was receiving a service. However, often health or disability services are provided to children at school, in the absence of parents, guardians or support persons. Dental services, vaccination programmes, hearing and eyesight tests, and even contraceptive advice and sex education classes are provided to children at school.

The Commissioner has often been asked to comment on the provision of services to children in this context. Her responses have emphasised the importance of obtaining informed consent before these services are provided. Where there are several components of the provision of service, such as with dental check-ups and treatment, the Commissioner has focused on the need for providers to obtain separate consent for each particular part of the treatment process - for instance, separate consent is required for both dental check-ups and x-rays. Further, the importance of keeping effective records such as immunisation certificates and written consent forms has been emphasised. Lastly, providers are encouraged to make adequate provision for communication with the children, by offering information appropriate to their level of understanding.

6. Conclusion

The provisions of the Code relating to informed consent are fundamental to the rights of all consumers, and the ability to make informed decisions is basic to the Code's cornerstone concept of individual dignity and respect. While the issue of consent in the case of children is complex and evolving, the provider who incorporates the principles of the Code of Rights into their protocols for obtaining informed consent - respecting the child's autonomy, and communicating effectively with children and their guardians - can only improve their relationship with consumers, increase the effective utilisation of their service and reduce the chance of serious complaints.

Commissioner's Case Notes

 

Crown Health Enterprise failed to obtain informed consent or provide all relevant information 

The perceived increased risk to consumers of contracting Creutzfeldt-Jakob Disease (CJD) from blood transfusions and blood products has led the Ministry of Health to make concerted efforts to ensure the public are informed of the benefits and risks of blood transfusions. It is likely that consumers who are at increased risk of contracting CJD from blood transfusions would expect to be informed of this risk. Such consumers must therefore be provided with realistic, accurate and understandable information so that they can make informed decisions about their treatment options.

One opinion by the Commissioner arose as a result of a complaint made by a consumer's parents against a CHE after the consumer, a minor, received a dose of Intragam from a batch of quarantined product. The product was issued by a technologist as if it were a non-quarantined product, and the consumer's parents had not given informed consent. The quarantined stock had been released with the approval of the Director-General of Health to be administered only with the informed consent of the recipient, as there was a possible link between the quarantined product and Creutzfeldt-Jakob Disease.

During a later visit to the Crown Health Enterprise by the child and its parents, a different technologist required specific informed consent before quarantined product was issued, which the parents refused. The earlier error was then discovered. The CHE notified the parents of the earlier issue of quarantined product and that it had been administered to their child without their informed consent.

The Commissioner found there was a breach of Right 6(1)(b), Right 6(1)(e) and Right 7(1) of the Code. The parents had not been given information about the use of a quarantined product in their child's care. As neither the child nor its parents had been given information about the proposed use of the quarantined product, Right 6(1)(e) had been breached. Right 7(1) was also breached as a service had been provided without the informed consent of the parents who were entitled to give consent on their child's behalf.

Naturopath failed to provide all relevant information 

One opinion by the Commissioner arose as a result of a complaint by a child's parents that a naturopath prescribed Ultrabifidus powder for their infant daughter which caused her to vomit and appear to lose consciousness. The child's parents had sought treatment for her eczema. They told the provider that the child had undergone bowel surgery two weeks after birth, that the child's mother was breast-feeding, and that the child had received her routine vaccinations. Following the provider's examination of the child and assessment of the information provided, the provider prescribed two homeobotanical products, a colic blend and bowel tonic. In addition the provider prescribed Ultrabifidus powder, a naturopathic remedy. The child was commenced on the homeobotanical products following the appointment, with no apparent problems.

The instructions on the Ultrabifidus Powder were to mix 1ml of the powder with 100mls of water. As this seemed a lot of liquid to give a baby on top of breastmilk, the child's father contacted the provider two days after the consultation, for advice on the administration of the powder. The provider advised the father to make a paste out of the powder and give it to the child on a spoon or dropper. The child was given the recommended dose via dropper at 7.30 - 8.00pm. At approximately 10.30pm the child vomited and appeared to lose consciousness. She was taken to hospital where she was admitted, and remained for observation for six days.

In the circumstances and in light of professional and other advice provided to the Commissioner, the Commissioner formed the opinion that the service provided by the naturopath met relevant professional standards and there had not been a breach of Right 4(2). No information had been found to identify the precise cause of the events leading to the child's hospitalisation. It was also the Commissioner's opinion that Right 6(1)(b) had not been breached. Given the nature of the products prescribed for the child, it was reasonable for the provider not to consider that any reaction may occur, and therefore not advise of any risks. However, in this case, a deviation from the usual instructions on the product label was required due to the child's age and feeding requirements. It was reasonable for the child's parents to receive directly from the provider the information required to administer the products. Therefore, the Commissioner found a breach of Right 6(1)(e).

The Commissioner suggested that the provider consider all aspects of an infant's requirements when prescribing any naturopathic or homeopathic therapy. In this case, as the baby had undergone major bowel surgery, the provider could have considered discussing the information with the family's medical practitioner. The Commissioner also recommended that the provider ensure consumers are given clear information at consultations on how to administer prescribed products, so consumers are not solely reliant on the product labels.

Podiatrist failed to seek informed consent or consider treatment options

One opinion by the Commissioner arose as a result of a complaint made about a podiatrist by the parent of a child, whose ingrown toenail was treated without either the child or the parent being fully informed and without their prior consent being obtained. The podiatrist treated the ingrown nail by removing it and destroying the nail root to prevent further re-growth. Neither the child nor parent were informed that the consequence of this procedure was permanent as the nail would not grow back. The Commissioner found the podiatrist in breach of the following Code rights.

Right 4(2) was breached as the podiatrist did not provide services that met professional standards. There may have been other treatment options available, but the podiatrist did not consider them. The consequences of the procedure were not considered or discussed, nor was any offer to seek a second opinion made.

Right 6(1) was breached as the podiatrist did not fully inform the child or parent of the proposed procedure, its consequences, or the other options available and the risks, benefits and costs of each option.

Right 7(1) of the Code was breached as neither parent nor child had made an informed choice about, or given informed consent to, the procedure before it was performed.

Notes

Right 3

While many children will be dependent on an adult to make certain decisions on their behalf, Right 3 directs providers to always keep in mind the objective of providing services so as to optimise the consumer's independence and quality of life. It does not necessarily follow from the fact that a child lives with his or her parents in the family home and is dependent upon them meeting many of his or her everyday needs, that the child is not able to make independent decisions regarding services in some situations.

The Commissioner recently received a complaint from a parent who was concerned that their 15 year old daughter had received contraceptive advice and had been prescribed contraceptive pills by a Family Planning Clinic which operated in the child's high school. The parent was not in fact averse to the child receiving such advice, but was concerned was that the advice had been given without their knowledge. It was important to draw the parent's attention to the fact that the Contraception, Sterilisation and Abortion Act places no restriction on the supply of contraceptive advice, or on medical practitioners prescribing contraception to young people under sixteen.

Right 8

A parent taking their infant to the family GP will usually stay with the child during the consultation. However, it may be appropriate for the GP to draw a curtain around the child while taking intimate examination in order to protect the child's privacy. It is also important to respect the child's choice not to have a support person. For example, for a 14 year old girl seeking contraceptive advice, the presence of a parent may hinder the free and open discussion to which she is entitled under Right 5.

Informed consent to school dental services

School enrolment forms may seek consent to initial dental check-ups and other dental care required for children in the future. There is a risk that the parent's consent to future care will not be based on sufficient information. However, it is clearly not possible to speculate about this information before the treatment is required. In responding to an enquiry as to how best to provide appropriate information to parents, the Commissioner highlighted the importance of seeking separate consent for each particular part of the treatment process. For example, while enrolment forms could be used to assist in the process of obtaining informed consent to check-ups, separate care plan letters should be used in the process of obtaining informed consent to later treatments. As consent to a check-up will not necessarily include consent to an x-ray, specific reference to x-rays should be made on the consent form.

Health (Immunisation) Regulations 1995 and the Code

Where mass immunisation of children is proposed, it is important that sufficient information is made available to both children and their parents ahead of time, so that an informed choice can be made. It may be useful to provide written information such as posters and pamphlets, and also to obtain the necessary consent in writing given that parents or guardians will usually not be present when the vaccination is given.

Another important aspect of immunisation programmes is effective record keeping and administration. The Health (Immunisation) Regulations 1995 require that all children born from January 1995 have an immunisation certificate to show whether they are fully immunised or not. Early childhood services and schools are required to sight this, and record the information on a register. In order that such systems operate smoothly, it will be essential to ensure effective records are kept. For instance, signed written consent forms will assist administration and also provide evidence of consent if this is required in the future. Well maintained records in such circumstances also contribute to the ongoing effective provision of quality services, for example, in terms of meeting the Right 4(5)'s requirements for continuity and communication between the various providers responsible for a child's early health care.