What is informed consent?
Informed consent is a fundamental concept in the provision of health care services, including immunisation. It is based on ethical obligations that are supported by legal provisions (eg, the Health and Disability Commissioner Act 1994, Code of Health and Disability Services Consumers’ Rights 1996, Health Information Privacy Code 1994, Privacy Act 1993 and Privacy Amendment Act 2013).
Providing meaningful information to enable an informed choice and to seek informed consent is a duty that all health and disability providers must meet to uphold the rights of health and disability consumers. Informed consent includes the right to be honestly and openly informed about one’s personal health matters. The right to agree to treatment carries with it the right to refuse and withdraw from treatment.
Informed consent is also an external expression of a health care provider’s pivotal ethical duty to uphold and enhance their patient’s autonomy by respecting the patient’s personhood in every aspect of their relationship with that individual.
The informed consent process
Informed consent is a process whereby the individual or parent/guardian are appropriately informed in an environment and manner that are meaningful. Having been well informed, they are willing and able to agree to what is being suggested without coercion.
Regardless of age, an individual and/or their parent/guardian must be able to understand:
- that they have a choice
- why they are being offered the treatment/procedure
- what is involved in what they are being offered
- the probable benefits, risks, side-effects, failure rates and alternatives, and the risks and benefits of not receiving the treatment or procedure.
To make an informed choice and give informed consent for vaccination, the individual or parent/guardian needs to understand the benefits and risks of vaccination, including those to the child and community.
Consent for patients who are incompetent (individuals who do not have the capacity to consent) may be given by:
- a welfare guardian appointed under the Protection of Personal and Property Rights Act 1988
- an attorney under an activated enduring power of attorney in respect of care and welfare.
If there is no welfare guardian or attorney under an enduring power of attorney, treatment may be provided under Right 7(4) of the Code of Health and Disability Services Consumers’ Rights if:
- the treatment is in the best interests of the patient; and
- attempts have been made to find out what the patient would have wanted if s/he were competent; or
- if it is not possible to find out what the patient would have wanted, the views of people interested in the patient’s welfare have been considered.
The essential elements of the informed consent process are effective communication, full information and freely given competent consent. The specific rights in the Code of Health and Disability Services Consumers’ Rights that represent these three elements are:
- Right 5: Right to effective communication
- Right 6: Right to be fully informed
- Right 7: Right to make an informed choice and give informed consent.[1]
For example, section 7(1) of the Code 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.’ Information on the Code of Health and Disability Services Consumers’ Rights can be found on theHealth and Disability Commissioner’s website.
Health professionals have legal obligations to obtain informed consent prior to a procedure and prior to data collection (eg, data collected for the AIR). Unless there are specific legal exceptions to the need for consent, the health professional who acts without consent potentially faces the prospect of a civil claim for exemplary damages, criminal prosecution for assault (sections 190 and 196 of the Crimes Act 1961), complaints to the Health and Disability Commissioner and professional disciplining.
Ensuring that an individual has made an informed choice regarding treatment options has been included in the Health Practitioners Competence Assurance Act 2003. This Act ensures that health practitioners are, and remain, competent and safe to practise. For example, the Nursing Council of New Zealand competencies for the Registered Nurse Scope of Practice, Competency 2.4, ‘ensures the client has adequate explanation of the effects, consequences and alternatives of proposed treatment options’ (see theNursing Council of New Zealand website).
Privacy and control over personal information
The right to authorise, or to exert some control over, the collection and disclosure of personal information about oneself is a right closely allied to that of consent to treatment and is also relevant to personal integrity and autonomy. The Health Information Privacy Code 1994 gives people the right to access, and seek correction of, health information about them (Rules 6 and 7). It also requires health agencies collecting identifiable information to be open about how and for what purpose that information will be stored, and who will be able to see it (Rule 3).
Parents and guardians have a similar right of access to information about their children under section 22F of the Health Act 1956. This right is limited in that access requests can be refused if providing the information would be contrary to the interests or wishes of the child.
Further information about privacy and health information can be found on thePrivacy Commissioner’s website, or by calling the privacy enquiries line: 0800803909.
Immunisation consent in primary care
Parents should be prepared during the antenatal period for the choice they will have to make about their child’s vaccination. During the third trimester of pregnancy, the lead maternity carer must provide Ministry of Health information on immunisation and the AIR. This is a requirement under clause DA21(c) of the Primary Maternity Services Notice 2007, pursuant to section 88 of the New Zealand Public Health and Disability Act 2000.
Vaccine hesitancy
"Vaccine hesitancy refers to delay in acceptance or refusal of vaccines despite availability of vaccination services. Vaccine hesitancy is complex and context specific, varying across time, place and vaccines. It includes factors such as complacency, convenience and confidence."
- WHO: Addressing Vaccine Hesitancy
Effective communication and active listening are key components of the informed consent process, especially when health care providers are working with vaccine-hesitant individuals/parents/guardians. In this situation, providers should:
- be willing to initiate the conversation, and avoid leaving it to others
- tailor content to the needs of the individual
- ensure respect and acknowledgement of concerns
- use plain language, open-ended questions and active listening
- avoid medical jargon, or ensure it is explained
- offer resources
- finish with an effective immunisation recommendation.
Information for parents, guardians and health care providers
Health care providers must offer information without individuals or parents/guardians having to ask for it. The depth of information offered or required may differ, but it should at least ensure that the individual or parent/guardian understands what the vaccine is for and the possible side-effects, as well as information about the vaccination programme, the AIR and the risks of not being vaccinated (seechapter3).
Every effort should be made to ensure that the need for information is met, including extra discussion time, use of an interpreter and alternative-language pamphlets. Health New Zealand | Te Whatu Ora immunisation pamphlets are produced in several languages, and are available from the local authorised provider or can be ordered, viewed and/or downloaded from theHealthEd website.
Issues to discuss with individuals or parents/guardians about immunisation include:
- the vaccine-preventable diseases
- the vaccines used on the Schedule (ie, the funded vaccines that are available)
- how vaccines work, known risks and adverse events, and what the vaccine is made of, in case of known allergies
- the collection of immunisation information on the AIR from birth, or as part of a targeted immunisation programme (eg, the information that will be collected, who will have access to it and how it will be used; seesection 2.3.5for more information on the AIR)
- the choice to vaccinate.
Informed consent is required for each immunisation episode or dose. Presentation for an immunisation event should not be interpreted as implying consent. Individuals and parents/guardians have the right to change their mind at any time. Where consent is obtained formally but not in writing, the provider should document what was discussed, and that consent was obtained and by whom.
Health New Zealand | Te Whatu Ora information
Health New Zealand | Te Whatu Ora immunisation information is available for parents and guardians on the Health New Zealand website. Parents and guardians may also order, view or download Health New Zealand immunisation information from theHealthEd websiteor from the local authorised resource provider, including:
- Immunise Your Child on Time (leaflet, available in English [HE1327] and other languages)
- Childhood Immunisation (health education booklet [HE1323]).
Further immunisation consent information for health care providers is also available inAppendix 3‘Immunisation standards for vaccinators and guidelines for organisations offering immunisation services’. Responses to commonly asked questions and suggestions for addressing myths and concerns are available inchapter 3.
Other information sources
- Sharing Knowledge About Immunisation(SKAI) is an Australian suite of online resources and tools to support vaccination communication designed to aid conversations about childhood immunisation for parents and health care providers.
- Offit PA, Moser C. 2011. Vaccines and Your Child – Separating fact from fiction. New York, NY: Columbia University Press.
- Vaccine manufacturers’ data sheets, available on theMedsafe website. Consumer and health care provider versions are available.
- Other recommended immunisation-related websites (seeAppendix 8).
Alternatively, contact:
- the Immunisation Advisory Centre on freephone 0800IMMUNE/0800 466 863, or see theIMAC website
- your local immunisation coordinator (a list and contact details are available on theIMAC website).
Immunisation consent in other settings (eg,schools)
In mass immunisation campaigns, such as those undertaken at schools, the consent requirements are different from those that apply to the vaccination of individuals in primary care. The parent/guardian may not be with the child on the day of immunisation, so immunisation should proceed only after the parent/guardian has had the opportunity to read the immunisation information and discuss any areas of concern. Consent forms are provided for immunisations given in schools by public health nurses and may also be used in mass vaccination settings. For children aged under 16 years who are being immunised at school, written consent must be obtained from the parent/guardian. Individuals who are aged 16 years or older may self-consent.
Consent and children
Under the Code of Rights, every consumer, including a child, has the right to the information they need to make an informed choice or to give informed consent. The law relating to the ability of children to consent to medical treatment is complex. There is no defined age at which all children can consent to all health and disability services. The presumption that parental consent is necessary to give health care to those aged under 16 years is inconsistent with common law developments and the Code of Rights.
The Code of Rights makes a presumption of competence (to give consent) in relation to children, although New Zealand is unusual in this respect (ie, the obligations regarding consent of minors are greater in New Zealand than in many other jurisdictions).
A child aged under 16 years has the right to give consent for minor treatment, including immunisation, providing he or she understands fully the benefits and risks involved. In 2002 the Health and Disability Commissioner provided an opinion of a child’s consent to a vaccine, whereby the Commissioner was satisfied that a 14-year-old was competent to give informed consent for an immunisation event due to an injury where a tetanus toxoid vaccine would be commonly given. More details of this opinion can be found on theHealth and Disability Commissioner’s website(Case: 01HDC02915).
Further information on informed consent can be found on theHealth and Disability Commissioner’s website.
