What do I need to know about "informed consent"?
The recent media debate about the Meningococcal B Immunisation Programme has led to a response from the Ministry of Health (Sunday Star Times, 19 June 2005, A19) to clarify issues surrounding the prevalence of the disease in New Zealand and facts about the vaccine. The debate raised questions about the nature of the information provided and prompted an assurance from the Ministry that it supports “informed consent”.
The concept of informed consent is central to most health procedures. It is a prerequisite to any intervention, including screening, testing, vaccination and treatment. It means that when a consumer consents – or agrees – to a health procedure, he or she has made his or her own decision about whether to undergo that procedure. Even when the decision is based on the provider’s recommendation, the consumer actively makes the decision, rather than simply going along with the provider’s recommendations. Clearly, in order to be able to agree to a procedure, a consumer must have all the information necessary to enable him or her to make that decision.
Information
A consumer is entitled to receive information about his or her condition, the options for treatment, and the anticipated outcome of each treatment option. This includes any associated physical, emotional, mental, social or sexual outcomes, expected risks and side effects of the treatment, the time frame in which these may occur, and any steps that can be taken to minimise them. Where relevant, ongoing implications of the procedure need to be discussed. The option of not agreeing to undergo the procedure, and the outcome of this option, should also be explained. If the provider recommends a particular option, he or she should give the reasons for the recommendation. The information provided should take into consideration the consumer’s individual circumstances, such as personal and family history, that may influence the treatment choices or outcomes. All viable options should be offered, not only those available through the publicly funded health system, and the cost of each option should be explained.
Consumers may also wish to consider complementary or alternative therapies, or services from providers outside conventional health services. Where a provider is not knowledgeable about such options, he or she should inform the consumer where to find the information.
In the case of vaccinations, consumers (or parents where young children are involved) can expect to be provided with information about the potential benefits, risks and side effects, along with relevant information about controversial areas and concerns about vaccination. If a child has previously experienced an adverse reaction to a vaccine, information provided will need to address this specifically.
Communication
Many problems of consent arise from poor communication. Consumers are entitled to “effective communication” – this means discussions should be conducted and questions answered in a form and language that enables the consumer to understand the information provided. Where necessary and reasonably practicable, this includes the services of a competent interpreter. It may also involve using culturally appropriate methods of communication, plain language rather than medical jargon, written or visual explanations, and diagrams or videos. The involvement of family, whanau or other support persons may assist understanding and provide support for people who are less confident about asking questions.
Effective communication depends not only on what information is requested and provided, but also on the manner in which the discussion is conducted. It is important that consumers are shown respect, feel comfortable about asking questions, and are given sufficient time to do so. Consumers are also entitled to receive, on request, a written summary of the information provided, in a form that enables the consumer to understand the information provided. Consumers must be given adequate time to consider the information and the available options, before making a decision.
Giving consent
Apart from exceptional situations (such as provision of life-saving treatment in an emergency, or when a consumer does not have the mental capacity to consent on his or her own behalf), the consumer’s consent is always required before services can be provided. Every consumer has the right to refuse to undergo any treatment or procedure, and to change his or her mind and withdraw consent to services at any time, even if those services are already under way. There are special provisions in the Code to cover circumstances where a consumer does not have the mental capacity to give consent for him- or herself, such as circumstances involving children. In addition to parental consent, it is good practice for a provider to give an explanation to children, to gain their confidence and their willing participation.
For most tests and treatment, consumers can give consent verbally. However, even where verbal consent is adequate, some providers wisely record in the consumer’s notes the fact that consent was obtained, as well as the information and options given.
For a general anaesthetic or where there is significant risk of adverse effects on the consumer, or where informed consent is required for participation in any research or experimental procedure, consent must be recorded in writing.
The rights underpinning the process of informed consent – the rights to effective communication, to be fully informed, and to give informed consent – are set out in the Code of Health and Disability Services Consumers’ Rights (Rights 5, 6 and 7).
30 June 2005