Informed Choice and Consent
Issue 3, April 2001
"The voluntary consent of the human subject is absolutely essential". In the practice of human experimentation, this is the first of the basic principles to satisfy moral, ethical and legal concepts, as laid down in the Nuremburg Code 1947. The Code is the concluding statement of the judgment in the trial of the Nazi doctors who were accused of crimes against humanity by conducting criminal scientific and medical experiments on concentration camp prisoners. The Nuremburg Code has become part of international law and it serves as the basis for many formulations of the ethics of research with human subjects.
There is little disagreement that the experiments that the Nazi doctors carried out were inhumane. Probably because their experiments were so repugnant and so alien to medical research and treatment carried out in New Zealand, there was a prevailing thought that such things would and could not happen here. Documents such as the Nuremburg Code and the 1964 Declaration of Helsinki were seen as being worthy but of peripheral importance.
The "Unfortunate Experiment" at National Women's Hospital and the resulting Commission of Inquiry conducted by Judge Silvia Cartwright shook New Zealanders' complacency and was a reminder that paternalism is not an acceptable replacement for informed consent in human treatment and experimentation. Since the Cartwright Report was released in 1988 and the Code of Rights for Health and Disability Consumers came into effect on 1 July 1996, informed consent in both treatment and research is a term that has become widely used in New Zealand.
It is not however a term that is necessarily widely understood or even accepted by all. In its simplest terms, it is a process that provides an individual with the information and understanding that is needed to choose to have or not to have treatment or undergo a procedure, free from coercion.
It is often claimed, particularly by members of the medical profession that informed consent is not possible as a health professional cannot impart complete understanding to a consumer. This is probably true but it is also true that levels of understanding in any communication will be neither complete nor accurate. For most people, imperfect knowledge allows them to make rational decisions and live their lives. The issue rather should be not one of complete understanding but rather one of adequate knowledge for the purpose at hand [i] .
Some people argue that informed consent implies that once having heard and understood the information, an individual will agree with or opt for treatment. For this reason, the term "informed choice and consent" may be preferred as it implies that informed choice is a pre-condition of informed consent. This principle of informed choice rather than that of informed consent was argued strongly by the Interchurch Commission presenters at the Royal Commission on Genetic Modification. They rejected the assumption that many of the people who are against genetic engineering oppose it because they do not understand it. Their argument was that understanding may result in consent but equally, it may result in rejection.
The purpose of the informed choice and consent
Health care providers have a legal obligation under the New Zealand Bill of Rights Act 1990 and The Code of Health and Disability Services Consumers' Rights 1996 , to disclose information to consumers of their services. The exercise of obtaining informed consent therefore provides legal protection for health providers. Informed consent is also about safety of individuals as it gives them greater protection from exploitation or manipulation in therapeutic treatment or research. Most importantly however, it is about showing respect for the self determination and personal autonomy of each human being and their right to individual beliefs, desires, values and goals.
Personal autonomy is described as "rule of the self that is free from both controlling interferences by others and from personal limitations that prevent meaningful choice, such as inadequate understanding" [ii] . Max Charlesworth describes it as the "condition for any human act to have moral value.... Acts of affection, courage and creativity are distinctively human acts only if they are autonomously done" [iii] .
Elements of informed choice and consent
As a concept, informed choice and consent is easier to understand if its elements and their applications are explained.
1. Adequate information which is accurate, objective, relevant and culturally appropriate. This should broadly include:
- the nature and likely effectiveness of the proposed treatment or procedure
- the risks which may arise
- the likelihood of risk and consequences if they eventuate
- other options, including the right to receive no treatment
- the right to a second opinion
This does not mean, as is sometimes assumed, that a health professional must pass on to a consumer everything there is to know about a condition or proposed treatment. The Code of Health and Disability Services Consumers' Rights 1996 states: "Every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, would expect to receive". This is the so-called rights-based approach in that the consumer has the right to know what treatment entails in order to make a reasoned choice and thus give valid consent. This approach also recognises that some consumers will not want to receive information. In these cases, the treatment provider should not inflict unwanted or unsought information on the consumer but make a genuine and reasonable attempt to find out the consumer's real wishes.
The health professional must pass on information that is "material" to the consumer making the decision. "Materiality" is a legal concept and in Rogers v Whitaker (Australia 1992), a risk is material if:
"In the circumstances of a particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it, or if the practitioner is or should be aware that the particular patient, if warned of the risk, would be likely to attach significance to it."
An example of this might be an ear operation that involves a very slight risk of damage to the lingual nerve, the nerve that is crucial for the sensation of taste. As the risk is so small, the Ear Nose and Throat Surgeon would probably not usually warn every consumer of it. However, if the consumer were a cook where the sense of taste is very important, that risk becomes "material" and should certainly be passed on.
2. Competence – The Code of Rights states that "Every person is presumed to be competent to make an informed choice and give informed consent unless there are reasonable grounds for believing the consumer is not competent".
Treating an individual as incompetent removes their autonomy so it is preferable to try to enhance or support the decision-making capacity of those who appear to have limited ability to give consent. It is important to determine the degree of capability. Children for instance will vary in capacity, according to their age and level of maturity. People with mental disability also vary enormously, from those who obviously lack decision-making capacity, to those who have the capacity to make many decisions for themselves. Every effort should be made to find indicators to how capable the person is, including their level of communication with family/caregivers and their ability to understand information and weigh up alternatives [iv] .
If a person is unable to give consent, then treatment will usually be given or withheld on the basis of "substituted judgement" or "the best interests of the person". Substituted judgement assumes that the individual has the right to his or her autonomy respected but is currently unable to exercise that autonomy in decision making. The question is then asked, "What decision would the person have made if they had been competent to make it?" The "best interests" standard protects another's wellbeing by assessing risks and benefits of various treatments and alternatives to treatment, by considering pain and suffering, and by evaluating restoration or loss of functioning. [v]
3. Absence of coercion – the person should act voluntarily and not be coerced or have undue pressure or influence applied by the providers or others.
Consent must be given freely and voluntarily. There must be no compulsion, force, coercion or deception. Undue pressure may be insidious or subtle, experimentation such as a person's fear of not being properly looked after if they turn down a particular treatment. They may also fear being criticised or being thought "a bad or difficult patient". It is better that consent is gained gradually or in stages so that the consumer has time to think about the information, to discuss it with others and be away from the environment where the provider is in a position of power.
In Catholic teaching, every person is created in the image of God and redeemed by Jesus Christ. He or she is therefore uniquely valued and worthy of respect as a member of the human family. The dignity of each human being grants them inalienable rights and informed consent is a practical and effective recognition and expression of these. In the health sector, this means that health professionals must recognise the inviolable limits that are created by respect for the person and by the protection of the person's right to live a life truly worthy of a human being.
[i] Gorowvitz, Samuel, Doctors' Dilemmas. New York: Macmillan Publishing, 1982, p. 43
[ii] Beauchamp, Tom, & Childress, James, Principles of Biomedical Ethics, New York: Oxford University Press, 1994, p.121
[iii] Charlesworth ,Max, "Personal Autonomy" in Bioethics Outlook, vol 5, no 4, Dec 94, p5
[iv] Basterra, Francisco, Bioethics, UK: St Pauls 1994, p.243
[v] Beauchamp & Childress, p. 178
Sharron Cole is Chair of the Wellington Ethics Committee and the ACC Medical Misadventure Advisory Committee. She is also a member of the Medical practitioners' Disciplinary Committee.