Informed consent: common mistakes and need-to-knows
Consent is one thing; informed consent is another. Being unable to ascertain when or if a patient is providing the latter rather than the former can create significant ethical and legal challenges for doctors.
Here’s our breakdown of what you need to know about patient consent, and the common mistakes and dilemmas medical practitioners face.
IN THIS FACT SHEET:
- What informed consent is and how doctors can ensure they have it.
- What needs to be discussed as part of obtaining informed consent.
- What to do when a patient is not competent to give informed consent.
Doctors need to inform patients about the potential risks and benefits of any treatment and support the patient to make an informed choice.
Informed consent is an interactive process between a doctor and patient where the patient gains an understanding of his or her condition and receives an explanation of the options available including an assessment of the expected risks, side effects, benefits and costs of each option and thus is able to make an informed choice and give their informed consent.
Under Right 5 of the Code of Health and Disability Services Consumers’ Rights (“the Code”) you must convey information to the patient in a form, language and manner that enables the patient understands the treatment or advice.
Right 6 of the Code states that every consumer has ‘the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive’. Specifically, the Code states patients are entitled to:
- an explanation of his or her condition; and
- an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and
- advice of the estimated time within which the services will be provided; and
- notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval; and
- any other information required by legal, professional, ethical, and other relevant standards; and
- the results of tests; and
- the results of procedures.
During this discussion it is necessary to provide the patient with an opportunity to ask questions and engage at an appropriate level which reflects the patient’s understanding.
It is recommended that doctors implement consent checklists for common consultations or procedures to establish a protocol which can be referred to in patient records.
In a non-urgent situation consent for a significant procedure should not be obtained immediately before it is performed. A patient should be given the opportunity to consider the information, discuss it with a support person if they choose, and ask follow-up questions at a later time.
A printed form is a good record of what is communicated as an aid to communication, but it is important that an informed discussion takes place and that all patient queries are satisfactorily addressed.
We are often asked “What risks should be discussed with the patient?” The answer to this is any material risk. An Australian authority (see Roger v Whitaker (1992) 175 CLR 479) describes a material risk as one:
- which in the circumstances a reasonable person in the patient’s position would be likely to attach significance to; or
- a risk which the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to.
If there is a significant risk or side effect associated with the procedure it may not be enough simply to refer to that. It may be necessary to outline what the realisation of that risk could mean to the patient taking into consideration their previous medical history.
It is the responsibility of the doctor who is providing the treatment or procedure for ensuring that the patient makes an informed choice and provides adequate consent before commencing. Please note that the patient’s signature on the consent form does not in itself constitute informed consent, but rather is a record for professional and legal purposes that some form of consent process has taken place.
While legally a doctor is required to obtain informed consent as defined by the HDC Code, there are a number of other statutory provisions that allow a doctor to proceed without obtaining informed consent. These are detailed in the Medical Council’s statement on ‘Information, choice of treatment and informed consent’ available at www.mcnz.org.nz. Please note that even where the necessity to obtain informed consent is removed, a patient’s right to communication and information will still apply. This means that you should continue to explain the procedure in sufficient detail to ensure the patient understands the purpose, benefits and risks.
Related content: Changes to informed consent — vigilance is required!
When a patient is not competent to give informed consent
In the situation where a patient has diminished competence under Right 7(3) of the Code, doctors must obtain consent from the patient for the aspects of the treatment that the patient understands.
Under Right 7 (4) of the Code, if the patient is not competent to make an informed choice and give informed consent; and no person entitled to consent on behalf of the patient is available, a doctor may provide services without obtaining the informed consent of the patient when:
- it is in the best interests of the patient; and
- reasonable steps have been taken to ascertain the views of the patient; and either
- the provider believes, on reasonable grounds, that the provision of the service is consistent with the informed choice that the patient would have made if he or she were competent; or
- if the patient’s views have not been ascertained, the provider takes into account the views of other suitable people who are interested in the welfare of the patient and available to advise the provider.
Related content: Informed consent of children
Consent in an emergency
An emergency is a serious situation where immediate action must be taken for the preservation of the life or health of the patient. The primary need is to treat the patient. In this situation it may not be possible to gain informed consent before treating the patient.
If it is an emergency situation you can provide key services necessary to prevent loss of life, limb or function without the patient’s consent. Any further treatment that can reasonably be delayed should be delayed until consent can be obtained. Where you do provide services without consent you should endeavour to obtain their consent after the event (where possible).
It is important to note that in an emergency, a patient who is competent to consent has the right to consent to or refuse treatment.
In short, it is important to gain consent that is not only affirmative, but informed; that the patient in question (or their guardians/carers/families) are able to fully understand the ramifications of a procedure to the best of their abilities, and within the realm of their faculties. While there are some instances where consent can be avoided, they are very much outside of the norm. If in doubt, wait for informed consent.
Current as at 30 October 2018
If you have any questions about informed consent or are concerned about a recent interaction that involved informed consent, get in touch with NZMPI’s medico-legal advisors now.