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Informed Consent

 

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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.

 


 

Informed consent: common mistakes and need-to-knows

 

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:

  1. it is in the best interests of the patient; and
  2. reasonable steps have been taken to ascertain the views of the patient; and either
  3. 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
  4. 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 NZMII’s medico-legal advisors now.

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View a presentation by Solicitor and Barrister Mark Kelly on informed consent.


Informed consent and the related concept of informed choice are underpinned by the patient-centred approach whereby the patient’s choice as a health care consumer is the paradigm.

Related content: Informed consent: what doctors need to know

Informed choice arises largely from your obligation to “a) Inform consumers of their rights; and b) Enable consumers to exercise their rights” Clause 1.1 a) and b) in the HDC Code of Health and Disability Services Consumers’ Rights Regulation 1996 (the Code), combined with Right 7 (7) in the Code whereby “Every consumer has the right to refuse services and withdraw consent to services.”

“Choice” is defined in clause 4 of the Code to mean a decision to receive services, refuse services or withdraw consent to services; and that right to refuse is also confirmed in the section 11 of the New Zealand Bill of Rights Act 1990, in addition to the above Right 7(7) of the Code.

And that ability to exercise an informed choice in turn requires the patient to have received the required standard of information, in the required form, from the medical practitioner(s) who are engaged in providing a medical treatment, process or medication.

Section 2(1) of the Health and Disability Commissioners Act 1994 defines “Informed consent” as:

 

… consent to that procedure where that consent –

(a) is freely given, by the health consumer or, where applicable, by any person who is entitled to consent on that health consumer’s behalf; and

(b) is obtained in accordance with such requirements as are prescribed by the Code.

 

To safely believe that a patient is properly consenting, there must be grounds to say that they have received “effective communication” under Right 5 in the Code (effective as to form, language, and manner, enabling the consumer to understand the information).  That includes being provided information in an environment that is enabling for open, honest and effective communication.  For instance, in the case of Re M [1] a doctor seeking to get a patient’s consent for a full abdominoplasty in the corridor of the operating theatre suite, with limited time for the patient to consider and reflect on the information given to her by the doctor shortly before being taken to theatre, was clearly in breach of that requirement for effective communication.

 

The doctor is not simply obliged to communicate to the patient a list of the risks inherent in a particular treatment, but has an ethical imperative to communicate with the patient in the broad meaning of that term.

 

Whilst an extreme example, that case does underline that doctors are required to use what are reasonable methods of communication in the circumstances, the requirements for which may include taking into account the patient’s age, apparent education, language, culture, special needs (translators, Braille, etc).

What will be apparent from the above is that the doctor is not simply obliged to communicate to the patient a list of the risks inherent in a particular treatment, but has an ethical imperative to communicate with the patient in the broad meaning of that term.  The focus that arises from the Code is upon the subjective needs of the patient, directing a partnership between doctor and patient to address the patient’s wishes, views and values. [2]

This begs the question as to what is the extent of the information that should be provided to, and discussed with, a patient.  The touchstone of this provision of information to achieve an informed consent is that there is a duty on a doctor to make sure that the patient is aware of the material risks involved in any recommended treatment, and of any reasonable or variant treatment.  An appropriate statement of the test of materiality is:

 

“Whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be aware that the particular patient would be likely to attach significance to it.” [3]

 

While the first part of the above quoted test appears objective, the alternative in the second part of the test is clearly subjective, and reliance on such an approach is probably the safest for any medical practitioner to adopt, given the stance of the regulatory authorities such as the HDC to such questions.

An assessment has to be made by you as a doctor which is fact-sensitive, and sensitive to the particular patient being treated.  This does not require you to warn patients about risks which are theoretical and not material.

 


IMPORTANT IMPLICATIONS OF THE ‘PATIENT-FOCUSED’ PARADIGM

 

The obligations placed on doctors by the above patient-focused approach, whilst laudable, places a significant burden on the practitioner because it operates in the same way for all doctors irrespective of the branch of medicine or specialist area in which they practice.  This would be true especially for GPs and other practitioners working in primary care medicine (A&M).

If you are in such areas of practice your relationship with patients is such that you may not have access to a full range of information to discharge the standard of informational care required by the Code, particularly as many patients expect “all their problems to be solved within a single appointment alongside unrealistic demands regarding referral/investigation/treatments etc”[4]

 

Many patients expect “all their problems to be solved within a single appointment alongside unrealistic demands regarding referral/investigation/treatments etc”.

 

Such inbuilt limitations can apply similarly to resident doctors who will be asked as part of their training to obtain informed consent for procedures they may not fully understand.

All the above has implications for medical education and suggests that there is a necessity for you to, if you will excuse the pun, be as fully informed about this subject as you can make yourself, along with engaging with your colleagues to share information about what, in days gone by, would have been an ancillary aspect of practice.


CONSENT AND EMERGENCY; OTHER INCAPACITY

 

But how does the burden on you of the above requirements get dealt with in circumstances where obtaining informed consent may not be feasible?

It is well established that in circumstances of emergency, you do not need to obtain consent before providing medical services to a patient.  You are protected by Clause 3 of the Code whereby you will not be in breach of the Code if you have “Taken reasonable actions in the circumstances” to give effect to the Code; and the phrase “the circumstances” means all the relevant circumstances, including the consumer’s clinical circumstances and your (and your colleagues’) resource constraints.

An example of this occurred where a patient was undergoing an angiogram (for which she had provided written consent), and in the course of that procedure (which had a number of complications) the surgeon detected an occluded left descending artery (a life threatening condition), turning this into a necessary angioplasty, and the surgeon elected to continue in spite of her ex post facto declaration that she had asked for the angiogram procedure to stop.

The surgeon’s actions were vindicated on two grounds: first that there was an event that threatened her life and he could ignore any withdrawal of consent; second, the medication that the patient had received would have affected her capacity to exercise judgment upon what was occurring. [5] This latter aspect is an area that requires substantial study by itself as it relates to the presence of an appropriate environment of the giving of information to enable a patient to make a choice.

 

Lack of competence

 

In addition to emergency situations, treatment can be given without consent where the patient is not competent to make an informed choice and therefore give informed consent, and no other person is available to exercise the choice and give informed consent on their behalf. In such cases, you are able to do what is “in the best interests of the consumer”, as provided for in Right 7(4)(a) of the Code.

 

In addition to emergency situations, treatment can be given without consent where the patient is not competent to make an informed choice and therefore give informed consent.

 

Therefore, if the patient is not able to competently receive information to make a choice and give informed consent, and all other avenues have been exhausted by way of trying to get consent of family members or others who should be interested in the patient’s welfare, then you can act appropriately as provided under Right 7(4)(a) (“…in the best interests of the consumer…”).

 

Therapeutic privilege

 

The third circumstance in which consent can be dispensed with is under the concept of therapeutic privilege, which had its genesis in the defence of necessity whereby you as a medical practitioner could act where information has been withheld from a patient in circumstances where it would hinder the necessary treatment or cause severe mental trauma. This is only permissible in situations of medical emergency where there is an imminent danger to the patient’s life and health. Once that risk has abated, the information should be disclosed.

An example of such therapeutic privilege being applied, but not being accepted by the Health and Disability Commissioner, was where a patient had tracheal stenosis and underwent laser surgery to relieve the narrowing. However, on exploration the narrowing was more severe than expected and an alternative non-laser endotracheal tube was used. The outcome was severe burning to the sub-glottis, glottis and laryngeal surface of the epiglottis, with other minor burns. The doctor had not informed the patient of this potential risk on the basis that it would cause undue anxiety and prevent the patient from undergoing a highly beneficial procedure. [6] The Commissioner said that this went against patient autonomy and did not foster a true partnership between patient and doctor. Whether or not one agrees with that outcome, it is a good indication of the environment in which you now practice.

A great deal of what is set out above requires reasonably fine judgment, and you will often benefit from reviewing this with colleagues or contacting us in order to provide you with advice.

 


THE DOCTRINE OF NECESSITY

 

This applies where it is necessary to act in the best interests of the patient’s life or physical or mental health, and it is not practicable to communicate with the patient and the action or treatment taken is that which a reasonable person would in all the circumstances take acting in the best interests of the patient. Right 7 (4)(a) discussed above would also apply here.

 


 

CONSENT AND CHILDREN

 

‘Children’ are not well defined by the law. A person does not attain majority until the age of 20, but the Care of Children Act 2004 defines a “child” as a person under the age of 18 years. However, a child of 16 or over who is or has been married or in a civil union, or living with another as a de facto partner, may consent to a medical procedure being carried out for his/her benefit by a doctor as if he/she was of full age (section 36(2) Care of Children Act 2004).

Beyond those statutes, case law says a parent or guardian may consent to medical treatment for the benefit of a child until a time that the child has attained sufficient understanding of the nature of the proposed treatment.

However, the Code recognises no distinction between adults and children as far as the Rights thereunder are concerned. It treats a child as a ‘consumer’ and therefore the duties on you in relation to informed choice and consent to a procedure or treatment applies equally to a child as to an adult.

 

The Code recognises no distinction between adults and children as far as the Rights thereunder are concerned.

 

So, a child is presumed competent unless reasonable grounds for believing otherwise. This means a judgment has to be made about a child and their ability to comprehend what is being said to them. An example from the UK, followed both by the High Court of Australia and New Zealand courts, is the Gillick case [7] where a mother sought a court ruling that parents have a right to make decisions as to contraceptive advice or treatment for her children. The children had been receiving information about contraception through a family planning clinic without the prior knowledge or consent of the parents. The children were under the age of 16.

First, the court held that minors may authorise medical treatment when they are old enough and mature enough to decide for themselves; it being arbitrary and unreal to draw a line between childhood and maturity, disregarding human development and social change. Second, the court held that the rights of parents to control their children are for the child’s benefit and are recognised only so long as they are needed for the protection of the child. If the child achieves a sufficient understanding and intelligence to enable her or him to understand fully what is proposed, then that is sufficient for the parental consent or refusal to be ignored.

After talking to the child, assess their competence in relation to the particular service to be given. That is, the level of understanding required to make an informed choice about whether or not to have a broken bone set will necessarily differ from that required to understand the complexity and risks of whether or not to undergo a regime of chemotherapy.

If children do not have the capacity to choose appropriate treatment, then a parent, guardian or a court may choose that treatment in the best interests of the child.

 

Read more: Informed Consent of Children Fact Sheet

 

None of these issues are easy to judge except in the clearest of situations and you must seek advice from NZMII should you have any doubt about the appropriate way forward.

 

[1] Re M, Medical Practitioners Disciplinary Tribunal, 8 June 2004 (File 287-04-118D)

[2] J Miola “On the Materiality of Risk: Paper Tigers and Panaceas” (2009) 17 Med L Rev 76

[3] Montgomery v Larkshire Health Board [2015] UKSC 11

[4] King’s Fund: “Understanding the pressures in general practice” (May 2016) at p27

[5] Connolly v Croydon Health Services NHS Trust [2015] EWHC 1339

[6] Anaesthetist, Dr B; Surgeon, Dr C; Otago District Health Board (Opinion 04HDC04340, 19 May 2006)

[7] Gillick v West Norfolk & Wisbech Area Health Authority [1986] AC 112

 


For more information about advance care planning and directive, get in touch with NZMII’s dedicated medico-legal advisory team.


Children have the right to give and the requirement to provide consent in regards to their healthcare in much the same way as adults, but ensuring that you, as a doctor, receive genuine informed consent can be difficult. Can a child of 10 truly understand the ramifications of major surgery? What about a young teen? It can be hard to gauge, but the responsibility lies with the doctor to ensure their patients are able to be informed about their care and provide genuine consent if necessary—and where this is not possible, that parental consent and/or guardian consent can be given instead.

 

IN THIS FACT SHEET:


 

Informed Consent Children

 

There is no exact age at which a child (defined as a person under 16 years) can legally consent to health services. The law in this area has moved away from age-related thresholds to focus instead on the individual child’s level of competence and understanding. The Code of Health and Disability Services Consumers’ Rights (the Code) recognises that some children will be able to understand information and make informed choices about particular services.

The Medical Council advises that an assessment of whether an individual child is competent rests on a judgment of their understanding and maturity, considered in light of the nature of the procedure. This assessment is probably best dealt with using common sense.  An example given by the Commissioner’s Office is that “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 in understanding to consent to heart surgery”. This is in accordance with Right 7 of the Code, the right to make an informed choice and give informed consent.

Where it is judged that a child is not able to provide informed consent this does not relieve the practitioner of the obligation to comply with Right 6, the right to be fully informed. Even though the parent may be providing the informed consent to a procedure, the child must still be provided with information proportionate to his or her level of understanding.  The information should be communicated in a form, language and manner that enables a child to understand it.

Accordingly, the Commissioner could insist upon a medical practitioner providing two sets of information as part of the obligations to comply with Rights 6 and 7. One set for the parent or guardian to enable them to give informed consent to the proposed treatment, and an age appropriate set of information for the child to enable him or her to understand what is happening.

Section 36 of the Care of Children Act 2004 (“the Act”) provides that the consent of a child of or over the age of 16 years has effect as if the child were of full age. Under section 38 of the Act a female child of any age has the right to consent or refuse to consent to a medical or surgical procedure for the purpose of terminating her pregnancy.

Where consent by another person on behalf of a child is necessary, that consent may be given by a guardian of the child, a person acting in the place of a parent (if no guardian can be found) or a District Court Judge or Chief Executive (if no person acting in the place of a parent).

In conclusion, when obtaining the consent of a child an assessment needs to be undertaken, considering the competency of the child and the nature of the procedure, along with the views of the child’s guardian having regard to the best interests of the child.

 


 

Guardian and consent for children

Where consent from the child patient is not possible due to a lack of competency, understanding, maturity, and so on, it is instead required to gain consent from a guardian or parent.

 

Consent on Behalf

Section 36 of the Care of Children Act 2004 (“the Act”) states that children over the age of 16 are considered legal adults who can provide informed consent.

People under 16 years of age are not automatically prohibited from consenting to medical, surgical or dental procedures so judgement of the patient’s competence to make an informed choice and give informed consent is needed in each instance. An assessment of the child’s competency should be undertaken and doctors should form an opinion on whether he or she is able to give informed consent.

Generally, a competent child is one who is able to understand the nature, purpose and possible consequences of the proposed investigation or treatment, as well as the consequences of non-treatment.

Under s 16 of the Act a guardian can consent to medical treatment on behalf of a child in circumstances where the child is deemed to be not competent to provide informed consent.

In circumstances where a child is not competent to provide consent and there is no suitable guardian to provide consent, section 36B the Act provides that consent may be given by a District Court Judge or the Chief Executive.

 

Refusal to Consent

If parents refuse consent and the medical opinion is that this is against the best interests of the child, a Court application will be necessary for the child to receive treatment. The Act allows for a Court order to be made, under which the Court assumes guardianship of the child, to ensure they receive the appropriate treatment.

In other situations where time does not permit a court application, and provision of services are in the best interests of the child, Right 7(4) of the Code of Health and Disability Services Consumers’ Rights should be relied upon.

The Act regards anyone who has reached the age of 16 as an adult for the purpose of consenting to treatment. However there are additional powers under this Act, to enforce treatment, where the person is aged between 16 and 20 and refuses to consent to treatment, against medical opinion. Legal advice should be sort before invoking these powers.

 

Current as at 17 October 2018

 


If you have further questions about informed consent for children, or you are concerned about a recent interaction that included the potential need for informed consent, get in touch with NZMPI’s team of medico-legal advisors now.

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