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Changes to informed consent — vigilance is required!

Informed consent blog 1170x500.jpgInformed 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.

 


 

Children and consent

 

‘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.

 

None of these issues are easy to judge except in the clearest of situations and you must seek advice from NZMP 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