Navigating the consent minefield

The GMC says that obtaining patient consent should no longer be “a tick box exercise”, but a highly complex process based on “partnership, not paternalism”. In practice, this may require the negotiation of some challenging moral and professional issues.

Who has the capacity to give consent, for example? Does a patient with dementia or paranoid schizophrenia, have the capacity to make decisions about their surgical treatment? If a pregnant mother refuses a life-saving injection, when this will result in the death of her and her unborn child, what should be done? Furthermore, how do you determine whether a patient fully understands the implications of their treatment and consent is therefore properly “informed”? The General Medical Council’s latest guidance stresses that clinicians must ensure the patient has been given all the information they need to make a decision, and be certain that the patient has fully understood the details and implications. Consent: patients and doctors making decisions together,1 which replaces Seeking patients’ consent: the ethical considerations, focuses on the importance of the doctor-patient partnership.

It states that consent should be part of a wider decision-making process, in which both the patient and physician have an important role to play. If the patient has the capacity to make decisions for themselves, the doctor should explain the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment.

Avoiding paternalism

The consequences of not providing such information on the risks of treatment were highlighted in 2004 by the legal case of “Chester versus Afshar” (illustrated in the GMC guidance). Carole Chester was left partially paralysed after surgery for lumbar disc protrusion. Central to the case was the fact that Dr Afshar failed to warn her this was a foreseeable (1-2%) but unavoidable risk of the surgery. The House of Lords concluded that, although this omission was not a direct cause of injury, it did result in negligence.

Commenting on the case, Lord Bingham said: “In modern law medical paternalism no longer rules and a patient has a prima facie right to be informed by a surgeon of a small, but well-established, risk of serious injury as a result of surgery.”

The GMC guidance has been written with the aim of helping clinicians to avoid such “paternalism” in their approach to the decision-making process. It states that doctors may “recommend a particular option, which they believe to be best for the patient, but must not put pressure on the patient to accept their advice.”

It further adds that patients have the right to accept or refuse an option for a reason that may seem irrational to the doctor, or for no reason at all. If the patient asks for a treatment that the doctor considers would not be of overall benefit to them, the doctor should discuss the issues with the patient and explore the reasons for their request. If, after discussion, the doctor still considers that the treatment would not be of overall benefit to the patient, they do not have to provide the treatment. However, the reasons should be explained to the patient, along with any other options that are available, including the option to seek a second opinion.

The GMC also states that clinicians should not make assumptions about the information a patient might want or a patient’s level of knowledge or understanding of what is proposed. They should check whether patients have understood the information provided, and make it clear that the patient can change their mind about a decision at any time. If a patient still does not want to know in detail about their condition or the treatment, the GMC says that the clinician should respect their wishes, but they must still give the patient the information they need in order to give their consent to a proposed investigation or treatment.

This is likely to include what the investigation or treatment aims to achieve and what it will involve, for example: whether the procedure is invasive; what level of pain or discomfort they might experience, and what can be done to minimise it; anything they should do to prepare for the investigation or treatment; and if it involves any serious risks. If a patient insists that they do not want even this basic information, the clinician must explain the potential consequences of them not having it, particularly if it might mean that their consent is not valid. The fact that the patient declined this information must be recorded.

Evidencing consent

The GMC advises that patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment – by rolling up their sleeve to have their blood pressure taken, for example. In the case of minor or routine investigations or treatments, oral or implied consent may be sufficient. But in cases that involve higher risk, it is important that the patient’s written consent is obtained, so that everyone involved understands what was explained and agreed. In addition, the law states that written consent must be given for certain treatments – such as fertility

treatment and organ donation. Before beginning treatment, a member of the healthcare team should check that the patient still wants to go ahead and the clinician must respond to any new or repeated concerns or questions raised. This is particularly important if a significant time has passed since the initial decision was made or where new information has become available about the risks of treatment; or about other treatment options available, for example.

Where possible, efforts should also be made to ensure the patient’s decision to accept a particular investigation or treatment is made voluntarily, since pressure may be applied by their employer, insurer or relatives, for example. Patients who may be particularly vulnerable to pressure include the elderly in residential care homes, or those subject to mental health legislation. In its guidance, the GMC highlights the example of a legal case where a 20-year-old pregnant woman, was injured in a car accident and developed complications that required blood transfusions. She did not indicate on admission that she was opposed to receiving transfusions but after spending some time with her mother, who was a practising Jehovah’s Witness, she decided to refuse the treatment.

The Court of Appeal considered that the woman had been pressurised by her mother and her ability to decide about the transfusions was further impaired by the drugs with which she was being treated. The court allowed the transfusions to proceed on the basis that consent to a particular treatment is not valid if it is given under pressure or duress exerted by another person.

If a patient is unable to make decisions for themselves, the doctor must work with those close to the patient and with other members of the healthcare team. The doctor must take into account any views or preferences expressed by the patient and must follow the law on decisionmaking when a patient lacks capacity.

Judging “capacity”

However, the guidance stresses a patient should not be assumed to lack the capacity to make a decision “solely because of their age, disability, appearance, behaviour, medical condition (including mental illness), their beliefs, their apparent inability to communicate, or the fact that they make a decision that the clinician disagrees with.” Whether lack of capacity is temporary or permanent should also be considered. While the right of patients to make their own healthcare choices and decisions is generally accepted by healthcare professionals, decision making for those who lack capacity can be especially problematic.

The Mental Capacity Act 2005 came into force last year to provide a solution to the complex issue of “capacity” (following the Adults with Incapacity Act established in Scotland, in 2000).

At a recent conference: Every Patient Matters, held by the College of Operating Department Practitioners, Sue Hodge – a lecturer in Health and Social Care – said the Mental Capacity Act will place increased demands on healthcare professionals.

“The act is very new, so we do not yet know how it is going to work. We are told that ‘what was considered best practice remains best practice’, but we are still unclear exactly what should be done to ensure this, in practical terms,” she commented. “We now have an Act of Parliament that could solve a lot of these problems or equally contribute to them, because it imposes a very rigid framework of steps that must be taken in relation to consent.

“However, the most important issue is that everyone is assumed to have capacity. In paternalistic terms, a clinician may believe they know what is in the ‘best interests’ of the patient but this has nothing to do with the individual’s capacity to make a decision. The Act says a person must not be treated as being unable to make a decision merely because the decision is unwise.”

The Act clearly describes a person as “lacking capacity” when there is a disturbance or impairment in the function of the mind or brain.

“We do not know what this means in legal terms, at present – no doubt the judges will tell us at some point. But we have to use common sense in the meantime,” she added.

Historically, the courts have not always interpreted a “disturbance of the mind” in the same way as the clinician treating an individual. The GMC points out that a court case involving a patient with paranoid schizophrenia highlighted the principle that mental illness does not automatically call a patient’s capacity into question. While at Broadmoor secure hospital, a patient developed gangrene in his leg but refused to agree to an amputation, which doctors considered was necessary to save his life. The court upheld the his decision on the basis that mental illness does not automatically mean a patient lacks capacity to make a decision about medical treatment. The court ruled that patients who have capacity (i.e. understand, believe, retain and evaluate the necessary information) can make their own decisions to refuse treatment, even if those decisions appear irrational to the doctor or may place the patient’s health or their life at risk.

Refusal of treatment

In cases where a patient refuses treatment when the results could prove fatal, it can be extremely difficult for the clinicians involved. Sue Hodge cited a particularly emotive case of a mother who delivered twins and urgently required blood products, but refused on religious grounds. “It is hard for the team delivering care in those circumstances,” she acknowledged.

“However, a patient has the right to say ‘no’ even if we believe the decision to be ‘madness’. At present, we do not know if ‘terror’ would be accepted by a judge as a disturbance of the mind. However, people are entitled to change their mind at the last minute, even when it does not appear to be a rational decision based on their best interests.”

The clinician proposing the treatment must make the assessment of the patient’s capacity for consent, but nurses or other healthcare professionals may also be involved in this process. This can prove problematic if the patient refuses to be cooperative.

“If the patient is non-compliant with the assessment of capacity, there is nothing that can be done unless the Mental Health Act powers can be used. This will rarely be the case, even when the new Mental Health Act comes into effect later this year.”

Considering patients’ wishes

In the event that a patient is unable to give their consent, such as in the case of emergency treatment in trauma cases, for example, Sue Hodge stated that a person’s “past and present wishes and feelings must be taken into consideration”.

She added: “Often in theatre it is impossible to know this information about the patient. However, you are only required to do what is ‘reasonable in all the circumstances’. If you have a patient in theatre and you know nothing about their background, except perhaps their religion, it is reasonable to go ahead with what is in their best interests.

“Some of the legal wording is quite vague – such as the need to take into account ‘any other factors that the person would like to be considered were he or she able to do so.’ I feel sorry for healthcare professionals having to make these decisions. However, I cannot over-emphasise the need to keep detailed records on how a decision has been reached.”

In some circumstances, clinicians may be required to consult with those caring for the individual or those interested in his or her welfare – presenting further issues which need to be considered. The parent of an adult patient may argue they are entitled to be consulted, for example.

The question arises: is this appropriate in a particular circumstance? The issue of breach of confidentiality must also be addressed. The law states that confidentiality must be protected unless it is in the person’s “best interests” for the information to be shared. Making a judgement on this inevitably leaves healthcare professionals open to scrutiny, however.

It is also important to consider lasting power of attorney, which gives a designated person the right to make all healthcare decisions on behalf of the patient. This must be specifically indicated on the correct form to be legally acceptable.

‘Right to die’

Most recently, a new “right to die” card has been highly publicised which allows anyone to refuse treatment in a medical emergency. The Advanced Decision to Refuse Treatment (ADRT) card is carried in a wallet or purse and instructs a doctor to withhold treatment should the carrier lose the capacity to make decisions, because of an accident or illness. Its supporters say it is a practical way of implementing the Mental Capacity Act, which allows individuals to outline “advance directives”.2

ADRT is perceived to be the replacement for living wills, but Sue Hodge pointed out that “if they are anything like living wills, they will prove useless”.

She stated that, in the UK, there has only been one legal judgement concerning a living will made by the patient, his wife and the consultant all working together. “When the patient lost consciousness, the Trust still had to go to court to establish whether it was permissable to stop treatment in accordance with the patient’s expressed wishes. The judge only ruled that the treatment could be stopped because the patient had communicated that he still stood by his original wishes by blinking.”

Despite this, Sue Hodge predicted that both ADRT and living wills would have a role to play in decisions on consent – since they give a clear indication of the patient’s wishes and feelings at a certain period in time.

The GMC guidance should give some further clarity to the process of obtaining patient consent and has been welcomed by patient groups – particularly those representing mental health issues. Effective communication is central to the guidance and GMC head of standards and ethics, Jane O’Brien, concluded that clinicians “need to engage more with patients in order to make good decisions.” The BMA has also given the 64-page GMC document its full support but raised the question: “How will doctors find the time needed to deal with each patient?” Ultimately, patient involvement in all aspects of decision making is being given greater emphasis in the healthcare sector, and this is reflected in the changes to the legal and policy frameworks concerning consent.

References

1 Consent: patients and doctors making decisions together, GMC, 19 May 2008.

2 www.bbc.co.uk, BBC News, accessed 21 May 08.