Abstract
Consent and capacity are ethical issues that doctors encounter every day in clinical practice. Informed consent, when taken correctly, can help empower patients and improve adherence and understanding of their treatment. Despite this, these areas seem to be poorly understood by clinicians, and are a major cause of calls to medico-legal defence organisations. This article is a concise amalgamation of General Medical Council (GMC) and British Medical Association (BMA) guidance, with justification for the importance of consent in practice. It covers the definitions of consent and capacity, how they are to be taken, lack of capacity, consent in minors, and parental responsibility. This is in order to provide clinicians with a base knowledge of these issues, which they can apply to their everyday practice.
The GP curriculum and consent
Develop and apply the primary care consultation to bring about an effective doctor–patient–family relationship to enable parents or carers, children and young people to:
^ Participate in their own care-planning and delivery ^ Be routinely involved and supported in making informed decisions and choices about care, taking into account age and development, increasing autonomy with age, and the need for confidentiality balanced with the parents’ need for information ^ Achieve concordance, including active listening and shared decision-making with you as their GP Describe the issues involved in delivering services for young people relating to access, communication, confidentiality and consent
Provide patients with information on the risks and benefits of treatments to allow them to make informed decisions
Understand the financial, regulatory and legal frameworks in which you provide healthcare both at practice level and in the wider NHS
As medicine moves away from the older paternalistic approach to patient care, and moves towards the modern concept of patient-centred autonomy, informed consent becomes one of the most important tools for doctors to ensure good patient care. Consent is not only a device to make sure patients are informed and confident in their management plans, but also it is a way for doctors to ensure patients are involved in discussing and deciding their own treatment. This is especially important in general practice, as so many interventions and treatments are initiated in that setting. Despite the obvious importance of consent, there are major disparities in how consent is taken from doctor to doctor. This is probably why consent is one of the most common reasons for calls to the medical defence organisations helplines (Medical Defence Union (MDU), 2011). The rules to be followed regarding consent are laid out in detail in ‘Consent: Patients and doctors making decisions together’ (GMC, 2008), ‘0-18 years: Guidance for all doctors’ (GMC, 2007) and the ‘Consent tool kit’ (BMA, 2009). However, it is clear that more needs to be done to make sure doctors are aware of the standards expected of them. This article is an up-to-date review of the fundamental rules regarding consent and capacity in adults and young people.
What is consent?
Consent is defined as ‘the principle that a person must give their permission before they receive any type of medical treatment or examination. This must be done on the basis of a preliminary explanation by a clinician’ (NHS, 2014). Consent must be taken before any and every procedure, examination, investigation, treatment, and research or educational involvement. For consent to be valid, it must be informed, voluntary and from someone who has the capacity to consent (NHS, 2014).
The doctor who will be performing the intervention should ideally take consent; however, this can be delegated to other doctors or healthcare practitioners if they have sufficient knowledge and understanding of the intervention, its risks and its benefits (GMC, 2008). If taking consent is delegated, the doctor performing the intervention is still responsible for ensuring valid consent is in place (BMA, 2009).
Consent can be explicit or implied. Implied consent is often used for simple, generally well-understood procedures, such as having one’s blood taken, or blood pressure measured (GMC, 2008). In these cases, implied consent is given when the patient reveals and extends an arm to allow the procedure.
Explicit consent can be written or oral. There are situations where written consent is required, for example, when procedures or interventions carry high risks. In primary care, most practices require patients to give written consent for information sharingabout adults with other family members, and invasive procedures such as joint injections, minor surgery or contraptive implants or intrauterine devices. In emergencies, however, oral consent is usually acceptable, due to the time-dependent nature of the situation (GMC, 2008).
It is good practice for clinicians to document that they have asked for and received verbal consent during a consultation. This is especially important when performing an intimate exam, for example, a vaginal, breast, or digital rectal exam.
Making sure consent is appropriately taken and well-informed seems to be an area that could use improvement within the medical community. There have been multiple complaints and actions taken regarding informed consent. One study in the Student BMJ (Raymond, 2003) found that only 24% of doctors took appropriate written consent when teaching students to do intimate examinations on anaesthetised patients. This is not only a poor example of professionalism, but also a very poor example to set to medical students.
Consent, more specifically informed consent, is vital in providing good quality patient care. Not only is informed consent important to ensure that patients feel safe, informed and confident in their care plans; it is also an essential part of shared decision-making between doctor and patient. This greatly increases patient understanding, participation and adherence to treatment (Durand et al., 2014). In fact, a recent cohort study found that offering patients an informed choice improved the uptake of colorectal cancer screening (Wong et al., 2014).
According to Ley’s model of adherence, shown in Fig. 1, the larger the extent of patients' comprehension of a situation, the greater are their levels of satisfaction and adherence to treatment (Kessels, 2003). Taking informed consent can greatly improve a patient’s understanding and can, based on Ley’s model, also improve patient adherence and satisfaction.
Ley’s model of adherence.
Consent and capacity
It can be argued that consent and capacity are inseparable. Without capacity, one cannot provide consent. In England and Wales, every adult is presumed to have the capacity to make their own decisions about their care unless proven otherwise. Doctors cannot assume a lack of capacity based on a patient’s looks, medical condition or disability. They also cannot presume someone lacks capacity because they are making an ‘unwise decision’ about their care (GMC, 2008).
The four steps to assess capacity.
Independent Mental Capacity Advocates
Informal advocacy options have existed for many years in medicine; however, Independent Mental Capacity Advocates (IMCAs) were introduced in the MCA 2005 to ensure the views of adults without capacity are considered while decisions are made on their behalf. The service assigns an advocate to support and represent the patient when they do not have appropriate family and friends with whom they can consult. GPs do not have to act on their advice; however, it must be taken into account as part of the decision-making process. IMCAs are trained professionals and are a statutory requirement in certain situations.
An IMCA must be instructed in the following situations.
The MCA 2005 does not define who is an appropriate family or friend, and this decision is based on the judgement of the GP. It does, however, define a serious medical treatment as a single treatment where there is a fine balance between the benefits and risks to the patient; a decision on the choice of treatment where there is no clear most appropriate option; or where the proposed treatment is likely to have serious consequences (BMA, 2010).
Lasting Power of Attorney
Before the MCA 2005, one could appoint an individual to make decisions about their property and affairs should they lose capacity. The MCA 2005 furthers this power, so that an appointed individual may also make decisions about health and social affairs. This is called the lasting power of attorney (LPA). The only decision the nominated individual may not automatically make, is the decision to withdraw life-saving treatment. However, this can be specifically authorised by the patient as part of the agreement, before capacity is lost.
When a person with a LPA loses capacity, a doctor must discuss and accept decisions made by the nominated individual. However, if the GP suspects that decisions are not being made in the patient’s best interest, the GP should consult with the wider health and social services team caring for the patient, the local Adult Safeguarding Team and ultimately the Court of Protection (Nicholson, Cutter, & Hotopf, 2008).
Advance decisions
Advance decisions can be made by patients to specify treatments they would not want to receive should they lose capacity in the future. Decisions must be made while the patient has capacity. They do not need to be in written format unless they are regarding life-saving treatment, when they must be written, witnessed and signed. Assuming the advance decision is relevant to the current scenario, GPs must act by them. It is the responsibility of the clinician to ascertain if there are any advance decisions for a patient. Should patients wish to reverse the decision they can do so verbally, but they must have capacity to do so (Nicholson et al., 2008).
Deprivation of Liberty
Situations that may constitute a deprivation of liberty.
Deprivation of liberty should be avoided wherever possible; when it is required, it is good practice to record and document the decision-making process behind it, as well as an assessment of the patient’s capacity. It is advised that the clinician keep the patient, as well as any supporting family and friends, as informed as is possible throughout the process.
When a patient is at risk of deprivation of liberty, the managing authority of the hospital or care home involved must submit an application to a supervisory body, in order to receive authority to deprive the patient of their liberty. In hospitals, the managing authority is the NHS authority responsible for its running, whereas in care homes the managing authority will be a person registered under the Care Standards Act 2000. Ideally, the application should be made in advance, although it is possible to obtain emergency decisions, which will be subsequently followed up with a standard authorisation (Alzheimer’s Society, 2015; BMA, 2008). It is important to note that all deaths of people subjects to DOLS must be reported to the coroner, so it is always worth asking if a patient that dies in a care home is subject to a DOLS. Currently DOLS do not apply to patients living in the community outside care homes.
Dementia
Due to the progressive nature of dementia, patients who have been recently diagnosed should think about their future medical care, and in particular, what they would like to happen when they no longer have the capacity to make their own decisions. Having dementia does not automatically mean that the patient will lack capacity, and the patient should have his or her capacity assessed on a decision-by-decision basis.
LPA and advance decisions are very important options to consider in a patient with dementia. If no LPA has been nominated and no advance decisions exist, a patient diagnosed with dementia and who lacks capacity can have decisions made in their best interest by the clinical team, guided by the MCA 2005 (NHS, 2015).
Learning disabilities
There are a wide range of learning disabilities, which cause a variety of effects on mental comprehension. GPs are not to assume a lack of capacity based on the appearance or medical condition of a patient. If lack of capacity is suspected, patients should have their capacity assessed on a case-by-case basis. A person with a learning disability may be able to make simple decisions, but may require support for more complex ones. When patients cannot make the decision themselves, the decision should be made in their best interest, after discussion with any family.
Young people and consent
When addressing consent in under 18 year olds, young people are split into two groups; under-16 s, and 16/17 year olds. The rules for these age groups, as well as adults, are summerised in Figs 2 and 3.
Can my patient consent to treatment? Can my patient refuse treatment?
In under-16s, it is ordinarily assumed that the child does not have capacity, and an adult with parental responsibility provides consent on their behalf. If it can be proven that the child possesses the necessary capacity, they can be declared ‘Gillick Competent’ and can consent to treatment themselves (Willsher and Macaulay, 2014). However, no child under-16 years in age can refuse a treatment that is in their best interest (GMC, 2007).
Assessing for Gillick competence can be a difficult process. It requires knowledge of the child’s medical and social situation, and an understanding of the context of the medical decision being made. The clinician should ensure that child understand the information they have been given; that they are mature enough to comprehend what is involved, the purpose and any consequences; that they can balance risks and benefits; and that they are not being coerced (BMA, 2010; Larcher and Hutchinson, 2010). This clearly requires a good knowledge of the child, and there is obvious room for inconsistencies depending on who interviews the child.
It is important to consider that a child may have the maturity and insight to consent to a simple, straightforward treatment, but may not be competent to consent to a more complex treatment with high risks and serious complications (GMC, 2007). For example, a child may be able to understand the procedure, risks and benefits to stitching a wound; however, the more complex nature and risks of surgery may be beyond their understanding.
In young people over 16 years of age, it is assumed that, as for adults, they can consent to treatment (GMC, 2007); however, they can also be found to lack the capacity to consent. In these cases, management plans are determined by the parents/guardians and the doctors (rather than the MCA 2005), all of whom must be acting in the patient’s best interests (GMC, 2007). A young person aged between 17 and 18 can also refuse treatment if deemed competent, unlike a person aged under-16 (BMA, 2010). However, this is a very complex area. In Scotland a competent child’s refusal cannot be overridden by parents or doctors. However, in England, Wales and Northern Ireland the situation is more complicated. If this situation arises, doctors are advised to seek legal advice (BMA, 2010).
Case study.
Elizabeth, a 15-year-old girl, visited her GP for a consultation together with a school friend. Elizabeth disclosed that she had unprotected sexual intercourse 6 weeks ago and has missed a period. She had taken three home pregnancy tests in the last week that were all positive. She asked the GP to refer her for an abortion and to have the same contraception as her school friend from then on. Elizabeth asked the GP not to inform her parents about the pregnancy, abortion referral or contraception.
The GP informed Elizabeth that she could consent to an abortion and contraception if she had the intelligence and maturity to understand the nature, purpose, benefits and risks of the treatments, as well as the consequences of not having an abortion. After discussing the issues, it was deemed by the GP that Elizabeth was able to consent to the abortion and contraception, and that confidentiality did not need to be broken. Consequently, Elizabeth’s parents were not informed. However, the GP strongly suggested that Elizabeth herself should inform her parents. This discussion was documented in Elizabeth’s notes.
Parental responsibility
Parental responsibility refers to the ‘rights, duties, powers and responsibilities that most parents have in respect of their children. It includes parents’ right to consent to treatment on their child’s behalf as long as the treatment is in the child’s interests’ (BMA, 2015). Stated in this form, parental responsibility includes the right to consent to treatment on a child’s behalf. However, a Gillick-competent child may overrule his or her parent(s) (GMC, 2007).
The mother is automatically assumed to have parental responsibility. The father will also have responsibility if he was married to the mother at the time of the birth, or if his name is on the birth certificate (BMA, 2006). An unmarried or non-registered father does not have responsibility. However, he can obtain it through the courts. On becoming divorced, both parents retain parental responsibility, irrespective of financial contribution or how often the parent sees the child (BMA, 2006).
Other people can also acquire parental responsibility for a child. A guardian appointed by the courts will have parental responsibility; adoptive parents will acquire responsibility upon adoption (foster parents do not usually have responsibility); when a child is in care, the local authorities obtain responsibility; and if both parents with responsibility pass away, a testamentary guardian may acquire it (BMA, 2006).
Even when someone has parental responsibility, he or she cannot consent to treatment that is inappropriate, and cannot refuse treatment that is in the child’s best interest (BMA, 2006). In cases of the latter, the case is usually taken to court for a decision. An example would be a Jehovah’s Witness refusing life-saving blood products for a child. This would not be binding as the intervention is in the child’s best interest.
Conclusions
According to the GMC, taking consent is ‘an important part of the process of discussion and decision-making, rather than as something that happens in isolation’ (GMC, 2015). It allows doctors to get patients involved in their own care and increases patient adherence to treatment; it also ensures patients are fully informed and have the autonomy to choose their own treatment. The current GMC guidance on consent maintains that, as long as patients are competent, they have the right to make any decision they wish – even if the doctor disagrees. It also advises doctors to provide all the possible practical help to allow patients to be deemed competent. For those who are not competent the MCA 2005 protects the patient by saying that any intervention should be in the patient’s best interests, while being the least invasive to the patient's life.
Consent is a fundamental part of medicine today, and not adhering to the guidance can result in sanctions or erasure (GMC, 2008). It is therefore essential that doctors and students act by the guidance given to ensure better patient care, adherence and autonomy.
Key points
Consent should be taken before any and every intervention, including prescribing any treatment, performing any procedure (including taking blood pressure), examining a patient and involving a patient in education Consent is not valid unless it is appropriately informed A patient making a decision you disagree with does not constitute a lack of capacity, so long as they meet the criteria for capacity - a patient has the right to make a decision you deem unwise Every effort must be taken to make sure a patient is able to consent for himself or herself - a patient only lacks capacity after you have given all the possible practical help for them to consent for themselves Having dementia does not automatically mean that a patient will lack capacity, and the patient should have his or her capacity assessed on a decision-by-decision basis Competence in young people varies on a case-to-case basis; you should always get children as involved in their care as possible, even if they are not Gillick-competent
Footnotes
Acknowledgement
We are very grateful to Tista Chakravarty-Gannon, Regional Liaison Advisor for the GMC, for all her help during the writing of this article.