GMC Consent

Question 1

The seven principles of decision making and consent

Answer 1

1. All patients have the right to be involved in decisions about their treatment and care and be supported to make informed decisions if they are able.
2. Decision making is an ongoing process focused on meaningful dialogue: the exchange of relevant information specific to the individual patient.
3. All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.
4. Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action.
5. Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity to make a specific decision at a specific time, and only after assessment in line with legal requirements.
6. The choice of treatment or care for patients who lack capacity must be of overall benefit to them, and decisions should be made in consultation with those who are close to them or advocating for them.
7. Patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible.

Question 2

The information you give patients

Answer 2

You must give patients the information they want or need to make a decision.

This will usually include:

1. diagnosis and prognosis
2. uncertainties about the diagnosis or prognosis, including options for further investigation
3. options for treating or managing the condition, including the option to take no action
4. the nature of each option, what would be involved, and the desired outcome
5. the potential benefits, risks of harm, uncertainties about and likelihood of success for each option, including the option to take no action.

You must try to make sure the information you share with patients about the options is objective. You should be aware of how your own preferences might influence the advice you give and the language you use. When recommending an option for treatment or care to a patient you must explain your reasons for doing so, and share information about reasonable alternatives, including the option to take no action. You must not put pressure on a patient to accept your advice.

You should not rely on assumptions about: a the information

1. patient might want or need
2. the factors a patient might consider significant
3. the importance a patient might attach to different outcomes

Other examples of information that might be relevant and, if so, should be shared with patients include:

1. whether an option is an innovative treatment designed specifically for their benefit
2. whether there is a time limit on making their decision and what the implications of delaying might be
3. the names and roles of key people who will be involved in their care, and who they can contact (and how) if they have questions or concerns
4. their right to refuse to take part in teaching or research
5. their right to seek a second opinion
6. any bills they will have to pay
7. any conflicts of interest that you or your organisation may have
8. any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.

Question 3

Exceptional circumstances in which you may decide not to share all relevant information to inform a patients decision

Answer 3

1. There may be circumstances in which you decide not to share all relevant information with a patient straight away. If you delay sharing information necessary for making a decision, you should let the patient know there’s more to discuss and make sure arrangements are made to share the information as soon as it’s appropriate to do so. You must make a record of the information you still need to share, your reasons for not sharing it now, and when it can be shared.
2. You should not withhold information a patient needs to make a decision for any other reason, including if someone close to the patient asks you to. In very exceptional circumstances you may feel that sharing information with a patient would cause them serious harm and, if so, it may be appropriate to withhold it. In this context ‘serious harm’ means more than that the patient might become upset, decide to refuse treatment, or choose an alternative. This is a limited exception and you should seek legal advice if you are considering withholding information from a patient.

Question 4

Discussing benefits and harm

Answer 4

1. You must give patients clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option, including the option to take no action.
2. It wouldn’t be reasonable to share every possible risk of harm, potential complication or side effect. Instead, you should tailor the discussion to each individual patient, guided by what matters to them, and share information in a way they can understand.
3. You should usually include the following information when discussing benefits and harms.
   
   • Recognised risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge and experience.
   • The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue could reveal more.
   • Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them.
   • Any risk of serious harm, however unlikely it is to occur.e Expected harms, including common side effects and what to do if they occur.

You should consider using visual or other explanatory aids to support patients to understand their personalised risk, taking account of their individual clinical and personal circumstances, compared with population level risk.

Question 5

Answering questions and dealing with uncertainty

Answer 5

1. You must answer patients’ questions honestly and accurately, and as fully as is practical in the circumstances. You must be clear about the limits of your knowledge and, if you can’t answer a question, explain whether it is something you are uncertain of or something that is inherently uncertain.
2. If you are uncertain about the diagnosis, or the clinical effect a particular treatment might have, or if the available evidence of benefits and harms of an option is unclear, you should explain this to the patient. Some things will become clearer after treatment starts, so you should discuss in advance what the arrangements will be for monitoring the effect of the treatment and reviewing the decision to provide it. You should also explore in advance what options the patient might prefer in the future, depending on how treatment progresses, and the factors that might influence their choice.

Question 6

The scope of decisions

Answer 6

You must be clear about the scope of decisions so that patients understand exactly what they are consenting to. You must not exceed the scope of a patient’s consent, except in an emergency. Agreeing the scope of a patient’s consent with them in advance is particularly important if:

• treatment or care will be provided in stages with opportunities to review and adjust in between
• different healthcare professionals will provide different parts of the treatment or care
• there may be opportunity, once an intervention is underway and the patient’s decision-making ability is compromised, to carry out another intervention
• there is significant risk of a specific harm occurring during an intervention, which would present more than one way to proceed.

Question 7

If you disagree with a patients choice of option

Answer 7

1. You must respect your patient’s right to decide. If their choice of option (or decision to take no action) seems out of character or inconsistent with their beliefs and values, it may be reasonable to check their understanding of the relevant information (see paragraph 10) and their expectations about the likely outcome of this option and reasonable alternatives. If it’s not clear whether a patient understands the consequences of their decision, you should offer more support to help them understand the relevant information. But you must not assume a patient lacks capacity simply because they make a decision that you consider unwise.
2. If a patient asks for treatment or care that you don’t think would be in their clinical interests, you should explore their reasons for requesting it, their understanding of what it would involve, and their expectations about the likely outcome. This discussion will help you take account of factors that are significant to the patient and assess whether providing the treatment or care could serve the patient’s needs. If after discussion you still consider that the treatment or care would not serve the patient’s needs, then you should not provide it. But, you should explain your reasons to the patient and explore other options that might be available, including their right to seek a second opinion.

Question 8

Circumstances that affect the decision-making process

Answer 8

Time and resource constraints

1. Being able to meet a patient’s individual needs for information and support depends, in part, on the time and resources available to you and your colleagues in the organisations where you work. Where there are pressures on your time or resources are limited, you should consider:
   
   • the role other members of the health and care team might play
   • what other sources of information and support are available to the patient, such as patient information leaflets, advocacy services, expert patient programmes, or support groups for people with specific conditions.
2. If factors outside your control mean that patients aren’t given the time or support they need to understand relevant information (see paragraph 10), and this seriously compromises their ability to make informed decisions, you must consider raising a concern. 4 You should also consider if it is appropriate to proceed, bearing in mind that you must be satisfied that you have a patient’s consent or other valid authority before providing treatment or care.

Treatment in emergencies

1. In an emergency, decisions may have to be made quickly so there’ll be less time to apply this guidance in detail, but the principles remain the same. You must presume a conscious patient has capacity to make decisions and seek consent before providing treatment or care.
2. In an emergency, if a patient is unconscious or you otherwise conclude that they lack capacity and it’s not possible to find out their wishes, you can provide treatment that is immediately necessary to save their life or to prevent a serious deterioration of their condition. If there is more than one option, the treatment you provide should be the least restrictive of the patient’s rights and freedoms, including their future choices.
3. For as long as the patient lacks capacity, you should provide ongoing care following the guidance in paragraphs 87–91. If the patient regains capacity while in your care, you must tell them what has been done and why, as soon as they are sufficiently recovered to understand. And you must discuss with them the options for any ongoing treatment.

If a patient doesn’t want to be involved in making a decision

1. No one else can make a decision on behalf of an adult who has capacity. If a patient who has capacity asks you or someone else to make a decision on their behalf, you should tell them this. You should explain that it’s important they understand some basic information so that you can proceed with treatment or care. This would usually include what the options are and what they aim to achieve.
2. If a patient has chosen an option but doesn’t want to discuss the details, you should explain they will need to have some information about what it would involve before you can proceed, such as:
   
   • a whether the procedure is invasive
   • what level of pain or discomfort they might experience and what can be done to minimise this
   • anything they should do to prepare for the intervention
   • if it involves any risk of serious harm.
3. You should try to find out why they don’t want to be involved in decision making and explore whether you can do anything to reassure and support them. They might be anxious about the decision or overwhelmed by the information and need time or support to process it.
4. If, after trying to discuss options with them along the lines set out above, your patient insists that they don’t want even this basic information, you will need to judge whether their consent is valid so that you can proceed. This is more likely to be the case if the proposed option is a well-established intervention commonly used for treating the condition they have, and there’s reason to believe the patient wants to be treated or cared for rather than take no action. You should consider seeking advice from your medical defence body or professional association in these circumstances.

If you are concerned a patient cannot make decision freely

1. Many factors influence patients’ decision making, but it’s important that nothing influences a patient to such an extent that they can’t exercise free will. If a patient can’t make a decision freely, they won’t be able to consent.
2. Patients may feel pressure to have particular treatment or care. Pressure can come from others – partners, relatives or carers, employers or insurers – or from patients’ beliefs about themselves and society’s expectations.
3. You should be aware of this possibility and of other situations in which patients may be particularly vulnerable or susceptible to pressure, for example, if they are:
   
   • experiencing domestic or other forms of abuse
   • resident in a care home
   • cared for or supported by others because of a disability
   • detained by the police or immigration services, or in prison
   • subject to compulsory treatment or assessment orders, or at risk of becoming so.
4. If you suspect a patient’s rights have been abused or denied, you must follow local safeguarding procedures and consider raising a concern.
5. You should do your best to make sure patients reach their own decision, having considered relevant information (see paragraph 10) about the available options, including the option to take no action. You should support them to make a decision, following the steps in paragraphs 27–30 as well as:
   
   • giving them more time and a safe, quiet space to consider the options
   • making sure you have an opportunity to talk to them on their own
   • signposting them to specialist support services.
6. You must make sure your patient is aware that they have the right to choose whether or not to have treatment. You should not proceed with treatment or care if you don’t think it will serve the patient’s needs.
7. If, after following the guidance in paragraphs , you still believe a patient is under such extreme pressure to agree to or refuse a particular intervention that they can’t exercise free will, you should seek advice through local procedures, consult your medical defence body or professional association or seek independent legal advice. The Court may be able to make declarations and orders to protect adults where they are not able to freely make a decision.

Question 9

If your patient lacks capacity to make a decision; overall benefit

Answer 9

1. We use the term ‘overall benefit’ to describe the ethical basis on which decisions are made about treatment and care for adult patients who lack capacity to decide for themselves. This involves weighing up the risks of harm and potential benefits for the individual patient of each of the available options, including the option of taking no action. The concept of overall benefit is consistent with the legal requirements to consider whether treatment ‘benefits’ a patient (Scotland), or is in the patient’s ‘best interests’ (England, Wales and Northern Ireland).
2. If you are the treating doctor, before concluding that it is your responsibility to decide which option(s) would be of overall benefit to a patient who lacks capacity, you should take reasonable steps to find out:
   
   • whether there’s evidence of the patient’s previously expressed values and preferences that may be legally binding, such as an advance statement or decision
   • whether someone else has the legal authority to make the decision on the patient’s behalf or has been appointed to represent them.
3. If there is no evidence of a legally binding advance refusal of treatment, and no one has legal authority to make this decision for them, then you are responsible for deciding what would be of overall benefit to your patient. In doing this you must:
   
   • consult with those close to the patient and other members of the healthcare team, take account of their views about what the patient would want, and aim to reach agreement with them
   • consider which option aligns most closely with the patient’s needs, preferences, values and priorities
   • consider which option would be the least restrictive of the patient’s future options.
4. If a proposed option for treatment or care will restrict a patient’s right to personal freedom, you must consider whether you need legal authorisation to proceed with it in the circumstances.
5. You should allow enough time, if possible, for discussions with those who have an interest in the patient’s welfare, and you should aim to reach agreement about how to proceed.

Resolving disagreements

1. Sometimes members of the healthcare team disagree about what would be of overall benefit to the patient, or those close to the patient disagree with you and the healthcare team. It is preferable, and usually possible, to resolve disagreements about a patient’s treatment and care through local processes. For example, by:
   
   • a involving an independent advocate or local mediation service
   • consulting a more experienced colleague and/or an independent expert
   • holding a case conference or seeking advice from a clinical ethics committee.
2. If, having taken these steps, there is still disagreement about a significant decision, you must follow any formal steps to resolve the disagreement that are required by law or set out in the relevant code of practice. You must make sure you are aware of the different people you must consult, their different decision-making roles and the weight you must attach to their views. You should consider seeking legal advice and may need to apply to an appropriate court or statutory body for review or for an independent ruling. Your patient, those close to them and anyone appointed to act for them should be informed as early as possible of any decision to start legal proceedings, so they have the opportunity to participate or be represented.