Ten questions about…consent

Good consent practice is at the heart of the doctor-patient relationship, but we know sometimes it is challenging to get this right. Here are some of the main questions doctors have been asking us and resources and tools to help you including our new mental capacity tool.

Help for you

1. Has the guidance changed as a result of recent legal developments?

A recent Supreme Court case, (pdf), has raised some question among professionals, and organisations, about how they can ensure best practice when seeking consent. We have included some articles on this case in the ‘Other support for you section of the hot topic.

This summarises the implications of the judgement for doctors from Communitybaptistpa’s Assistant Director for Standards and Guidance, Mary Agnew.

The Supreme Court endorsed the approach taken in our guidance and so you can be confident in following the existing Communitybaptistpa advice. As part of our usual cycle of review, we will begin an update of our guidance on consent later this year. We believe that the fundamental principles are sound but we will look to making the guidance more helpful and clear in any ways we can. We will talk to the profession, stakeholders and the public during the review to ensure that we get it right.

2. How much information do I have to give patients?

Our consent guidance says that the amount of information about risk that you should share will depend on what the individual patient wants and needs to know and on the nature of the risks associated with the treatment options. It’s important to focus on the patient’s individual circumstances and the risk to them personally, rather than the population level risks. You’ll need to understand the outcomes they are most concerned about, including what might happen if you do nothing. You must give information about risk in a balanced way, avoiding bias about the expected benefits and risks of treatment options.

You must tell patients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small; and you should tell patients about less serious side effects or complications if they occur frequently. In doing so you should bear in mind that patients may understand information about risk differently from you, and that it might be helpful to use visual aids, patient decision guides, recordings and other support tools, to explain the benefits and risks of any proposed intervention.

You should also be aware of the  which tells organisations how they should make sure that disabled patients receive information in formats that they can understand and receive appropriate support to help them to communicate.

3. How can I ensure that my patient has understood the information?

When communicating with patients you should consider their needs and maximise their ability to understand and retain the information. Different patients will have different needs, and it’s important to be aware of these. We have included some resources to help you in this area in the Other support for you section.

This can be particularly difficult if you are using an interpreter. Patients tell us that they don’t always feel they get adequate information from their doctor when they use a translator who may not be familiar with medical terms or doesn’t have a strong enough grasp of the language. They’ve said that often in these circumstances they agree to treatments without fully knowing or understanding the options or risks. It is best to avoid using family members as interpreters if there are alternatives available. It is important that when using any interpreting services, you take steps to ensure that the information is being relayed correctly and that patients have the opportunity to ask questions. You could consider repeating the information in different ways and ensuring that the interpreter understands what you are trying to communicate.

Patients with learning disabilities tell us they often feel that they are not part of the decision making process. Our learning disabilities website has lots of helpful practical tips and advice from experienced doctors, other healthcare professionals and patients themselves, including how to promote effective communication and decision-making with patients who have learning disabilities.

It is important you address your patient directly during the consultation. Speak to the patient, even if it seems that they may not be able to communicate verbally, and even if it’s the carer who is addressing you. Ask about, but don’t assume, how the patient prefers to communicate and whether they would like information in a particular format – for example, easy read leaflets. Find out whether your organisation has a learning disabilities specialist nurse or other experienced staff member who could support the patient, and if so, make use of their help.

4. How can I record everything I have discussed with the patient?

You must use the patient’s medical records or a consent form to record the key elements of your discussion with the patient. This should include the information you discussed, including any specific requests from the patient, any written, visual or audio information given to the patient, and details of any decisions that were made.

The best way to record information will vary depending on the nature of the information. In some cases, if there are particular procedures that you often seek patients consent for, you could consider using a pre-printed checklist and recording that you have discussed everything on it, therefore removing the need to write everything repeatedly. However, if you do this it is important that you consider any other information that may be relevant to that individual patient and show that you have tailored the information based on their needs. It should not be a tick box exercise.

You will need to think about what methods work for you. You do not need to have a transcript of the conversation, just a record of what was discussed and how you reached a decision with your patient.

5. My patient has signed a consent form – is that enough?

The question of written consent comes up often. Sometimes we are asked if consent needs to be written or if it can be verbal consent, and if a signed consent form is ‘proof’ that the patient gave their consent. What is important is that doctor and patients make decisions together and that patients are given the information and support to do this. How consent is expressed will vary depending on the situation.

By law you must get written consent for certain treatments, such as fertility treatment and organ donation. You must follow the laws and codes of practice that govern these situations. You should also get written consent if the investigation or treatment is complex or involves significant risks (including risks to the patient’s employment or personal life), if providing clinical care is not the primary purpose of the investigation or treatment, or the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.

However, simply having a signed consent form does not show that you have given the patient all of the relevant information or that you’ve ensured that they have understood it. You should still make a record in the same way as you would if there was no written consent form and you should still be aware that consent is an ongoing process and does not end when the patient signs the form.

6. How can I tell if my patient has capacity to make the decision?

We understand that assessing a patient’s capacity can be challenging. You can use our new mental capacity tool to help you in this area.

Many of you have told us that this is an area where you are not confident. There are a number of points to remember to help you with this:

  • everyone is presumed to have capacity to make decisions unless it can be proved that they do not. If you think there is reason to believe that someone does not have capacity to make a decision you need to do a capacity assessment;
  • a person should not be considered unable to make a decision simply because their decision is considered unwise or eccentric by others;
  • you are assessing a patient’s capacity to make a particular decision. If a patient lacks capacity to make one decision you must not assume that they lack capacity to make any decisions at all, or that they will not be able to make similar decisions in the future;
  • You should support patients to make their own decisions using all practicable steps before it is decided that they are unable to do so;
  • if a patient is unable to make a decision at a particular time you should consider whether you can revisit it at another time or whether it needs to be made immediately.

Assessing capacity is a two stage test and these stages need to be considered together.

  1. 1. Is there an impairment of or disturbance in the functioning of the person’s mind or brain?
  2. 2. Is the impairment or disturbance sufficient that the person lacks the capacity to make that particular decision?

To answer the second you should consider whether your patient can;

  • understand information about the decision to be made;
  • retain that information in their mind;
  • use or weigh-up the information as part of the decision process;
  • communicate their decision.

If a person is not able to do all of these things, then this represents a lack of capacity.

You should follow the specific advice in the relevant codes of practice which you can find in the Other support for you section of this hot topic.

7. What about when my patient is under 18?

You should involve children and young people as much as possible in discussions about their care, even if they are not able to make decisions on their own.

A young person’s ability to make decisions depends more on their ability to understand and weigh up options, than on their age. When assessing a young person's capacity to make decisions, you should bear in mind that:

  1. a. a young person under 16 may have capacity to make decisions, depending on their maturity and ability to understand what is involved;
  2. b. at 16, a person can be presumed to have capacity to make decisions about their treatment and care.

It is important that you assess maturity and understanding on an individual basis and with regard to the complexity and importance of the decision to be made. You should remember that a young person who has the capacity to consent to straightforward, relatively risk-free treatment may not necessarily have the capacity to consent to complex treatment involving high risks or serious consequences.

Our 0-18 guidance includes resources to help you in this area.

8. Do you issue different guidance for doctors in England, Scotland, Wales, and Northern Ireland?

The Communitybaptistpa is a four country regulator and so our guidance applies to all doctors across the UK. However, there are different legal frameworks operating in the four countries and you should be aware of these. Our guidance is consistent with the law across the UK but it is important that you keep up to date with, and comply with, the laws and codes of practice that apply where you work. If you are unsure about how the law applies in a particular situation, you should consult your defence body or professional association, or seek independent legal advice.

You should follow the specific advice in your relevant code of practice, which you can find in the Other Support for you section of the guidance.

You should also be aware of your statutory obligations in this area, you can find relevant links in the Other Support for you section.

9. How can I meet the standards in the short time I have with my patient?

We know that this is a huge challenge for doctors and that there are ever increasing pressures and demands on your time. GPs in particular have raised this issue with us and have highlighted how difficult it can be to give individual patients the time they need.

To help in this, you should consider the role that other members of the healthcare team might play. You should also be aware of and consider the use of other sources of information and support which may include, for example, patient information leaflets, patient decision aids, advocacy services, expert patient programmes, or support groups for people with specific conditions.

If you are not able to give patients the time or information they need and you think this is seriously compromising their ability to make an informed decision, you should raise your concerns with your employing or contracting organisation. See our guidance Raising and acting on concerns and our decision support tool.

10. How can I protect myself from legal action or complaint to the Communitybaptistpa?

Our guidance is not intended to be a rule book. We understand that the situations you are faced with in your practice vary widely and that is why we expect doctors to use their professional judgement when applying our guidance to their practice. The most important thing is that you can justify your actions if required, and that you keep clear records to help you to do so.

If you are in doubt about how to handle certain situations you should seek advice from colleagues and experts and document any advice you receive. This will help you if ever you are at risk of legal or regulatory action.

You should be confident that you will be able to demonstrate that you acted in a manner that upholds the public’s trust in your profession if you:

  • follow our guidance and the law
  • reflect on your practice and continually learn
  • keep your patient at the centre of any decisions that you make
  • keep clear records

If something goes wrong, you should do what you can to put matters right, explain what has happened and apologise to the patient. The professional duty of openness and honesty with patients would apply to all such circumstances. Read our guidance on Openness and honesty when things go wrong: the professional duty of candour.

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