Consent to Treatment

One of the founding principles of the NHS – and medical ethics more broadly – is that of Consent to Treatment.

Here is what the NHS website has to say about Consent to Treatment:

Consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination.

This must be done on the basis of an explanation by a clinician.

Consent from a patient is needed regardless of the procedure, whether it’s a physical examination, organ donation or something else.

The principle of consent is an important part of medical ethics and international human rights law.

Defining consent

For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision.

The meaning of these terms are:

  • voluntary – the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family
  • informed – the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead
  • capacity – the person must be capable of giving consent, which means they understand the information given to them and can use it to make an informed decision

If an adult has the capacity to make a voluntary and informed decision to consent to or refuse a particular treatment, their decision must be respected.

This is still the case even if refusing treatment would result in their death, or the death of their unborn child.

If a person does not have the capacity to make a decision about their treatment and they have not appointed a lasting power of attorney (LPA), the healthcare professionals treating them can go ahead and give treatment if they believe it’s in the person’s best interests.

But clinicians must take reasonable steps to discuss the situation with the person’s friends or relatives before making these decisions.

How consent is given

Consent can be given:

  • verbally – for example, a person saying they’re happy to have an X-ray
  • in writing – for example, signing a consent form for surgery

Someone could also give non-verbal consent, as long as they understand the treatment or examination about to take place – for example, holding out an arm for a blood test.

Consent should be given to the healthcare professional responsible for the person’s treatment.

This could be a:

  • nurse arranging a blood test
  • GP prescribing new medication
  • surgeon planning an operation

If someone’s going to have a major procedure, such as an operation, their consent should be secured well in advance so they have plenty of time to understand the procedure and ask questions.

If they change their mind at any point before the procedure, they’re entitled to withdraw their previous consent.

Let’s explore some of these concepts in more detail from the perspective of an adult considering a medical procedure. Let’s use the example of a COVID-19 vaccination as that’s a treatment a lot of people are considering at the moment.


The person considering the treatment should receive impartial, factual information from and have the opportunity to ask questions of a suitably qualified healthcare professional. In an ideal scenario the healthcare professional will be familiar with the person or will have access to their medical history so that they can provide tailored advice and information that takes into account the person’s unique set of circumstances.


The NHS tells us that voluntary means “the decision to either consent or not to consent to treatment must be made by the person, and must not be influenced by pressure from medical staff, friends or family”.

The decision can only be made by the person who would be the recipient of the medical procedure or treatment. No-one can decide for them (unless they lack the capacity to make the decision themselves, which we’ll explore in more detail later). 

The decision must not be influenced by pressure. The NHS refer to pressure from medical staff, friends and family. Under normal circumstances, this would appear to be an exhaustive list because who else would want to apply pressure to an individual’s decision whether to consent or not consent to a medical treatment?

But at the moment (May 2021) we are in far from normal circumstances and so we must ask and answer that question: 

Who else would want to apply pressure to an individual's decision whether to consent or not consent to a COVID-19 vaccine?

Here are just a few ideas:

  • employers
  • service providers
  • travel companies
  • pharmaceutical companies
  • governments

Can you think of any more?

How might that pressure be applied? 

Applying pressure or trying to influence someone’s decision can take many forms from the direct to the more subtle. An example of direct pressure would be “No Jab, No Job” from your employer whereas an example of subtle pressure would be a media narrative such as “Refuseniks Threaten Freedom”. There is also indirect pressure where those seeking to influence and coerce someone using people who they trust to, often unwittingly, apply the pressure. An example of this is the “I’ve had my Covid Vaccine” Facebook profile photos which may make some people feel obliged to also get their vaccine.

How Can You Ensure Your Decision is Voluntary?

It can be very easy to be influenced given the constant messaging, advertising and media focus about the vaccine rollout – and related subjects like new virus variants, travel restrictions, possible future lockdowns and the like. You may be worried about catching the virus and getting very ill or worse, or you might just be fed up of how long this has been dragging on and be willing to do anything to get back to normal. 

The only way to be sure you are making a voluntary decision is to firstly tune into what emotions you are feeling and thoughts you are having when you consider the subject. Fear? Frustration? A sense of moral duty? Not wanting to upset or lose friends or family?

Secondly, you need to apply some critical thinking.  You can do that by asking some important questions of both yourself and the healthcare professionals you are dealing with.

So let’s explore that idea further as we look at the second aspect of consent – informed…


The NHS tells us that informed means “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.”

What the Treatment Involves

There should be clear information given regarding the nature of the treatment. While information should be provided in layman’s terms, it should not gloss over or omit key information.

Key questions to ask yourself and your healthcare professional include:

  • How does this particular vaccine work?
  • Is the vaccine fully approved or is it still in testing?
  • Am I participating in a clinical trial?
  • What is known about the efficacy of the vaccine?
  • What is is known about the short and long term effects of the vaccine?
  • Is the manufacturer liable for any harm caused by the vaccine?
  • What testing has been done and how does this compare with the testing usually carried out for a new vaccine?
  • What studies have been carried out regarding interaction with other medications I may be on or likely to need in the future?
  • How long is the vaccine effective for and how often will I need a booster?


What the person gains by having the treatment. In the case of a COVID-19 vaccination, the person needs to ascertain whether the vaccine gives them immunity from COVID-19, or something else e.g. reduces the symptoms they’ll experience if they get the disease.

Key questions to ask yourself and your healthcare professional include:

  • What do I gain by having this treatment?
  • How is my health improved by having this treatment?
  • Can I still get COVID-19?
  • Can I pass on COVID-19 to other people?


Risk assessment is a key factor in making an informed decision. The person needs to assess the balance and relative risks of the treatment itself and the disease it is aimed at.

Key questions to ask  yourself and your healthcare professional include:

  • what are the short term risks from the treatment?
  • What are the long term risks from the treatment?
  • Have these been studied and how?
  • Are there any reported side effects that I may be particularly susceptible to?
  • Has anyone died within a short time of having the treatment?

Alternative Treatments

What options the person has to achieve comparable or better outcomes by other means. In the case of COVID-19 vaccines, as well as comparing the vaccines themselves, what other options are there either to reduce the risk of getting COVID-19 or of minimising severity and treating symptoms.

Key questions to ask yourself and your healthcare professional include:

  • What adverse reactions and side effects have there been and which vaccine is least likely to lead to an adverse reaction for me?
  • Are there lifestyle and diet changes I can make to improve my overall health and immune system?
  • Are there treatment protocols available for COVID-19 that use well established medicines with good safety track records?

What Happens If the Treatment Doesn't Go Ahead

If the person decides not to go ahead with the treatment, how their health will be affected. This is an interesting factor in the case of COVID-19 vaccines. Usually when a person is considering a medical procedure it is because they are ill or injured.  If a person arrives at hospital with a broken leg, it is clear that without having the treatment of setting the bone, it will not heal properly leading to the possibility of the person having walking difficulties in the future. But the same clarity cannot be given regarding a vaccination, especially one that is still in the trial phase. The person may not come into contact with the virus at all in the future for instance.

Key questions to ask yourself and your healthcare professional include:

  • Given my age and health, what is the risk of me dying from COVID-19?
  • Given my age and health, what is the risk of me requiring hospitalisation due to COVID-19?
  • Given my age and health, what is the risk of me experiencing anything more than mild symptoms of COVID-19?
  • What is the risk of me catching the virus?
  • What is the likelihood of me having natural immunity?

How Can You Ensure Your Decision is Informed?

“The Doctor knows best” has been a long held maxim in the UK, and in yesteryear this was probably very true. However with decades of underinvestment in the NHS, the service hasn’t been able to keep pace with the growth in the population. GPs serve ever larger groups of people and familiarity with individual patients and their health is a thing of the past, as is the opportunity to have a lengthy discussion with your GP about any aspect of your health.  Equally, GPs and other health professionals stretched to the limit treating patients have little time for keeping their knowledge updated. They increasingly rely on instructions and policies sent down through the NHS management structure to inform their work with patients rather than keeping abreast of scientific development and independent research and studies.

So if you cannot be sure that the healthcare professional treating you is fully informed, can you make an informed decision based solely on what they tell you? Equally, as we’ve already explored, there are a lot of additional parties interested in your health choices these days.  Can you be certain that your healthcare professional hasn’t also been influenced by those same parties?

The COVID-19 vaccination centres are set up to process hundreds of people a day. They simply don’t have the time to sit with any one person and discuss the ins and outs of the treatment and its suitability. Equally GP surgeries are only allowing a few minutes per person and you will probably be seen by a nurse or other healthcare worker rather than your GP. So it’s vital that you have done your research and got the answers to all your questions before you go to get your jab.

How can you do that?

  • You can use the questions we’ve set out above as the basis for a conversation with your GP, if you can get an appointment or you can send them in a letter to get them answered.
  • You can look at important information about the vaccines such as the Patient Information Leaflets before you attend your appointment (in many cases you aren’t given this information until after the treatment, if at all).
  • You can look at official sources of data such as the Office of National Statistics to learn how COVID-19 has affected people in your risk profile.
  • You can use websites such as the British Medical Journal to read about research and studies that have taken place, alternative treatment protocols for treating COVID-19 itself and the like.
  • You can visit the websites of the vaccine manufacturers (Pfizer/BioNTech, Astra Zeneca & Moderna) to learn about where they are up to in the process of trialing these new treatments. Phase 3 trials are ongoing and not due to finish until 2023 so new information is emerging all the time about how the vaccines affect people, how they interact with other medicines and how long their effects last.
  • You can look at the Medicine & Healthcare products Regulatory Authority (MHRA) website to understand the rules under which these vaccines have been given temporary emergency authorisation and their Yellow Card database to find out about adverse reactions that have been reported.

So now let’s move on to look at the next concept in Informed Consent – capacity…


The NHS tells us that someone has capacity if they are “capable of giving consent, which means they understand the information given to them and can use it to make an informed decision.”

We’ve already learned that an “informed decision” is one where all the information about the treatment has been explained, the benefits and risks have been weighed, alternatives considered and consequences of not having the treatment taken into account.

Let’s see what else the NHS website has to say about capacity to consent to treatment.

All adults are presumed to have sufficient capacity to decide on their own medical treatment, unless there’s significant evidence to suggest otherwise.

What is capacity?

Capacity means the ability to use and understand information to make a decision, and communicate any decision made. A person lacks capacity if their mind is impaired or disturbed in some way, which means they’re unable to make a decision at that time.

Examples of how a person’s brain or mind may be impaired include:

  • mental health conditions – such as schizophrenia or bipolar disorder
  • dementia
  • severe learning disabilities
  • brain damage – for example, from a stroke or other brain injury
  • physical or mental conditions that cause confusion, drowsiness or a loss of consciousness
  • intoxication caused by drugs or alcohol misuse

Someone with such an impairment is thought to be unable to make a decision if they cannot:

  • understand information about the decision
  • remember that information
  • use that information to make a decision
  • communicate their decision by talking, using sign language or any other means

Where someone lacks capacity, the decision regarding treatment falls to the healthcare professional unless the person had previously appointed a Lasting Power of Attorney (LPA) for their health and welfare. The healthcare professional can only administer a treatment if they believe it is in the best interests of the patient. Even when no LPA is in place, clinicians must take reasonable steps to discuss the situation with the person’s friends or relatives before making these decisions.

Ultimately, if someone who has capacity consents or does not consent to treatment, their decision must be respected.  Having beliefs or opinions that differ from the mainstream view and that may seem irrational does not equate to lacking capacity and as long as the person understands the reality of their situation their decision cannot be challenged.

But note that if a person changes their mind and withdraws consent, they cannot be forced to undergo the treatment.

In our next article we'll be looking further at Consent to Treatment and how it works with regard to Children and Young People.

Essential Context for Understanding this report

These reports contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of the COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the report alone. When viewing the report, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.

  • It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of the condition being treated rather than being caused by the vaccine.

  • Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction. When monitoring the safety of medicines and vaccines, MHRA staff carry out careful analysis of these factors.

  • It is not possible to compare the safety of different vaccines by comparing the numbers presented in the vaccine reports. Reporting rates can be influenced by many factors including the seriousness of the adverse reactions, their ease of recognition and the extent of use of a particular vaccine. Reporting can also be stimulated by promotion and publicity about a product.

For a vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people receive vaccinations without having any serious side effects.

Risks and benefits of medicines

For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions. It is important to note that most people take medicines without suffering any serious side effects.

All medicines can cause reactions. The patient information leaflet accompanying the medicine, or available from your pharmacist, lists the known side effects associated with the medicine. Healthcare professionals such as doctors and pharmacists can also provide this information. Information on side effects of medicines can be found on the NHS website.

Monitoring the safety of medicines and vaccines

Information collected through the Yellow Card scheme is an important tool in helping the MHRA and CHM monitor the safety of medicines. Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects.

If a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine or vaccine, and how it compares with other medicines used to treat the same condition.

The MHRA will take action, if necessary, to ensure that the product is used in a way that minimises risk, while maximising patient benefit. Such changes may include, for example, restricting the indication, or special warnings and precautions. Rarely, a drug may need to be withdrawn from the market if the risk of side effects is considered to outweigh the benefits of treatment. Please see our How we monitor the safety of medicines section for further information.

Use of Yellow Card data for publication

If you wish to copy or circulate the information contained within a report to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card scheme in research and for publication, but wish to ensure that the limitations of interpretation of the data are made clear.

If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice on how the Yellow Card information might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Deputy Director, Safety and Surveillance Group by email.