Features

COVID-19 vaccination: your guide to consent

Managing this vital part of the roll-out, plus the process for those who lack capacity

Gaining consent is a vital part of the vaccination process and nurses need to ensure it is done properly

  • Consent is needed for any procedure, including vaccination, and nurses could be held accountable if a jab is given without it
  • Patients need clear information about the vaccine before they can consent. The COVID-19 vaccination programme has patient information and consent forms that have been designed for different patient groups
  • Principles of consent, settings and implications for consent and capacity, and a guide to consent for people who lack capacity

The COVID-19 vaccination campaign is the biggest in the history of the NHS, with millions of people being offered the vaccine.

Gaining consent is a vital part of the vaccination process and nurses need to ensure it is done properly

  • Consent is needed for any procedure, including vaccination, and nurses could be held accountable if a jab is given without it
  • Patients need clear information about the vaccine before they can consent. The COVID-19 vaccination programme has patient information and consent forms that have been designed for different patient groups
  • Principles of consent, settings and implications for consent and capacity, and a guide to consent for people who lack capacity
A patient reading information about the COVID-19 vaccination programme
Picture: iStock

The COVID-19 vaccination campaign is the biggest in the history of the NHS, with millions of people being offered the vaccine.

Consent must be obtained before starting any treatment or physical investigation or before providing personal care for a patient. This includes the administration of all vaccines.

Patients must provide consent before the vaccine can be given

For many, the idea of consent is inextricably linked to signing a form, and the government has introduced a number of consent forms specifically for the COVID-19 vaccine programme, including forms for adults and care home residents.

Yet RCN and government guidance is clear: consent should be a process rather than a single event and a signature alone does not demonstrate that the consent process has been followed.

Giving patients information is part of the consent process
Giving patients information is part of the consent process
Picture: Public Health England

Here, we look at the key issues surrounding consent, and the implications for nursing staff who are involved in the COVID-19 vaccine programme.

Information must be appropriate for the individual patient

Consent for vaccinations should focus on ensuring the individual is fully informed about the vaccine they are having.

Public Health England’s vaccination guide the Green Book says consent must be given voluntarily and freely.

The individual must be informed about the process, benefits and risks of immunisation and be able to communicate their decision. Information given should be relevant to the individual patient, properly explained and questions should be answered fully.

‘To be able to give consent, the individual must have had the right information. Different people will need different amounts of information, so there needs to be a personalised response’

Helen Donovan, RCN professional lead for public health nursing

According to the RCN, individuals should:

  • Understand what vaccine they are receiving and where on their body it will be given.
  • Be informed about possible side effects.
  • Be given information about where to get help if they need it after the injection.

Giving the individual an information leaflet covering these points before or after the jab is a useful part of this consent process.

Consent: what is expected of nurses

Getting consent is a fundamental part of giving a vaccine.

The Green Book advises nurses that they risk action from the Nursing and Midwifery Council (NMC) if they do not gain consent before giving a vaccine.

The NMC code states that nurses are personally accountable for their practice.

‘Giving an immunisation without consent could leave the health professional vulnerable to legal action and action by their regulatory body,’ the Green Book says.

Signed forms provide evidence of consent

RCN professional lead for public health nursing Helen Donovan says the consent process needs to be adapted to the individual receiving the injection.

‘To be able to give consent, the individual must have had the right information,’ she says. ‘Different people will need different amounts of information, so there needs to be a personalised response.

Helen Donovan, RCN professional lead for public health nursing
Helen Donovan, RCN professional lead for public health nursing

‘Sometimes people want a detailed response and information they can look into, while others will want more of an overview; either is fine.

‘For the COVID-19 vaccine, the information that people may want will be covered in the training that all nurses will undertake before offering the vaccine.’

Ms Donovan says that it is legal to gain verbal consent, but a signature and consent form is a useful confirmation of the process.

‘Consent is someone saying they know what they are receiving and are happy to go ahead,’ she says.

‘The form is proof that that has happened.’

To aid the process, the government has produced a number of different standard consent forms and letters that allow people to indicate if they want to go ahead with vaccination or not.

COVID-19 vaccination guides have been produced for different patient groups
COVID-19 vaccination guides have been produced for different patient groups Picture: Public Health England

There are already versions for healthcare staff, adults with capacity, care homes residents and social care staff.

How does consent apply for different age groups and conditions?

The COVID-19 vaccine is not currently offered to people aged under 16, however those aged 16 and above with underlying health conditions that put them at higher risk of disease and mortality are on the priority list.

Adults over 18 with capacity and young people aged 16 and 17 can all give consent for themselves.

Children under the age of 16 can consent to their own vaccination if they are believed to have the intelligence, competence and understanding to fully appreciate what’s involved in their treatment. This is known as being Gillick competent.

For younger children not capable of giving consent, those with parental responsibility can provide it.

Where English is not a person’s first language, translations and properly recognised interpreters should be used to ensure they are fully informed, the Green Book says.

The process becomes more complex when it comes to assessment of capacity to consent.

Healthcare professionals must be guided by the Mental Capacity Act 2005. This states that you should assume a person has capacity to consent unless evidence clearly proves otherwise.

Consent for vaccination: principles to follow

  • Does the individual know what they are there for?
  • Do they know the potential side effects of the vaccine?
  • Have you advised where will you give the injection?
  • Has it been explained how they might feel afterwards?
  • Have they had information about what to do should they feel unwell, what they can do to help themselves, and when to seek further clinical advice?
  • Have they had an information leaflet to read before and after vaccination?
  • Are they happy for you to give them the vaccine?

Adapted from the RCN’s Supervision and Leadership for Delivery of Large-Scale Vaccination

Respect the patients’ choice

People should be supported to make a decision themselves wherever possible. This process could involve using communication tools, including someone the person knows and trusts in the conversation, or speaking to the person at the best time of day for them.

Nurses should respect what they might consider ‘unwise’ decisions and not assume they have been made due to a lack of capacity.

If, however, the person does not have the mental capacity to make the decision themselves then a ‘best interests’ decision about vaccination will need to be made on their behalf, although they should still be involved as much as they can.

Settings and implications for consent and capacity

The vaccine programme is being delivered in three main ways: at dedicated hospital vaccination hubs, in the community via GP surgeries, care homes and pharmacies, and in dedicated vaccination centres set up to treat large numbers of people.

A number of mass vaccination centres opened in early January to boost numbers of people being able to receive the jab.

Nurses talk to patients about consent at the NHS vaccination centre at Epsom Downs Racecourse, Surrey
Nurses talk to patients about consent at the NHS vaccination centre at Epsom Downs Racecourse, Surrey Picture: Alamy

However, the RCN says that these large sites may not be the best setting when issues of capacity are being considered.

‘This might be best served in a familiar residential or GP practice setting,’ the RCN advice says.

Any individual who does not feel ready to give consent at their initial appointment should also be given other options for where to get their injection.

‘Large vaccination centres may not be the appropriate place. The clinic supervisor needs to know of other opportunities for individuals to receive the vaccine,’ the RCN’s Supervision and Leadership for Delivery of Large-Scale Vaccination presentation says.

Lasting power of attorney

If an individual has appointed a lasting power of attorney (LPA) for health and welfare, that person can take the decision on whether to consent.

If there is no LPA for health and welfare in place and the person does not have the mental capacity to make the decision themselves, then healthcare professionals must make a decision in the person’s ‘best interests’. This should be based on the individual’s previous wishes and decisions, as well as close consultation with family or friends.

For example, the Alzheimer’s Society suggests that in relation to people with dementia this could include asking ‘have they held strong views against vaccines?’ or ‘have they always been public-spirited, thinking about the well-being of others first?’.

Though it is unlikely to mention vaccination, nurses should also check if there is an an advanced decision to refuse treatment, or ADRT, in place. This is a written statement recording a person’s wishes to refuse a certain treatment in a specific situation.


Further information


Sign up to continue reading for FREE

OR

Subscribe for unlimited access

Enjoy 1 month's access for £1 and get:

  • Full access to nursing standard.com and the Nursing Standard app
  • Monthly digital edition
  • RCNi Portfolio and interactive CPD quizzes
  • RCNi Learning with 200+ evidence-based modules
  • 10 articles a month from any other RCNi journal

This article is not available as part of an institutional subscription. Why is this?

Jobs