UKHSA clarification on Healthcare Support Workers and Informed Consent for Immunisation
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Update for General Practice Teams
Update to National Minimum Standards for Immunisation – NHS England Southeast Statement
What does this mean for General Practice delivery of vaccinations using Health Care support workers?
Update for General Practice Teams
We continue to hear from practices seeking clarification on UKHSA guidance relating to informed consent for vaccination. In particular, questions continue to be raised about whether Healthcare Support Workers (HCSWs), including HCAs and other non-registered healthcare workers, can obtain informed consent for vaccination treatment. This page provides further information on the current guidance and what it means in practice.
Update to National Minimum Standards for Immunisation – NHS England Southeast Statement
The national minimum standards for immunisation training for registered healthcare professionals – National Minimum Standards and Core Curriculum for Vaccination Training – GOV.UK was updated in July 2025 to bring together the National Minimum Standards and Core Curriculum for both registered healthcare practitioners (RHCPs) and healthcare support workers (HCSW) into a single document. In relation to the role of the HCSWs in vaccination, the updated guidance does not introduce any new requirements compared with previous versions, but it does offer clearer wording and additional clarification. Specifically, the guidance confirms that it is outside the scope of practice of a HCSW to undertake a clinical assessment for vaccination, take informed consent or work to Patient Group Directions (PGDs).
In relation to Patient Specific Directions (PSDs), a RHCP should oversee the clinical assessment and consent process before delegating vaccine administration to a HCSW. The prescriber (registered health care professional) is accountable for the initial patient assessment, consent process, and the decision to delegate the administration. The HCSW is accountable for ensuring that the patient has not raised any new clinical concerns since the initial assessment. They must refer any new issues back to the prescriber.
Therefore, registered healthcare professionals (e.g., nurses, pharmacists, GPs) should obtain consent for immunisations, in line with best practice outlined in the updated guidance.
We recognise that these clarifications may have operational implications for many GP practices and vaccination providers. Where changes to current practice are required, time will be needed to align local protocols with the updated national standards. This will take careful planning, particularly during periods of high service demand such as the flu vaccination season.
Contractually, it is the responsibility of the provider to ensure that they adhere to the national guidance; therefore, every effort must be made to implement the necessary changes and achieve compliance as soon as practicable.
NHS England South East & West acknowledges the potential disruption this may cause and is committed to supporting practices to make these adjustments in a way that minimises impact on service delivery and patient access.
Here is a link to the amended document release by UKHSA: UKHSA_National_Minimum_Standards_for_immunisation_training_2025.pdf
Here is a copy of the text causing the concern
| · …delegation of the vaccinator role to non-registered staff does not necessarily result in operational efficiencies. For example, it is outside the scope of practice of a HCSW to undertake a clinical assessment for vaccination, take informed consent or work to Patient Group Directions (PGDs). For this reason, they may be better employed in roles other than vaccine administration which will then maximise the capacity of RHCPs to undertake the more complex tasks |
This is taken from page 7 of the document (bullet point 4)
The UK Health Security Agency (UKSHA) has issued further advice to confirm their position in relation to Health Care Supporter Workers (HCSW) and informed consent for treatment, click here to access this. NHS England has also issued operational guidance on the role of Healthcare Support Workers (HCSWs) in vaccination programmes. The BMA’s Focus on Provision of vaccinations by non-registered healthcare workers includes a useful summary table of the HCSW role and a practice checklist.
What does this mean for General Practice delivery of vaccinations using Health Care support workers?
There are two groups of people who provide healthcare: registrants (Registered Healthcare Professionals (RHCP) and non-registrants (Healthcare Support Workers (HCSW)).
The term RHCP refers to any healthcare worker who is on a professional register, for example, that of the Nursing and Midwifery Council (NMC), the General Medical Council (GMC), the General Pharmaceutical Council (GPhC) or the Health and Care Professions Council (HCPC).
The term HCSW is used for an employee who, whilst not on a professional register, has been delegated a role in vaccination by an appropriate registered healthcare professional. Eg HCA.
The new wording in UKHSA guidance highlights a crucial distinction: the difference between obtaining informed consent for treatment and gaining a patient’s consent to proceed with the act of giving an injection.
The Core Distinction
- Informed consent for treatment
This is the process in which a patient receives enough information to make a clear, voluntary, and well‑understood decision about receiving a treatment such as a vaccination. It includes sharing the benefits, risks, alternatives, and the implications of declining with the patient. UKHSA’s position reaffirms that this is a clinical responsibility and must be undertaken by a registered healthcare professional.
- Consent to proceed with an injection
This refers to the moment a patient agrees to the physical act of receiving the vaccine. It is procedural and does not replace the informed consent conversation. A trained Healthcare Support Worker may check that the patient is still willing for the procedure to go ahead, but this is not the same as undertaking informed consent for treatment.
The BMA describes informed consent as not necessarily being a single event. Information can be provided through multiple channels including leaflets or prior conversations immediately prior to an event or over an extended period of time.
Green Book chapter 2 (below) highlights that consent is a continuing process and can be withdrawn at any time. Consent for one immunisation does not automatically cover others unless explicitly obtained for a full course.
Why this matters now
UKHSA has amended its wording to clarify the role of the HCSW in taking consent (as noted above), and the wording in the Green book has been amended to reflect the UKHSA changes.
Here is a link to the Green Book Chapter 2 “Consent”: Green book on immunisation chapter 2 consent
| · Whilst it is outside the scope of healthcare support workers to seek informed consent to treatment with a vaccine, they may seek consent to administer a vaccine for which informed consent has been gained by a registered healthcare professional. |
The RCN has also amended its position based on the wording change made by UKHSA.
Many practices have longstanding workflows in which HCSWs play an important part in delivering vaccination programmes. The updated UKHSA wording clarifies that although HCSWs can competently administer injections within the scope of a Patient Specific Direction (PSD), they cannot be responsible for securing informed consent to treatment.
It is also worth reminding practices that a PSD must be in place and signed before a clinic is run rather than signed after the event. Electronic documents are date stamped and could therefore place the practice and health care professionals involved at risk should an adverse incident occur at a time noted prior to electronic signing.
HCSW Training
The 2025 standards for Immunisation training for Heath Care Support Workers (HCSW) are detailed in this document:
UKHSA_National_Minimum_Standards_for_immunisation_training_2025.pdf
Activity |
Permitted for HCSW? |
Conditions / Notes |
| Clinical assessment for vaccination | ❌ | RHCP responsibility |
| Obtaining the technical aspect of consent | ✅ | Only if trained, competent, and supervised |
| Work under a PGD | ❌ | HCSWs cannot use PGDs |
| Administer vaccine under PSD | ✅ | Only if trained, competent, and supervised |
| Administer injected vaccine to infants/pre-schoolers | ❌ | Outside scope of HCSWs |
| Administer vaccine to adults with complex medical histories | ⚠️ | Only if assessed appropriate by RHCP, and where a valid PSD exists |
| Administer travel vaccines | ❌ | RHCP must complete travel risk assessment |
| Cold chain management | ✅ | Must complete relevant training |
| Record keeping / data entry | ✅ | Under supervision and as directed |
| Responding to vaccine queries | ⚠️ | Escalate to RHCP |
| Vaccine ordering and stock control | ✅ | In line with organisational procedures |
(information taken from:
Focus On…Provision of vaccinations by non-registered healthcare workers )
Registered Nurse Associates
Although the Nursing Associate role is one that requires registration with the NMC, it is not currently on the list of healthcare professionals that are able to work under a Patient Group Directive (PGD) (see GP mythbuster 19: Patient Group Directions (PGDs)/Patient Specific Directions (PSDs) – Care Quality Commission), so this legal mechanism is not an option.
However, provided appropriate training has been undertaken and with the necessary knowledge and understanding of the vaccination being offered so that they can answer any questions about it to help the person consent to it, Registered Nurse Associates (Nas) are able to obtain informed consent for treatment, and administer vaccinations such as flu, COVID-19, shingles and Pneumonia. The legal mechanism that would need to be used for NAs is a Patient Specific Direction (PSD), and it is important to remember that there should be appropriate on-site supervision available.
Importantly, the PSD must be signed by a prescriber after they have satisfied themselves that consent has been obtained and before the NA administers.
NAs cannot obtain informed consent for travel vaccinations or an injectable such as B12, this must be undertaken as part of a clinical assessment by a prescriber/other registered professional, but with appropriate training they can administer (with appropriate on-site supervision) to a patient if an appropriate PSD is in place.
Contractual and Legal Responsibilities
Training is an essential requirement which should be included as a core element in vaccination contracts. The NHS England General practice vaccination and vaccination services: standards and core contractual requirements states that ‘all healthcare professionals involved in the administration of vaccines must have the necessary skills and training’. In addition, the Health and Social Care Act 2008 states ‘Persons employed by the service provider in the provision of a regulated activity must…receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform’. These training standards provide best practice guidelines which have been developed by the UKHSA in consultation with relevant healthcare and professional organisations. Whilst they are not mandatory, it is strongly recommended that providers of vaccination services ensure that those advising about or administering vaccinations are suitably knowledgeable and competent to do so in accordance with these standards.
It is recommended that only experienced HCSWs take on a role in administering vaccines. It is expected that these HCSWs will have achieved education and training to Level Three of the Qualifications and Credit Framework (QCF) or equivalent and that they would be working at Level Three or above of the NHS Career Framework.
What Practices Need to Do
To ensure compliance with updated guidance, practices should:
- Review current vaccination clinic processes to identify any points where seeking informed consent to treatment may be implicitly delegated to HCSWs and remove them from this process.
- Ensure that a registered healthcare professional is responsible for obtaining the informed consent to treatment, whether in advance or within the clinic workflow.
- Document the consent pathway so it is clear who has given the information, how it is recorded, and how HCSWs confirm ongoing consent.
- Ensure staff training reflects the distinction, particularly for HCSWs and non‑clinical support roles.
- The green book has a chapter on obtaining consent for vaccination Green book on immunisation chapter 2 consent
In this chapter it is noted that “in the routine school-based immunisation programmes, an information leaflet and consent form are usually sent to the parent to complete and return as they are not present at the time of vaccination. Email or electronic forms of consent are increasingly being used.”
Practices may wish to take this into consideration when designing their own consent process.
Practices should be confident that patients have received all the relevant information needed to provide informed consent for treatment with any vaccine being given, and that you have a mechanism for recording this. Patients should be given an opportunity to discuss any questions they might have about their vaccine/treatment with a registered healthcare professional if required. This applies to both mass vaccination programs such as flu and covid as well as single vaccines such as shingles vaccine.
The updated UKHSA wording does not restrict the role of appropriately trained HCSWs in administering vaccines.
If you have any issues that you would like to raise with your area vaccination team you can contact them on:
england.swvast@nhs.net South West
england.hiow-sit@nhs.net South East
Further Information
Please also take a listen to our podcasts on this subject.
Consent for a vaccine – who has to do this and how?
Dr Will Howard (Medical Director) chats to Kerry March (Deputy Director of Primary Care) and Zoe Tobin (Nurse Advisor) following the publication of a recent document from UKSHA. They look at informed consent for treatment and consent to proceed to administer a vaccine and explore the situations that might arise in practice when nurses and HCSWs are running vaccination clinics.
What exactly are PGDs & PSDs? And why are they important?
Louise Greenwood (Director of Education & Training) asks Kerry March (Deputy Director of Primary Care) and Zoe Tobin (Nurse Advisor) what exactly are PGDs & PSDs? And why are they important? During the discussion, the legal importance of these directives and their practical application is analysed in addition to how they are used and why. Delegated responsibility & consent are among the topics scrutinised during their conversation.
