Consent and the provision of vaccinations by non-registered healthcare providers 

This issue has arisen following changes to UK Health Security Agency (UKHSA) guidance on the training and scope of practice for staff involved in delivering vaccination programmes. 

UKHSA distinguishes between healthcare professionals who are registered with a professional regulator, such as GPs, nurses and pharmacists, and those who are not, described as Healthcare Support Workers (HCSWs). While national guidance recognises the expanded scale and importance of vaccination programmes, it also makes clear that certain activities remain outside the scope of practice of HCSWs. 

UKHSA guidance states that it is outside the scope of practice of an HCSW to undertake a clinical assessment for vaccination, take informed consent, or work under a Patient Group Direction (PGD). The guidance also advises that HCSWs should not administer injected vaccines to infants and pre-school age children. 

Practices will be familiar with their contractual responsibilities under Primary Medical Services contracts (GMS, PMS and APMS) to ensure that staff to whom work is delegated are appropriately trained, competent and supported. UKHSA guidance indicates that HCSWs involved in vaccination delivery are expected to be experienced and appropriately trained, typically to Level Three of the Qualifications and Credit Framework or equivalent, and working at Level Three or above of the NHS Career Framework. 

PGDs are written with the requirement that only trained and registered professionals can use them. UKHSA publishes national template PGDs for use across the NHS. 

No. A Patient Specific Direction (PSD) provides the legal authority for a named patient to receive a specified medicine, including a vaccine. A PSD does not in itself constitute consent. 

As unregistered staff, HCSWs may administer prescription-only medicines only where there is a valid legal mechanism in place, such as a prescription or a PSD. 

Where a vaccine is given under a PSD, responsibility for obtaining informed consent rests with the prescriber. Informed consent and agreement to proceed do not need to occur at the same time or in the same place. 

Where informed consent has already been obtained by a registered healthcare professional, it is good practice for an HCSW to confirm at the point of administration that the individual is still happy to proceed. HCSWs undertaking vaccination should have access to a registered healthcare professional for advice or support if needed. 

National guidance emphasises that informed consent should not be regarded as a single event, but as a process that culminates in the vaccination being given. 

Informed consent involves providing individuals with appropriate information and support to help them make a decision, giving them the opportunity to ask questions, and engaging them as much as is feasible. For individuals who cannot make a wholly independent decision, those responsible for them should have access to the same information and support. 

There is no requirement for consent to be recorded in writing. However, it is good practice to document any significant discussions or questions raised in relation to vaccination in the clinical record. 

The overarching principles of consent within the national immunisation programme are set out in Chapter 2 of the Green Book (Consent), which remains the authoritative national reference. 

Where appropriate legal mechanisms are in place, and where staff are trained, competent and supported, national guidance recognises that HCSWs may contribute to vaccination programmes, including administering vaccines under a PSD. 

Clinical assessment of vaccine suitability remains the responsibility of a registered healthcare professional and would be documented through the relevant prescribing mechanism. HCSWs should not undertake clinical assessment, seek informed consent, or work under PGDs. 

National guidance also describes a range of supportive roles that HCSWs may contribute to within vaccination programmes, including preparation of vaccination areas and equipment, cold chain management, stock control, supporting patient flow and observation post-vaccination, and escalating patient questions or concerns to a registered healthcare professional. 

Practices are approaching this in different ways depending on their staffing, workflows and patient population. The examples below are illustrative rather than prescriptive. 

• Some practices share written information when inviting patients for vaccination, for example by text or email, so that patients have access to trusted information in advance and know how to raise questions if they wish to do so. 

• Others use existing clinician contacts, such as routine reviews or consultations, to discuss upcoming vaccinations and address questions, particularly for patients with complex medical histories or previous concerns. 

At vaccination appointments, where informed consent has already been obtained, it is common practice for staff administering vaccines to confirm that the individual still wishes to proceed. This confirmation should not be treated as a new consent discussion, but as part of consent being an ongoing process. 

UKHSA provides a range of patient-facing resources that practices may choose to use when communicating with patients. 

This guidance does not require new consent forms, additional paperwork or extra appointments solely for consent. It does not require all practices to adopt the same operational model, and it does not replace professional judgement or national guidance. 

Its purpose is to support practices in thinking clearly about how the different elements fit together, rather than to prescribe a particular way of working. 

This is a developing national issue and further clarification is expected. 

In the meantime, practices are encouraged to ensure that local arrangements are thought through, documented and defensible, and that staff are appropriately trained and supported within their scope of practice. 

This page will be updated as soon as clearer national direction becomes available.