GP leaders have raised concerns that updated UKHSA guidance clarifying that healthcare assistants (HCAs) are unable to take informed consent for vaccination will have ‘significant implications’ for practices.
UKHSA published updated guidance in June clarifying that it is ‘outside the scope of practice’ of healthcare support workers (HCSW) including HCAs to ‘undertake a clinical assessment for vaccination, take informed consent or work to Patient Group Directions (PGDs)’.
But GPs have raised concerns that the clarification around informed consent will have a major impact on how practices deliver mass vaccination programmes.
Informed consent is the process in which a patient receives enough information to make a voluntary decision about receiving a treatment such as a vaccination.
In an update to practices Wessex LMC said the updated wording has caused concern because many practices have ‘longstanding workflows’ in which HCAs play an important part in delivering vaccination programmes.
‘The updated UKHSA wording clarifies that although HCAs can competently administer injections within the scope of a Patient Specific Direction (PSD), they cannot be responsible for securing informed consent to treatment,’ it added.
The LMC has advised practices to review current vaccination clinic processes to identify any points where seeking informed consent to treatment ‘may be implicitly delegated’ to HCAs and remove them from this process.
Practices were also advised to ensure that a registered healthcare professional is responsible for obtaining the informed consent to treatment, ‘whether in advance or within the clinic workflow’ (see box).
In a message to GPs, the LMC said: ‘We’ve been contacted by a number of practices who have been surprised, like us, by the change in wording in updated UKHSA guidance which suggests that healthcare support workers such as HCAs are unable to take informed consent for vaccination.
‘We have raised this issue with the UKHSA vaccination teams, and they have stated that policy has not been changed but the wording has been made clearer.
‘We have pointed out that many practices will have interpreted the previous wording differently and the “clarification” is likely to have significant implications for how practices deliver vaccinations, especially in the context of mass vaccination programs.
‘We have also encouraged the regional NHSE vaccination teams to reach out to practices to fully inform them of the new wording and what this means to practices on a practical level.’
The LMC update also said that the BMA is raising this issue with UKHSA.
The LMC advice
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 HCAs 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 HCAs confirm ongoing willingness to proceed.
- Ensure staff training reflects the distinction, particularly for HCAs and non‑clinical support roles.
- The green book has a chapter on obtaining consent for vaccination Green book on immunisation chapter 2 consent
Source: Wessex LMC
NHS England told the LMC that the updated guidance ‘does not introduce any new requirements’ compared with previous versions, but it does offer ‘clearer wording and additional clarification’.
UKHSA confirmed that it has not changed its position in relation to the role of Healthcare Support Workers (HCSWs) but that changes to wording in the Green Book and Minimum Standards and Core Curriculum for Immunisation Training are ‘clarifications to ensure guidance is aligned’.
It also said that working within these regulations ‘ensures safety for patients and protects staff’ administering vaccines by ensuring they are working within their scope of practice.
A spokesperson said: ‘Vaccines are Prescription Only Medicines (POMS) and consent to receive these has to be undertaken in line with current regulations (published by the General Medical Council).
‘Where the vaccine is being supplied or administered under a Patient Group Direction (PGD), it is the responsibility of the registered healthcare professional operating under the PGD to ensure they have gained informed consent before vaccine supply or administration. Delegation under PGDs is not permitted.
‘Where a vaccine is prescribed, for example under a Patient Specific Direction, responsibility for seeking informed consent to vaccination as a prophylactic treatment lies with the prescriber (General Medical Council 2021, Nursing and Midwifery Council 2025).
‘Whilst it is outside the scope of healthcare support workers and other non-registrants to seek informed consent to prophylactic treatment with a vaccine, they should seek agreement to administer a vaccine for which informed consent has been gained by a specified registered healthcare professional.
‘This applies to HCSWs working under a national protocol for influenza or COVID vaccines or where the vaccine has been prescribed.’
The BMA has been contacted for comment.
Earlier this year NHS England said that health visitors will be used to boost uptake of childhood vaccination from 2026.
What the UKHSA guidance says about the role of HCSWs
The HCSW’s duties may now include a role in administration of these vaccines. Some areas also include HCSWs within the school vaccination team to deliver the childhood influenza vaccine programme. HCSWs may also have become involved in the delivery of other vaccine programmes.
However, if they are going to be involved in vaccine administration, they must be trained and competent and the following areas should be carefully considered:
- there need to be appropriate mechanisms in place for prescribing, delegation, accountability and supervision in order that vaccine administration is safe and effective
- all vaccinators must be confident, competent and well supported to ensure public confidence in vaccination is maintained: quality, safety and reputation are vitally important
- delegation of vaccination must be both appropriate and in the best interests of the provider organisation and, most importantly, of the patient. Each profession has its own standards or code of conduct which provide information on delegation responsibilities and RHCPs who delegate roles in vaccination should follow these
- 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
Source: UKHSA
A version of this story first appeared on our sister title Pulse.
