Audience: Guidance for Leicester, Leicestershire and Rutland (LLR) Practices
Document owner: LLR LMC
Review date: October 2027
National resources last checked: 19 October 2026
1. Introduction
Obtaining valid informed consent is an essential part of every vaccination programme. Practices must ensure that patients receive appropriate information, have an opportunity to ask questions and make a voluntary, informed decision before vaccination.
The UK Health Security Agency (UKHSA) Green Book, Chapter 2, sets out the principles of consent for immunisation, including consent for children and young people and people who may lack capacity.
The legal mechanism used to authorise vaccine administration determines which healthcare professionals may undertake the assessment, obtain consent and administer the vaccine. These arrangements include Patient Specific Directions (PSDs), Patient Group Directions (PGDs), Vaccine Group Directions (VGDs) and other applicable legal mechanisms.
This guidance explains how practices can obtain and document consent, use digital consent tools and ensure that healthcare support workers (HCSWs) undertake vaccination activities within the applicable legal framework.
Key national reference: UKHSA Green Book — Chapter 2: Consent
2. Key principles of informed consent
Consent is a process, not simply a signature, a completed questionnaire or attendance at a vaccination appointment.
Practices should ensure that:
- Patients receive appropriate information about the proposed vaccine, including its benefits, material risks and relevant considerations.
- Patients have an opportunity to ask questions and request further discussion.
- Consent is informed, voluntary and obtained from a person with the relevant capacity or lawful authority.
- The patient’s decision is documented appropriately in the clinical record.
- Patients are given the opportunity to change their mind or withdraw consent before vaccination.
- Consent is reconsidered where circumstances change or new concerns arise.
- Information is provided in an accessible format appropriate to the patient’s needs.
Consent for one vaccine should not automatically be assumed to cover another vaccine or a subsequent dose where a new decision is required.
Useful resources
3. Who can obtain consent for vaccination?
The healthcare professional responsible for obtaining informed consent must be authorised to undertake that activity under the relevant legal framework and must have the necessary knowledge, training and competence.
3.1 Patient Specific Direction (PSD)
A PSD is a written instruction from an authorised prescriber for a named individual to receive a specified medicine or vaccine.
Where vaccination is undertaken under a PSD, the prescriber must be satisfied that the required individual clinical assessment has been completed, that vaccination is suitable and that valid informed consent has been obtained through an appropriate process. The PSD must be issued before administration.
An HCSW administering a vaccine under a PSD cannot independently undertake the informed-consent process required of the prescriber. The consent process must be undertaken by an appropriately registered healthcare professional.
Informed consent may be obtained before the vaccination appointment, provided the process is appropriate and the patient’s decision is adequately documented. The patient’s continued agreement should be checked as appropriate at the point of vaccination.
Supporting resource: Assessment and Consent for Immunisation under a PSD
3.2 Patient Group Direction (PGD)
A PGD permits specified registered healthcare professionals to supply and/or administer a medicine to eligible patients who meet the direction’s criteria.
The activities specified in a PGD must be undertaken by the authorised registered healthcare professional. PGD activities cannot simply be delegated to an HCSW.
Practices must ensure that the relevant PGD is current, applicable to the vaccination programme and properly authorised for use.
3.3 Vaccine Group Direction (VGD)
VGDs provide a legal mechanism for vaccination within specified NHS vaccination programmes.
Only the registered healthcare professionals permitted by the applicable legislation and named in the VGD may undertake the assessment and obtain informed consent.
Where the VGD permits it, subsequent activities such as vaccine preparation, administration and record keeping may be delegated to appropriately trained and competent registered or non-registered practitioners.
The VGD must be followed precisely. Practices must not assume that every activity can be delegated or that the arrangements are identical across vaccination programmes.
3.4 Other legal mechanisms
Practices must establish the correct legal mechanism for the vaccine and programme concerned rather than assuming that one mechanism applies to every vaccination.
National guidance
- UKHSA — Immunisation PGD and VGD templates
- NHS Specialist Pharmacy Service — UKHSA PGD resources
- Legal Mechanisms for Vaccine Administration and the Principle of Delegation
4. Obtaining consent in advance of vaccination
Informed consent can be obtained by an appropriately authorised healthcare professional before a vaccination clinic. This can support efficient delivery of seasonal vaccination programmes and allow the required clinical assessment to take place before the patient attends.
A practice may send vaccine information and a digital questionnaire through Accurx, enabling the patient to review the information and record their decision.
The practice must have a clear process to ensure that the response is reviewed by the appropriate healthcare professional and that any required clinical assessment is completed before the relevant legal authority for vaccination is issued.
Consent obtained in advance does not remove the need to address questions, changes in circumstances or concerns arising at the appointment.
If a patient withdraws consent, expresses uncertainty or raises an unresolved concern, vaccination must not proceed until the matter has been appropriately addressed.
5. Digital consent using Accurx
Avon LMC has developed a suite of digital consent templates for use within Accurx. These cover adult influenza, childhood influenza, COVID-19, shingles and RSV vaccination for eligible adults who are not pregnant.
LLR has reviewed the Accurx questionnaires and is incorporating them into this guidance as practical resources for practices.
Practices remain responsible for ensuring that the questionnaire used is suitable for their patient population and consistent with current programme requirements, vaccine product information and local governance arrangements.
5.1 Direct links to Accurx templates
| Vaccination programme | Accurx consent questionnaire |
| Adult influenza | Open adult flu template |
| Childhood influenza | Open childhood flu template |
| COVID-19 | Open COVID-19 template |
| Shingles | Open shingles template |
| RSV — eligible adults who are not pregnant | Open RSV template |
The RSV template listed above is for the adult programme described by Avon LMC. Practices must use the appropriate arrangements for pregnant patients and must not assume that this template covers pregnancy vaccination.
5.2 Digital consent is not suitable for everyone
Some patients may be unable or unwilling to use digital consent because of limited digital literacy, lack of access to technology, language barriers, difficulties understanding written information, capacity concerns or a preference to discuss vaccination with a healthcare professional.
Practices must retain suitable alternative methods, including discussion with an appropriate healthcare professional and accessible written information where required.
5.3 Attendance does not constitute sufficient evidence of informed consent
Practices should not send vaccine information through Accurx and treat attendance at the appointment as consent.
Attendance alone does not establish that a patient has read, understood and considered the information or made an informed decision.
A recorded consent response provides a more robust record of the patient’s decision. However, a digital response does not automatically establish that consent is valid in every circumstance. The healthcare professional must consider the patient’s understanding, voluntariness, capacity where relevant, and any questions or concerns.
A non-response must never be treated as consent.
6. Prescriber responsibilities and clinical assessment
Where a PSD is used, the prescriber remains professionally and legally accountable for the prescribing decision.
Before issuing a PSD, the prescriber must be satisfied that:
- The patient is eligible for vaccination, or has been appropriately assessed for vaccination outside the criteria of a relevant PGD or VGD.
- The required individual clinical assessment has been completed.
- Relevant contraindications, precautions, allergies and other clinical considerations have been assessed.
- The patient has received appropriate information and has had the opportunity to ask questions.
- Valid informed consent has been obtained and appropriately documented.
- The vaccine and administration arrangements are appropriate for the individual patient.
A questionnaire or screening response may support this process but cannot replace the required clinical assessment.
Where vaccination is delivered under a PGD or VGD, the assessment and consent responsibilities specified by the relevant direction must be followed. Practices must not automatically apply the PSD process to a different legal mechanism.
The relevant legal authority must be in place before the vaccine is administered.
7. Processing consent responses in Accurx
Practices should have a documented process for reviewing and acting on digital consent responses in sufficient time before the vaccination appointment.
The process should cover:
- Consent given: ensuring the response is recorded and available to the appropriate healthcare professional.
- Consent declined: recording the decision and ensuring the patient is not vaccinated unless a valid new decision is subsequently made.
- No response: arranging appropriate follow-up where required; non-response must not be treated as consent.
- Incomplete or unclear responses: seeking clarification before proceeding.
- Requests for further information: arranging discussion with an appropriately qualified healthcare professional.
- Clinical concerns: ensuring the appropriate assessment is completed before vaccination.
- Changes at the appointment: checking for new concerns, changes in relevant circumstances or withdrawal of consent.
The practice should identify who is responsible for reviewing responses, completing the assessment, issuing any required PSD and ensuring that the appropriate legal mechanism is followed.
7.1 Processing vaccination consent responses
Open Avon LMC’s Processing Vaccination Consent Responses in Accurx guide
7.2 Importing and sharing custom questionnaires
Accurx — How to share questionnaires with colleagues
8. Children, young people and adults who may lack capacity
Consent arrangements must reflect the relevant legal framework and the circumstances of the individual patient.
For children and young people, practices should consider parental responsibility, the competence of the child or young person to make the decision, their views and the applicable guidance on disagreement between those with parental responsibility.
For adults who may lack capacity to make the specific vaccination decision, practices must follow the Mental Capacity Act 2005 where applicable, including the requirements for decision-specific capacity assessment and best-interests decision-making.
A relative or carer does not automatically have authority to consent on behalf of an adult who lacks capacity. Any applicable legal authority must be established.
Reference: UKHSA Green Book — Chapter 2: Consent
9. Local practice policies and governance
Practices using digital consent or delegating vaccination activities should maintain a local policy or protocol appropriate to their arrangements.
This should specify:
- The legal mechanism used for each vaccination programme.
- The roles and responsibilities of prescribers, registered healthcare professionals and HCSWs.
- Who sends and reviews digital questionnaires.
- How consent responses and clinical assessments are documented.
- How eligibility, contraindications and precautions are assessed.
- How incomplete responses, refusals and requests for discussion are managed.
- How consent is checked at the appointment and withdrawal of consent is handled.
- What alternative arrangements are available for patients unable to use digital methods.
- How staff training, competence and authorisation are maintained.
- How relevant directions and supporting records are retained.
- How the process is reviewed and audited.
Practices should ensure that staff undertake only those activities permitted by the applicable legal mechanism and their training, competence and authorisation.
10. Current national vaccination documents
The following resources were checked against published UKHSA and NHS England resources on 19 October 2026. Practices should confirm that the linked document remains current and appropriately authorised before use.
10.1 Influenza vaccination — 2026–27
- National influenza programme guidance for healthcare practitioners
- Influenza vaccine PGD — inactivated and live attenuated vaccines
- Influenza vaccine VGD — inactivated and live attenuated vaccines
The published PGD and VGD versions checked were valid from 1 September 2026 to 31 March 2027. Practices should check the current published versions and applicable authorisation arrangements before use.
10.2 COVID-19 vaccination — autumn 2026 and spring 2027
The published PGD version 5.0 and VGD version 2.0 checked were valid from 1 October 2026 to 1 February 2027. Practices must check for updated or replacement directions before the expiry date and follow their local procedures for accessing the authorised documents.
10.3 RSV vaccination
The RSV VGD published in July 2026 supports the national programme for pregnant women from 28 weeks of pregnancy and specified older-adult groups. The published validity period checked was 1 September 2026 to 31 August 2029.
Practices must check the current programme criteria and direction before use.
10.4 Shingles vaccination
The published version 3 checked was valid from 1 September 2025 to 31 August 2028 and covers the specified immunocompromised population. It must not be assumed to cover every patient eligible for shingles vaccination.
Practices must identify the applicable current legal mechanism for the individual patient’s programme and eligibility group.
10.5 General immunisation resources
- UKHSA — Immunisation PGD and VGD templates
- UKHSA Green Book — full collection
- NHS Specialist Pharmacy Service — UKHSA PGD templates
11. Keeping this guidance current
National vaccination programmes, legal directions and eligibility criteria can change during the year.
Practices should check the latest UKHSA and NHS England publications, the relevant Green Book chapter, the vaccine’s Summary of Product Characteristics and the applicable authorised direction before using these resources.
The publication and expiry dates listed above reflect the official resources checked on 19 October 2026. They should be rechecked whenever this LLR guidance is reviewed.
Suggested review frequency: at least annually and whenever a material change occurs to national consent guidance, vaccination programmes or the legal mechanisms for vaccine administration.
Acknowledgement
LLR LMC acknowledges and thanks Avon LMC for generously sharing its digital vaccination consent resources and practical guidance. With permission, this guidance incorporates and adapts material from Avon LMC’s work, including its Accurx consent templates and supporting resources.
We are grateful to Avon LMC for sharing its work and supporting the development of practical resources to help general practices deliver safe, effective and patient-centred vaccination services.
Important note: This guidance is intended to support local practice processes and does not replace national guidance, the applicable legal direction or professional judgement. Practices remain responsible for ensuring that their arrangements comply with current legislation, national programme requirements, professional standards and local governance arrangements.