Healthcare professionals involved in immunisation frequently use the terms “informed consent” and “consent to vaccinate” interchangeably. However, they are not the same process. Confusion between the two can create clinical, legal and governance risks, particularly when vaccination is delegated under mechanisms such as Patient Group Directions (PGDs), Patient Specific Directions (PSDs) or Vaccine Group Directions (VGDs).
Understanding the distinction is increasingly important as vaccination services expand across primary care, pharmacies, schools, occupational health and mass vaccination settings.
According to the UK Health Security Agency (UKHSA) Green Book, consent is a legal and ethical requirement before administering any vaccine (GOV.UK). The Human Medicines Regulations 2012 also govern who may supply and administer vaccines, and under which legal framework (Legislation.gov.uk).
What is informed consent?
Informed consent is the process by which a suitably qualified healthcare professional ensures that an individual, or someone with parental responsibility, has sufficient information to make a voluntary and informed decision about vaccination.
The Green Book states that valid consent must be:
- given voluntarily
- provided by an appropriately informed person
- given by someone with capacity or legal authority
- obtained before vaccination takes place (GOV.UK)
Importantly, informed consent is not merely obtaining a signature or asking “Are you happy to go ahead?”. It is a professional discussion involving:
- the purpose of the vaccine
- expected benefits
- common and serious side effects
- risks of declining vaccination
- alternative options where relevant
- opportunity for questions
- assessment of understanding and capacity (GOV.UK)
The Green Book also emphasises that consent is a continuing process rather than a single event (GOV.UK).
What is “consent to proceed”?
Consent to proceed refers to the final confirmation immediately before administration that the individual still agrees to receive the vaccine.
This is operationally different from the earlier informed consent process.
Examples include:
- confirming the patient still wishes to receive the vaccine
- checking there has been no change in health status
- confirming no new contraindications
- verifying identity and vaccine details
- ensuring willingness at the point of administration
This final agreement is essential because consent can be withdrawn at any time, including moments before administration (GOV.UK).
In practice, many vaccination services separate these functions:
| STAGE | PURPOSE | TYPICALLY UNDERTAKEN BY: |
| Informed Consent | Clinical discussion and decision-making | Registered Healthcare Professional with appropriate competence |
| Consent to proceed | Immediate confirmation before administration | Vaccinator at point of care |
Why the distinction matters
The distinction becomes particularly important where vaccination is delegated.
A healthcare support worker, assistant practitioner or non-registered vaccinator may be trained and authorised to administer vaccines under an approved legal mechanism. However, this does not automatically mean they are competent or authorised to obtain informed consent independently.
The Green Book revisions and subsequent professional guidance have reinforced that organisations must clearly define:
- who is responsible for obtaining informed consent
- who is authorised to administer vaccines
- who assesses clinical suitability
- how these responsibilities are documented (GOV.UK)
Failure to distinguish between these roles can create uncertainty around accountability.
Legal mechanisms and their relevance to consent
Vaccines are prescription-only medicines (POMs). Their supply and administration must comply with the Human Medicines Regulations 2012 (Legislation.gov.uk).
The Specialist Pharmacy Service (SPS) outlines the principal legal mechanisms used in vaccination services (SPS – Specialist Pharmacy Service).
These include:
- Patient Specific Directions (PSDs)
- Patient Group Directions (PGDs)
- Vaccine Group Directions (VGDs) (replacing National Protocols)
- Written instructions
- Exemptions within the Human Medicines Regulations
The legal mechanism governs how the medicine may legally be supplied or administered. It does not replace the professional obligation to obtain valid informed consent.
Patient Specific Directions (PSDs)
A PSD is a prescriber instruction for an individual patient (SPS – Specialist Pharmacy Service).
Under a PSD:
- the clinician authorising vaccination remains responsible for the prescribing decision
- consent must still be obtained
- administration may be delegated to another suitably trained person
In many services, informed consent is obtained by the clinician assessing the patient, while the vaccinator confirms consent to proceed immediately before administration.
Patient Group Directions (PGDs)
A PGD allows named registered healthcare professionals to supply and/or administer medicines to groups of patients meeting defined criteria (SPS – Specialist Pharmacy Service).
Under a PGD, the practitioner working within it is professionally accountable for:
- assessing eligibility
- excluding contraindications
- obtaining informed consent
- administration and documentation
This means the practitioner operating under the PGD cannot separate themselves from the informed consent process.
National Protocols (discontinued) and Vaccine group Directions (VGDs) – (introduced 01/04/2026)
National Protocols introduced additional flexibility in vaccination programmes by allowing certain aspects of the process to be split between professionals (NHS England).
For example:
- one practitioner may undertake clinical assessment and consent
- another may prepare the vaccine and administer it
In these models, governance arrangements must clearly identify responsibility for informed consent and ensure the administrator still confirms consent to proceed before vaccination.
Please note: Since 1st April 2026, National Protocols have been discontinued and replaced with Vaccine Group Directions (VGDs) GOV.UK.
Recent consultations regarding amendments to the Human Medicines Regulations have reiterated that informed consent remains the responsibility of the registered healthcare professional overseeing vaccination delivery (GOV.UK).
The role of non-registered vaccinators
Many organisations now use healthcare support workers and other non-registered staff in vaccination programmes.
This can be safe and lawful where:
- appropriate legal mechanisms are in place
- training and competency are documented
- delegation is clearly defined
- supervision arrangements exist
However, organisations should avoid assuming that competence to administer automatically includes competence to obtain informed consent.
The key question is not simply “Can this person vaccinate?” but also:
“Are they trained, competent and authorised to undertake a legally and professionally valid consent discussion?”
Where the answer is no, informed consent should be obtained by a registered healthcare professional before administration occurs.
The vaccinator may still confirm consent to proceed immediately before administration.
Practical implications for services
To strengthen governance and reduce risk, vaccination providers should ensure that policies clearly distinguish between:
1. Clinical consent discussions
Who:
- explains risks and benefits
- assesses understanding
- answers questions
- evaluates capacity and suitability
2. Authority to vaccinate
Which legal mechanism applies:
- PSD
- PGD
- VGD
- exemption or written instruction
3. Final consent to proceed
Who:
- checks willingness at the point of care
- confirms no changes since assessment
- ensures the patient still agrees
4. Documentation
Records should demonstrate:
- how informed consent was obtained
- who obtained it
- the legal mechanism used
- who administered the vaccine
- any questions or concerns raised
Conclusion
Informed consent and consent to proceed are connected but distinct stages of the vaccination pathway.
Informed consent is the clinical and legal process of enabling a person to make an informed decision about vaccination. Consent to proceed is the final confirmation immediately before administration that the individual still agrees.
The distinction matters because the legal authority to administer a vaccine does not automatically confer authority or competence to undertake the informed consent process.
As vaccination delivery models evolve, organisations must ensure that governance arrangements clearly define professional responsibilities, legal mechanisms and accountability for consent throughout the vaccination journey (GOV.UK).
We hope this blog has been useful, for more information or to discuss Consent and Legal Mechanisms for vaccine delivery further, why not join one of our immunisation training sessions.
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