Informed and valid consent

Consent is valid only when a person has sufficient information to make a decision. Informed consent means providing the information a reasonable person in that situation would need and identifying what matters to the individual.

What people usually need to know

• What is proposed: what the service, treatment, check, or intervention actually involves.
• Why it is being offered: the purpose, expected benefit, and limits of what it can achieve.
• Important risks and side effects: including common or significant harms relevant to the decision.
• Reasonable alternatives: including doing nothing, waiting, self-care, or referral elsewhere if relevant.
• Practical consequences: follow-up, monitoring, restrictions, likely inconvenience, or what happens if the person declines.
• Costs and service basis: where relevant, whether the service is NHS or private and what charges may apply.

In pharmacy practice this also includes who is providing the service, whether results or information will be shared with the GP or another clinician, and what will happen if the service identifies a problem requiring referral.

Valid consent needs more than information

To be valid, consent requires capacity for the decision, a voluntary choice, and a clear decision. A signature or tick-box does not make consent valid if the discussion was inadequate.

What should be recorded and when written or electronic consent is sensible

A signed form is evidence that a conversation took place. It is not proof on its own that the person was properly informed or that the consent was valid.