COVID-19 VACCINATION CONSENT FORM

Purpose:

This form has been designed to support the Informed Consent process for Covid-19 vaccinations.

FOR THE LEGAL ADMINISTRATION OF ANY CV19 VACCINE, BOTH PARTIES MUST READ AND SIGN THIS DOCUMENT

Audience:

• Doctors (or their delegated Health Care Professionals)

• Patients receiving Covid-19 Vaccine

  Background:

  This document is based on the Montgomery Judgement and GMC Guidelines. The Montgomery Judgement and Informed Consent

  https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informed-consent

  This Supreme Court judgement of Montgomery v Lanarkshire (2015) changed the standards of consent. The key passages from Montgomery Judgement state:

  “...The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of
  any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments....”
  “The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

  Before Montgomery, a doctor's duty to warn patients of risks was based on whether they had acted in line with a responsible body of medical opinion - known as the “Bolam test”. Now, doctors must provide information about all material risks to which a reasonable person in the patient's position would attach significance. This puts the patient at the centre of consent process, as their understanding of material risk must be considered. Both patient and doctor need to sign this document.

  If doctors fail to properly discuss the risks and alternative treatments with the patient, this renders them personally responsible for damages. This document therefore protects the patient and the doctor.

  General Medical Council Guidance - Decision Making and Consent (2020)

  https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent)
  This states that doctors MUST attempt to find out what matters to patients, so they can share information about the benefits and harms of proposed options and reasonable alternatives.
  Note the word MUST makes this a legally binding directive.

  GMC Guidance states doctors MUST address the following information:

  1. a)  Recognise risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge and experience.

  2. b)  The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue could reveal more.

  3. c)  Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them.

  4. d)  Any risk of serious harm, however unlikely it is to occur.

  5. e)  Expected harms, including common side effects and what to do if they occur.

UK MFA COVID-19 Vaccine Consent Form www.ukmedfreedom.org 1