Consent and Capacity and the legal framework for COVID-19 vaccine
While speed and efficiency of the COVID-19 vaccines rollout are crucial to help save lives and protect the NHS, the issue of consent and capacity becomes of central importance. In this article, Sue Inker, lawyer and subject matter expert, considers the legal framework for healthcare professionals.
With the exciting news of the rollout of the Oxford/AstraZeneca vaccine in the fight against COVID-19, the UK has commenced the biggest vaccination programme in the history of the NHS.
While speed and efficiency of the rollout are crucial to help save lives and protect the NHS, the issue of consent and capacity becomes of central importance.
Almost one month ago, the Pfizer/BioNTech vaccine was administered for the first time outside of a clinical trial at Coventry Hospital. Since then, more than three quarters of a million people have been vaccinated with the Pfizer/BioNTech vaccine.
Although those who live and work in care homes are number one in the priority group, it has proved difficult to administer the Pfizer/BioNTech vaccine in sufficiently large numbers to this group due to difficulties in transportation and storage of the vaccine.
As the Oxford/AstraZeneca does not face the same transport and storage challenges, we can potentially expect to see millions of doses of vaccines being administered over the coming weeks to those in the highest priority groups.
The task ahead
A proportion of the people who have already been vaccinated will have had capacity to consent to the vaccination and will have consented, some may have exercised their autonomy and self-determination and refused, but a significant proportion of those people may have lacked capacity to consent to the vaccination for COVID-19.
Professionals administering the COVID-19 vaccine must have both exceptional clinical knowledge, but also sound legal knowledge around informed consent and capacity.
- What is the “salient” information you would have had to understand, retain, use and weigh and communicate to consent?
- Patients with relevant mental capacity to consent
- Patients with relevant mental capacity to consent but who refuse
- Patients with a health and welfare attorney or deputy
- Patients who lack the relevant mental capacity to consent
- Recording and Evidencing