Informed Consent

What is this you ask? Why is it so important?

Professionals have a duty of care to ensure that the patient should have adequate understanding of the vaccine to accept or decline.

The Government has rolled out the mass, non-mandatory, Covid19 vaccination programme, which is still in phase three clinic trials, with the drive toward full acceptance. There has been a noticeable confusion and absence of information with regards to its efficacy, in addition to a disturbing silence with regards to the possible adverse side affects. Patients must be kept informed by timely updates, as and when, new information become available. 

The historically successful Yellow Card Scheme, allowed the doctor to report patient adverse side effects. Currently, the onus of responsibility is on the patient to do the reporting of unpredictable affects.  Recent reporting suggests only a small percentage of patients actually complete this.

Informed consent is universally accepted as an agreement or permission to do something to someone who has been given full information about the possible effects or results including benefits and risks, thus enabling them to accept or decline.

The concept of informed consent began to take form after the Second World War, following the atrocities of medical experimentation on prisoners by the Nazis, which led to the formulation of the Nuremberg Code 1947,  aimed at protecting human subjects from cruelty and exploitation. The Code included principles of informed consent and freedom from coercion, in the participation of scientific experimentation that should be conducted with due kindness and respect toward participants in the experiments.

The Declaration of Geneva, adopted by the General Assembly of the World Medical Association at Geneva in 1948 with subsequent amendments, refines further the Nuremberg Code by defining the physician’s dedication to the humanitarian goals of medicine. The Declaration of Helsinki, first adopted in 1964, deals more especially with the ethical aspects and standards of medical research.

Given that all the Covid vaccines being used in the mass vaccination programme have not been licensed, but merely given emergency authorisation by the Government, this is not widely known by the public.

It could be argued, that the commonly held view of turning up for vaccination and presenting an arm is tantamount to giving consent. However, that is not informed consent. Providing a standardised patient information leaflet could assist with any decision-making process, but would also require regular updating with any adverse effects as they become notified to monitoring authorities.  Medical information should be presented in clear English text with accurate translations as appropriate.

Recipients of the vaccine erroneously believe that once they are vaccinated, they would be not only be immune to fatality from Covid, but protected from developing severe symptoms. The Government should therefore, include such disclaimers in the information for consent. 

From various feedbacks and reports on social media, it appears that there is neither reliable or satisfactory discussion, prior to vaccination, with any designated member of the team, who is responsible for obtaining informed consent.  This opportunity should be available at all Vaccination Centres.  

There is therefore, much that is deficient in the mass roll-out programme of the Covid vaccines, particularly the important matter of informed consent. It is in the public interests that this deficiency is promptly and adequately addressed.

Nurse Kay

Proud of Care Workers

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