Informed Consent

Seeking informed consent to medical treatments from patients is a fundamental principle of medicine. It is the process by which an individual agrees to a particular medical treatment be it a vaccine, a pharmaceutical treatment, surgery, or investigative or diagnostic tests, after considering known risks and benefits of the treatment or test in question.

Informed consent also requires that an individual is provided with relevant information on available alternatives.

There are four basic pre-requisites for informed consent to be valid:

• Consent must be given voluntarily, without coercion or duress
• The individual giving consent must be deemed to have the mental capacity/ability to make the decision
• The clinician or other health professional responsible for administering or prescribing the treatment, test or procedure must disclose the expected benefits and risks of the given treatment, test or procedure along with the likelihood of those risks/benefits occurring
• The individual needs to be able to understand the information she or he is given.

Legal precedent has refined the definition of informed consent in the UK to stating that “…doctors must ensure their patients are aware of the risks of any treatments they offer and of the availability of any reasonable alternatives.”

Elsewhere, the definition is similar, such as in the US, the European Union, Australia and South Africa.