Informed consent

OBTAINING proper consent from patients for any planned investigation or treatment is a fundamental principle of medicine, recognising the importance of patient autonomy. Valid consent must of course be voluntary and “competent” – that is patients must have the maturity and mental capacity to freely make a decision. It must also be informed and this is perhaps the one aspect of consent that leads most to discussion and debate.

Clearly a patient needs to be given sufficient information to make a decision, but what constitutes “sufficient” in this respect? The diagnosis, prognosis, need for the procedure, the potential risks and benefits and the alternatives, including doing nothing, should all be covered, but it can be difficult to know how much detail to include. All major complications, common or rare, and common minor complications would normally be included, but in complex procedures with a large number of potential risks, how do doctors decide what to discuss?

“Reasonable” standard

Past court judgments in the UK have tended to rely on a “professional standard” when judging such issues, ruling that doctors should include the amount and type of information that would be provided by a doctor of that particular specialty if exercising ordinary skill or reasonable care. In essence, doctors have been judged according to norms existing amongst their peers. Thus if the amount of information given is in accordance with normal practice, any claim for negligence was likely to fail.

More recently, however, there has been a move by some judges to adopt a “reasonable patient standard”, in other words the amount of information that a reasonable patient would wish to be told in that situation. In other jurisdictions, this patient-centred approach has been extended to a “particular patient standard” – that is the information a particular patient would have wanted to know about a procedure.

One example of this comes from a case in Australia (Chappel v Hart) in which a patient underwent a pharyngeal pouch operation. During the consent process, she asked specifically about possible effects on her voice. She was reassured there would be no problem but subsequently developed the rare complication of mediastinitis following perforation in which her voice was damaged. The patient worked in broadcasting and the court found that the doctor was negligent in not explaining this particular risk, however rare. Such a risk may not have required specific disclosure in all cases but the patient had indicated its particular importance to her.

Interestingly, GMC guidance on consent states: “The amount of information about risk that you should share with patients will depend on the individual patient and what they want or need to know. Your discussions with patients should focus on their individual situation and risk to them.” This clearly points to a patient-orientated rather than doctororientated standard.

What you don’t know….

Very occasionally, patients may wish a procedure to go ahead without any detailed information – the “just do what needs to be done doctor” approach. The GMC advises attempting to give basic information about what the procedure aims to achieve, what is involved and any serious risks. But where the patient adamantly refuses, the advice is as follows: “If a patient insists that they do not want even this basic information, you must explain the potential consequences of them not having it, particularly if it might mean that their consent is not valid. You must record the fact that the patient has declined this information. You must also make it clear that they can change their mind and have more information at any time.”

Consent can be verbal but for procedures associated with any significant risk – including surgical procedures – it is more commonly written. Consent is best obtained by the doctor responsible for carrying out the procedure, or if delegated, then another professional with the knowledge and skills to accurately inform the patient. Although a consent form may be signed at a particular time, consent should be considered an ongoing process rather than a single event, with opportunity for questioning and clarification up until the time of the procedure.

Failure to obtain informed consent leaves doctors open to allegations of clinical negligence. In order to prove this, patients must establish that they were not properly informed about the possible consequences of an intervention, that the intervention brought about that risk even though the risk was not increased by the failure to warn, and even though the patient had not shown necessarily that they would never have had the operation knowing of that risk. It is therefore of medicolegal as well as clinical importance that proper informed consent is obtained and documented.

Dr Barry Parker is a medical adviser at MDDUS