New Guidance on informed consent for surgical procedures

Posted by Kym Provan on
informed consent form

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The Royal College of Surgeons (RCS) have revealed new guidance regarding Informed Consent, advising that patients need to be fully aware of all of the available procedures and associated risks before giving their consent to surgery.

In law, doctors are required to obtain the informed consent of their patients before carrying out any surgical procedure (unless it is in an emergency and the patient is not in a position to give or withhold their consent). However, what constitutes "informed consent" has been the subject of much legal debate over the past decade or so.

Last year, the Supreme Court considered the issue once again in the case of Montgomery –v-Lanarkshire Health Board. Mrs Montgomery brought the case on behalf of her son, who has cerebral palsy and was born in 1999. Mrs Montgomery has type 1 diabetes and is of slight build. Mothers who have type 1 diabetes can have larger than usual babies. At the time of delivery Mrs Montgomery was not informed of the small increased risk that her baby may become stuck due to shoulder dystocia and she was not given the option of a caesarean section.

Sadly, her son did become stuck and was deprived of oxygen for a period of time, resulting in permanent brain injury.

Mrs Montgomery argued that she should have been advised of the increased risk of shoulder dystocia and that the option of caesarean section should have been discussed with her, to include the risks associated with that procedure. Had this happened, she would have elected for a caesarean section and her son would have avoided oxygen deprivation and brain injury.

The Health Board's position was that the risk of shoulder dystocia was still small and that at the time a reasonable body of competent obstetricians would not have warned of the small increased risk and would not have offered caesarean section. On that basis, they argued that there had been no breach of duty and therefore that no compensation was payable.

The judges held that it was not for doctors to decide what the patient needed to know, which risks were worthy of mention and which were not, nor to decide for the patient which was the best method of treatment for them. That decision should rest with the patient once all the risks and benefits had been explained.    

In the circumstances of this particular case, the Court found in favour of Master Montgomery and awarded a substantial award of compensation. 

The case has caused much consternation amongst professionals both in medical and legal fields, although in reality, it simply confirms what most people felt should have been happening in any event. The RCS has though taken these concerns seriously, particularly as a failure to properly discuss the patient's treatment options and to detail all the risks involve could potentially result in allegations of clinical negligence and a claim for compensation should something go wrong. 

The RCS has published further guidance to surgeons on the steps that should be taken to ensure that their patients are indeed giving fully informed consent in accordance with the principles set out in Montgomery. Surgeons are advised to avoid a "paternalistic approach", in which the surgeon effectively decides upon the best course of treatment for their patient, and then asks the patient to sign the consent form for that treatment option. Instead, surgeons are encouraged to spend a greater amount of time explaining the various treatment options available and the pros and cons of each. They are encouraged to explore in greater detail what is important to their patient in terms of their lifestyle and beliefs, and how the different treatment options and risks may impact upon those. The Times today suggests that it should be senior doctors who have these discussions with the patients, and that at least 30 minutes should be spent with each patient on the informed consent process. The Guardian spoke with Leslie Hamilton, a council member of the RCS, who expressed the opinion that the familiar Consent form, which has in practice sometimes been seen as a box-ticking exercise on the day of theatre, should be replaced with a formalised "decision-making record".  This would give details of the discussions that have taken place between surgeon and patient providing protection for both.

The consent process is incredibly important for both patients and doctors and it is equally important that no assumptions are made about the patient's preferences without these having been properly discussed, in the full knowledge of the risks and benefits that attach to each. Whilst it is easy to see that this may cause problems for doctors in departments that may already be under-resourced, getting this process right can save very significant levels of distress, time and money in the longer term, as well as ensuring that the patient's right to autonomy is preserved. 

Too often I have been contacted by clients who are adamant that the risks of a particular procedure were not adequately explained to them, and that had they understood the practical consequences of the risk that has materialised in their case, they would not have agreed to the procedure.

An example of this involves nerve damage during elective spinal surgery. This may well be noted on the consent form but the patient often has no comprehension that this means that there is a small risk that they could be left doubly incontinent. Should they be unfortunate enough to suffer such a complication, they may then seek help from a solicitor and it is at that point, I am told that had they understood that this was a risk of the surgery, they would not have given their consent. Cases brought on this basis alone are difficult because they do not necessarily involve the benefit of hindsight, and usually there are questions to be raised about the standard of surgery and/or follow-up as well. However, I have seen first-hand how important it is for the risks of surgery to be spelt out to patients in a way that they understand how their life may be affected, should those risks materialise.       

It is to be hoped that the guidelines produced by the RCS will go some way to ensuring that all patients really are properly informed about their treatment options, and are able to make informed choices about the treatment that they undergo, thus alleviating the potential for misunderstanding and future conflict.   

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About the Author

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Kym specialises in clinical negligence claims and heads our clinical negligence team in Southampton.

Kym Provan
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023 8085 7317

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