Consent is a fundamental part of clinical practice and has been the subject of a recent review by the Ministry of Health. Here Peter Mordecai, Claims Manager at Medical Protection, and Dr Katie Grant, Medicolegal Consultant at Medical Protection, look at what has changed and how it affects your work.

Informed consent and the provision of medical information are core aspects of medical practice. With the legal position in this area having been the subject of a recent review by the Ministry of Health, it has shed light on existing concerns that some doctors found it difficult in practice to fully understand what their patients wanted, or needed to know, and this may have led to overly defensive practice.

This article will explore the recent changes and provide you with advice and tips on how to minimise your risk, and optimise your consenting processes.

Consent law in Singapore – the background

The law surrounding the provision of medical information in Singapore was originally based on common law. It had been criticised over the years as a paternalistic doctor-centred approach (the Bolam-Bolitho test) because it placed emphasis on peer review to determine whether a doctor’s conduct was appropriate.

However, this changed in 2017 following the case of Hii Chii Kok v Ooi Peng Jin London Lucien.^[1] This case adopted (with modifications) the UK position regarding the legal test of informed consent^[2] and made it a more patient-centred approach, by framing a three-stage test that the courts would apply when considering whether a doctor had been negligent in his advice. This was known as the Modified Montgomery (MM) Test and we previously wrote about it here.

The common law therefore focused on informing the patient of any information that a reasonable person in the patient’s position would feel was significant. For example, the risk of a loss of sight during cataract surgery would be more significant to a patient with sight in only one eye instead of two.

What are the new changes?

On 6 October 2020, Singapore codified the legal test regarding informed consent and there is now a statutory obligation, as well as a common law one, when providing medical information and seeking consent.

The statutory obligations  can be found in section 37 of the Civil Law Act  and intends to provide a balance of doctor-centred (Bolam-Bolitho) and patient-centred approaches (MM), which aims to reflect practice in real life.

In summary, Singapore has gone further than the MM test. They have set out that in order to satisfy that the appropriate standard of care was given, one must:

1. Act in a manner that is accepted by a respectable body of medical opinion (“peer professional opinion”) and
2. This “peer professional opinion” must stand up to logical analysis (Bolam-Bolitho test).

In order to determine whether the “peer professional opinion” has been met, there is a three-staged test that aims to reflect and respect the importance of both patient autonomy and professional peer opinion, thereby enhancing patient-doctor partnerships:

1. The doctor-centred approached, ie have you given information (which you know or should reasonably know) that a person in the same circumstances as the patient would reasonably require to make an informed decision about whether to undergo a treatment or follow medical advice?
2. The patient-centred approach as set out in Hii Chii Kok v Ooi Peng Jin London Lucien, ie have you given the patient information that you know or should reasonably know to be material to that particular patient, for him or her to make an informed decision about whether to undergo a treatment or follow medical advice (MM)?
3. If you have not provided the necessary information to the patient, then there must be reasonable justification for this non-provision. This cannot be failing to inform the patient simply because you consider it not in the patient’s best interests to know, or that it would dissuade him or her from undergoing what you feel is the best treatment option. Situations where non-disclosure may be justifiable include cases of emergency, cases where giving the patient the information could cause him or her significant harm, if the patient is unconscious and there is no person present with legal capacity to make medical decisions on their behalf, or if the patient has previously been informed of other treatment options, along with their risks and benefits, and expressly confirms that they do not want to be given the information again.

All three stages have to be satisfied in order to obtain a patient’s informed consent.

When considering the information that one should reasonably know to be material to the patient, this would include:

1. Risks or information the patient has enquired or communicated about – if they have specifically asked, then it would be deemed important to a reasonable person in the patient’s position.
2. Risks or information that can be implied to be important to the patient – an example being that if in the medical records the patient has a concern about loss of hair and this is a risk of the treatment you are proposing, then it would be deemed important to a reasonable person in the patient’s position. By no means are you required to review every record in detail for the whole of the patient’s life but if, as a result of a reasonable review, there are risks or information that can be identified as being important to the patient, then these should be discussed with them.

In practice, you should continue to focus on understanding your patient’s individual needs and circumstances, and building this into your consenting process. Consent is a journey, rather than a one-off event, and you should clearly document steps taken within the consenting process in detail. The case studies below highlight the importance of provision of medical information.

Case study A

A very anxious patient consulted a consultant hand surgeon due to wrist pain. The surgeon recommended surgery but decided not to explain the details of the surgery with the patient due to her anxiety. Unfortunately, recognised complications occurred.

While the surgeon undoubtedly had the patient’s best interests in mind, as the details of the surgery were not explained to the patient, the Medical Protection team was unable to show that the patient’s informed consent had been obtained.

Case study B

A patient attended a consultant breast surgeon for a mastectomy and breast reconstruction surgery. In her witness statement, the surgeon stated that she explained the various treatment options available and the risks and benefits of each treatment option. However, there was no contemporaneous evidence of this discussion and the surgeon admitted she did not write down the same.

There was, therefore, a factual dispute between the patient and the surgeon regarding the risks, benefits and alternatives that were explained. This was a dispute that could have been resolved had the surgeon written down the details of the discussion.

Case study C

A patient attended a consultant gynaecologist with suspected cancer. The gynaecologist decided to perform a diagnostic laparoscopy, but he did not:

1. Offer alternative investigation strategies that, while less reliable, were less invasive.
2. Explain to the patient that there was a risk of bowel perforation, which was a recognised risk and did occur in this case.

Medical Protection was unable to defend this matter because, again, while the gynaecologist did have the patient’s best interests in mind and the surgery itself was uneventful, the patient’s informed consent was not obtained because the alternative investigation options were not discussed, nor were the significant risks of the proposed procedure.

Here are some practical tips to enhance your practice in taking informed consent from patients.

Things to consider when obtaining the patient’s consent

1. What treatment and investigation options are available? The various treatment and investigation options should be explained to the patient. This includes the treatment option of doing nothing. It does not matter if the option you are recommending has a 75% chance of success and the second best option only has a 25% chance of success, the patient still needs to be made aware of the alternatives.
2. What are the risks, benefits and alternatives of the treatment options I am proposing? These should be explained to the patient and fall into four broad categories:
   • Colleague consideration – what risks, benefits and alternatives would your colleagues explain in this scenario?
   • Risk consideration – what are the standard risks in performing this treatment, for example, bleeding or infection?
   • Severity consideration – what severe risks are there in performing this procedure, for example, a procedure may carry a 0.1% chance of a loss of limb, but this is a severe risk if it occurs.
   • Patient consideration – are there any risks that are likely to be material to the patient’s decision making? As the law above shows, this will be the focus of any court or tribunal.
3. When do I obtain the patient’s consent? Obtaining the patient’s consent on the day of a surgical procedure is likely to be deemed inadequate when considering if the patient’s consent is truly informed, unless the procedure is an urgent one. Aim to discuss the treatment options and risks and benefits of each of them some time before any treatment, offer different sources of reliable information about these options and document these steps.
4. Is the consent form enough? – The short answer is no. The consent form is required but it is not enough on its own to show that informed consent has been obtained. There should be a clear record of the discussion between yourself and the patient going through the various treatment options and the risks and benefits of each of them. Revisiting consent throughout the patient’s journey is important, for example asking the patient to consider and sign the consent form prior to the day of the procedure and then reaffirming it on the day.
5. As per the famous quote “Tell them what you are going to tell them, tell them, then tell them what you told them” – if you are able to, have more than one discussion regarding the risks, benefits and alternative treatment options. This will show you have indeed made efforts to obtain the patient’s informed consent.
6. Document the discussion – Medical Protection has seen a number of cases where the lack of documentation has been the downfall of a case. Don’t be caught out. Time is limited in the medical world but a detailed consultation note can be the very thing that prevents a protracted litigation or disciplinary process.

Conclusion

You can perform the best treatment in the world, but a legal case can still be made if you have not obtained the patient’s informed consent. It is therefore important that you take the time to go through the risks and benefits and alternative treatment options in plenty of time with the patient, and document your discussion accordingly.

If you have any queries, your Medical Protection team is here to advise and support. Contact us here or by calling our toll free helpline on 800 616 7055.

Peter J Mordecai LLB(Hons), PgDip is Claims Manager at Medical Protection for Asia and Caribbean and Bermuda, and Solicitor-Advocate (Higher Courts Civil Proceedings) (Admitted in England and Wales)

Dr Katie Grant BSc(Hons) BM(Hons) MA DLM FRCA is Medicolegal Consultant at Medical Protection for Asia and Caribbean and Bermuda