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Informed consent

Eric Tin, partner and head of medicolegal practice group at Donaldson & Burkinshaw LLP, and Dr Janet Page, senior medicolegal adviser at MPS, look at the key aspects of informed consent, with some analysis of recent cases in Singapore

Informed consent is a fundamental element of all clinical interactions between a doctor and his patient and forms part of his overall duty of care to his patients. It is trite law,1 and also professional ethics,2 that before a doctor performs a medical procedure, the patient should be adequately advised on their medical condition; the nature of the procedure; the respective benefits, risks and possible complications of the procedure and available alternative treatment options (collectively “relevant information”) so as to enable the patient to participate in a meaningful way in decisions about his own treatment.

The onus remains on the doctor to provide advice, regardless of whether the patient asks any questions, since a patient cannot ask for information if they are unaware of its existence.3 It has also been observed in a Singapore Medical Council (SMC) case involving a treatment of a novel nature that: “It is not for the patient to prove that he had not been given full information about any procedure that he is about to go through. It is for the doctor to prove that he had obtained proper and informed consent from the patient.”4 The patient must be advised if the treatment is novel or experimental and the extent of any known or anticipated risks associated with it. Patients participating in clinical trials should also be made aware of any specific provisions for indemnity and clearly advised where the potential harm to the patient outweighs any potential benefit.

Informed consent is a fundamental element of all clinical interactions between a doctor and his patient

Express or implied?

Consent may be express or implied. It can be expressed verbally during consultation or in print, when the patient signs a consent form after discussion of the relevant information. It may also be inferred from the patient’s conduct, such as when a patient willingly extends his hand to receive an injection. Under the SMCEthical Code and Ethical Guidelines (2002), discussions of treatment options and informed consent are expected to be documented in sufficient detail in the patient’s medical records to enable proper transfer of care when necessary.5

SMC disciplinary inquiry cases have shown that failure to document per seor inadequate documentation7 can lead to indefensibility of professional misconduct charges. Written consent should be obtained for all invasive procedures unless the risks are negligible (eg, routine venepuncture). Verbal consent, including details of any discussion with the patient, should be documented in the patient’s record and signed and dated.

A proforma checklist of risks and complications is a useful aide memoire and speeds the documentation process, but is not a substitute for a discussion with the patient.

Mental capacity

Informed consent is predicated on a patient’s free will and mental capacity. A person who is sufficiently mature may freely give or withhold consent to any medical treatment.8 If the patient is a minor, or of diminished ability to give consent (whether temporary or permanent), information should be explained to their parent or legal guardian, or the person legally responsible for them (eg, a donee or a court-appointed deputy under the Mental Capacity Act9), who will consent on behalf of the patient (“legally authorised consent”).10 No one else, however close by reason of kinship or friendship, is legally entitled to decide for the patient.11 It is, however, often helpful to involve family members in the discussions if the patient so wishes.

Consent in an emergency

The decision as to what is in the patient’s best interests from the point of view of the doctors is strictly a medical one, and one that is expected to be professionally formed.

An exception where a doctor may proceed with a medical procedure without actual or legally authorised consent is in a situation of emergency or necessity to save their patient’s life.12 In such a case, the doctor’s only course of action is to act in the best interests of the patient.13 The decision as to what is in the patient’s best interests from the point of view of the doctors is strictly a medical one, and one that is expected to be professionally formed.14 Discussions with the patient’s close family may assist the doctor in deciding where those interests lie if time permits, although the family’s views are not determinative.

The decision-making process should be documented in the patient’s records. Apart from this recognised exception, it must be noted that performing a procedure without having obtained prior valid consent can yield dire consequences for a doctor.

No consent: the consequences

In a serious case, the doctor can be prosecuted for the Penal Code offence of use of criminal force, which carries an imprisonment term and a fine.15 Failure to obtain valid consent can also ground a civil case under the tort of negligence16 or tort of battery,17 leading to claims for monetary compensation. It can also be the subject of professional misconduct charges against a doctor upon complaint to the SMC.18

In one SMC case, the disciplinary tribunal held that a failure to obtain informed consent to invasive surgery is a serious form of professional misconduct, and the suspension term it meted out to the respondent doctor was upheld on appeal by the High Court.19 A doctor may therefore be put through the criminal, civil and/or disciplinary justice process for operating without consent. In medicolegal cases, what was discussed and advised during the consent-taking process is largely a question of fact, and the court or disciplinary tribunal will examine the available oral and documentary evidence of those who partook in the process to determine where the truth lies. Whether the advice to the patient meets the required standard of care (or conversely whether it constitutes a breach of the duty of care), will be a question that usually hinges on expert opinion.

In Singapore, the Bolam-Bolitho test applies to the standard of care for diagnosis, treatment as well as advice. Under this test, a doctor is not liable for negligence if they have acted in accordance with a responsible body of medical opinion, provided that this opinion stands up to logical analysis and scrutiny. In this regard, the court will assess whether the expert opinion in support of a certain standard of care has balanced the comparative risks and benefits relating to the matter, considered and weighed all the countervailing factors relevant to the issue, and arrived at a defensible conclusion that is internally cogent and not contradicted by proven extrinsic facts.20

What the patient needs to know

Where the court considers that a decision not to warn of certain risks is illogical, the court can find against the doctor.21 Thus whilst the standard of advice for patients is based on what doctors consider patients need to know, the court acts as a bulwark against any illogically held standards. This has been the legal position adopted by the Court of Appeal in the case of Gunapathy in 200222 and consistently followed to date in a line of High Court decisions.23

whilst the standard of advice for patients is based on what doctors consider patients need to know, the court acts as a bulwark against any illogically held standards

This position differs from jurisdictions such as Australia, Canada, Malaysia and the United States, which have embraced a patient-centric or “reasonable patient” test for informed consent. As the point on informed consent was not fully addressed in Gunapathy, it nevertheless remains open to the court to take a different position in the future.24 There is generally no requirement for doctors to explain risks that an average person is ordinarily aware of, or of which the particular patient has prior knowledge.25

The standard of advice that the doctor should provide to a patient may therefore differ according to the patient’s pre-existing knowledge.26 But a doctor would be in breach of their duty if they simply assumed that their patient had the relevant information by reason of having undergone a previous similar procedure.27 The onus remains on the doctor to take steps to ascertain that the patient indeed had the relevant information for informed consent, and to document the ascertained facts.

Who can take consent?

The giving of information is a process, and not an event, which begins from the moment relevant information is given to the patient until final confirmation of that information before the medical procedure begins.28 The relevant information need not emanate from the same source throughout the process of informing the patient.29 It was held in a High Court case that whilst it is good practice for the doctor performing the procedure to take consent, information can be communicated by other relevant medical professionals such as the primary treating physician, medical officers, nurses, or even through available resources such as information pamphlets.30

It must be added that those individuals should have the appropriate knowledge and expertise of the intended procedure and are in a position to answer any questions the patient may have. In a team care situation, once a team member has advised the patient of certain information, and the patient understands the information, the other team members need not repeat the same information to the patient.31 This judicial view takes into account the practicalities in healthcare institutions like hospitals or medical centres, where a patient is usually attended to by various medical personnel who may individually or collectively communicate advice at different times and places.

clear and sufficient documentation, as well as sound protocols for transmitting information amongst the medical team, will help prevent unnecessary communication breakdown that can be detrimental to the patient’s care

In such clinical contexts, clear and sufficient documentation, as well as sound protocols for transmitting information amongst the medical team, will help prevent unnecessary communication breakdown that can be detrimental to the patient’s care. There are certain medical procedures, such as obstetrics, which provide patients with a choice of anaesthetic options. In a recent High Court case, the court held that the anaesthetist and the obstetrician were both responsible for advising on considerations relevant to their own specialty.32 This requires effective communication between the doctors to ensure that the patient has been apprised of all the relevant considerations to enable her to make an informed choice.33 The doctors’ actions will be judged in accordance with the Bolam- Bolitho test referred to earlier.34

In summary, informed consent is not a one-off event. It is also not a simple matter of obtaining a signature on a consent form. It is a communication process before a medical procedure to provide patients with relevant information so that they can meaningfully participate in decisions about their own medical treatments. Such information can emanate from more than one source, and it will be useful to ascertain the patient’s pre-existing knowledge to help assess the amount of information that needs to be given.

In determining the appropriate standard of care for advice, the Bolam-Bolitho test is still good law in Singapore. Where medical situations call for joint responsibility of different specialists, doctors should communicate with each other and also with the patient to avoid information gaps that can potentially imperil patients. Unless situations of necessity present themselves, a doctor should always obtain consent from a patient or his legally authorised representative, and have the advice adequately documented, before proceeding with a procedure. Where consent cannot be obtained and the patient’s life will be in danger if the necessary medical procedure is not performed, the doctor must always act in the patient’s best interest and record the reasons for his decision.

BOX 1.

  1. Who should take consent?
    • Someone with sufficient knowledge and expertise.
    • Does more than one specialty need to be involved?
  2. Capacity to consent
    • Does the patient understand the nature, purpose and effect of what is proposed? And if not, who is the appropriate person to consent on behalf of the patient? (In an emergency, the doctor must act in the patient’s best interests.)
  3. When to take consent
    • Consent is a process, not an isolated event.
    • Revisit the process before the procedure (especially if there is a delay between the consent and proposed treatment).
  4. How to take consent
    • Provide sufficient information:
      • The nature, purpose and effect of the proposed treatment
      • Alternative options (including doing nothing), risks and benefits
      • Consider the use of visual aids, eg, a CD or leaflets
    • Give time to the patient to consider their decision, have discussions with their family, or take other advice.
    • In an emergency: assess the patient’s best interests – include the family in the discussion as time permits.
  5. Provide evidence of consent
    • Consent should be written for all invasive procedures.
    • A signature alone is insufficient as a record of consent being taken.
    • Document discussions: with whom, any warnings given, etc.

References

  1. [2011] SGHC 193 at [125]
  2. SMC, Ethical Code and Ethical Guidelines, paragraph 4.2.2
  3. [2011] SGHC 193 at [130]
  4. SMC disciplinary inquiry grounds of decision dated 23 July 2013 at [116]
  5. SMC, Ethical Code and Ethical Guidelines, paragraph 4.1.2
  6. SMC disciplinary inquiry grounds of decision dated 4 May 2012
  7. [2008] 3 SLR(R) 612
  8. [2006] 2 SLR(R) 13 at [4].
  9. Chapter 177A, 2010 Revised Edition.
  10. [2006] 2 SLR(R) 13 at [4].
  11. [2006] 2 SLR(R) 13 at [4].
  12. [2006] 2 SLR(R) 13 at [6] and [10].
  13. [2006] 2 SLR(R) 13, at [10].
  14. [2006] 2 SLR(R) 13 at [9].
  15. Section 352, Chapter 224, 2008 Revised Edition.
  16. Eg. [2002] 1 SLR(R) 1024.
  17. Eg. [2000] SGHC 248.
  18. Eg. [2008] 3 SLR(R) 612; [2011] 2 SLR 1089.
  19. [2011] 2 SLR 1089.
  20. [2002] 1 SLR(R) 1024 at [64]-[65].
  21. [2011] SGHC 193 at [124].
  22. [2002] 1 SLR(R) 1024.
  23. [2013] 2 SLR 18; [2011] SGHC 193.
  24. Chao Hick Tin JA, “5th Chao Tze Cheng Memorial Lecture - Recent Developments in Informed Consent”, Annals Academy of Medicine (Vol. 14, No. 11, November 2012), at pp.543 and 547.
  25. [2011] SGHC 193 at [128].
  26. [2011] SGHC 193 at [128]. 
  27. [2011] SGHC 193 at [128].
  28. [2013] 2 SLR 18 at [69] and [73].
  29. [2013] 2 SLR 18 at [69].
  30. [2013] 2 SLR 18 at [73].
  31. [2011] SGHC 193 at [129]; [2013] 2 SLR 18 at [74].
  32. [2013] 2 SLR 18 at [70].
  33. [2013] 2 SLR 18 at [75].
  34. [2013] 2 SLR 18 at [69], [70] and [72].
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