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Informed Consent

Informed Consent

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Informed Consent

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  1. Informed Consent Presented By Associate Professor Catherine TayNational University of Singapore (NUS)Faculty of Business AdministrationBachelor of Laws (Hons), LondonMaster of Laws, LondonBarrister-at-Law (England)Advocate & Solicitor, SingaporeAuthor of ‘Medical Negligence’ Book

  2. Informed Consent • Things can go wrong in surgical procedure and bad outcome and adverse results may result due to human error, negligent or not.

  3. Informed Consent • You did not inform me of the risk which became a reality. I would not have consented to the operation if I had known of the risks, so you have - caused my injury and - failedin your medical duty of care to inform

  4. Inforrmed Consent • Is there sufficient information to patient’s consent?

  5. Inforrmed Consent • Consent is an ethical principle • Medical treatment can only be performed with consent of competent pt

  6. Informed Consent • Giving treatment without consent is failure to respect patient’s autonomy violating an individual’s right of self-determination

  7. Informed Consent • Consent must be freely given with patient understanding - the nature - risks - benefits - alternatives - limitations of proposed treatment.

  8. Informed Consent • Any medical treatment given without consent is an action for trespass where damages are payable

  9. Inforrmed Consent • The consent form is for patient to acknowledge that the nature & purpose of treatment has been - fully explained - understood and - consented to.

  10. Informed Consent • Pt never consented to doctor’s negligence but only to risks & complications involved

  11. Inforrmed Consent • In an emergency, where pt is unable to consent eg unconsciousness, a doctor is justified to carry out emergency treatment based on - doctrine of necessity or - implied consent

  12. Informed Consent • Implied Consent It is presumed that pt would have consented to treatment as it was necessary to save his life or from serious harm

  13. Doctor’s Legal Duty to Disclose information • What is the level or standard of disclosure to be expected in medical law? • A pt can only give real consent to treatment if he has sufficient information to make a decision for an informed consent

  14. Checklist - Informed Consent • name of operation • nature of proposed treatment • what the operation involves • other treatment options or alternatives • potential complications • risks of operation • risk of no treatment

  15. Checklist • special precautions required post-operatively • benefits of treatment • limitations of treatment • success rate of operation • what happens on admission • how pt will feel after treatment

  16. Informed Consent • Information include warning • Warn of any real risk that treatment may be ineffective • Alternative treatments should be told esp. if got choice between surgical & medical procedures

  17. Informed Consent • The fact that pt asked questions showing concern about the risk would make doctor aware that pt does attach significance to the risk • A lot depends on pt’s way of questioning

  18. Rogers v Whittaker (1992) • A 1:14,000 of blindness turned into a risk which it was found to be negligent not to disclose • A risk, even if it is a mere possibility, should be regarded as ‘material’ if its occurrence causes serious consequences

  19. Informed Consent • Once pt ask “How serious?” the operation is, doctor should discuss - the relative conveniences - expertise - possible risks.

  20. Informed Consent • To say less is misleading & inadequate • Good communication is stressed and is highly desirable between doctor-pt relationship

  21. Medical Negligence • Failure by doctor to disclose risks of treatment can result in action for negligence • The test which medical negligence is assessed isBolam test , now modified byBolitho case

  22. Bolitho case • Failure of hospital doctor to examine & intubate child experiencing respiratory distress, leading to brain damage through asphyxia

  23. Bolitho case (1997) • Pt had expert evidence that a reasonably competent doctor would have intubated in those circumstance - Doctor had own expert witnesses saying that non-intubation was clinically justifiable response

  24. Bolam Test • A doctor is not negligent if what he has done is accepted current practice by a responsible body of medical opinion

  25. Bolitho case • House of Lords case • The court must be satisfied that the body of opinion is logical • Clearly this rejection of Bolam test

  26. Bolitho case • It is now a matter for court & not medical opinion to decide standard of professional care • Bolitho case represented a significant nail on Bolam’s coffin

  27. Kamalam v Eastern Planttaion Agency(1996) • Malaysian case – where Bolam test not folllowed • A Malaysian judge can now decide on his own disregarding expert medical evidence on the sufficiency of consent – informed consent

  28. Informed Consent • Medical opinions are still required to assist the court in its deliberation • Bolam test has been challenged & rejected in America, Canada, Australia, South Africa & Malaysia

  29. Singapore cases • Dennis Matthew Harte v Dr Tan Hun Hoe & Gleneagles Hospital Ltd [1999] • Gumapathy Muniandy v Dr James Khoo & 2 others – July 2001 • Pai Lily v Yeo Peng Hock Henry [2000]

  30. Informed Consent • Highly desirable for doctor to record in his medical notes that - risks and alternatives were disclosed & - understood by pts, apart from pt signing consent form

  31. Medical Ethics • It is no harm to disclose all ‘material risks’ & information to pts as they have a right to dowhat they want with their own bodies

  32. Medical Ethics • Pts could choose to do nothing after being informed of options/alternatives& consequences of no treatment • This is respecting pt’s autonomy or self-determination in biomedical ethics

  33. Medical Ethics • Doctors must abide by the high professional standards • Hippocratic Oath is a moral code concerning beneficence & non-maleficence ie. the pillars of medical ethics – do good,do no harm

  34. Medical Ethics • Declaration of Geneva • Singapore Physician Pledge

  35. Principles of Biomedical Ethics 1. Autonomy - decision-making - respect for individuals - patient’s rights 2. Beneficence Do Good

  36. Medical Ethics 3. Non-Maleficence Do No Harm 4. Justice equitable distribution of benefits & burdens

  37. Medical Ethics 5. Fidelity - truth-telling - confidentiality 6. Veracity - honesty

  38. Medical Ethics • Medical ethics must lead medical law • A good medical law is an ethical law • Doctor must practice sound medical ethics

  39. Complaints & Complaints • Doctors who fail to establish relationship with patients will endanger trust & confidence • Doctor who takes time to explain what and why he propose to do & how much it cost are less likely to be subject of complaints

  40. Proving Medical Negligence 1. Duty of Care 2. Standard of Medical Care 3. Causation 4. Remoteness (ie suffer damage)

  41. NEGLIGENCE • Is failure to exercise reasonablecare and skill, or • Omission to do something which a reasonable man would do, or • Something which a reasonable man would not do

  42. Negligence • Careful doctor but still negligent • Things can go wrong – 1. Diagnosis 2. Treatment 3. Information Disclosure

  43. Standard of Medical Care • Careful doctor but still Negligent • Keeping abreast with latest developments and technology & incorporate them in his practice • Not expected to read every article in medical journals

  44. Doctor judged by standard or awareness and sophistication to be expected of a doctor in his sort of profession • All doctors not expected to have level of awareness available to a professor • To be judged on what is to be expected of doctor/dentist in regular practice

  45. If GP fail to refer patient to consultant when reasonable GP would, GP is negligent • No allowance made for inexperience and age • 60 year old GP in private practice, must meet same standard of alertness as 30 year GP

  46. Medical Negligence is a Civil Wrong TORT • Tort = Wrongful Act

  47. Criminal liability Wrongful Act Contractual liable Civil liability Tortiously liable

  48. ARBITRATION MEDIATION LITIGATION