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The doctrine of informed consent: does it exist and has it crossed the Atlantic?

Published online by Cambridge University Press:  02 January 2018

Alasdair R Maclean
Alasdair R Maclean*
Affiliation:
School of Law, The University of Glasgow
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Abstract

Use of the term ‘informed consent’ is commonplace in both bioethics and medical law. In the legal context the term may be referred to as ‘the doctrine of informed consent’ but the way that this latter term is used raises doubt as to its value as a legal concept. In this paper I explore the concept of the ‘doctrine of informed consent’ and suggest that it may be useful, but only if limited to the autonomy-driven duty to disclose rather than as a more general referent. Having established the nature of the concept I then consider whether the doctrine - which is applied in a minority of US states, Canada and Australia - has crossed the Atlantic and become part of the law in England and Wales. In particular, I analyse Lord Woolf MR's judgment in Pearce v United Bristol Healthcare NHS Trust and suggest that the law has moved towards the doctrine but that it still falls short of the disclosure required by the reasonable patient standard.

Type
Research Article
Information
Legal Studies , Volume 24 , Issue 3 , June 2004 , pp. 386 - 413
Copyright
Copyright © Society of Legal Scholars 2004

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References

1. Tiller v Atlantic Coast Line Railroad Co 318 US 54 at 68 (1943). Quoted in ML Plante ‘An Analysis of “Informed Consent’” (1968) 36 Fordham LR 639.

2. It is also not uncommon in other areas of law where consent is relevant. See Skegg, Pdg English Medical Law and” Informed Consent“: An Antipodean Assessment and Alternative’ (1999) 7 Google Scholar Med LR 135 at 137.

3. Moreno, Jd and Lederer, Se Revising the History of Cold War Research Ethics’ (1996) 6(3)Google ScholarPubMed Kennedy Institute of Ethics J 223 at 227.

4. Salgo v Leland Stanford Jr University 317 P 2d 170 (Cal App, 1957).

5. A search (28 July 2003) of Westlaw revealed seven articles published that year with ‘informed consent in the title’. If the search is expanded to include the text of the article then 327 are returned. A key word search of Medline for 2003 returned 398 English language articles (1,274 when not restricted to English). Use of the phrase in UK legal journals is far less extensive. A search of LexisNexis returned just nine articles, and none with the phrase in the title of the article. A search of Westlaw returned just one article that included the phrase in the title.

6. A Grubb and I Kennedy ‘Consent to Treatment: The Competent Person’ in I Kennedy and A Grubb (eds) Principles of Medical Law (Oxford: Oxford University Press, 1998) p 147.

7. Skegg, n 2 above, at 138.

8. PDG Skegg “’Informed Consent” to Medical Procedures' (1975) 15 Med Sci Law 124. Although I am discussing the ‘doctrine of informed consent as a term’ and here I have noted problems with the ‘Informed’ part of that term, this does not mean that I think the concept of consent is free of problems. A discussion of consent itself, however, must wait for another time.

9. See the use of the term ‘doctrine of informed consent’ in P Walter ‘The Doctrine of Informed Consent: To Inform or Not to Inform?’ (1997) 71 St John's LR 543 at 547.

10. Rogers v Whittaker (1992) 16 BMLR 148 at 157, HCA. The Canadian case is Reibl v Hughes (1980) 114 DLR (3d) 1 SCC.

11. Plante, n 1 above.

12. R Faden and TL Beauchamp A History of Informed Consent (New York: Oxford University Press, 1986). See also, H Teff ‘Consent to Medical Procedures: Paternalism, Self-determination or Therapeutic Alliance’ (1985) 101 LQR 432.

13. See Teff, n 12 above, at 433, 434.

14. Despite a distinct lack of cases, it is arguable that the Scottish courts would adopt a similar approach to the doctrine. In Moyes v Lothian 1990 SLT 444, Lord Caplan relied on both Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 and Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 and stated: ‘As I see it the law in both Scotland and England has come down firmly against the view that the doctor's duty to the patient involves at all costs obtaining the informed consent of the patient.’ The relationship between Scots and English law in this context is given further weight by the fact that, in Bolam, McNair J relied on Lord President Clyde's judgment in the Scottish case Hunter v Hanley 1995 SLT 213. Finally, the Bolitho v City and Hackney Health Authority [1998] AC 232 caveat to Bolam has been relied on in Scottish negligence cases, eg Keen v Tayside Contracts 2003 SLT 500.

15. See DL Medin ‘Concepts and Conceptual Structure’ (1989) 44 Am Psychologist 1469; W Ahn ‘Why are different features central for natural kinds and artifacts?: the role of causal status in determining feature centrality’ (1998) 69 Cognition 135; LK Komatsu ‘Recent Views of Conceptual Structure’ (1992) 112 Psychological Bulletin 500. I am here utilising the theory-based view of concepts. Other views, such as the exemplar or prototype approaches are also possible: see Komatsu's paper. Space does not permit an exploration of the evidence supporting these different views of concepts. The theory-based view is adopted here because it appears to have a greater explanatory force.

16. AR Maclean ‘Consent, sectionalisation and the concept of a medical procedure’ (2002) 28 J Med Ethics 249 at 250. See also, W Ahn ‘Why are different features central for natural kinds and artefacts?: the role of causal status in determining feature centrality’ (1998) 69 Cognition 135.

17. For the relationship between concepts and conceptions see R Dworkin Law's Empire (Oxford: Hart Publishing, 1998) p 71.

18. U Hahn and N Chater ‘Concepts and Similarity’ in K Lamberts and D Shanks (eds) Knowledge, Concepts and Categories (Hove: Psychology Press, 1997) p 43.

19. See eg LK Komatsu ‘Recent Views of Conceptual Structure’ (1992) 112 Psychological Bulletin 500 at 502.

20. Brown, R How shall a thing be called?’ (1958) 65 Google Scholar Psychological Review 14.

21. B Bix ‘Conceptual Questions and Jurisprudence’ (1995) 1 Legal Theory 465.

22. Halpin, A Concepts, Terms, And Fields of Enquiry’ (1998) 4 Google Scholar Legal Theory 187 at 188.

23. Waldron, J Vagueness in Law and Language: Some Philosophical Issues’ (1994) 82 Google Scholar Calif LR 509 at 512.

24. R Gillon Philosophical Medical Ethics (Chichester: John Wiley & Sons, 1985, 1996) p 113; A Meisel and M Kuczewiski ‘Legal and Ethical Myths About Informed Consent’ (1996) 156 Archives of Internal Medicine 2521 at 2522; T McConnell Inalienable Rights: The Limits of Consent in Medicine and the Law (New York: Oxford University Press, 2000) p 8.

25. See eg O O'Neill Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press, 2002) p 43.

26. See eg Wertheimer, A Consent and Sexual Relations’ (1996) 2 Google Scholar Legal Theory 89 at 94.

27. See eg Sherwin, E Infelicitous Sex’ (1996) 2 Google Scholar Legal Theory 209 at 209, 217.

28. See eg Usher, Kj and Arthur, D Process consent: a model for enhancing informed consent in mental health nursing’ (1998) 27 Google ScholarPubMed J Advanced Nursing 692.

29. Alexander, L The Moral Magic of Consent (II)’ (1996) 2 Google Scholar Legal Theory 165.

30. Consent may not be effective because I lack the necessary control over the object of consent to give an effective consent or because consent is insufficient justification for the particular intervention: see R v Brown [1993] 2 WLR 556, HL

31. Autonomy may be characterised as self-determination (deciding for oneself), rational self-determination or moral, rational self-determination (as reflected in Kant's imperative that we will only those laws that can be universally applied). See G Dworkin The Theory and Practice of Autonomy (Cambridge: Cambridge University Press, 1988); O'Neill, n 25 above; I Kant Groundwork of the Metaphysics of Morals (M Gregor, trans) (Cambridge: Cambridge University Press, 1998) p 31 (4:421).

32. See Justice Cardozo's much-quoted judgment in Schloendorff v Society of New York Hospital 211 NY 125 at 129 (1914).

33. Perhaps the most accepted limit is justified by the ‘harm principle’, which sanctions limits on liberty in order to prevent harm to others and is most famously associated with JS Mill: see JS Mill ‘On Liberty’ in J Gray (ed) On Liberty and Other Essays (Oxford: Oxford University Press, 1991) p 14.

34. Chatterton v Gerson [1981] 1 All ER 257.

35. Charterton v Gerson [1981] 1 All ER 257 at 265.

36. See eg Lord Scarman's judgment in Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 at 885, HL.

37. Davis v Barking, Havering and Brenmood Health Authority [1993] 4 Med LR 85.

38. For a further discussion of this case and the issues arising from it see Maclean, n 16 above.

39. TL Beauchamp and JF Childress Principles of Biomedical Ethics (New York: Oxford University Press, 5th edn, 2001) p 78.

40. Beauchamp and Childress, n 39 above.

41. Beauchamp and Childress, n 39 above, p 81.

42. Beauchamp and Childress, n 39 above.

43. M Brazier ‘Patient autonomy and consent to treatment: the role of the law?’ (1987) 7 LS 169 at 180. See also Grubb and Kennedy, n 6 above, p 149.

44. Robertson, G Informed consent to medical treatment’ [1981] 97 Google ScholarPubMed LQR 102 at 123–124.

45. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 at 587. The statement was based on Lord Clyde's judgment in Hunter v Hanley 1955 SLT 213 at 217.

46. Natanson v Kline 350 P 2d 1093, opinion on denial of motion for rehearing, 354 P 2d 670 (1960).

47. Faden and Beauchamp, n 12 above, pp 125–139. The one current exception is the state of Pennsylvania where the doctrine of informed consent remains a battery claim: Duttry v Patterson 565 Pa 130 (Penn SC, 2001); JW Berg, PS Applebaum, CW Lidz and LS Parker Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2nd edn, 2001) p 135.

48. Faden and Beauchamp, n 12 above, p 135.

49. Canterbury v Spence 464 F 2d 772 (DC Cir, 1972). Although the phrase ‘informed consent’ may be used to refer to disclosure governed by the professional standard (See the New York Medical Malpractice Act 1975), I understand the doctrine to require a standard based on the patient rather than the physician.

50. Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871, HL.

51. Faden and Beauchamp, n 12 above, p 133.

52. Canterbury v Spence 464 F 2d 772 at 778 (DC Cir, 1972).

53. 464 F 2d 772 at 780 (DC Cir, 1972).

54. 464 F 2d 772 at 781–784 (DC Cir, 1972).

55. 464 F 2d 772 at 785 (DC Cir, 1972).

56. 464 F 2d 772 at 786 (DC Cir, 1972).

57. 464 F 2d 772 at 787 (DC Cir, 1972), quoting from J R Waltz and T W Scheuneman ‘Informed Consent to Therapy’ (1970) 64 Nw ULR 628 at 640.

58. 464 F2d 772 at 788 (DC Cir, 1972).

59. 464 F 2d 772 at 789 (DC Cir, 1972).

60. 464 F 2d 772 at 789 (DC Cir, 1972).

61. 464 F 2d 772 at 791 (DC Cir, 1972).

62. SF Kurtz ‘The Law of Informed Consent: From “Doctor is Right” to “Patient has Rights”’ (2000) 50 Syr LR 1243 at 1252.

63. BJ Warren ‘Pennsylvania Medical Informed Consent Law: A Call to Protect Patient Autonomy Rights by Abandoning the Battery Approach’ (2000) 38 Duquesne LR 917.

64. The term ‘child’ refers to a concept hierarchically lower than the ‘parent’ concept and existing in a ‘type of’ relationship (as opposed to an ‘example of’) with the parent concept.

65. The ‘doctrine of informed consent’ may be seen as synonymous with ‘informed consent’ but keeping a distinction between the ethical concept and the application of that concept in law seems worthwhile.

66. Berg et al, n 47 above, p 12.

67. S Wear Informed Consent: Patient Autonomy and Clinician Beneficence Within Health Care (Washington, DC: Georgetown University Press, 2nd edn, 1998) pp 14–27. See also D Kroft ‘Informed Consent: A Comparative Analysis’ (1997) 6 J Int Law and Practice 457 at 459–463; The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Making Health Care Decisions Volume One: The Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship (Washington, DC, 1982) pp 18–23.

68. See also eg JH Richards ‘Informed Confusion: The Doctrine of Informed Consent in Georgia’ (2003) 37 Ga LR 1129 at 1139–1140.

69. See also, the discussion above nn 39–40.

70. Berg et al, n 47 above, p 65.

71. Wisconsin is one such jurisdiction: Johnson v Kokemoor 199 Wis 2d 615 (1996).

72. Apparently the only jurisdiction that has not made this distinction is Pennsylvania, where information disclosure is wholly an issue of battery law: see n 47 above.

73. Excluding Pennsylvania for obvious reasons. Reference to the doctrine remains valid in Pennsylvania but only to indicate those elements of disclosure that would, in other jurisdictions, form part of the physician's obligation regulated by negligence law.

74. Robertson, n 44 above, at 123–124; Brazier, n 43 above, at 180; Grubb and Kennedy, n 6 above, p 149.

75. Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 at 883, HL.

76. Excluding, for the time being, the law in Pennsylvania.

77. It might be argued that ‘consent’ in negligence is not really a form of consent but simply a duty to disclose based on a paternalistic approach to the need for an ethical consent that emphasises patient welfare and clinical autonomy at the expense of patient self-determination. In this case, it would be distinguishable from the third approach only by virtue of a different ethical conception of consent. I do not think it matters whether the approach is described as two different ‘consents’ or as a single consent but with an added duty of disclosure. The argument does not stand or fall on the choice of label but on whether there is sufficient difference between the approaches to support the value of a distinct doctrine of ‘informed consent’. However, referring to it as a type of consent provides a clear distinction from the third approach and, if the reader prefers, may be seen as shorthand that avoids the need to clutter the text with explanations about the respective ethical approach. The crucially important aspect of this approach is that it originates from the doctor's duty rather than the patient's right. As such, it is ideally suited to negligence rather than battery and to the professional rather than the prudent patient standard of disclosure.

78. Rogers v Whittaker (1992) 16 BMLR 148 at 157, HCA.

79. MA Jones ‘Informed Consent and Other Fairy Stories’ (1999) 7 Med LR 103 at 105.

80. Reibl v Hughes (1980) 114 DLR (3d) 1 at 11, SCC.

81. Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 at 888, HL.

82. [1985] 1 AC 871 at 892, HL.

83. [1985] 1 AC 871 at 895, HL.

84. See Chester v Afshar [2002] EWCA Civ 724, [2002] 3 All ER 552.

85. F v West Berkshire Health Authority [1989] 2 All ER 545 at 563, per Lord Goff.

86. Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 at 895, HL, per Lord Diplock. Lord Diplock was actually referring to a ‘highly educated man of experience’ such as a judge, but if his outrageously paternalistic bias is ignored, the statement is equally applicable to any autonomously competent individual.

87. [1985] 1 AC 871 at 894, HL.

88. [1985] 1 AC 871 at 895, HL.

89. Slater v Baker and Stapleton (1767) 2 Wils 359; (1767) 95 ER 860 at 862.

90. The court did not argue that a failure to get consent should be brought in assumpsit, it simply refused to allow the defendant to avoid liability by pleading that the plaintiff had used wrong form of action. Thus, the court held ‘That the plaintiff ought to receive a satisfaction for the injury, seems to be admitted; but then it is said, the defendants ought to have been charged as trespassers vi & armis. The Court will not look with eagle's eyes to see whether the evidence applies exactly or not to the case, when they can see the plaintiff has obtained a verdict for such damages as he deserves, they will establish such verdict if it be possible’: Slater v Baker and Stapleton (1767) 2 Wils 359; (1767) 95 ER 860.

91. [1985] 1 AC 871 at 895, HL.

92. [1985] 1 AC 871 at 893, HL.

93. [1985] 1 AC 871 at 895, HL.

94. Canterbury v Spence 464 F 2d 772 at 780 (DC Cir, 1972).

95. Schloendorff v Society of New York Hospital 211 NY 125 at 129 (1914). See eg Berg et al, n 47 above, pp 43–44; Kurtz, n 62 above, at 1246.

96. Such as Article 8 of the European Convention of Human Rights, now part of UK law by virtue of the Human Rights Act 1998.

97. Because battery law is predicated on the right of the victim, the doctrine includes disclosure rules required Pennsylvania that go beyond those necessary for a ‘real’ consent.

98. Vaughan v Menlove (1837) 3 Bing NC 468.

99. Blyth v Birmingham Waterworks (1856) 11 Ex 781 at 784.

100. This answers one of Plante's objections - that there was nothing new in ‘informed consent’ cases - although his criticism was valid when he wrote his article: Plante, n 1 above.

101. See the preceding discussion, above nn 66–69, in which I note that leading US commentators use the doctrine in a way that is inclusive of all of the legal requirements of consent (including competency).

102. Jones, n 79 above, at 113.

103. A subjective standard of disclosure would also be an acceptable value for the doctrine's core attribute, but such a standard has not yet been accepted by any common law jurisdiction.

104. Four of the five Lords delivered their own judgments with the fifth, Lord Keith, agreeing with Lord Bridge.

105. Sidaway v Governors of Bethlam Royal Hospital [1985] 1 AC 871 at 885, HL.

106. [1985] 1 AC 871 at 882, HL.

107. [1985] 1 AC 871 at 883, HL.

108. Bolam v Friern [1957] 1 WLR 582; Chatterton v Gerson [1981] 1 All ER 257; Hills v Potter [1984] 1 WLR 641.

109. [1985] 1 AC 871 at 896, HL.

110. [1985] 1 AC 871 at 899, HL.

111. [1985] 1 AC 871 at 900, HL.

112. [1985] 1 AC 871 at 900, HL.

113. For a discussion of the difference between a normative and a sociological application of the standard of care see JL Montrose ‘Is Negligence an Ethical or a Sociological Concept?’ (1958) MLR 259. See also AR Maclean Beyond Bolam and Bolitho (2002) 5(3) Med Law Int 205 at 206–207.

114. Teff, n 12 above, at 450.

115. [1985] 1 AC 871 at 905, HL.

116. [1985] 1 AC 871 at 903, HL.

117. [1985] 1 AC 871 at 903, HL.

118. [1985] 1 AC 871 at 905, HL.

119. I Kennedy ‘The Patient on the Clapham Omnibus’ in Treat Me Right: Essays in Medical Law and Ethics (Oxford: Clarendon Press, 1988) p 175; A Grubb ‘Contraceptive Advice and Doctors - A Law Unto Themselves’ (1988) 47 CLJ 12 at 13. See also, S Lee ‘Towards a Jurisprudence of Consent’ in J Eekelaar and J Bell (eds) Oxford Essays in Jurisprudence (Oxford: Oxford University Press, 1997) p 216; S Lee ‘Operating Under Informed Consent’ (1985) 101 LQR 316.

120. See, eg Teff, n 12 above, at 450.

121. K Williams ‘Pre-operative Consent and Medical Negligence’ (1985) 15 Anglo-Am LR 169 at 179–180.

122. Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151, CA (decided 1987); Gold v Haringey Health Authority [1988] 1 QB 481, CA.

123. Moyes v Lothian Health Board [1990] 1 Med LR 463 at 469.

124. Smith v Tunbridge Wells Health Authority [1994] 5 Med LR 334; McAllister v Lewisham and North Southwark Health Authority [1994] 5 Med LR 343; Gascoine v Sheridan [1994] 5 Med LR 437; Newell and Newell v Goldenberg [1995] 6 Med LR 371.

125. McAllister v Lewisham and North Southwark Health Authority [1994] 5 Med LR 343 at 351.

126. Eg see Heath v West Berkshire Health Authority [1992] 3 Med LR 57; Parry v Day [1996] 7 Med LR 396; Poynter v Hillingdon Health Authority (1997) 37 BMLR 192.

127. Eyre v Measeday [1986] 1 All ER 488, CA; Palmer v Eadie (1987) LEXIS, 18 May, CA. For a rare exception see Loveday v Renton [1990] 1 Med LR 117, CA.

128. See eg Abbas v Kenney [1996] 7 Med LR 47; Judge v Huntingdon Health Authority [1995] 6 Med LR 223; Ratty v Haringey Health Authority [1994] 5 Med LR 413, CA; De Freitas v O'Brien [1995] 6 Med LR 108.

129. Eg see M Brazier and J Miola ‘Bye-Bye Bolam: A Medical Revolution?’ (2000) 8 Med LR 85.

130. Bolitho v City and Hackney Health Authority [1998] AC 232.

131. [1998] AC 232 at 241.

132. Brazier and Miola, n 129 above, at 95–107.

133. Brazier and Miola n 129 above, at 107–108.

134. Bolitho v City and Hackney Health Authority [1998] AC 232 at 243.

135. Pearce v United Bristol Healthcare NHS Trust [1999] PIQR 53; (1999)48 BMLR 118.

136. [1999] PIQR 53 at 54; (1999) 48 BMLR 118 at 120.

137. [1999] PIQR 53 at 59; (1999) 48 BMLR 118 at 124.

138. Brazier and Miola, n 129 above, at 110.

139. Maclean, n 113 above, at 214.

140. The 10% figure comes from the Canadian case: Reibl v Hughes (1981) 114 DLR (3d) 1.

141. [1999] PIQR 53 at 59; (1999) 48 BMLR 118 at 125.

142. B Adam and J van Loon ‘Introduction: Repositioning Risk; the Challenge for Social Theory’ in B Adam, U Beck and J van Loon (eds) The Risk Society and Beyond: Critical Issues for Social Theory (London: Sage, 2000) p 4.

143. [1999] PIQR 53 at 59; (1999) 48 BMLR 118 at 125.

144. Maclean, 113 above, at 214.

145. Canterbury v Spence 464 F 2d 772 at 787 (DC Cir, 1972).

146. I would like to thank one of the anonymous reviewers for suggesting the relevance of this point.

147. I have recently presented the main arguments of this future article at the SLSA conference in Glasgow (2004) and the UK Forum on Health Law and Ethics in Newcastle (2004). The title of the presentation was ‘Significant risk and the reasonable patient’. The article will be co-authored by Dr Pauline Whitehouse who assisted me in the small empirical study looking at this issue. The study will also be reported in the article.

148. Jones, n 79 above, at 125.

149. Jones, n 79 above, at 130–s131.

150. Seeking Patient's Consent: The Ethical Considerations (London: GMC, 1998), available at http://www.gmc-uk.org/standards/default.htm (accessed 17 February 2004). See also, Senate of Surgery of Great Britain and Ireland The surgeon's duty of care (London, 1997).

151. See eg the recommendations of The Inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984–1995 (Cm 5207, 2001), available at http://www.bristol-inquiry.org.uk/ (accessed 17 February 2004).

152. GMC, n 150 above, para 6.

153. I would like to thank one of the anonymous reviewers for raising this issue.

154. See Teff's argument, n 12 above, at 433, 443.

155. In the Supreme Court of Canada hearing of Reibl v Hughes (1981) 114 DLR (3d) 1 at 8–9, Laskin CJC - giving the judgment of the court - argued that: ‘In my opinion, these findings do not justify the imposition of liability for battery. The popularization of the term “informed consent” for what is, in essence, a duty of disclosure of certain risks of surgery or therapy appears to have had some influence in the retention of battery as a ground of liability … It would be better to abandon the term when it tends to confuse battery and negligence.’

156. Lord Woolf s inaugural lecture in the Provosts Lecture Series, University College, University of London ‘Are The Courts Excessively Deferential To The edical Profession?’ (2001) 9 Med LR 1 at 10; Pearce v United Bristol Healthcare NHS Trust [1999] PIQR 53; (1999) 48 BMLR 118.

157. Jones, n 79 above, at 109.

158. GMC, n 150 above.

159. Brazier and Miola, n 129 above, at 110. It may be thought that the Human Rights Act 1998 might affect the law in this area. Perhaps the only relevant European human rights case is Association X v UK (1979) 14 DR 31 in which the Commission stated: ‘it is legitimate for the State to take the view that checks for contra-indications are matters best left to clinical judgment.’ This case involved the state's obligations to warn about the risks of vaccination and the Commission's statement perhaps suggests that the Bolam standard would be acceptable under the Act (see A Maclean ‘Crossing the Rubicon on the Human Rights Ferry’ (2001) 64(5) MLR 775 at 781). The only caveat is that, since the Convention is a ‘living document’ things may be differently decided today. However, given the margin of appreciation allowed to signatory states and the vague Convention rights, it is arguable that both the prudent patient and the professional standards of disclosure would be acceptable. This point may be given added weight since Pearce was decided only shortly before the Human Rights Act 1998 came into force and if Lord Woolf MR had thought it particularly relevant he would, perhaps, have considered its implications.