Informed consent in hospital practice: Health professionals' perspectives and legal reflections

Medical Law Review

Volumn 18, Issue 2, 2010, Pages 152-184

  Heywood, Rob ^a   Macaskill, Ann ^b   Williams, Kevin ^b  

^a UNIVERSITY OF EAST ANGLIA   (United Kingdom)

^b SHEFFIELD HALLAM UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HOSPITAL PERSONNEL; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; INTERVIEW; LEGAL ASPECT; MALPRACTICE; PATERNALISM; PRACTICE GUIDELINE;

COMMUNICATION; DEFENSIVE MEDICINE; HUMANS; INFORMED CONSENT; INTERVIEWS AS TOPIC; PATERNALISM; PERSONNEL, HOSPITAL; PRACTICE GUIDELINES AS TOPIC; TRUTH DISCLOSURE;

EID: 77956397491     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwq008     Document Type: Article

References (178)

1. Sidaway v Board of Governors of the Bethlem Royal Hospital and others [1985] AC 871.
2. Pearce v United Bristol Healthcare Trust (1998) 48 BMLR 118.
3. The first author would like to thank all the health professionals who kindly participated in the study.
4. M Jones, 'Informed Consent and Other Fairy Stories' (1999) 7 Med L Rev 103, 123.
5. The participants were from a range of different specialisms, including general and colorectal surgery, neuro surgery, gynaecology/obstetrics, and orthopaedics.
6. The participants were based in general and colorectal surgery and endoscopy. The medical input into the study advised that consultants and registrars perform similar duties. Accordingly, for the purposes of thematic analysis, the consultants' and registrars' interviews were combined.
7. Only a limited number of senior house officers and house officers were available to take part in the study due to the frequency of their surgical rotations. Accordingly, the number of specific themes in relation to these grades was reduced. As these participants were involved in surgical rotations, they had experience in a range of specialisms. At the time they were interviewed they were based in the department of general and colorectal surgery.
8. For discussion see S Kvale, Interviews: An Introduction to Qualitative Research Interviewing (Sage, London 1996).
9. This is the point where it becomes evident that the participants are covering the same issues and no new themes emerge from the analysis.
10. See R Heywood, 'The Law and Practice of Consent to Medical Intervention' (PhD Thesis, Sheffield Hallam University 2006).
11. L Todres and S Wheeler, 'The Complementarity of Phenomenology, Hermeneutics, and Existentialism as a Philosophical Perspective for Nursing Research' (2001) 38 International Journal of Nursing Studies 1, 6.
12. Owing to the qualitative nature of this work there are no references in the discussion to the numbers of participants or to percentages but the number of times a theme occurred is reported as an indication of importance.
13. There were a total of 128 occurrences across the interviews: 68 occurrences in the consultants/registrars' interviews, 14 in the SHO/house officers' interviews, and 46 in the nurses' interviews.
14. In support of this model of healthcare and decision-making, see D Feldman-Stewart and others, 'Practical Issues in Shared Decision Making' (2000) 3 Health Expectations 46.
15. For discussion, see R Heywood and others, 'Patient Perceptions of the Consent Process: Qualitative Inquiry and Legal Reflection' (2008) 24 JPN 104 at 106, 115.
16. There were a total of 82 occurrences across the interviews: 48 occurrences in the consultants/registrars' interviews, 9 in the SHO/house officers' interviews, and 25 in the nurses' interviews.
17. This issue is identified and discussed below in the context of theme 4.
18. There were a total of 63 occurrences across the interviews: 33 occurrences in the consultants/registrars' interviews, 15 in the SHO/house officers' interviews, and 15 in the nurses' interviews.
19. This issue is explored in greater detail in theme 5 below.
20. There were a total of 179 occurrences across the interviews: 120 occurrences in the consultants/registrars' interviews, 11 in the SHO/house officers' interviews, and 48 in the nurses' interviews.
21. See below n 48.
22. Sidaway v Board of Governors of the Bethlem Royal Hospital and others [1984] 1 QB 493 at 521-522.
23. See GMC 'Consent: Patients and Doctors Making Decisions Together' (2008).
24. Tailoring information to particular types of patients is explored below n 67.
25. For discussion on the desirability of disclosing information by reference to the individual, see AJ Brooks and others, 'Information Required to Provide Informed Consent for Endoscopy: An Observational Study of Patients' Expectations' (2005) 37 Endoscopy 1136.
26. TE Quill, 'Autonomy in a Relational Context: Balancing Individual, Family, Cultural, and Medical Interests' (2002) 20 Families, Systems and Health 229.
27. There were a total of 31 occurrences across the interviews: 23 occurrences in the consultants/registrars' interviews, 1 in the SHO/house officers' interviews, and 7 in the nurses' interviews.
28. There were a total of 229 occurrences across the interviews: 112 occurrences in the consultants/registrars' interviews, 43 in the SHO/house officers' interviews, and 74 in the nurses' interviews.
29. For consultant perspectives on what should be disclosed to cancer patients, see EJ Gordan and CK Daughhery, 'Hitting You over the Head: Oncologists' Disclosure of Prognosis to Advanced Cancer Patients' (2003) 12 Bioethics 142.
30. For patient perspectives on the amount of information desired about terminal illnesses, see SJ Marwit and SL Datsun 'Disclosure Preferences about Terminal Illness: An Examination of Decision-Related Factors' (2002) 26 Death Studies 1.
31. SJ Yardley and others, 'Receiving a Diagnosis of Lung Cancer: Patients' Interpretations, Perceptions and Perspectives' (2001) 15 Palliative Medicine 379
32. See n 90 for further discussion.
33. There were a total of 98 occurrences across the interviews: 52 occurrences in the consultants/registrars' interviews, 21 in the SHO/house officers' interviews, and 25 in the nurses' interviews.
34. For empirical evidence in support of this, see BM Stanley and others 'Informed Consent: How Much Information is Enough?' (1998) 68 ANZ Journal of Surgery 788.
35. See for discussion, T Baker, 'The Goods on Defensive Medicine' in T Baker (ed), The Medical Malpractice Myth (University of Chicago Press, Chicago 2005) 118.
36. G McGovern and A Simpson, 'We're Reaping What We Sue' (2002) Wall Street Journal 17.
37. Baker, above n 30.
38. For UK literature, see also JB Fanning, 'Uneasy Lies the Neck that Wears a Stethoscope: Some Observations on Defensive Medicine' (2008) 24 JPN 93.
39. A Symonds, 'Reactions to Perceived Risk: Defensiveness in Clinical Practice' (2003) 9 Clinical Risk 182.
40. G McFarlane, 'Clinical Negligence - Risk Management and Reporting' (2001) 2 JPIL 164.
41. The most recent figures from the NHSLA suggest that in 2007/2008 there were 5,470 claims (including potential claims) under its clinical negligence schemes (NHSLA Fact Sheet No 3, November 2008).
42. Between 2002 and 2003, there were 7,798 estimated claims. Between 2003 and 04, they decreased to 6,251 (NHSLA Fact Sheet No 3, August 2004). During 2004-2005, there were 5,609 estimated claims (NHSLA Fact Sheet No 3, July 2005).
43. For further discussion, see The Report of the House of Commons Constitutional Affairs Committee on the Compensation Culture (Third Report of Session 2005-06 Vol.1).
44. Jones has indicated that allegations of inadequate disclosure are rarely the principal basis for the negligence action.
45. See Jones, above n 3 at 122 and also G Robertson, 'Informed Consent Ten Years Later: The Impact of Reibl v Hughes' (1991) 70 Canadian Bar Review 423.
46. D Kessler and M McClellan, 'The Effects of Malpractice Pressure and Liability Reforms on Physicians' Perceptions of Medical Care' (1997) 60 Law and Contemporary Problems 81.
47. D Kessler and M McClellan, 'Do Doctors Practice Defensive Medicine?' (1996) 111 Quarterly Journal of Economics 353.
48. S Zuckerman, 'Medical Malpractice: Claims, Legal Costs, and the Practice of Defensive Medicine' (1984) 3 Health Affairs 128.
49. Despite this, there is evidence that the overall impact of defensive medicine on healthcare costs is small.
50. See Baker, above n 30 at 134.
51. Baker, above n 30 at 135.
52. There were a total of 22 occurrences across the interviews: 16 occurrences in the consultants/registrars' interviews, 2 in the SHO/house officers' interviews, and 4 in the nurses' interviews.
53. See K Williams, 'Doctors as Good Samaritans: Some Empirical Evidence Concerning Emergency Treatment in Britain' (2003) 2 Journal of Law and Society 258, 268.
54. Only 54% of doctors recognised their professional obligation (GMC) to treat patients in emergencies.
55. See Jones, above n 3 at 126.
56. In Chatterton v Gerson [1981] 1 All ER 257 it was stated that in English law, once that patient is informed in broad terms about the nature of the procedure and signs the consent form, a legal claim in battery is no longer an option.
57. For discussion, see Feldman-Stewart, above n 13.
58. H Teff, 'Consent to Medical Procedures: Paternalism, Self-determination or Therapeutic Alliance' (1985) 101 LQR 432.
59. For an interesting discussion in support of this, see RV Clements, 'Informed Choice: Should We Bin the Consent Form?' (2005) Clinical Risk 69.
60. Jones, above n 3 at 125.
61. D Berry, Risk, Communication and Health Psychology (Open University Press, Berkshire 2004) 23.
62. Chatterton, above n 39.
63. For a general discussion, see TL Beauchamp and JF Childress, Principles of Biomedical Ethics (6th edn OUP, New York 2008).
64. In America, the phrase informed consent derives from the case of Salgo v Leland Stanford, Jr, University Board of Trustees 154 Cal. App. 2d 560, 317 P. 2d 170 (1957).
65. However, the later famous case of Canterbury v Spence (1972) 464 F.2d 772 developed what is sometimes referred to as the legal doctrine of informed consent within the remit of the negligence action.
66. This places an obligation on doctors to disclose all the material risks that the reasonable patient would want to know in the circumstances. To speak of an American legal doctrine of informed consent is perhaps misleading as it gives the false impression that it is of general application across all states.
67. Some US states still rely on the reasonable doctor standard of disclosure and one state still treats risk disclosure as a matter for liability in battery.
68. See the Pennsylvanian cases of Gray v Grunnagle, 423 Pa. 144, 223 A.2d 663 (1966).
69. Cooper v Roberts, 220 Pa. Super. 260, 286 A.2d 647 (1971).
70. The English courts have never fully accepted the Canterbury doctrine.
71. See Sidaway, above n 1.
72. Historically in England there was considerable debate over whether disclosure should be judged in accordance with the accepted standards of the medical profession (Bolam), or from the point of view of the reasonable patient (Canterbury).
73. See Sidaway, above n 1. Now, apart from some fine-tuning, it seems fairly clear following Pearce and Chester that the standard is what the reasonable doctor believes the reasonable patient would need to know.
74. See Pearce, above n 1; Chester v Afshar [2004] UKHL 41; [2005] 1 AC 134.
75. For discussion, see AR Maclean, 'The Doctrine of Informed Consent: Does it Exist and Has it Crossed the Atlantic?' (2004) LS 386.
76. M Brazier, 'Patient Autonomy and Consent to Treatment' (1987) 7 LS 169.
77. The participants were never asked directly about their understanding of the law and so this did not develop into a theme within its own right.
78. However, they were asked where the emphasis on 1-2% risk disclosure came from and there was a strong indication that this was categorically what the law required.
79. For a recent and interesting discussion, see J Miola, 'On the Materiality of Risk: Paper Tigers and Panaceas' (2009) 17 Med L Rev 76.
80. Academics have argued about whether or not this is an indirect acceptance of the American doctrine of informed consent. Brazier and Miola state that the reasonable doctor test received a 'real body blow' as a result of the decision in Pearce, above n 1.
81. See M Brazier and J Miola, 'Bye-Bye Bolam: A Medical Litigation Revolution?' (2000) 8 Med L Rev 85, 110.
82. However, one problem with this approach is in what sense the court can actually make an objective assessment of what the reasonable patient would want to know. The courts may think this is what they are doing when actually they are not.
83. All the courts can do is consider what ought reasonably to have been disclosed in the circumstances. This surely demands at least some thought about the patient's position in addition to an assessment of the medical evidence pertaining to the nature and frequency of the risk in question.
84. This has led Maclean to suggest that the test is reduced to no more than an examination of what the reasonable doctor believes the reasonable patient ought to find significant to a decision.
85. See for discussion A Maclean, 'Beyond Bolam and Bolitho' (2002) 5 Med L Int 205, 214.
86. For discussion of risk calculus, see above theme 4.
87. I Kennedy, 'The Patient on The Clapham Omnibus Postscript: The House of Lords' Decision' in I Kennedy (ed) Treat Me Right: Essays in Law and Medical Ethics (Clarendon Press, Oxford 1988) 200.
88. This clearly happened in Pearce where a great deal of emphasis seemed to be placed on percentages in identifying the significance (or otherwise) of a 0.1/0.2% risk.
89. See Pearce, above n 1.
90. The Secretary of State for Trade and Industry once suggested that 'fifty percent of the public doesn't actually know what 50% means'.
91. See Patricia Hewitt quoted in the Independent, 30 November 2002.
92. JM Gutteling and O Wiegman, Exploring Risk Communication (Kluwer, Dordrecht 1996) 121.
93. Pearce, above n 1 at 124.
94. A Maclean, 'Giving the Reasonable Patient a Voice: Information Disclosure and the Relevance of Empirical Evidence' (2005) 7 Med L Int 1, 12.
95. Maclean, above n 58 at 11.
96. Lord Scarman in Sidaway stated that the law does not operate in utopia and a subjective approach would create a danger of self-serving testimony given with the benefit of hindsight.
97. See Sidaway, above n 1 at 888.
98. See also Maclean above. However, Brazier points out that this approach may not be any more absurd than attempting to second-guess what the hypothetical reasonable patient may want to know.
99. Brazier, above n 47 at 189.
100. Maclean, above n 58.
101. Kennedy, above n 52 at 200.
102. Arguably the Australian case of Rogers v Whitaker (1992) 109 ALR 625 advocates a standard of disclosure which contains a specific subjective element.
103. For discussion, see D Chalmers and R Schwartz, 'Rogers v Whitaker and Informed Consent in Australia: A Fair Dinkum Duty of Disclosure' (1993) 1 Med L Rev 139, 150.
104. See also K Tickner 'Rogers v Whitaker - Giving Patients a Meaningful Choice' (1995) 15 OJLS 109.
105. The Court of Appeal has, of late, shown a degree of sympathy towards the subjective position of the patient without explicitly saying so.
106. See Wyatt v Curtis [2003] EWCA Civ 1779; [2003] WL 22827037.
107. Kennedy, above n 52 at 189.
108. The obligation to disclose all risks within the region of 1-2% is not mentioned in any of the guidance given from the GMC or the DoH.
109. See GMC 'Consent: Patients and Doctors Making Decisions Together' (2008).
110. Department of Health Circular 'Good Practice in Consent Implementation Guide: Consent to Examination or Treatment' (2001).
111. However, a recent article suggested the standard level of disclosure in modern medicine encompasses all risks within the region of 1-2% and above.
112. See W Hussain and others, 'Consent and Invasive or Interventional Cardiology' (2001) 7 Clinical Risk 127, 129.
113. In the recent House of Lords' decision of Chester v Afshar (above n 47) the surgeon was held liable for failing to disclose a risk which stood at around 1-2%. The question as to whether this failure constituted a breach was not open to debate.
114. The court stated categorically that the surgeon was clearly negligent in failing to disclose this.
115. For a general discussion of excessive disclosure and medical practice, see R Heywood, 'Excessive Risk Disclosure: The Effects of the Law on Medical Practice' (2005) 7 Med L Int 93.
116. See SM Miller, 'Coping with Impending Stress: Psychophysiological and Cognitive Correlates of Choice' (1979) 16 Psychophysiology 572.
117. One of the consultants in this study referred to the patients who do not want to know as 'blockers'.
118. See N Beresford and others, 'Risks of Elective Cardiac Surgery: What Do Patients Want to Know?' (2001) 86 Heart 626.
119. For further empirical evidence, see CW Lidz and others, 'Therapeutic Misconceptions and the Appreciation of Risks in Clinical Trials' (2004) 58 Social Science & Medicine 1689-1697.
120. see also AG Fraser, 'Do PatientsWant to be Informed?' (1984) 4 British Heart Journal 468.
121. If the Bolam test is applied, the law supports professional discretion in the sense that it defers its objective powers of assessment to a peer-review of what is professionally accepted practice. If, however, the reasonable patient standard of disclosure is used, the therapeutic privilege operates as a component of this standard of care to allow doctors to withhold information if they feel it will be detrimental to the mental or physical health of the patient. Thus, if the doctor withholds information on these grounds there is simply no breach.
122. For an Australian case in which the therapeutic privilege was applied see Battersby v Tottmann (1985) 37 SASR 524 (SA Sup Ct).
123. For further discussion, see R Mulheron, 'The Defence of Therapeutic Privilege in Australia' (2003) 11 JLM 201.
124. For discussion on how the waiver can be tied into the therapeutic privilege in order that the law can account for the passive patient, see Heywood, above n 66.
125. See I Kennedy and A Grubb, Medical Law (3rd edn Butterworths, London 2000) 752.
126. Baker, above n 30 at 135.
127. Balancing risks and benefits is a complex exercise. For example, the risks associated with a medical procedure are typically of a totally different nature, form, and frequency compared with the benefits.
128. For most patients, there is only a single benefit sought from a procedure; the risks are multiple. A further complication is that different people will attach different values to the different dimensions. Thus, risk and benefit are fundamentally evaluative terms.
129. See A Edwards and others, 'Concepts in Risk-Benefit Assessment: A Simple Merit Analysis of Medicine?' (1996) 15 Drug Safety 1.
130. RJ Hekkenberg and others, 'Informed Consent in Head and Neck Surgery: How Much do Patients Actually Remember?' (1997) 26 Journal of Otolaryngology 155.
131. DK Smith and others, 'Informed Consent to Undergo Serum Screening for Down's Syndrome: The Gap Between Policy and Practice' (1994) 309 BMJ 776.
132. The jurisdictions that have made most inroads into this are Canada and the USA.
133. For a Canadian example see, Haughian v Paine (1987) 37 DLR (4th) 624 (Sask CA).
134. Truman v Thomas (1980) 611 P 2d 902 (Cal Sup Ct) for an American example.
135. Kennedy and Grubb, above n 71 at 711.
136. See Sidaway, above n 1 at 876.
137. See Pearce, above n 1.
138. [2008] EWHC 2237.
139. For discussion see R Heywood, 'Medical Disclosure of Alternative Treatments' [2009] 68 CLJ 30.
140. Most notably, in Chester v Afshar (above n 47), there was evidence of the courts warming to the idea that autonomy is significant as an ideal in itself, and not just as a component in an negligence action.
141. See S Devaney, 'Autonomy Rules OK' (2005) 13 Med L Rev 102.
142. For a general discussion of the changing nature of the law and its attitude towards patient rights, see H Brooke, 'Patients, Doctors and the Law (1963-2003): A Few Reflections' (2004) 72 Medico-Legal Journal.
143. D Irvine, 'The Patient, The Doctor, Their Lawyers and the Judge' (1999) 7 Med L Rev 255.
144. [1994] 5 Med LR 334.
145. See also Lybert vWarrington Health Authority (1995) 25 BMLR 91.
146. Smith v Salford Health Authority [1994] 5 Med L Rev 321.
147. The need for patient comprehension was also stressed in Pearce, above n 1 at 124.
148. Smith, above n 83 at 339.
149. See A Grubb, 'Medical Negligence: Information and Bolam' (1995) 3 Med L Rev 198, 201.
150. Grubb notes that in Canada, the more onerous duty seems to be the law.
151. See Ciarlariello v Keller (1993) 100 D.L.R. (4th) 609 (Can. Sup. Ct.).
152. See, for example, K Williams, 'Comprehending Disclosure: Must Patients Understand the Risks They Run?' (2000) 4 Med L Int 97 at 101.
153. For an interesting discussion of the problems with patient understanding and the law, see AR Maclean, Autonomy, Informed Consent and Medical Law: A Relational Challenge (Cambridge University Press, Cambridge 2009).
154. NC Manson and O O'Neill, Rethinking Informed Consent in Bioethics (Cambridge University Press, Cambridge 2007).
155. See Medicines for Human Use (Clinical Trials) Regulations 2004, Schedule 1 Part 3.
156. There is empirical evidence relating to the benefits of decision-aids and written information in the consent process.
157. See R Barrett, 'Quality of Informed Consent: Measuring Understanding Among Participants in Oncology Clinical Trials' (2005) 32 Oncology Nursing Forum 751.
158. A Barratt and others, 'Use of Decision Aids to Support Informed Choices about Screening' (2004) 329 BMJ 507.
159. D Feldman-Stewart, 'A Decision Aid for Men with Early Stage Prostate Cancer: Theoretical Basis and a Test by Surrogate Patients' (2001) 4 Health Expectations 221.
160. M Schapira and J VanRuiswyk, 'The Effect of an Illustrated Pamphlet Decision-Aid on the Use of Prostate Cancer Screening Tests' (2000) 49 The Journal of Family Practice 418.
161. For evidence on the effectiveness of written information, see EM Taylor and others, 'Patients' Receipt and Understanding of Written Information about a Resuscitation Policy' (1998) 12 Bioethics 64.
162. Williams, above n 87 at 99.
163. A case search of both Westlaw and LexisNexis retuned no results in which delegation was a legal issue in negligent disclosure cases.
164. B Soin and others, 'Informed Consent: ACase for More Education of the Surgical Team' (1993) 75 Annals of the Royal College of Surgeons of England 62.
165. Jones, above n 3 at 125.
166. See Hatcher v Black. The Times, 2 July 1954.
167. Samanta et al. identified that the appellate courts have never been asked to make a definitive statement on the role of guidelines as standards for liability in clinical negligence. However, they appear to have been used to assess the appropriateness of doctors' conduct in the withholding or withdrawal of life sustaining treatment.
168. See Airedale NHS Trust v Bland [1993] 1 All ER 821.
169. Burke v GMC [2005] EWCA 103.
170. Equally, there is a paucity of evidence concerning the use of guidelines in defining the standard care in the courts of first instance.
171. See Re C (a minor) (medical treatment) [1998] Lloyd's Rep. Med. 1 in which the courts approved the guidance from the Royal College of Paediatrics and Child Health.
172. See also Early v Newham Health Authority (1994) 5 Med L Rev 214 (guidelines adopted provided evidence of a reasonable standard of anaesthesia).
173. DF v St George's Healthcare NHS Trust [2005] EWHC 1327 (guidelines from the Royal College of Gynaecologists and Obstetricians gave a clear indication that an instrumental delivery was not acceptable practice).
174. See also Thomson v James and others (1996) 31 BMLR 1.
175. Penney, Palmer and Cannon v East Kent Health Authority [2000] Lloyd's Rep Med 41.
176. For further discussion, see A Samanta and others, 'The Role of Clinical Guidelines in Medical Negligence Litigation: A Shift from the Bolam Standard' (2006) 14 Med L Rev 321.
177. In Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 it was stated by McNair J. at 587 that it was no defence for those who 'obstinately and pig-headedly carry on with some old technique'.
178. Heywood and others, above n 14.