Medical research on patients with dementia - The role of advance directives in European legal instruments

European Journal of Health Law

Volumn 13, Issue 3, 2006, Pages 235-261

  Lötjönen, Salla ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICINE; DEMENTIA; HUMAN; HUMAN RIGHTS; INTERNATIONAL COOPERATION; LAW; LEGAL ASPECT; LIVING WILL; MEDICAL RESEARCH; PATIENT CARE; PATIENT DECISION MAKING; REVIEW;

ADVANCE DIRECTIVES; CLINICAL TRIALS; DEMENTIA; DOUBLE EFFECT; EPIDEMIOLOGIC STUDIES; EUROPE; FINLAND; GREAT BRITAIN; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PATIENT ADVOCACY; PATIENT RIGHTS; PATIENT SELECTION; PERSONAL AUTONOMY; PHILOSOPHY, MEDICAL; RESEARCH SUBJECTS;

EID: 33751558571     PISSN: 09290273     EISSN: None     Source Type: Journal    
DOI: 10.1163/157180906778852394     Document Type: Review

References (78)

1. Ferri, C.P., Prince, M., Brayne, C., Brodaty, H., Fratiglioni, L., Ganguli, M., Hall, K., Hasegawa, K., Hendrie, H., Huang, Y., Jorm, A., Mathers, C., Menezes, P.R., Rimmer, E., Scazufca, M., 'Global prevalence of dementia: a Delphi consensus study', Lancet 366 (2005), 2112-2117.
2. For the prevalence of dementia according to age and estimates on the number of patients in the future, see the article by S. Gevers and its references in this issue.
3. nd ed., Oxford, Elsevier Science BV, 2001), pp. 259-273.
4. nd ed., Oxford, Elsevier Science BV, 2001), pp. 193-215,
5. and P.F. Reyes 'Biomedical Research in Alzheimer Disease' in: Purtilo, ten Have (eds.), Ethical Foundations of Palliative Care for Alzheimer Disease (Baltimore, The Johns Hopkins University Press, 2004), pp. 311-319.
6. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Official Journal of the European Communities, L 121/34, 1 May 2001, Article 2(a).
7. P.F. Reyes 'Biomedical Research in Alzheimer Disease' in: Purtilo, ten Have (eds.), Ethical Foundations of Palliative Care for Alzheimer Disease (Baltimore, The Johns Hopkins University Press, 2004), p. 313.
8. See, for example, Article 17.2 of the Council of Europe Convention on Human Rights and Biomedicine. Strasbourg, 4 April 1997, European Treaty Series 164.
9. See also, for example, Roscam Abbing, H.D.C., 'Medical Research Involving Incapacitated Persons: What Are the Standards', European Journal of Health Law 1 (1994), 147-160, and
10. Lötjönen, S., 'Regulation of Clinical Medical Research on the Decisionally Impaired Adults in Europe', Oikeustiede - Jurisprudentia 26 (2003), 351-420.
11. Article 17 of the Council of Europe Convention on Human Rights and Biomedicine, and Article 5 of the Directive 2001/20/EC.
12. See, for example, Gunn, M.J., Wong, J.G., Clare, I.C.H., Holland, A.J., 'Decision-Making Capacity' Medical Law Review 7 (1999), 269.
13. A thorough critique of this practice has been written by Bielby, P., 'The conflation of competence and capacity in English medical law: A philosophical critique', Medicine, Health Care and Philosophy 8 (2005), 357-369.
14. See also Lötjönen, S., 'Regulation of clinical medical research on the decisionally impaired adults in Europe', Oikeustiede - Jurisprudentia 36 (2003), 357-358.
15. Notice that in the US, these two concepts are used in an entirely opposite way: 'capacity' is used to describe the psychological ability and 'competence' is used to describe the legal relevance given to capacity. See, for example, Berg, J.W., Appelbaum, P.S., Grisso, T., 'Constructing Competence: Formulating Standards of Legal Competence to Make Medical Decisions', Rutgers Law Review 48, No. 2 (1996), 348-349.
16. See Welie, J.V.M., Welie, S.P.K., 'Patient decision making competence: Outlines of a conceptual analysis', Medicine, Health Care and Philosophy 4 (2001), 127-138.
17. See also a multi-faceted analysis of competence and capacity in English law, S. Pattinson, Medical law and ethics, (London, Sweet & Maxwell, 2006), pp. 129-141.
18. Council of Europe Committee of Ministers Recommendation No. R (99) 4 on principles concerning the legal protection of incapable adults, Principle 2.
19. B. Reisberg, E. Franssen, M.A. Shah, J. Weigel, M. Bobinski, H.M. Wisniewski 'Clinical Diagnosis of Dementia: A Review' in: Maj, Sartorius (eds.), Dementia (Chichester, John Wiley & Sons, 2000), pp. 95-97.
20. Brodaty, H., Dresser, R., Eisner, M., Erkinjuntti, I., Gauthier, S., Graham, N., Jonker, C., Sachs, G., Whitehouse, P., 'Alzheimer's Disease International and International Working Group for Harmonization of Dementia Drug Guidelines for Research Involving Human Subjects with Dementia', Alzheimer Disease and Related Disorders 13, No. 2 (1999), 73.
21. See also, Feinberg, L.F., Whitlatch, C.J., 'Are Persons With Cognitive Impairment Able to State Consistent Choices?', The Gerontologist 41, No. 3 (2001), 374-382.
22. The capacity threshold can also depend on the method of how the information has been presented to the elderly population. If the information is presented in an easily understandable form and repeated in certain intervals, the involvement of the potential participant can be considerably more autonomous than by using the standard information sheets designed for entirely cognitively unimpaired adults. However, if the patient has been clearly diagnosed as suffering from dementia, the method of information disclosure does not seem to bear relevance. See, for example, Tymchuck, A. J., Ouslander, J.G., Rader, N., 'Informing the Elderly - A Comparison of Four Methods', Journal of the American Geriatric Society 34 (1986), 818-822,
23. Gunn, M.J., Wong, J.G., Clare, I.C.H., Holland, A.J., 'Decision-Making Capacity' Medical Law Review 7 (1999), 269-306.
24. Convention on Human Rights and Biomedicine, Article 17.1(iii).
25. See also, World Medical Association, Declaration of Helsinki (2000), Paragraph 24. Also the EC Directive on clinical trials (2001/20/EC) refers to 'essential validation' of results obtained in earlier trials with competent adults or by other research methods as a precondition (Article 5(e)). As earlier trials with competent adults are not the sole precondition for trials on incapacitated adults, the question arises whether the Directive leaves room for research on adults who lack capacity to take place directly after e.g. studies on animal models. This could only happen, however, in exceptional circumstances, where the expected benefit outweighs the risk or where there is no risk involved (Article 5(i)). See also Recitals 3 and 4 of the same Directive, which convey a restrictive attitude towards clinical trials on incapacitated adults compared to pediatric trials.
26. Advance directives are defined here as 'written, signed and dated expressions of the patient's wishes concerning future health care decisions when the patient has lost capacity'. For the present purposes, they do not need to fulfil any other formal criteria (such as registration or witnesses). Advance directives can relate to either nominating a particular person(s) to make the decisions on behalf of the patient, or give instructions on the nature of care that the patient wishes to receive or refuse. This paper focuses on advance directives of the latter kind, the instructive advance directives. See, for example, Gevers, S., 'Advance directives in Psychiatry', European Journal of Health Law 9 (2002), 20.
27. http://www.alzheimer-europe.org/ (accessed 15 August 2006).
28. Berghmans, R.L.P., 'Advance directives for non-therapeutic dementia research: some ethical and policy considerations', Journal of Medical Ethics 24 (1998), 33-34.
29. See, for example, Nys, H., 'Emerging legislation in Europe on the legal status of advance directives and medical decision-making with respect to an incompetent patient ('living wills')', European Journal of Health Law 5 (1997), 179-188,
30. Berghmans, R.L.P., 'Advance directives for non-therapeutic dementia research: some ethical and policy considerations' Journal of Medical Ethics 24 (1998), 32-37,
31. Vollman, J., 'Advance directives in patients with Alzheimer's disease', Medicine, Health Care and Philosophy 4 (2001), 161-167,
32. Welie, J.V.M., 'Living wills and substituted judgments: A critical analysis' Medicine, Health Care and Philosophy 4 (2001),169-183.
33. The question of personhood with regard to dementia patients is best illustrated in the works of Derek Parfit (D. Parfit, Reasons and persons (Oxford, Oxford University Press, 1984))
34. and Ronald Dworkin (R. Dworkin, Life's dominion: an argument about abortion and euthanasia (London, Harper Collins, 1993)).
35. Their views are eloquently compared by e.g. Berghmans, R.L.P., 'Advance directives for non-therapeutic dementia research: some ethical and policy considerations' Journal of Medical Ethics 24 (1998), 32-37,
36. Holm, S. 'Autonomy, authenticity, or best interest: Everyday decision-making and persons with dementia' Medicine, Health Care and Philosophy 4 (2001), 153-159,
37. and Hughes, J.C. 'Views of the person with dementia' Journal of Medical Ethics 27 (2001), 86-91.
38. Council of Europe, Convention on Human Rights and Biomedicine. European Treaty Series No. 164, Strasbourg, 4 April 1997.
39. Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, European Treaty Series No. 195, Strasbourg, 25 January 2005.
40. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Official Journal of the European Communities, L 121/34, 1 May 2001.
41. Italics added by the author.
42. See paragraph 62 of the Explanatory Report to the CHRB. Paragraph 85 of the Explanatory report to the Additional Protocol on Biomedical research confirms this position and specifically mentions advance directives as one possible way of clarifying a person's wishes.
43. This is referred to as the Locke-Parfit view of personhood in Hughes, J.C., 'Views of the person with dementia' Journal of Medical Ethics 27 (2001), 86-91.
44. The separateness of persons is only recognised in law with regard to health care decisions, as the financial arrangements that the patient has made prior to the onset of incapacity (e.g. in a will) are still valid.
45. See Holm, S. 'Autonomy, authenticity, or best interest: Everyday decision-making and persons with dementia' Medicine, Health Care and Philosophy 4 (2001), 157, although Holm seems to adopt a compromise position himself.
46. Italics added by the author.
47. For an account of these safeguards, see Lötjönen, S., 'Regulation of clinical medical research on the decisionally impaired adults in Europe', Oikeustiede - Jurisprudentia 36 (2003), 351-420.
48. Article 13 of the Additional Protocol provides a list of information provided to the subject before asking for consent for participation. The list includes, for example, information about the ethics committee approval, practical arrangements concerning the procedures, possible adverse events, confidentiality, availability of research results, details of compensation, use of biological materials after the project and the source of funding for the project.
49. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm (accessed 15 August 2006).
50. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal of the European Union L 91/13, 9 April 2005.
51. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-3/pdfs-en/ 3cc1aen.pdf, (accessed 15 August 2006). The alternative reference to the guidelines is ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95.
52. Principle 22 of the Helsinki Declaration. World Medical Association Declaration of Helsinki, 'Ethical Principles for Medical Research Involving Human Subjects', First adopted in 1964 (amended 1975, 1983, 1989, 1996 and 2000), http://www.wma.net/e/policy/b3.htm, (accessed 15 August 2006). The legal status of the Declaration remains unclear, as the 1996 version of the Declaration is only mentioned in the Recitals of the Directive as an example of an accepted basis for the conduct of clinical trials in humans (Recital 2).
53. Dworkin, R., 'Autonomy and the Demented Self', Milbank Quarterly 64, Supplement 2, (1986), 13.
54. Dworkin, R., 'Autonomy and the Demented Self', Milbank Quarterly 64, Supplement 2, (1986), 5.
55. For narrative perspectives (or situated-embodied-agent views), see Widdershoven, G., Berghmans, R., 'Advance directives in psychiatric care: a narrative approach' Journal of Medical Ethics 27 (2001), 92-97
56. and Hughes, J.C. 'Views of the person with dementia' Journal of Medical Ethics 27 (2001), 86-91.
57. Vollman, J., 'Advance directives in patients with Alzheimer's disease', Medicine, Health Care and Philosophy 4 (2001), 161-167.
58. Article 2(j) and 3.2(a)-(b) and (e).
59. Medical Research Act (9 April 1999/488).
60. Act on the Status and Rights of Patients (17 August 1992/785), s.8 (urgent treatment). Cf. s.6.3, according to which the legal representative only has to take into account the previously expressed wishes of the patient. On the status of advance directives in Finland, see also A. Mäki-Petäjä- Leinonen, Dementoituvan henkilön oikeudellinen asema (Helsinki, Suomalainen Lakimiesyhdistys, 2003)
61. and I. Pahlman, Potilaan itsemääräämisoikeus (Helsinki, Edita Publishing Oy, 2003).
62. Statutory Instrument 2004 No. 1031.
63. nd ed., 2005).
64. As to the application of the common law test of best interests to medical research on incompetent adults under English common law, see Lewis, P., 'Procedures that are Against the Medical Interests of the Incompetent Adults', Oxford Journal of Legal Studies 22, No. 4 (2002), 575-618.
65. The Mental Capacity Act 2005 only applies in the territories of England, Wales and Northern Ireland. In Scotland, the Adults with Incapacity (Scotland) Act 2000 is applied instead.
66. Council of Europe, Convention on Human Rights and Fundamental Freedoms, European Treaty Series No. 5, Rome, 4 November 1950. On the interplay between the ECHR and the CHRB, see Glass v. United Kingdom (Application 61827/00, 9 March 2004),
67. and A. Plomer, The Law and Ethics of Medical Research: International Bioethics and Human Rights (London, Cavendish Publishing, 2005), p. 18-21.
68. Guidelines for researchers on information sheets and consent forms, version 2.0, 22 November 2005 http://www.corec.org.uk/applicants/help/guidance. htm#consent, (accessed 15 August.2006).
69. See also, COREC information paper on informed consent in clinical trials of investigational medicinal products version 1.1, 26 September 2005 http://www.corec.org.uk/applicants/help/guidance.htm#consent, (accessed 15 August 2006).
70. Guidelines for researchers on information sheets and consent forms, p. 3.
71. A remark could be made of the UK decision to allow both personal and professional proxies to act as legal representatives for the patient, but due to the restrictions of this Article, that point cannot be explored here further. See, however, S. Pattinson, Medical law and ethics, (London, Sweet & Maxwell, 2006), p. 374
72. and a more critical account by Lötjönen, S., 'Regulation of Clinical Medical Research on the Decisionally Impaired Adults in Europe', Oikeustiede - Jurisprudentia 26 (2003), 382-383.
73. Department of Health, Consultation on Regulations to be made under the Mental Capacity Act 2005, June 2006 http://www.dh.gov.uk/assetRoot/04/13/60/49/ 04136049.pdf (accessed 15 August 2006).
74. Harris, J., 'Scientific research is a moral duty', Journal of Medical Ethics 31 (2005), 242-248.
75. Alzheimer Europe, Position paper No. 3/2001, Advance Directive (living will) http://www.alzheimer-europe.org/upload/SPTUNFUYGGOM/downloads/ 7109E4619FA4.pdf, (accessed 15 August 2006).
76. See, Alzheimer Europe, 'Advance directives - a position paper 6/2005' http://www. alzheimer-europe.org/upload/SPTUNFUYGGOM/downloads/7939D9FD4CEE.pdf (accessed 15 August 2006),
77. Alzheimer Europe 'Position paper on Research with people with dementia' http://www.alzheimer-europe.org/?lm2=225A8956AC31 (accessed 15 August 2006),
78. and the Alzheimer's Association 'Ethical Issues in Dementia Research (with special emphasis on "informed consent") http://www.alz.org/ Advocacy/downloads/statements_ethicalissues.pdf (accessed 15 August 2006).