SciELO - Scientific Electronic Library Online

SciELO - Scientific Electronic Library Online

Article References

PETRINI, Carlo. Informed consent from cognitively impaired persons participating in research trials: comparative law observations. Ann. Ist. Super. Sanità [online]. 2011, vol.47, n.4, pp. 353-362. ISSN 0021-2571.  http://dx.doi.org/10.4415/ANN_11_04_06.

    1. International Association of Catholic Bioethicists. Caring and giving hope to persons with progressive cognitive impairments. Fourth IACB Colloquium. 12-16 July 2009. The National Castholic Bioethics Quarterly 2010;10(3):547-67. [ Links ]

    2. Bielby, P. Towards supported decision-making in biomedical research with cognitively vulnerable adults. In: Corrigan O, McMillan J, Liddell K, Richards M, Weijer C (Ed.). The limits of consent. A socio-ethical approach to human subject research in medicine. Oxford: Oxford University Press; 2009. p. 151-71. [ Links ]

    3. Mozes T, Tyano S, Manor I, Mester R. Informed consent: myth or reality. Medicine and Law 2002;21(3):473-83. [ Links ]

    4. Manson NC, O'Neill N. Rethinking informed consent. Cambridge: Cambridge University Press; 2007. [ Links ]

    5. Katz J. Informed consent. Must it remain a fairy tale? Journal of Contemporary Health Law and Policy 2009;10(1):69-91. [ Links ]

    6. Petrini C. Informed consent in experimentation involving mentally impaired patients: ethical issues. Ann Ist Super Sanità 2010;46(4):411-21. [ Links ]

    7. Karlawish, JHT. Research on cognitive impaired adults. In: Steinbock B (Ed.). The Oxford handbook of bioethics. Oxford: Oxford University Press; 2007. p. 597-620. [ Links ]

    8. Roelke, V. Historical perspectives on human subjects research during the 20th century, and some implications for present day issues in bioethics. In: Roelke V, Maio G (Ed.). Twentieth century ethics of human subject research. Historical perspectives on values, practices, and regulations. Stuttgart: Franz Steiner Verlag; 2004. p. 11-8. [ Links ]

    9. Beecher H K. Ethics and clinical research. N Engl J Med 1966; 274 (24):1354-60. [ Links ]

    10. Lenoir N, Mathieu B. Les normes internationales de la bioéthique. Paris: Presses Universitaires de France (PUF); 2004. [ Links ]

    11. Nuremberg Military Tribunal. Permissible medical experiment (known as The Nuremberg Code). In: Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law no. 10. Nuremberg, October 1946 – April 1949. Washington, DC: Government Printing Office; 1949-1953. Vol. 2. p. 181-2. [ Links ]

    12. Jonsen AR, Veatch RM, LeRoy W. Source book in bioethics. A documentary history. Washington DC: Georgetown University Press; 1998. [ Links ]

    13. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Ethical principles and guidelines for the protection of human subjects of research (known as The Belmont Report). Washington, DC: US Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), Public Health Service (PHS), Human Health Service (HHS); 1979. [ Links ]

    14. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. 2002. Available from: www.cioms.ch/publications/layout_guide2002.pdf. [ Links ]

    15. World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. 1964-2008. Available from: www.wma.net/en/30publications/10policies/b3/ 17c.pdf. [ Links ]

    16. Benasayag M, Comte-Sponville A, Farhi D, Huriet C, Khayat D, Ternon Y. De Nuremberg à la loi Huriet. Essais thérapeutiques et recherche médicale. Paris: Ellipses; 2001. [ Links ]

    17. DuBois JM. Ethics in mental health research. Principles, guidance and cases. Oxford: Oxford University Press; 2008. [ Links ]

    18. Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med 1997;337(20):1436-40. [ Links ]

    19. Buchanan AE, Brock DW. Deciding for the others. The ethics of surrogate decision making. Cambridge: Cambridge University Press; 1990. [ Links ]

    20. Bæroe K. Patient autonomy, assessment of competence and surrogate decision-making: a call for reasonableness in deciding for others. Bioethics 2010;24:(2):87-95. [ Links ]

    21. Atkinson JM. Advance directives in mental health. London: Jessica Kingley Publisher; 2007. [ Links ]

    22. Cantor NL. Making medical decisions for the profoundly mentally disabled. Cambridge, MA: The Massachusetts Institute of Technology (MIT) Press; 2009. [ Links ]

    23. The National Bioethics Advisory Commission. Research involving persons with mental disorders that may affect decisionmaking capacity. NBAC; 1998. Available from: http://bioethics.georgetown.edu/nbac/capacity/toc.htm. [ Links ]

    24. Wendler D, Sha S, Whittle A, Wildond BS. Nonbeneficial research with individuals who cannot consent: Is it ethically better to enroll healthy or affected individuals? IRB. A Review of Human Subjects Research 2003;25(4):1-4. [ Links ]

    25. Nys H, Welie S, Garanis-Papadatos T, Ploumpidis D. Patient capacity in mental health care: legal overview. Health Care Anal 2004;12(4):329-37. [ Links ]

    26. Banaroyo L, Widdershoven GAM. Competence in mental health care: a hermeneutic perspective. Health Care Annal 2004;12(4):295-306. [ Links ]

    27. United Nations Educational, Scientific and Cultural Organization (UNESCO). Report of the International Bioethics Committee (IBC) on consent. Paris: UNESCO; 2008. Available from: unesdoc.unesco.org/images/0017/001781/178124E.pdf. [ Links ]

    28. Levine, ML. Introduction. In: Levin ML (Ed.). Mental illness, medicine and the law. Farnham: Ashgate; 2009. p. xvii-xxix. [ Links ]

    29. Gray Susan W. Competency-based assessments in mental health practice. Cases and practical applications. Hoboken, New Jersey: John Wiley & Sons; 2011. [ Links ]

    30. Leikin S. Minor's assent, consent or dissent to medical research. IRB. A Review of Human Subjects Research 1993;15(2):1-7. [ Links ]

    31. American Psychiatric Association. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. Am J Psychiatry 1998;155:1649-50. [ Links ]

    32. Grisso T, Appelbaum PS. Assessing competence to consent to treatment. A guide for physicians and other health professionals. New York and Oxford: Oxford University Press; 1998. [ Links ]

    33. Appelbaum PS. Assessment of patients' competence to consent to treatment. New Engl J Med 2007;357:1834-40. [ Links ]

    34. Wendler T. Protecting subjects who cannot give consent: towards a better standard for "minimal risk". Hastings Cent Rep 2005;35(5):7-40. [ Links ]

    35. Council of Europe. Additional protocol on the Convention on Human Rights and Biomedicine concerning Biomedical Research. Strasbourg: Council of Europe; 2005. Available from: conventions.coe.int/treaty/en/treaties/html/195.htm. [ Links ]

    36. Council of Europe. Convention for the protection of human rights and dignity of human being with regards to the application of biology and medicine: Convention on human rights and biomedicine. Oviedo, 4 April 1997. Available from: conventions.coe.int/treaty/en/treaties/html/164.htm. [ Links ]

    37. Department of Health and Human Services, National Institutes of Health, Office for Human Research Protections. The Common Rule. Title 45 (Code of Federal Regulations). Part 46 (Protection of Human Subjects). June 23, 2005. Available from: www.hhs.gov/ohrp/humsnsubjects/guidance/45cfr46.htm. [ Links ]

    38. Freedman B, Fuks A, Weijer C. In loco parentis: Minimal risk as an ethical threshold for research upon children. Hastings Centre Report 1993;23(2):13-9. [ Links ]

    39. Kopelman LM. Children as research subjects: A dilemma. J Med Philosophy 2000;25(6):745-64. [ Links ]

    40. Allars, M. The distinction between "clinical practice" and "research": the case of pituitary derived hormones and Creutzfeld-Jakob disease. In: Weisstub DN. (Ed.). Research on human subjects. Ethics, law and social policy. Kindlington: Pergamon -Elsevier Science Ltd; 1998. p. 88-110. [ Links ]

    41. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5(3-4):319-29. [ Links ]

    42. Council of Europe. Recommendation Rec(99)4 of the Committee of Ministers to member states on the legal protection of incapable adults. 23 February 1999. Available from: www.coe.int/t/dg3/healthbioethic/texts_and_documents/Rec(99)4E.pdf [ Links ]

    43. Council of Europe. Committee of Ministers. Recommendation n. R(90) 3 of the Committee of Ministers to member States concerning medical research on human beings. Adopted by the Committee of Ministers on 6 February 1990 at the 433rd meeting of the Ministers' Deputies. In: Council of Europe. Texts of the Council on bioethical matters. Strasbourg: Council of Europe, Directorate General I, Legal Affairs, Bioethics Department; 2005. Vol. 1. p. 25-8. [ Links ]

    44. Council of Europe. "White paper" on the protection of the human rights and dignity of people suffering from mental disorder, especially those placed as involuntary patients in a psychiatric establishment. DIR/JUR (2000) 2. 3 January 2000. Available from: www.coe.int/t/dg3/healthbioethic/activities/08_psychiatry_and_human_rights_en/dir-jur(2000)2whitepaper.pdf. [ Links ]

    45. Council of Europe. Recommendation Rec(2004)10 of the Committee of Ministers to member states concerning the protection of human rights and the dignity of persons with mental disorders and its explanatory memorandum. Adopted by the Committee of Ministers on 22 September 2004 at the 896th meeting of the Ministers' Deputies. Available from: www.coe.int/t/dg3/healthbioethic/activities/08_psychiatry_and_human_rights_en/Rec(2004)10e.pdf. [ Links ]

    46. European Parliament and Council of the European Union. 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 Union 2001;L 121:34-44. [ Links ]

    47. Miller FG. Facing up to paternalism in research ethics. Hastings Cent Rep 2007;37(3):24-34. [ Links ]

    48. Council of Europe. Convention for the protection of Human Rights and dignity of human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine (ETS n. 164). Explanatory report. 1996. Available from: http://conventions.coe.int/Treaty/EN/Treaties/html/164.htm. [ Links ]

    49. European Medicines Agency. ICH topic E6. Note for guidance on Good Clinical Practice. CPMP/ICH/135/95. 2002. Available from: www.eortc.be/Services/Doc/ICH_GCP.pdf. [ Links ]

    50. Gifford F. The conflict between randomized clinical trial and the therapeutic obligation. J Med Phil 1986;11(4):347-66. [ Links ]

    51. World Health Organization. Neurological disorder public health challenges. Geneva: WHO Press; 2006. p. 232 [ Links ]

    52. Ferri CP, Prince M, Brayne C, Brodaty H, Fratiglioni L, Ganguli M, Hall K, Hasegawa K, Hendrie H, Huang Y, Jorm A, Mathers C, Menezes PR, Rimmer E, Scazufca M. Global prevalence of dementia: a Deplhi consensus study. Lancet 2005;366(9503):2112-7. [ Links ]

    53. World Health Organization. Mental and neurological disorders. 2001. who.int/mediacentre/factsheets/fs265/en/. [ Links ]

    54. Président de la République Française. Plan Alzheimer et maladies apparentées 2008-2012. 2008. Available from: www.ile-defrance.sante.gouv.fr/img/pdf/plan_alzheimer_2008-2012.pdf. [ Links ]

    55. Commission Nationale Chargée de l'Élaboration de Propositions pour un Plan National Concernant la Maladie d'Alzheimer et les Maladies Apparentées. Ménard J (Ed.). Pour le malade et ses proches. Chercher, soigner et prendre soin. Rapport au Président de la République. Remis le 8 novembre 2007. 2007. Available from: www.ladocumentationfrancaise.fr/rapports-publics/074000711/index.shtml?xtor=rss-436. [ Links ]

    56. Department of Health (United Kingdom). No health without mental health: a cross-Government mental health outcomes strategy for people of all ages. 2011. Available from: www.dh.gov.uk/en/healthcare/mentalhealth/mentalhealthstrategy/index.htm. [ Links ]

    57. Research Mental Health. Mental health research in the UK. The London Declaration 2009. 14 October 2009. Available from: www.researchmentalhealth.org.uk/media/common/uploads/mental_health_research_declaration.pdf. [ Links ]

    58. Berghmans RLP, Widdershoven GAM. Ethical perspectives on decision-making capacity for treatment and research. Medicine and Law 2003;22(3):391-400. [ Links ]

    59. Fennell, P. Informed consent and clinical research in psychiatry. In: Doyal L, Tobias J (Ed.). Informed consent in medical research. London: BMJ books; 2001. p. 182-92. [ Links ]

    60. McLean SAM. Informed consent, medical research and the competent adult. In: Doyal L, Tobias J (Eds.). Informed consent in medical research. London: BMJ books; 2001. p. 166-72. [ Links ]

    61. Alzheimer's Society. Volunteering for research into dementia. 2005. Available from: www.alzheimers.org.uk/after_dagnosis/PDF/409_volunteeringforresearch.pdf. [ Links ]