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Volumn 47, Issue 4, 2011, Pages 353-362

Informed consent from cognitively impaired persons participating in research trials: Comparative law observations

Author keywords

Bioethics; Human research; Informed consent; Legislation; Mental disability

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); COGNITIVE DEFECT; EUROPEAN UNION; HARM REDUCTION; HUMAN; INFORMED CONSENT; ITALY; LEGAL ASPECT; RESEARCH ETHICS; RISK; STANDARD;

EID: 84555205770     PISSN: 00212571     EISSN: None     Source Type: Journal    
DOI: 10.4415/ANN_11_04_06     Document Type: Article
Times cited : (4)

References (62)
  • 1
    • 84555201602 scopus 로고    scopus 로고
    • Caring and giving hope to persons with progressive cognitive impairments. Fourth IACB Colloquium
    • International Association of Catholic Bioethicists, 12-16 July 2009
    • 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.
    • (2010) The National Castholic Bioethics Quarterly , vol.10 , Issue.3 , pp. 547-567
  • 2
    • 84922760497 scopus 로고    scopus 로고
    • Towards supported decision-making in biomedical research with cognitively vulnerable adults
    • Corrigan O, McMillan J, Liddell K, Richards M, Weijer C (Ed.), Oxford: Oxford University Press
    • 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.
    • (2009) The Limits of Consent. A Socio-Ethical Approach to Human Subject Research in Medicine , pp. 151-171
    • Bielby, P.1
  • 3
    • 0036400059 scopus 로고    scopus 로고
    • Informed consent: Myth or reality
    • Mozes T, Tyano S, Manor I, Mester R. Informed consent: myth or reality. Medicine and Law 2002;21(3):473-83. (Pubitemid 35173927)
    • (2002) Medicine and Law , vol.21 , Issue.3 , pp. 473-483
    • Mozes, T.1    Tyano, S.2    Manor, I.3    Mester, R.4
  • 5
  • 6
    • 79551602076 scopus 로고    scopus 로고
    • Informed consent in experimentation involving mentally impaired patients: Ethical issues
    • Petrini C. Informed consent in experimentation involving mentally impaired patients: ethical issues. Ann Ist Super Sanità 2010;46(4):411-21.
    • (2010) Ann Ist Super Sanità , vol.46 , Issue.4 , pp. 411-421
    • Petrini, C.1
  • 7
    • 78349258574 scopus 로고    scopus 로고
    • Research on cognitive impaired adults
    • Steinbock B (Ed.), Oxford: Oxford University Press
    • Karlawish, JHT. Research on cognitive impaired adults. In: Steinbock B (Ed.). The Oxford handbook of bioethics. Oxford: Oxford University Press; 2007. p. 597-620.
    • (2007) The Oxford Handbook of Bioethics , pp. 597-620
    • Karlawish, J.H.T.1
  • 8
    • 64749083558 scopus 로고    scopus 로고
    • 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.), Stuttgart: Franz Steiner Verlag
    • 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.
    • (2004) Twentieth Century Ethics of Human Subject Research. Historical Perspectives on Values, Practices, and Regulations , pp. 11-18
    • Roelke, V.1
  • 9
    • 0014019552 scopus 로고
    • Ethics and clinical research
    • Beecher H K. Ethics and clinical research. N Engl J Med 1966; 274 (24):1354-60.
    • (1966) N Engl J Med , vol.274 , Issue.24 , pp. 1354-1360
    • Beecher, H.K.1
  • 12
    • 41149112703 scopus 로고    scopus 로고
    • Source book in bioethics
    • Washington DC: Georgetown University Press
    • Jonsen AR, Veatch RM, LeRoy W. Source book in bioethics. A documentary history. Washington DC: Georgetown University Press; 1998.
    • (1998) A Documentary History
    • Jonsen, A.R.1    Veatch, R.M.2    LeRoy, W.3
  • 13
    • 0003713743 scopus 로고
    • The national commission for the protection of human subjects of biomedical and behavioral research
    • Washington, DC: US Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), Public Health Service (PHS), Human Health Service (HHS
    • 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.
    • (1979) Ethical Principles and Guidelines for the Protection of Human Subjects of Research (known as The Belmont Report)
  • 17
    • 51849154454 scopus 로고    scopus 로고
    • Ethics in mental health research
    • Oxford: Oxford University Press
    • DuBois JM. Ethics in mental health research. Principles, guidance and cases. Oxford: Oxford University Press; 2008.
    • (2008) Principles Guidance and Cases
    • DuBois, J.M.1
  • 18
    • 0031566681 scopus 로고    scopus 로고
    • Fifty years later: The significance of the nuremberg code
    • Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med 1997;337(20):1436-40. (Pubitemid 127777477)
    • (1997) New England Journal of Medicine , vol.337 , Issue.20 , pp. 1436-1440
    • Shuster, E.1
  • 20
    • 73449146663 scopus 로고    scopus 로고
    • Patient autonomy assessment of competence and surrogate decision-making: A call for reasonableness in deciding for others
    • 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.
    • (2010) Bioethics , vol.24 , Issue.2 , pp. 87-95
    • Bæroe, K.1
  • 24
    • 0346556128 scopus 로고    scopus 로고
    • Nonbeneficial research with individuals who cannot consent: Is it ethically better to enroll healthy or affected individuals?
    • 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.
    • (2003) IRB. A Review of Human Subjects Research , vol.25 , Issue.4 , pp. 1-4
    • Wendler, D.1    Sha, S.2    Whittle, A.3    Wildond, B.S.4
  • 26
    • 12544255791 scopus 로고    scopus 로고
    • Competence in mental health care: A hermeneutic perspective
    • Banaroyo L, Widdershoven GAM. Competence in mental health care: a hermeneutic perspective. Health Care Annal 2004;12(4):295-306.
    • (2004) Health Care Annal , vol.12 , Issue.4 , pp. 295-306
    • Banaroyo, L.1    Widdershoven, G.A.M.2
  • 27
    • 77949776753 scopus 로고    scopus 로고
    • United Nations Educational, Scientific and Cultural organization (UNESCO), Paris: UNESCO
    • 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.
    • (2008) Report of the International Bioethics Committee (IBC) on Consent
  • 29
    • 84868235165 scopus 로고    scopus 로고
    • Competency-based assessments in mental health practice
    • Hoboken New Jersey: John Wiley & Sons
    • Gray Susan W. Competency-based assessments in mental health practice. Cases and practical applications. Hoboken, New Jersey: John Wiley & Sons; 2011.
    • (2011) Cases and practical applications
    • Gray, S.W.1
  • 30
    • 0027571658 scopus 로고
    • Minor's assent, consent or dissent to medical research
    • Leikin S. Minor's assent, consent or dissent to medical research. IRB. A Review of Human Subjects Research 1993;15(2):1-7.
    • (1993) IRB. A Review of Human Subjects Research , vol.15 , Issue.2 , pp. 1-7
    • Leikin, S.1
  • 31
    • 0032210162 scopus 로고    scopus 로고
    • Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment
    • American Psychiatric Association
    • American Psychiatric Association. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. Am J Psychiatry 1998;155:1649-50.
    • (1998) Am J Psychiatry , vol.155 , pp. 1649-1650
  • 33
    • 35748974550 scopus 로고    scopus 로고
    • Assessment of patients' competence to consent to treatment
    • Appelbaum PS. Assessment of patients' competence to consent to treatment. New Engl J Med 2007;357:1834-40.
    • (2007) New Engl J Med , vol.357 , pp. 1834-1840
    • Appelbaum, P.S.1
  • 34
    • 31544450293 scopus 로고    scopus 로고
    • Protecting subjects who cannot give consent: Towards a better standard for "minimal risk"
    • Wendler T. Protecting subjects who cannot give consent: towards a better standard for "minimal risk". Hastings Cent Rep 2005;35(5):7-40.
    • (2005) Hastings Cent Rep , vol.35 , Issue.5 , pp. 7-40
    • Wendler, T.1
  • 37
    • 84858955216 scopus 로고    scopus 로고
    • Department of Health and Human Services, National institutes of Health, Office for Human Research Protections, June 23
    • 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.
    • (2005) The Common Rule. Title 45 (Code of Federal Regulations). Part 46 (Protection of Human Subjects)
  • 38
    • 0027569844 scopus 로고
    • In loco parentis: Minimal risk as an ethical threshold for research upon children
    • 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.
    • (1993) Hastings Centre Report , vol.23 , Issue.2 , pp. 13-19
    • Freedman, B.1    Fuks, A.2    Weijer, C.3
  • 39
    • 0034503543 scopus 로고    scopus 로고
    • Children as research subjects: A dilemma
    • Kopelman LM. Children as research subjects: A dilemma. J Med Philosophy 2000;25(6):745-64. (Pubitemid 32118526)
    • (2000) Journal of Medicine and Philosophy , vol.25 , Issue.6 , pp. 745-764
    • Kopelman, L.M.1
  • 40
    • 84860834222 scopus 로고    scopus 로고
    • The distinction between "clinical practice" and "research": The case of pituitary derived hormones and Creutzfeld Jakob disease
    • Weisstub DN. (Ed.), Kindlington: Pergamon - Elsevier Science Ltd
    • 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.
    • (1998) Research on Human Subjects. Ethics, Law and Social Policy , pp. 88-110
    • Allars, M.1
  • 41
    • 0020390058 scopus 로고
    • The therapeutic misconception: Informed consent in psychiatric research
    • Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5(3-4):319-29.
    • (1982) Int J Law Psychiatry , vol.5 , Issue.3-4 , pp. 319-329
    • Appelbaum, P.S.1    Roth, L.H.2    Lidz, C.3
  • 44
    • 84860836501 scopus 로고    scopus 로고
    • rd meeting of the Ministers' Deputies
    • 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, Council of Europe, Strasbourg: Council of Europe, Directorate General I, Legal Affairs, Bioethics Department
    • rd 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.
    • (2005) Texts of the Council on bioethical matters , vol.1 , pp. 25-28
  • 47
    • 0003177157 scopus 로고    scopus 로고
    • 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
    • European Parliament and Council of the European Union
    • 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.
    • (2001) Official Journal of the European Union , vol.121 L , pp. 34-44
  • 48
    • 34250622864 scopus 로고    scopus 로고
    • Facing up to paternalism in research ethics
    • Miller FG. Facing up to paternalism in research ethics. Hastings Cent Rep 2007;37(3):24-34.
    • (2007) Hastings Cent Rep , vol.37 , Issue.3 , pp. 24-34
    • Miller, F.G.1
  • 51
    • 0022814675 scopus 로고
    • The conflict between randomized clinical trial and the therapeutic obligation
    • Gifford F. The conflict between randomized clinical trial and the therapeutic obligation. J Med Phil 1986;11(4):347-66.
    • (1986) J Med Phil , vol.11 , Issue.4 , pp. 347-366
    • Gifford, F.1
  • 52
  • 54
    • 0011897547 scopus 로고    scopus 로고
    • World Health Organization
    • World Health Organization. Mental and neurological disorders. 2001. who.int/mediacentre/factsheets/fs265/en/
    • (2001) Mental and Neurological Disorders
  • 55
    • 84860833927 scopus 로고    scopus 로고
    • Président de la République Française
    • 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.
    • (2008) Plan Alzheimer et Maladies Apparentées 2008-2012
  • 56
    • 84860833809 scopus 로고    scopus 로고
    • Commission Nationale Chargée de l'Élaboration de Propositions pour un Plan National Concernant la Maladie d'Alzheimer et les Maladies Apparentées. Ménard J (Ed.), Remis le 8 novembre 2007
    • 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.
    • (2007) Pour le Malade et Ses Proches. Chercher, Soigner et Prendre Soin. Rapport au Président de la République
  • 58
    • 84860840524 scopus 로고    scopus 로고
    • Research Mental Health, 14 October 2009
    • 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.
    • Mental health research in the UK. The London Declaration 2009
  • 59
    • 0242363748 scopus 로고    scopus 로고
    • Ethical perspective on decision-making capacity and consent for treatment and research
    • Berghmans RLP, Widdershoven GAM. Ethical perspectives on decision-making capacity for treatment and research. Medicine and Law 2003;22(3):391-400. (Pubitemid 37351047)
    • (2003) Medicine and Law , vol.22 , Issue.3 , pp. 391-400
    • Berghmans, R.L.P.1    Widdershoven, G.A.M.2
  • 60
    • 67049120618 scopus 로고    scopus 로고
    • Informed consent and clinical research in psychiatry
    • Doyal L, Tobias J (Ed.), London: BMJ books
    • 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.
    • (2001) Informed Consent in Medical Research , pp. 182-192
    • Fennell, P.1
  • 61
    • 51349142915 scopus 로고    scopus 로고
    • Informed consent, medical research and the competent adult
    • Doyal L, Tobias J (Eds.), London: BMJ books
    • 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.
    • (2001) Informed Consent in Medical Research , pp. 166-172
    • McLean, S.A.M.1
  • 62
    • 84860837348 scopus 로고    scopus 로고
    • Alzheimer's Society
    • Alzheimer's Society. Volunteering for research into dementia. Available from: www.alzheimers.org.uk/after-dagnosis/PDF/409-volunteeringforresearch.pdf.
    • Volunteering for research into dementia


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.