메뉴 건너뛰기




Volumn 23, Issue 2, 2016, Pages 158-173

Integrating advance research directives into the European Legal Framework

Author keywords

Advance directives; Clinical trials; Consent; Council of Europe; Dementia research; European Union

Indexed keywords

CLINICAL TRIAL (TOPIC); DEMENTIA; EUROPEAN UNION; HUMAN; INFORMED CONSENT; LEGISLATION AND JURISPRUDENCE; LIVING WILL; RESEARCH SUBJECT;

EID: 84975226337     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/15718093-12341380     Document Type: Article
Times cited : (20)

References (47)
  • 1
    • 70249111199 scopus 로고    scopus 로고
    • Advance health care directives. Towards a coordinated European policy?
    • See R. Andorno, N. Biller-Andorno and S. Brauer, 'Advance Health Care Directives. Towards a Coordinated European Policy?', European Journal of Health Law 16(3) (2009) 207-227
    • (2009) European Journal of Health Law , vol.16 , Issue.3 , pp. 207-227
    • Andorno, R.1    Biller-Andorno, N.2    Brauer, S.3
  • 3
    • 84858391623 scopus 로고    scopus 로고
    • Advance directives as an instrument in an ageing Europe
    • T. Goffin, 'Advance Directives as an Instrument in an Ageing Europe', European Journal of Health Law 19(2) (2012) 121-140
    • (2012) European Journal of Health Law , vol.19 , Issue.2 , pp. 121-140
    • Goffin, T.1
  • 4
    • 84941028316 scopus 로고    scopus 로고
    • Advance directives in some Western European countries: A legal and ethical comparison between Spain, France, England, and Germany
    • D. Veshi and G. Neitzke, 'Advance Directives in Some Western European Countries: A Legal and Ethical Comparison between Spain, France, England, and Germany', European Journal of Health Law 22(4) (2015) 321-345.
    • (2015) European Journal of Health Law , vol.22 , Issue.4 , pp. 321-345
    • Veshi, D.1    Neitzke, G.2
  • 5
    • 33751558571 scopus 로고    scopus 로고
    • Medical research on patients with dementia: The role of advance directives in European legal instruments
    • See S. Lötjönen, 'Medical research on patients with dementia: the role of advance directives in European legal instruments', European Journal of Health Law 13(3) (2006) 235-261
    • (2006) European Journal of Health Law , vol.13 , Issue.3 , pp. 235-261
    • Lötjönen, S.1
  • 6
    • 74749088366 scopus 로고    scopus 로고
    • A changing landscape for advance directives in dementia research
    • R. Pierce, 'A changing landscape for advance directives in dementia research', Social Sciences and Medicine 70 (2010) 623-630
    • (2010) Social Sciences and Medicine , vol.70 , pp. 623-630
    • Pierce, R.1
  • 8
    • 84938544976 scopus 로고    scopus 로고
    • Advance directives in dementia research: The opinions and arguments of clinical researchers - An empirical study
    • published online 8 August 2014
    • K. Jongsma and S. van de Vathorst, 'Advance directives in dementia research: The opinions and arguments of clinical researchers - an empirical study', Research Ethics (2014), published online 8 August 2014: doi: 10.1177/1747016114523422.
    • (2014) Research Ethics
    • Jongsma, K.1    Van De Vathorst, S.2
  • 9
    • 84976429249 scopus 로고    scopus 로고
    • para. 31 retrieved 14 July 2015
    • Alzheimer Europe, Position paper on the use of advance directives (2009), para. 31, online at www.alzheimer-europe.org/Policy-in-Practice2/Our-opinion-on/Advance-directives, retrieved 14 July 2015.
    • (2009) Position Paper on the use of Advance Directives
  • 13
    • 84860740486 scopus 로고    scopus 로고
    • Using data to improve surrogate consent for clinical research with incapacitated adults
    • E. Abdoler and D. Wendler, 'Using data to improve surrogate consent for clinical research with incapacitated adults', Journal of Empirical Research on Human Research Ethics 7(2)(2012) 37-50.
    • (2012) Journal of Empirical Research on Human Research Ethics , vol.7 , Issue.2 , pp. 37-50
    • Abdoler, E.1    Wendler, D.2
  • 14
    • 0029401240 scopus 로고
    • Dworkin on dementia: Elegant theory, questionable policy
    • See for instance R. Dresser, 'Dworkin on Dementia: Elegant Theory, Questionable Policy', Hastings Center Report 25(6) (1995) 32-38.
    • (1995) Hastings Center Report , vol.25 , Issue.6 , pp. 32-38
    • Dresser, R.1
  • 18
    • 0029954452 scopus 로고    scopus 로고
    • Advance directives for research: Ethical problems and responses
    • at 107
    • A. Moorehouse and D. Weisstub, 'Advance directives for research: ethical problems and responses', International Journal of Law and Psychiatry 19(2) (1996) 107-141, at 107
    • (1996) International Journal of Law and Psychiatry , vol.19 , Issue.2 , pp. 107-141
    • Moorehouse, A.1    Weisstub, D.2
  • 19
    • 0043073259 scopus 로고    scopus 로고
    • Anticipatory planning for research participants with psychotic disorders like schizophrenia
    • P. Backlar, 'Anticipatory planning for research participants with psychotic disorders like Schizophrenia', Psychology, Public Policy, and Law 4(3) (1998) 829-853.
    • (1998) Psychology, Public Policy, and Law , vol.4 , Issue.3 , pp. 829-853
    • Backlar, P.1
  • 21
    • 84976436216 scopus 로고    scopus 로고
    • Article 17, Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4. IV. 1997, ETS 164 [hereinafter Biomedicine Convention]
    • Article 17, Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4. IV. 1997, ETS 164 [hereinafter Biomedicine Convention].
  • 22
    • 84976400368 scopus 로고    scopus 로고
    • Article 31, Council Regulation 536/2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, 2014 OJ (L 158) 1 [hereinafter EU Regulation on Clinical Trials]
    • Article 31, Council Regulation 536/2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, 2014 OJ (L 158) 1 [hereinafter EU Regulation on Clinical Trials].
  • 23
    • 84976432089 scopus 로고    scopus 로고
    • Council Directive 2001/20 on the Approximation of the Law, 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, OJ L 121/34 (2001) [hereinafter 2001 Directive]
    • Council Directive 2001/20 on the Approximation of the Law, 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, OJ L 121/34 (2001) [hereinafter 2001 Directive].
  • 26
    • 84976419426 scopus 로고    scopus 로고
    • Mental Capacity Act 2005, s 33(2)
    • Mental Capacity Act 2005, s 33(2).
  • 28
    • 84880627837 scopus 로고    scopus 로고
    • chapter 4 retrieved 14 July 2015
    • Alzheimer Europe, 'The Ethics of Dementia Research' (2011), chapter 4, www.alzheimer-europe.org/Ethics/Ethical-issues-in-practice/Ethics-of-dementia-research. retrieved 14 July 2015.
    • (2011) The Ethics of Dementia Research
  • 29
    • 0035241527 scopus 로고    scopus 로고
    • Advance directives in dementia research. Promoting autonomy and protecting subjects
    • at 4
    • R. Dresser, 'Advance directives in dementia research. Promoting Autonomy and Protecting Subjects', IRB. Ethics & Human Research 23(1) (2001) 1-6 at 4.
    • (2001) IRB. Ethics & Human Research , vol.23 , Issue.1 , pp. 1-6
    • Dresser, R.1
  • 30
    • 84930512955 scopus 로고    scopus 로고
    • Cognitive fluctuations as a challenge for the assessment of decision-making capacity in patients with dementia
    • M. Trachsel, H. Hermann, and N. Biller-Andorno, 'Cognitive Fluctuations as a Challenge for the Assessment of Decision-Making Capacity in Patients with Dementia', American Journal of Alzheimer's Disease and Other Dementias 30(4) (2015) 360-363.
    • (2015) American Journal of Alzheimer's Disease and Other Dementias , vol.30 , Issue.4 , pp. 360-363
    • Trachsel, M.1    Hermann, H.2    Biller-Andorno, N.3
  • 32
    • 33751581713 scopus 로고    scopus 로고
    • Dementia and the law
    • at 217
    • Regarding the importance of the specificity of the consent, see S. Gevers, 'Dementia and the Law', European Journal of Health Law 13(3) (2006) 209-217, at 217.
    • (2006) European Journal of Health Law , vol.13 , Issue.3 , pp. 209-217
    • Gevers, S.1
  • 33
    • 84938522417 scopus 로고    scopus 로고
    • Dementia research and advance consent: It is not about critical interest
    • published online 19 September 2014
    • K. Jongsma and S. van de Vathorst, 'Dementia research and advance consent: it is not about critical interest', Journal of Medical Ethics (2014) (published online 19 September 2014; doi:10.1136/medethics-2014-102445).
    • (2014) Journal of Medical Ethics
    • Jongsma, K.1    Van De Vathorst, S.2
  • 35
    • 84976350687 scopus 로고    scopus 로고
    • Biomedicine Convention Article 17.1.v; Additional Protocol on Biomedical Research, Article 15 1.v
    • Biomedicine Convention Article 17.1.v; Additional Protocol on Biomedical Research, Article 15 1.v.
  • 37
    • 84858397089 scopus 로고    scopus 로고
    • End-of-life decisions and demented patients. What to do if patient's current and past wishes are in conflict with each other?
    • T. Lemmens, 'End-of-life decisions and demented patients. What to do if patient's current and past wishes are in conflict with each other?', European Journal of Health Law 19(2) (2012) 177-186.
    • (2012) European Journal of Health Law , vol.19 , Issue.2 , pp. 177-186
    • Lemmens, T.1
  • 38
    • 84976354107 scopus 로고    scopus 로고
    • Biomedicine Convention, Articles 6.3 and 17.iv; EU Regulation on Clinical Trials, Article 31.1.a
    • Biomedicine Convention, Articles 6.3 and 17.iv; EU Regulation on Clinical Trials, Article 31.1.a.
  • 39
    • 84938519667 scopus 로고    scopus 로고
    • Advance consent, critical interests and dementia research
    • published online 12 August 2014
    • See T. Buller, 'Advance consent, critical interests and dementia research', Journal of Medical Ethics (2014) published online 12 August 2014, doi: 10.1136/medethics-2014-102024)
    • (2014) Journal of Medical Ethics
    • Buller, T.1
  • 45
    • 28444445949 scopus 로고    scopus 로고
    • Research advance directives: Protection or obstacle?
    • P. Muthappan, H. Foster, and D. Wendler, 'Research advance directives: protection or obstacle?', American Journal of Psychiatry 162(12) (2005) 2389-2391.
    • (2005) American Journal of Psychiatry , vol.162 , Issue.12 , pp. 2389-2391
    • Muthappan, P.1    Foster, H.2    Wendler, D.3
  • 46
    • 84930804432 scopus 로고    scopus 로고
    • Strasbourg: Council of Europe Retrieved 14 July 2015
    • See Council of Europe's Steering Committee on Bioethics, Guide for Research Ethics Committee Members, (Strasbourg: Council of Europe, 2012). Retrieved 14 July 2015, www.coe.int/t/dg3/healthbioethic/activities/02-biomedical-research-en/guide/Guide-EN.pdf.
    • (2012) Guide for Research Ethics Committee Members
  • 47
    • 84976399361 scopus 로고    scopus 로고
    • Retrieved 14 July 2015
    • See European Commission, Clinical Trials. General Information. Retrieved 14 July 2015, http://ec.europa.eu/health/human-use/clinical-trials/information/index-en.htm#ct4.
    • Clinical Trials. General Information


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.