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Volumn 17, Issue 1, 2016, Pages

Research involving adults lacking capacity to consent: The impact of research regulation on 'evidence biased' medicine

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; CASE REPORT; CLINICAL TRIAL; ENGLAND; HUMAN; INFORMED CONSENT; MEDICAL PRACTICE; MEDICAL RESEARCH; MEDICINE; MENTAL CAPACITY; PROXY; UNCERTAINTY; WALES; ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); DECISION MAKING; ETHICS; GOVERNMENT REGULATION; HEALTH CARE DISPARITY; LEGISLATION AND JURISPRUDENCE; PATERNALISM; PERSONAL AUTONOMY; RESEARCH SUBJECT; RISK ASSESSMENT; STATISTICAL BIAS; VULNERABLE POPULATION;

EID: 84986892999     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/s12910-016-0138-9     Document Type: Review
Times cited : (56)

References (30)
  • 1
    • 85053144506 scopus 로고    scopus 로고
    • Researching scabies outbreaks among people in residential care and lacking capacity to consent
    • Advanced Access published online 16 Apr
    • Head MG, Walker SL, Nalabanda A, Bostock J, Cassell JA. Researching scabies outbreaks among people in residential care and lacking capacity to consent: A case study. Public Health Ethics. Advanced Access published online 16 Apr 2015. doi: 10.1093/phe/phv011.
    • (2015) A case study. Public Health Ethics
    • Head, M.G.1    Walker, S.L.2    Nalabanda, A.3    Bostock, J.4    Cassell, J.A.5
  • 2
  • 3
    • 84986915067 scopus 로고    scopus 로고
    • Participation of people with a learning disability in medical research
    • Accessed 6 June 2016.
    • Lewis K. Participation of people with a learning disability in medical research. Royal Mencap Society. 2014. https://www.mencap.org.uk/sites/default/files/documents/Participation%20of%20people%20with%20a%20learning%20disability%20in%20medical%20-1.pdf. Accessed 6 June 2016.
    • (2014) Royal Mencap Society
    • Lewis, K.1
  • 4
    • 84986893599 scopus 로고    scopus 로고
    • Vulnerable/special participant populations
    • Lott JP. Vulnerable/special participant populations. Developing World Bioethics. 2005;5:31-54.
    • (2005) Developing World Bioethics , vol.5 , pp. 31-54
    • Lott, J.P.1
  • 5
    • 0036597640 scopus 로고    scopus 로고
    • Issues in conducting research in nursing homes
    • Maas M, Kelle L, Park M, Specht J. Issues in conducting research in nursing homes. West J Nurs Res. 2002;4:373-89.
    • (2002) West J Nurs Res , vol.4 , pp. 373-389
    • Maas, M.1    Kelle, L.2    Park, M.3    Specht, J.4
  • 6
    • 70349312905 scopus 로고    scopus 로고
    • Challenges to conducting research with older people living in nursing homes
    • Hall S, Longhurst S, Higgingson I. Challenges to conducting research with older people living in nursing homes. BMC Geriatr. 2009;9(38):38.
    • (2009) BMC Geriatr , vol.9 , Issue.38 , pp. 38
    • Hall, S.1    Longhurst, S.2    Higgingson, I.3
  • 7
    • 84881183875 scopus 로고    scopus 로고
    • Consent, including advanced consent, of older adults to research in care homes: A qualitative study of stakeholders' views in South Wales
    • Wood F, Prout H, Bayer A, Duncan D, Nuttall J, Hood K, Butler CC. Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales. Trials. 2013;14(1):247.
    • (2013) Trials , vol.14 , Issue.1 , pp. 247
    • Wood, F.1    Prout, H.2    Bayer, A.3    Duncan, D.4    Nuttall, J.5    Hood, K.6    Butler, C.C.7
  • 10
    • 56749179811 scopus 로고    scopus 로고
    • SI 2004/1031 Accessed 7 Sep 2016.
    • Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031. http://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi-20041031-en.pdf. Accessed 7 Sep 2016.
    • (2004) (Clinical Trials) Regulations
    • Medicines for Human Use1
  • 11
    • 67249097567 scopus 로고    scopus 로고
    • Research involving adults who lack capacity: How have research ethics committees interpreted the requirements?
    • Dixon-Woods M, Angell EL. Research involving adults who lack capacity: how have research ethics committees interpreted the requirements? J Med Ethics. 2009;35(6):377-81.
    • (2009) J Med Ethics , vol.35 , Issue.6 , pp. 377-381
    • Dixon-Woods, M.1    Angell, E.L.2
  • 13
    • 84960603005 scopus 로고
    • Aged heterogeneity: Fact or fiction? the fate of diversity in gerontological research
    • Nelson EA, Dannefer D. Aged heterogeneity: fact or fiction? The fate of diversity in gerontological research. Gerontologist. 1992;32:17-23.
    • (1992) Gerontologist , vol.32 , pp. 17-23
    • Nelson, E.A.1    Dannefer, D.2
  • 15
  • 17
    • 84888610885 scopus 로고    scopus 로고
    • World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects
    • World Medical Association
    • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191.
    • (2013) JAMA , vol.310 , Issue.20 , pp. 2191
  • 18
    • 84986894738 scopus 로고    scopus 로고
    • (Clinical trials on medicinal products for human use) OJ L158.
    • Council Regulation (No. 536/2014) (Clinical trials on medicinal products for human use) OJ L158.
    • Council Regulation (No. 536/2014)1
  • 19
    • 0037809470 scopus 로고    scopus 로고
    • Recruiting vulnerable populations for research: Revisiting the ethical issues
    • Sutton LB, Erlen JA, Glad J, Siminoff LA. Recruiting vulnerable populations for research: revisiting the ethical issues. J Prof Nurs. 2003;19(2):106-12.
    • (2003) J Prof Nurs , vol.19 , Issue.2 , pp. 106-112
    • Sutton, L.B.1    Erlen, J.A.2    Glad, J.3    Siminoff, L.A.4
  • 20
    • 0010030912 scopus 로고
    • Philosophical Reflections on Experimenting with Human Subjects
    • Jonas H. Philosophical Reflections on Experimenting with Human Subjects. Daedalus. 1969;98(2):219-47.
    • (1969) Daedalus , vol.98 , Issue.2 , pp. 219-247
    • Jonas, H.1
  • 21
    • 78751519776 scopus 로고    scopus 로고
    • Ethical Challenges in Clinical Research at Both Ends of Life
    • Wrobel P, Dehlinger-Kremer M, Klingmann I. Ethical Challenges in Clinical Research at Both Ends of Life. Drug Inf J. 2011;45(1):89-105.
    • (2011) Drug Inf J , vol.45 , Issue.1 , pp. 89-105
    • Wrobel, P.1    Dehlinger-Kremer, M.2    Klingmann, I.3
  • 22
    • 33750529955 scopus 로고    scopus 로고
    • Medical research involving incapacitated adults: Implications of the EU clinical trials directive 2001/20/EC
    • Liddell K, Bion J, Chamberlain D, Druml C, Kompanje E, Lemaire F, et al. Medical research involving incapacitated adults: implications of the EU clinical trials directive 2001/20/EC. Med Law Rev. 2006;14(3):367-417.
    • (2006) Med Law Rev , vol.14 , Issue.3 , pp. 367-417
    • Liddell, K.1    Bion, J.2    Chamberlain, D.3    Druml, C.4    Kompanje, E.5    Lemaire, F.6
  • 23
    • 84986906032 scopus 로고    scopus 로고
    • When Should Research with Infants, Children, or Adolescents Be Permitted?
    • A. Smith Iltis (eds) Routledge London
    • Kopelman LM. When Should Research With Infants, Children, Or Adolescents Be Permitted? In: Smith Iltis A, editor. Research Ethics. London: Routledge; 2006. p. 67-76.
    • (2006) Research Ethics , pp. 67-76
    • Kopelman, L.M.1
  • 24
    • 84986906036 scopus 로고    scopus 로고
    • Clinical Trials Directive) OJ L121 2001/20/EC
    • Council Directive 2001/20/EC (Clinical Trials Directive) OJ L121
    • Council Directive1
  • 25
    • 84872315968 scopus 로고    scopus 로고
    • Impact of the demand for 'proxy assent' on recruitment to a randomised controlled trial of vaccination testing in care homes
    • Whelan PJ, Walwyn R, Gaughran F, Macdonald A. Impact of the demand for 'proxy assent' on recruitment to a randomised controlled trial of vaccination testing in care homes. J Med Ethics. 2013;39(1):36-40.
    • (2013) J Med Ethics , vol.39 , Issue.1 , pp. 36-40
    • Whelan, P.J.1    Walwyn, R.2    Gaughran, F.3    Macdonald, A.4
  • 27
    • 84939143018 scopus 로고    scopus 로고
    • Setting up a clinical trial in care homes: Challenges encountered and recommendations for future research practice
    • 10.1186/s13104-015-1276-8
    • Shepherd V, Nuttall J, Hood K, Butler CC. Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice. BMC Res Notes. 2015;8:306. doi: 10.1186/s13104-015-1276-8.
    • (2015) BMC Res Notes , vol.8 , pp. 306
    • Shepherd, V.1    Nuttall, J.2    Hood, K.3    Butler, C.C.4
  • 28
    • 78650377330 scopus 로고    scopus 로고
    • Is best interests a relevant decision making standard for enrolling non-capacitated subjects into clinical research?
    • Berger JT. Is best interests a relevant decision making standard for enrolling non-capacitated subjects into clinical research? J Med Ethics. 2011;37(1):45-9.
    • (2011) J Med Ethics , vol.37 , Issue.1 , pp. 45-49
    • Berger, J.T.1
  • 29
    • 0037525339 scopus 로고    scopus 로고
    • Consent is not enough - Putting incompetent patients first in clinical trials
    • Corrigan OP, Williams-Jones B. Consent is not enough - putting incompetent patients first in clinical trials. Lancet. 2003;361(9375):2096-7.
    • (2003) Lancet , vol.361 , Issue.9375 , pp. 2096-2097
    • Corrigan, O.P.1    Williams-Jones, B.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.