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Volumn 67, Issue SUPPL. 1, 2011, Pages

Ethical key issues and fundamental rights in paediatric research

Author keywords

Children; Clinical research; Ethics; Fundamental rights; Trials

Indexed keywords

ARTICLE; BENEFICENCE; BIOETHICS; CHILD CARE; CHILD WELFARE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; EUROPEAN UNION; GOOD CLINICAL PRACTICE; HEALTH CARE DISTRIBUTION; HEALTH CARE POLICY; HUMAN; HUMAN RIGHTS; INTERNATIONAL COOPERATION; JUSTICE; MEDICOLEGAL ASPECT; PATIENT RIGHT; PEDIATRICS; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESEARCH ETHICS;

EID: 79955586901     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-010-0929-8     Document Type: Article
Times cited : (6)

References (52)
  • 2
    • 0642310428 scopus 로고    scopus 로고
    • Dying children and medical research: Access to clinical trials as benefit and burden
    • Oberman M, Frader J (2003) Dying children and medical research: access to clinical trials as benefits and burden. Am J Law Med 29:301-317 (Pubitemid 39530596)
    • (2003) American Journal of Law and Medicine , vol.29 , Issue.2-3 , pp. 301-317
    • Oberman, M.1    Frader, J.2
  • 3
    • 1242284429 scopus 로고    scopus 로고
    • Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)
    • Gill D (2004) Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Paediatr 163:53-57
    • (2004) Eur J Paediatr , vol.163 , pp. 53-57
    • Gill, D.1
  • 4
    • 84866365043 scopus 로고    scopus 로고
    • Regulation (EC) no. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use, amended by Regulation (EC) no. 1902/2006
    • EC
    • EC (2006) Regulation (EC) no. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use, amended by Regulation (EC) no. 1902/2006. Offic J Eur Union L 378 :1-19
    • (2006) Offic J Eur Union L , vol.378 , pp. 1-19
  • 5
    • 53549085708 scopus 로고    scopus 로고
    • Medical research involving children
    • Editorial
    • Gevers JKM (2008) Editorial. Medical research involving children. Eur J Health Law 15(2):103-108
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 103-108
    • Gevers, J.K.M.1
  • 6
    • 0003578535 scopus 로고
    • United Nations General Assembly Accessed July 2009
    • United Nations General Assembly (1948) Universal declaration of human rights. http://www.un.org/en/documents/udhr/. Accessed July 2009
    • (1948) Universal Declaration of Human Rights
  • 7
    • 79955633817 scopus 로고
    • United Nations General Assembly Accessed July 2009
    • United Nations General Assembly (1989) Convention on the rights of the child.http://www2.ohchr.org/english/law/crc.htm. Accessed July 2009
    • (1989) Convention on the Rights of the Child
  • 11
    • 0004177253 scopus 로고    scopus 로고
    • Accessed July 2009
    • World Medical Association (2008) Declaration of Helsinki. http:// www.wma.net/e/policy/b3.htm. Accessed July 2009
    • (2008) Declaration of Helsinki
  • 13
    • 79955592423 scopus 로고    scopus 로고
    • International conference on harmonization of technical requirements for the registration of pharmaceuticals for human use
    • ICH Accessed July 2009
    • ICH (2002) International conference on harmonization of technical requirements for the registration of pharmaceuticals for human use. ICH guideline for good clinical practice E6 (R1), CPMP/ICH/ 135/95 of 10 July 1996. http://www.emea.europa.eu/pdfs/human/ ich/013595en.pdf. Accessed July 2009
    • (2002) ICH Guideline for Good Clinical Practice E6 (R1), CPMP/ICH/ 135/95 of 10 July 1996
  • 14
    • 79955597042 scopus 로고    scopus 로고
    • Clinical investigation of medicinal products in the paediatric population E11
    • ICH CPMP/ICH/27H/ 99. Accessed July 2009
    • ICH (1999) Clinical investigation of medicinal products in the paediatric population E11. Note for guidance on clinical investigation of medicinal products in the paediatric population, CPMP/ICH/27H/ 99. http://www.emea.europa. eu/pdfs/human/ich/271199en.pdf. Accessed July 2009
    • (1999) Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population
  • 19
    • 0000172782 scopus 로고
    • Children's involvement in research participation decisions
    • Grodin MA, Glantz LH (eds) Oxford University Press, Oxford
    • Werthorn LA, Scherer DG (1994) Children's involvement in research participation decisions. In: Grodin MA, Glantz LH (eds) Children as research subjects. Science, Ethics and Law. Oxford University Press, Oxford, pp 133-179
    • (1994) Children As Research Subjects. Science, Ethics and Law , pp. 133-179
    • Werthorn, L.A.1    Scherer, D.G.2
  • 21
    • 0036118657 scopus 로고    scopus 로고
    • Ethics of clinical research in children
    • Shevell MI (2002) Ethics of clinical research in children. Semin Pediatr Neurol 9(1):46-52
    • (2002) Semin Pediatr Neurol , vol.9 , Issue.1 , pp. 46-52
    • Shevell, M.I.1
  • 23
    • 29544434430 scopus 로고    scopus 로고
    • Children's understanding of the risks and benefits associated with research
    • DOI 10.1136/jme.2003.003228
    • Burke TM, Abramovitch R, Zlotkin S (2005) Children's understanding of the risks and benefits associated with research. J Med Ethics 31:715-720 (Pubitemid 43013385)
    • (2005) Journal of Medical Ethics , vol.31 , Issue.12 , pp. 715-720
    • Burke, T.M.1    Abramovitch, R.2    Zlotkin, S.3
  • 25
    • 0042093634 scopus 로고    scopus 로고
    • Child assent and parental permission in pediatric research
    • DOI 10.1023/A:1024690712019
    • Rossi WC, Reynolds W, Nelson RM (2003) Child assent and parental permission in paediatric research. Theor Med 24:131-148 (Pubitemid 36966181)
    • (2003) Theoretical Medicine and Bioethics , vol.24 , Issue.2 , pp. 131-148
    • Rossi, W.C.1    Reynolds, W.2    Nelson, R.M.3
  • 26
    • 0037628881 scopus 로고    scopus 로고
    • Factors influencing parental consent in pediatric clinical research
    • DOI 10.1542/peds.111.5.1037
    • Rothmier JD, Lasley MV, Shapiro GG (2003) Factors influencing consent in paediatric clinical research. Paediatrics 111:1037-1041 (Pubitemid 36542618)
    • (2003) Pediatrics , vol.111 , Issue.5 I , pp. 1037-1041
    • Rothmier, J.D.1    Lasley, M.V.2    Shapiro, G.G.3
  • 27
    • 33745760460 scopus 로고    scopus 로고
    • Children are not small adults: Documentation of assent for research involving children
    • Ungar D, Joffe S, Kodish E (2006) Children are not small adults: documentation of assent for research involving children. J Paediatr 149(1):31-33
    • (2006) J Paediatr , vol.149 , Issue.1 , pp. 31-33
    • Ungar, D.1    Joffe, S.2    Kodish, E.3
  • 28
    • 19444370192 scopus 로고    scopus 로고
    • Le consentement dans les essais cliniques pédiatriques
    • DOI 10.1016/j.arcped.2005.04.021, PII S0929693X05002101, Congres National de la Societe Francaise de Pediatrie
    • Chappuy H, Gary A, Chéron G, Tréluyer JM (2005) Le consentement dans les essays cliniques pédiatriques. Arch Pédiatr 12:778-780 (Pubitemid 40724682)
    • (2005) Archives de Pediatrie , vol.12 , Issue.6 , pp. 778-780
    • Chappuy, H.1    Gary, A.2    Cheron, G.3    Treluyer, J.M.4
  • 29
    • 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
    • EC
    • EC (2001) 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. Off J Eur Union L121:34-44
    • (2001) Off J Eur Union , vol.L121 , pp. 34-44
  • 31
    • 53549131496 scopus 로고    scopus 로고
    • European survey on ethical and legal framework of clinical trials in paediatrics: Results and perspectives
    • Altavilla A, Giaquinto C, Ceci A (2008) European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives. J Int Bioéthique 19(3):17-48
    • (2008) J Int Bioéthique , vol.19 , Issue.3 , pp. 17-48
    • Altavilla, A.1    Giaquinto, C.2    Ceci, A.3
  • 32
    • 85013593756 scopus 로고    scopus 로고
    • Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: Results of a survey
    • Altavilla A, Giaquinto C et al (2009) Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: results of a survey. Pharm Policy Law 11:1-9
    • (2009) Pharm Policy Law , vol.11 , pp. 1-9
    • Altavilla, A.1    Giaquinto, C.2
  • 33
    • 53549133963 scopus 로고    scopus 로고
    • Clinical research with children: The European legal framework and its implementation in French and Italian law
    • Altavilla A (2008) Clinical research with children: the European legal framework and its implementation in French and Italian law. Eur J Health Law 15(2):109-125
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 109-125
    • Altavilla, A.1
  • 35
    • 4344597708 scopus 로고    scopus 로고
    • Charter of fundamental rights of European Union
    • Accessed July 2009
    • European Union (2001) Charter of fundamental rights of European Union. Offic J Eur Comm C364:1-22. http://www.europarl.europa.eu/charter/pdf/text-en. pdf. Accessed July 2009
    • (2001) Offic J Eur Comm , vol.C364 , pp. 1-22
  • 37
    • 33645229263 scopus 로고    scopus 로고
    • Accessed July 2009
    • UNESCO (2005) Universal declaration on bioethics and human rights. http://portal.unesco.org/en/ev.php-URL-ID=31058&URL-DO=DO-TOPIC&URL- SECTION=201.html. Accessed July 2009
    • (2005) Universal Declaration on Bioethics and Human Rights
  • 38
    • 7644233870 scopus 로고    scopus 로고
    • Accessed July 2009
    • UNESCO (2003) International declaration on human genetic data. http://portal.unesco.org/en/ev.php-URL-ID=17720&URL-DO=DO-TOPIC&URL- SECTION=201.html. Accessed July 2009
    • (2003) International Declaration on Human Genetic Data
  • 39
    • 29344453431 scopus 로고    scopus 로고
    • 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 authorization of the manufacturing or importation of such products
    • EU
    • EU (2005) 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 authorization of the manufacturing or importation of such products. Offic J Eur Union L91:13-19
    • (2005) Offic J Eur Union , vol.L91 , pp. 13-19
  • 40
    • 0003187764 scopus 로고
    • Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
    • EU
    • EU (1995) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Offic J Eur Comm L 281:31-50
    • (1995) Offic J Eur Comm L , vol.281 , pp. 31-50
  • 42
    • 0029876672 scopus 로고    scopus 로고
    • Health and human rights. Protecting human rights is essential for promoting health
    • Mann J (1996) Health and human rights. Protecting human rights is essential for promoting health. Br Med J 312:924
    • (1996) Br Med J , vol.312 , pp. 924
    • Mann, J.1
  • 43
    • 20444467724 scopus 로고    scopus 로고
    • Ethical concerns regarding guidelines for the conduct of clinical research on children
    • DOI 10.1136/jme.2004.009555
    • Edwards SD, McNamee MJ (2005) Ethical concerns regarding guidelines for the conduct of clinical research on children. J Med Ethics 31:351-354 (Pubitemid 40823804)
    • (2005) Journal of Medical Ethics , vol.31 , Issue.6 , pp. 351-354
    • Edwards, S.D.1    McNamee, M.J.2
  • 44
    • 4444351808 scopus 로고    scopus 로고
    • Clinical trials in children
    • DOI 10.1016/S0140-6736(04)16942-0, PII S0140673604169420
    • Caldwell PHY, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364:803-811 (Pubitemid 39165102)
    • (2004) Lancet , vol.364 , Issue.9436 , pp. 803-811
    • Caldwell, P.H.1    Murphy, S.B.2    Butow, P.N.3    Craig, J.C.4
  • 45
    • 53549128382 scopus 로고    scopus 로고
    • Research with minors in Germany
    • Buchner B, Hart D (2008) Research with minors in Germany. Eur J Health Law 15(2):127-134
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 127-134
    • Buchner, B.1    Hart, D.2
  • 46
    • 53549111332 scopus 로고    scopus 로고
    • Medical research on minors in Finland
    • Lötjönen S (2008) Medical research on minors in Finland. Eur J Health Law 15(2):135-144
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 135-144
    • Lötjönen, S.1
  • 47
    • 53549103575 scopus 로고    scopus 로고
    • Legislation and review of medical research with minors in the Netherlands
    • Kenter MJH (2008) Legislation and review of medical research with minors in the Netherlands. Eur J Health Law 15(2):145-151
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 145-151
    • Kenter, M.J.H.1
  • 48
    • 53549088329 scopus 로고    scopus 로고
    • The implementation of Directive 2001/20/EC into Belgian law and specific provisions on paediatric research
    • Pinxten W, Dierickx K, Nys H (2008) The implementation of Directive 2001/20/EC into Belgian law and specific provisions on paediatric research. Eur J Health Law 15(2):153-161
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 153-161
    • Pinxten, W.1    Dierickx, K.2    Nys, H.3
  • 49
    • 53549118589 scopus 로고    scopus 로고
    • Research with minors in Greece and the EU Directive on clinical trials
    • Canellopoulou-Bottis M (2008) Research with minors in Greece and the EU Directive on clinical trials. Eur J Health Law 15 (2):163-168
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 163-168
    • Canellopoulou-Bottis, M.1
  • 50
    • 53549108867 scopus 로고    scopus 로고
    • Ireland and medical research with minors: Some medico-legal aspects
    • Sheikh AA (2008) Ireland and medical research with minors: some medico-legal aspects. Eur J Health Law 15(2):169-181
    • (2008) Eur J Health Law , vol.15 , Issue.2 , pp. 169-181
    • Sheikh, A.A.1
  • 51
    • 0035488136 scopus 로고    scopus 로고
    • Balancing recruitment and protection: Children as research subjects
    • DOI 10.1080/014608601753260335
    • Meaux JB, Bell PL (2001) Balancing recruitment and protection: children as research subjects. Issues Compr Paediatr Nurs 24:241-251 (Pubitemid 33604803)
    • (2001) Issues in Comprehensive Pediatric Nursing , vol.24 , Issue.4 , pp. 241-251
    • Meaux, J.B.1    Bell, P.L.2


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