메뉴 건너뛰기




Volumn 17, Issue 1, 2015, Pages 23-30

Ethics Review of Pediatric Multi-Center Drug Trials

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 84921885450     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.1007/s40272-014-0098-9     Document Type: Article
Times cited : (15)

References (59)
  • 1
    • 0036916573 scopus 로고    scopus 로고
    • Pediatricians’ attitudes toward randomized controlled trials involving children
    • PID: 12461496
    • Caldwell PH, Butow PN, Craig JC. Pediatricians’ attitudes toward randomized controlled trials involving children. J Pediatr. 2002;141(6):798–803. doi:10.1067/mpd.2002.129173.
    • (2002) J Pediatr. , vol.141 , Issue.6 , pp. 798-803
    • Caldwell, P.H.1    Butow, P.N.2    Craig, J.C.3
  • 2
    • 0038696447 scopus 로고    scopus 로고
    • Parents’ attitudes to children’s participation in randomized controlled trials
    • PID: 12756389
    • Caldwell PH, Butow PN, Craig JC. Parents’ attitudes to children’s participation in randomized controlled trials. J Pediatr. 2003;142(5):554–9. doi:10.1067/mpd.2003.192.
    • (2003) J Pediatr. , vol.142 , Issue.5 , pp. 554-559
    • Caldwell, P.H.1    Butow, P.N.2    Craig, J.C.3
  • 3
    • 20244368931 scopus 로고    scopus 로고
    • Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children
    • COI: 1:STN:280:DC%2BD3c%2FptVOhsA%3D%3D, PID: 10625257
    • Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000;320(7227):79–82.
    • (2000) BMJ. , vol.320 , Issue.7227 , pp. 79-82
    • Conroy, S.1    Choonara, I.2    Impicciatore, P.3    Mohn, A.4    Arnell, H.5    Rane, A.6
  • 4
    • 24044436574 scopus 로고    scopus 로고
    • A literature review on off-label drug use in children
    • PID: 15912383
    • Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164(9):552–8. doi:10.1007/s00431-005-1698-8.
    • (2005) Eur J Pediatr. , vol.164 , Issue.9 , pp. 552-558
    • Pandolfini, C.1    Bonati, M.2
  • 5
    • 3042769516 scopus 로고    scopus 로고
    • Antidepressants and suicide: what is the balance of benefit and harm
    • COI: 1:CAS:528:DC%2BD2cXms1yltbo%3D, PID: 15231620
    • Gunnell D, Ashby D. Antidepressants and suicide: what is the balance of benefit and harm. BMJ. 2004;329(7456):34–8. doi:10.1136/bmj.329.7456.34.
    • (2004) BMJ. , vol.329 , Issue.7456 , pp. 34-38
    • Gunnell, D.1    Ashby, D.2
  • 6
    • 0021060709 scopus 로고
    • Chloramphenicol toxicity in neonates: its incidence and prevention
    • COI: 1:STN:280:DyaL2c%2FlsVWhsw%3D%3D
    • Mulhall A, de Louvois J, Hurley R. Chloramphenicol toxicity in neonates: its incidence and prevention. Br Med J. 1983;287(6403):1424–7.
    • (1983) Br Med J. , vol.287 , Issue.6403 , pp. 1424-1427
    • Mulhall, A.1    de Louvois, J.2    Hurley, R.3
  • 7
    • 84887977963 scopus 로고    scopus 로고
    • Adverse drug reactions and off-label and unlicensed medicines in children: a nested case–control study of inpatients in a pediatric hospital
    • PID: 24229060
    • Bellis JR, Kirkham JJ, Thiesen S, Conroy EJ, Bracken LE, Mannix HL, et al. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case–control study of inpatients in a pediatric hospital. BMC Med. 2013;11:238. doi:10.1186/1741-7015-11-238.
    • (2013) BMC Med. , vol.11 , pp. 238
    • Bellis, J.R.1    Kirkham, J.J.2    Thiesen, S.3    Conroy, E.J.4    Bracken, L.E.5    Mannix, H.L.6
  • 8
    • 50949115424 scopus 로고    scopus 로고
    • Children are not just small adults: the urgent need for high-quality trial evidence in children
    • PID: 18700813
    • Klassen TP, Hartling L, Craig JC, Offringa M. Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med. 2008;5(8):e172. doi:10.1371/journal.pmed.0050172.
    • (2008) PLoS Med. , vol.5 , Issue.8 , pp. e172
    • Klassen, T.P.1    Hartling, L.2    Craig, J.C.3    Offringa, M.4
  • 9
    • 79960521621 scopus 로고    scopus 로고
    • Profound changes in drug metabolism enzymes and possible effects on drug therapy in neonates and children
    • PID: 21548840
    • de Wildt SN. Profound changes in drug metabolism enzymes and possible effects on drug therapy in neonates and children. Expert Opin Drug Metab Toxicol. 2011;7(8):935–48. doi:10.1517/17425255.2011.577739.
    • (2011) Expert Opin Drug Metab Toxicol , vol.7 , Issue.8 , pp. 935-948
    • de Wildt, S.N.1
  • 10
    • 84904196927 scopus 로고    scopus 로고
    • Ontogeny of human hepatic and intestinal transporter gene expression during childhood: age matters
    • COI: 1:CAS:528:DC%2BC2cXhtlKntbzK, PID: 24829289
    • Mooij MG, Schwarz UI, de Koning BA, Leeder JS, Gaedigk R, Samsom JN, et al. Ontogeny of human hepatic and intestinal transporter gene expression during childhood: age matters. Drug Metab Dispos Biol Fate Chem. 2014;42(8):1268–74. doi:10.1124/dmd.114.056929.
    • (2014) Drug Metab Dispos Biol Fate Chem. , vol.42 , Issue.8 , pp. 1268-1274
    • Mooij, M.G.1    Schwarz, U.I.2    de Koning, B.A.3    Leeder, J.S.4    Gaedigk, R.5    Samsom, J.N.6
  • 11
    • 0042594499 scopus 로고    scopus 로고
    • Seven vulnerabilities in the pediatric research subject
    • Kipnis K. Seven vulnerabilities in the pediatric research subject. Theor Med Bioethics. 2003;24(2):107–20.
    • (2003) Theor Med Bioethics. , vol.24 , Issue.2 , pp. 107-120
    • Kipnis, K.1
  • 12
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • COI: 1:STN:280:DC%2BD3c3otVSmsQ%3D%3D
    • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA J Am Med Assoc. 2000;283(20):2701–11.
    • (2000) JAMA J Am Med Assoc. , vol.283 , Issue.20 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 13
    • 79955586901 scopus 로고    scopus 로고
    • Ethical key issues and fundamental rights in paediatric research
    • PID: 21103986
    • Altavilla A. Ethical key issues and fundamental rights in paediatric research. Eur J Clin Pharmacol. 2011;67(Suppl 1):117–23. doi:10.1007/s00228-010-0929-8.
    • (2011) Eur J Clin Pharmacol. , vol.67 , pp. 117-123
    • Altavilla, A.1
  • 14
    • 84921876900 scopus 로고    scopus 로고
    • Canadian Institutes of Health Research and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2010
    • Canadian Institutes of Health Research and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2010.
  • 15
    • 0036627224 scopus 로고    scopus 로고
    • Walking the moral tightrope: respecting and protecting children in health-related research
    • Miller PB, Kenny NP. Walking the moral tightrope: respecting and protecting children in health-related research. Camb Q Healthc Ethics CQ Int J Healthc Ethics Comm. 2002;11(3):217–29.
    • (2002) Camb Q Healthc Ethics CQ Int J Healthc Ethics Comm. , vol.11 , Issue.3 , pp. 217-229
    • Miller, P.B.1    Kenny, N.P.2
  • 16
    • 1642458616 scopus 로고    scopus 로고
    • How do institutional review boards apply the federal risk and benefit standards for pediatric research?
    • COI: 1:CAS:528:DC%2BD2cXos12msA%3D%3D
    • Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA J Am Med Assoc. 2004;291(4):476–82. doi:10.1001/jama.291.4.476.
    • (2004) JAMA J Am Med Assoc. , vol.291 , Issue.4 , pp. 476-482
    • Shah, S.1    Whittle, A.2    Wilfond, B.3    Gensler, G.4    Wendler, D.5
  • 17
    • 84921834802 scopus 로고    scopus 로고
    • European Organisation for Rare Diseases. 2009.What is a rare disease?. Accessed 24 Sept 2013
    • European Organisation for Rare Diseases. 2009.What is a rare disease? http://www.eurordis.org/content/what-rare-disease. Accessed 24 Sept 2013.
  • 19
    • 84860808732 scopus 로고    scopus 로고
    • Ethical challenges in paediatric clinical trials in multiple sclerosis
    • COI: 1:CAS:528:DC%2BC38XhtVShsbrI, PID: 22590478
    • Tenembaum SN. Ethical challenges in paediatric clinical trials in multiple sclerosis. Ther Adv Neurol Disord. 2012;5(3):139–46. doi:10.1177/1756285612437360.
    • (2012) Ther Adv Neurol Disord. , vol.5 , Issue.3 , pp. 139-146
    • Tenembaum, S.N.1
  • 20
    • 77957709216 scopus 로고    scopus 로고
    • Pediatric clinical research networks: current status, common challenges, and potential solutions
    • PID: 20837583
    • Slora EJ, Harris DL, Bocian AB, Wasserman RC. Pediatric clinical research networks: current status, common challenges, and potential solutions. Pediatrics. 2010;126(4):740–5. doi:10.1542/peds.2009-3586.
    • (2010) Pediatrics. , vol.126 , Issue.4 , pp. 740-745
    • Slora, E.J.1    Harris, D.L.2    Bocian, A.B.3    Wasserman, R.C.4
  • 21
    • 80053922499 scopus 로고    scopus 로고
    • Establishing a multicentre clinical research network: lessons learned
    • COI: 1:STN:280:DC%2BC3MfptlOhtw%3D%3D, PID: 21980256
    • Hagen NA, Stiles CR, Biondo PD, Cummings GG, Fainsinger RL, Moulin DE, et al. Establishing a multicentre clinical research network: lessons learned. Curr Oncol. 2011;18(5):e243–9.
    • (2011) Curr Oncol. , vol.18 , Issue.5 , pp. e243-e249
    • Hagen, N.A.1    Stiles, C.R.2    Biondo, P.D.3    Cummings, G.G.4    Fainsinger, R.L.5    Moulin, D.E.6
  • 22
    • 53549108038 scopus 로고    scopus 로고
    • Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
    • Union E. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law. 2008;15(2):223–50.
    • (2008) Eur J Health Law. , vol.15 , Issue.2 , pp. 223-250
    • Union, E.1
  • 23
    • 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)
    • PID: 14716559
    • Gill D, Ethics Working Group of the Confederation of European Specialists in P. 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 Pediatr. 2004;163(2):53–7. doi:10.1007/s00431-003-1378-5.
    • (2004) Eur J Pediatr. , vol.163 , Issue.2 , pp. 53-57
    • Gill, D.1    Ethics Working Group of the Confederation of European Specialists in, P.2
  • 25
    • 84898027814 scopus 로고    scopus 로고
    • Consent and assent in paediatric research in low-income settings
    • PID: 24597948
    • Cheah P, Parker M. Consent and assent in paediatric research in low-income settings. BMC Med Ethics. 2014;15(1):22.
    • (2014) BMC Med Ethics. , vol.15 , Issue.1 , pp. 22
    • Cheah, P.1    Parker, M.2
  • 27
    • 57549117036 scopus 로고    scopus 로고
    • Ethical issues in health research in children
    • Fernandez C. Ethical issues in health research in children. Paediatr Child Health. 2008;13(8):707–20.
    • (2008) Paediatr Child Health. , vol.13 , Issue.8 , pp. 707-720
    • Fernandez, C.1
  • 28
    • 25144454655 scopus 로고    scopus 로고
    • Regional variation in ICU care for pediatric patients with asthma
    • PID: 16182675
    • Bratton SL, Odetola FO, McCollegan J, Cabana MD, Levy FH, Keenan HT. Regional variation in ICU care for pediatric patients with asthma. J Pediatr. 2005;147(3):355–61. doi:10.1016/j.jpeds.2005.05.008.
    • (2005) J Pediatr , vol.147 , Issue.3 , pp. 355-361
    • Bratton, S.L.1    Odetola, F.O.2    McCollegan, J.3    Cabana, M.D.4    Levy, F.H.5    Keenan, H.T.6
  • 29
    • 18844380471 scopus 로고    scopus 로고
    • Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis
    • Hyder AA, Dawson L. Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis. Dev World Bioethics. 2005;5(2):142–52. doi:10.1111/j.1471-8847.2005.00109.x.
    • (2005) Dev World Bioethics. , vol.5 , Issue.2 , pp. 142-152
    • Hyder, A.A.1    Dawson, L.2
  • 30
    • 0037022818 scopus 로고    scopus 로고
    • Paying research subjects: an analysis of current policies
    • PID: 11874309
    • Dickert N, Emanuel E, Grady C. Paying research subjects: an analysis of current policies. Ann Intern Med. 2002;136(5):368–73.
    • (2002) Ann Intern Med. , vol.136 , Issue.5 , pp. 368-373
    • Dickert, N.1    Emanuel, E.2    Grady, C.3
  • 32
    • 82955162766 scopus 로고    scopus 로고
    • Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives
    • COI: 1:STN:280:DC%2BC387jvV2htg%3D%3D, PID: 21732978
    • Altavilla A, Manfredi C, Baiardi P, Dehlinger-Kremer M, Galletti P, Pozuelo AA, et al. Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr. 2012;101(1):e27–32. doi:10.1111/j.1651-2227.2011.02401.x.
    • (2012) Acta Paediatr. , vol.101 , Issue.1 , pp. e27-e32
    • Altavilla, A.1    Manfredi, C.2    Baiardi, P.3    Dehlinger-Kremer, M.4    Galletti, P.5    Pozuelo, A.A.6
  • 33
    • 84864950992 scopus 로고    scopus 로고
    • Ethics application protocols for multicentre clinical studies in Canada: a paediatric rheumatology experience
    • PID: 23730169
    • Matheson LA, Huber AM, Warner A, Rosenberg AM. Ethics application protocols for multicentre clinical studies in Canada: a paediatric rheumatology experience. Paediatr Child Health. 2012;17(6):313–6.
    • (2012) Paediatr Child Health. , vol.17 , Issue.6 , pp. 313-316
    • Matheson, L.A.1    Huber, A.M.2    Warner, A.3    Rosenberg, A.M.4
  • 34
    • 0029832719 scopus 로고    scopus 로고
    • Delays and diversity in the practice of local research ethics committees
    • COI: 1:STN:280:DyaK2s%2FmslelsQ%3D%3D, PID: 8910776
    • Ahmed AH, Nicholson KG. Delays and diversity in the practice of local research ethics committees. J Med Ethics. 1996;22(5):263–6.
    • (1996) J Med Ethics. , vol.22 , Issue.5 , pp. 263-266
    • Ahmed, A.H.1    Nicholson, K.G.2
  • 35
    • 33745662181 scopus 로고    scopus 로고
    • A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval
    • PID: 16828670
    • Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol. 2006;59(8):784–90. doi:10.1016/j.jclinepi.2005.11.018.
    • (2006) J Clin Epidemiol. , vol.59 , Issue.8 , pp. 784-790
    • Greene, S.M.1    Geiger, A.M.2
  • 36
    • 0037925635 scopus 로고    scopus 로고
    • Problematic variation in local institutional review of a multicenter genetic epidemiology study
    • McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA J Am Med Assoc. 2003;290(3):360–6. doi:10.1001/jama.290.3.360.
    • (2003) JAMA J Am Med Assoc. , vol.290 , Issue.3 , pp. 360-366
    • McWilliams, R.1    Hoover-Fong, J.2    Hamosh, A.3    Beck, S.4    Beaty, T.5    Cutting, G.6
  • 37
    • 12344327560 scopus 로고    scopus 로고
    • Nature and extent of changes in the patient’s information sheets of international multicentre clinical trials as requested by Spanish Research Ethics Committees
    • Dal-Re R, Morejon E, Ortega R. Nature and extent of changes in the patient’s information sheets of international multicentre clinical trials as requested by Spanish Research Ethics Committees. Med Clin. 2004;123(20):770–4.
    • (2004) Med Clin. , vol.123 , Issue.20 , pp. 770-774
    • Dal-Re, R.1    Morejon, E.2    Ortega, R.3
  • 38
    • 0034988768 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard protocol for a multicenter clinical trial
    • COI: 1:STN:280:DC%2BD3MzltVCnsg%3D%3D, PID: 11388939
    • Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med. 2001;8(6):636–41.
    • (2001) Acad Emerg Med. , vol.8 , Issue.6 , pp. 636-641
    • Stair, T.O.1    Reed, C.R.2    Radeos, M.S.3    Koski, G.4    Camargo, C.A.5
  • 39
    • 0032600385 scopus 로고    scopus 로고
    • Adolescent medicine HIVARN. A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs
    • PID: 11657967
    • Rogers AS, Schwartz DF, Weissman G, English A. Adolescent medicine HIVARN. A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs. IRB. 1999;21(1):6–10.
    • (1999) IRB. , vol.21 , Issue.1 , pp. 6-10
    • Rogers, A.S.1    Schwartz, D.F.2    Weissman, G.3    English, A.4
  • 40
    • 0035116519 scopus 로고    scopus 로고
    • Variability among institutional review boards’ decisions within the context of a multicenter trial
    • COI: 1:STN:280:DC%2BD3M7pslegtQ%3D%3D, PID: 11246299
    • Silverman H, Hull SC, Sugarman J. Variability among institutional review boards’ decisions within the context of a multicenter trial. Crit Care Med. 2001;29(2):235–41.
    • (2001) Crit Care Med. , vol.29 , Issue.2 , pp. 235-241
    • Silverman, H.1    Hull, S.C.2    Sugarman, J.3
  • 41
    • 0033791332 scopus 로고    scopus 로고
    • The case for a new system for oversight of research on human subjects
    • COI: 1:STN:280:DC%2BD3crgsFGhtw%3D%3D, PID: 11055035
    • Jamrozik K. The case for a new system for oversight of research on human subjects. J Med Ethics. 2000;26(5):334–9.
    • (2000) J Med Ethics. , vol.26 , Issue.5 , pp. 334-339
    • Jamrozik, K.1
  • 42
    • 84905276157 scopus 로고    scopus 로고
    • Variability in IRBs regarding parental acceptance of passive consent
    • PID: 25002659
    • Higgerson RA, Olsho LE, Christie LM, Rehder K, Doksum T, Gedeit R, et al. Variability in IRBs regarding parental acceptance of passive consent. Pediatrics. 2014;134(2):e496–503. doi:10.1542/peds.2013-4190.
    • (2014) Pediatrics. , vol.134 , Issue.2 , pp. e496-e503
    • Higgerson, R.A.1    Olsho, L.E.2    Christie, L.M.3    Rehder, K.4    Doksum, T.5    Gedeit, R.6
  • 43
    • 33947509950 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard, observational, pediatric research protocol
    • Mansbach J, Acholonu U, Clark S, Camargo CA Jr. Variation in institutional review board responses to a standard, observational, pediatric research protocol. Acad Emerg Med Off J Soc Acad Emerg Med. 2007;14(4):377–80. doi:10.1197/j.aem.2006.11.031.
    • (2007) Acad Emerg Med Off J Soc Acad Emerg Med. , vol.14 , Issue.4 , pp. 377-380
    • Mansbach, J.1    Acholonu, U.2    Clark, S.3    Camargo, C.A.4
  • 44
    • 77955062455 scopus 로고    scopus 로고
    • Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator’s perspective
    • PID: 20673343
    • Ezzat H, Ross S, von Dadelszen P, Morris T, Liston R, Magee LA, et al. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator’s perspective. BMC Health Serv Res. 2010;10:223. doi:10.1186/1472-6963-10-223.
    • (2010) BMC Health Serv Res. , vol.10 , pp. 223
    • Ezzat, H.1    Ross, S.2    von Dadelszen, P.3    Morris, T.4    Liston, R.5    Magee, L.A.6
  • 45
    • 4143062563 scopus 로고    scopus 로고
    • Oversight of human participants research: identifying problems to evaluate reform proposals
    • PID: 15313744
    • Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004;141(4):282–91.
    • (2004) Ann Intern Med. , vol.141 , Issue.4 , pp. 282-291
    • Emanuel, E.J.1    Wood, A.2    Fleischman, A.3    Bowen, A.4    Getz, K.A.5    Grady, C.6
  • 46
    • 41149177476 scopus 로고    scopus 로고
    • Ontario Cancer Research Ethics Board: lessons learned from developing a multicenter regional institutional review board
    • Saginur R, Dent SF, Schwartz L, Heslegrave R, Stacey S, Manzo J. Ontario Cancer Research Ethics Board: lessons learned from developing a multicenter regional institutional review board. J Clin Oncol Off J Am Soc Clin Oncol. 2008;26(9):1479–82. doi:10.1200/JCO.2007.12.6441.
    • (2008) J Clin Oncol Off J Am Soc Clin Oncol. , vol.26 , Issue.9 , pp. 1479-1482
    • Saginur, R.1    Dent, S.F.2    Schwartz, L.3    Heslegrave, R.4    Stacey, S.5    Manzo, J.6
  • 47
    • 77449109638 scopus 로고    scopus 로고
    • Costs and benefits of the national cancer institute central institutional review board
    • Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the national cancer institute central institutional review board. J Clin Oncol Off J Am Soc Clin Oncol. 2010;28(4):662–6. doi:10.1200/JCO.2009.23.2470.
    • (2010) J Clin Oncol Off J Am Soc Clin Oncol. , vol.28 , Issue.4 , pp. 662-666
    • Wagner, T.H.1    Murray, C.2    Goldberg, J.3    Adler, J.M.4    Abrams, J.5
  • 48
    • 84921859719 scopus 로고    scopus 로고
    • Health Research Ethics Authority. 2014. Welcome to the Health Research Ethics Authority (HREA) Website. Accessed 26 June 2014
    • Health Research Ethics Authority. 2014. Welcome to the Health Research Ethics Authority (HREA) Website. http://www.hrea.ca/Home.aspx. Accessed 26 June 2014.
  • 49
    • 84921893383 scopus 로고    scopus 로고
    • Province of Alberta. 2000. Health Information Act. Accessed 26 June 2014
    • Province of Alberta. 2000. Health Information Act. https://www.assembly.ab.ca/HIAReview/Health_Information_Act.pdf. Accessed 26 June 2014.
  • 50
    • 84921846001 scopus 로고    scopus 로고
    • Health Research Ethics Board of Alberta. 2014. Coming soon: one ethics review for health research in Alberta. Accessed 26 June 2014
    • Health Research Ethics Board of Alberta. 2014. Coming soon: one ethics review for health research in Alberta. http://hreba.ca/coming-soon-one-ethics-review-for-health-research-in-alberta/. Accessed 26 June 2014.
  • 51
    • 84921859337 scopus 로고    scopus 로고
    • Clinical Trials Ontario. 2014. Streamlined research ethics review. Accessed 28 June 2014
    • Clinical Trials Ontario. 2014. Streamlined research ethics review. http://www.ctontario.ca/streamlined-ethics-review-system/. Accessed 28 June 2014.
  • 52
    • 84921851023 scopus 로고    scopus 로고
    • European Forum for Good Clinical Practice. 2012. EFGCP report on the procedure for the ethical review of protocols for clinical research Projects in Europe and beyond. Accessed 16 Sept 2014
    • European Forum for Good Clinical Practice. 2012. EFGCP report on the procedure for the ethical review of protocols for clinical research Projects in Europe and beyond. http://www.efgcp.eu/EFGCPReports.asp?L1=5&L2=1. Accessed 16 Sept 2014.
  • 53
    • 84921875559 scopus 로고    scopus 로고
    • Australian Government National Health and Medical Research Council. 2014. The National approach to single ethical review of multi-centre research. Data accessed 24 Sept 2014
    • Australian Government National Health and Medical Research Council. 2014. The National approach to single ethical review of multi-centre research. http://hrep.nhmrc.gov.au/national-approach. Data accessed 24 Sept 2014.
  • 54
    • 84921848772 scopus 로고    scopus 로고
    • Maternal Infant Child and Youth Network. 2011. MICRYN workshop: research ethics harmonization. Accessed 29 July 2013
    • Maternal Infant Child and Youth Network. 2011. MICRYN workshop: research ethics harmonization. http://www.micyrn.ca/PDF/REBWorkshopReportOctober2011.pdf. Accessed 29 July 2013.
  • 55
    • 0036252223 scopus 로고    scopus 로고
    • Ethical approval for multicentre clinical trials in children. Contrasting systems in three European countries
    • COI: 1:STN:280:DC%2BD383mvVKnuw%3D%3D, PID: 12008192
    • Pinkerton CR, Ablett S, Boos J, Philip T. Ethical approval for multicentre clinical trials in children. Contrasting systems in three European countries. Eur J Cancer. 2002;38(8):1051–8.
    • (2002) Eur J Cancer. , vol.38 , Issue.8 , pp. 1051-1058
    • Pinkerton, C.R.1    Ablett, S.2    Boos, J.3    Philip, T.4
  • 56
    • 33645754988 scopus 로고    scopus 로고
    • Ethics review of multi-centre clinical trials in Canada
    • Enzel ME, Schmaltz R. Ethics review of multi-centre clinical trials in Canada. Health Law Rev. 2005;13(2–3):51–7.
    • (2005) Health Law Rev. , vol.13 , Issue.2-3 , pp. 51-57
    • Enzel, M.E.1    Schmaltz, R.2
  • 57
    • 42549129895 scopus 로고    scopus 로고
    • How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review
    • PID: 18373857
    • Coleman CH, Bouesseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics. 2008;9:6. doi:10.1186/1472-6939-9-6.
    • (2008) BMC Med Ethics. , vol.9 , pp. 6
    • Coleman, C.H.1    Bouesseau, M.C.2
  • 58
    • 79954508843 scopus 로고    scopus 로고
    • A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn
    • Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics JERHRE. 2011;6(1):3–19. doi:10.1525/jer.2011.6.1.3.
    • (2011) J Empir Res Hum Res Ethics JERHRE. , vol.6 , Issue.1 , pp. 3-19
    • Abbott, L.1    Grady, C.2
  • 59
    • 84864594211 scopus 로고    scopus 로고
    • Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings
    • PID: 22332841
    • de Jong JP, van Zwieten MC, Willems DL. Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings. Sociol Health Illn. 2012;34(7):1039–52. doi:10.1111/j.1467-9566.2012.01458.x.
    • (2012) Sociol Health Illn. , vol.34 , Issue.7 , pp. 1039-1052
    • de Jong, J.P.1    van Zwieten, M.C.2    Willems, D.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.