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Volumn 59, Issue 5, 2012, Pages 1205-1220

Ethical Issues in Neonatal and Pediatric Clinical Trials

Author keywords

Clinical trials; Ethics; Genetic testing; Hypoxic ischemic encephalopathy; Informed consent; Risk benefit assessment; Stem cell transplantation

Indexed keywords

CHILD SAFETY; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DONOR SELECTION; ETHICAL DECISION MAKING; GENETIC SCREENING; GENETIC SUSCEPTIBILITY; GOVERNMENT REGULATION; HEALTH CARE POLICY; HUMAN; HYPOXIC ISCHEMIC ENCEPHALOPATHY; INDUCED HYPOTHERMIA; NEWBORN CARE; NONHUMAN; PRACTICE GUIDELINE; RESEARCH ETHICS; REVIEW; RISK BENEFIT ANALYSIS; SIBLING; STEM CELL TRANSPLANTATION; VULNERABLE POPULATION;

EID: 84867087849     PISSN: 00313955     EISSN: 15578240     Source Type: Journal    
DOI: 10.1016/j.pcl.2012.07.007     Document Type: Review
Times cited : (61)

References (50)
  • 1
    • 0014019552 scopus 로고
    • Ethics and clinical research
    • Beecher H.K. Ethics and clinical research. N Engl J Med 1966, 274(24):1354-1360.
    • (1966) N Engl J Med , vol.274 , Issue.24 , pp. 1354-1360
    • Beecher, H.K.1
  • 3
    • 0015217429 scopus 로고
    • Experiments at the Willowbrook State School
    • Goldby S. Experiments at the Willowbrook State School. Lancet 1971, 297(7702):749.
    • (1971) Lancet , vol.297 , Issue.7702 , pp. 749
    • Goldby, S.1
  • 4
    • 0015215010 scopus 로고
    • Experiments at the Willowbrook State School
    • Krugman S. Experiments at the Willowbrook State School. Lancet 1971, 1(7706):966-967.
    • (1971) Lancet , vol.1 , Issue.7706 , pp. 966-967
    • Krugman, S.1
  • 5
    • 0015211790 scopus 로고
    • Prevention of viral hepatitis: mission impossible?
    • Prevention of viral hepatitis: mission impossible?. JAMA 1971, 217(1):70-71.
    • (1971) JAMA , vol.217 , Issue.1 , pp. 70-71
  • 6
    • 0020123973 scopus 로고
    • Were Tuskegee & Willowbrook 'studies in nature'?
    • Rothman D.J. Were Tuskegee & Willowbrook 'studies in nature'?. Hastings Cent Rep 1982, 12(2):5-7.
    • (1982) Hastings Cent Rep , vol.12 , Issue.2 , pp. 5-7
    • Rothman, D.J.1
  • 7
    • 0037206361 scopus 로고    scopus 로고
    • Testing medications in children
    • Steinbrook R. Testing medications in children. N Engl J Med 2002, 347(18):1462-1470.
    • (2002) N Engl J Med , vol.347 , Issue.18 , pp. 1462-1470
    • Steinbrook, R.1
  • 8
    • 0003999254 scopus 로고
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • Report and recommendations on research involving children. Washington, DC: US Government Printing Office
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and recommendations on research involving children. Washington, DC: US Government Printing Office; 1977.
    • (1977)
  • 9
    • 0003999254 scopus 로고
    • The Commission, Bethesda (MD), United State National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • United State National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Research involving children: report and recommendations 1977, The Commission, Bethesda (MD).
    • (1977) Research involving children: report and recommendations
  • 10
    • 80051795968 scopus 로고    scopus 로고
    • How best to define the concept of minimal risk
    • Westra A.E., Wit J.M., Sukhai R.N., et al. How best to define the concept of minimal risk. J Pediatr 2011, 159(3):496-500.
    • (2011) J Pediatr , vol.159 , Issue.3 , pp. 496-500
    • Westra, A.E.1    Wit, J.M.2    Sukhai, R.N.3
  • 11
    • 1642458616 scopus 로고    scopus 로고
    • How do institutional review boards apply the federal risk and benefit standards for pediatric research?
    • Shah S., Whittle A., Wilfond B., et al. How do institutional review boards apply the federal risk and benefit standards for pediatric research?. JAMA 2004, 291(4):476-482.
    • (2004) JAMA , vol.291 , Issue.4 , pp. 476-482
    • Shah, S.1    Whittle, A.2    Wilfond, B.3
  • 12
    • 0018195153 scopus 로고
    • Research involving children: recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • Jonsen A.R. Research involving children: recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Pediatrics 1978, 62(2):131-136.
    • (1978) Pediatrics , vol.62 , Issue.2 , pp. 131-136
    • Jonsen, A.R.1
  • 13
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987, 317(3):141-145.
    • (1987) N Engl J Med , vol.317 , Issue.3 , pp. 141-145
    • Freedman, B.1
  • 14
    • 0001144134 scopus 로고    scopus 로고
    • Ethical issues in pediatric research
    • University Publishing Group, Frederick (MD), H.Y. Vanderpool (Ed.)
    • Bartholome W. Ethical issues in pediatric research. The ethics of research involving human subjects 1996, 360-361. University Publishing Group, Frederick (MD). H.Y. Vanderpool (Ed.).
    • (1996) The ethics of research involving human subjects , pp. 360-361
    • Bartholome, W.1
  • 15
    • 80054953755 scopus 로고    scopus 로고
    • Ethical considerations in conducting pediatric research 1st Edition
    • Roth-Cline M., Gerson J., Bright P., et al. Ethical considerations in conducting pediatric research 1st Edition. Handb Exp Pharmacol 2011, 205:219-244.
    • (2011) Handb Exp Pharmacol , vol.205 , pp. 219-244
    • Roth-Cline, M.1    Gerson, J.2    Bright, P.3
  • 16
    • 77950573933 scopus 로고    scopus 로고
    • The experiences of children enrolled in pediatric oncology research: implications for assent
    • Unguru Y., Sill A.M., Kamani N. The experiences of children enrolled in pediatric oncology research: implications for assent. Pediatrics 2010, 125(4):e876-e883.
    • (2010) Pediatrics , vol.125 , Issue.4
    • Unguru, Y.1    Sill, A.M.2    Kamani, N.3
  • 17
    • 2542643189 scopus 로고    scopus 로고
    • Institutional review board practices regarding assent in pediatric research
    • Whittle A., Shah S., Wilfond B., et al. Institutional review board practices regarding assent in pediatric research. Pediatrics 2004, 113(6):1747-1752.
    • (2004) Pediatrics , vol.113 , Issue.6 , pp. 1747-1752
    • Whittle, A.1    Shah, S.2    Wilfond, B.3
  • 18
    • 80052857705 scopus 로고    scopus 로고
    • Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators; advance notice of proposed rulemaking
    • Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators; advance notice of proposed rulemaking. Fed Regist 2011, 76(143):44512-44531.
    • (2011) Fed Regist , vol.76 , Issue.143 , pp. 44512-44531
  • 19
    • 77649186879 scopus 로고    scopus 로고
    • Variation among institutional review boards in evaluating the design of a multicenter randomized trial
    • Stark A.R., Tyson J.E., Hibberd P.L. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol 2010, 30(3):163-169.
    • (2010) J Perinatol , vol.30 , Issue.3 , pp. 163-169
    • Stark, A.R.1    Tyson, J.E.2    Hibberd, P.L.3
  • 20
    • 0033816047 scopus 로고    scopus 로고
    • Ethical issues in genetic testing of children
    • Ross L.F., Moon M.R. Ethical issues in genetic testing of children. Arch Pediatr Adolesc Med 2000, 154(9):873-879.
    • (2000) Arch Pediatr Adolesc Med , vol.154 , Issue.9 , pp. 873-879
    • Ross, L.F.1    Moon, M.R.2
  • 21
    • 0033747979 scopus 로고    scopus 로고
    • Characterisation and genetic mapping of a new X linked deafness syndrome
    • Martin D.M., Probst F.J., Camper S.A., et al. Characterisation and genetic mapping of a new X linked deafness syndrome. J Med Genet 2000, 37(11):836-841.
    • (2000) J Med Genet , vol.37 , Issue.11 , pp. 836-841
    • Martin, D.M.1    Probst, F.J.2    Camper, S.A.3
  • 22
    • 73849149737 scopus 로고    scopus 로고
    • Genotype to phenotype-discovery and characterization of novel genomic disorders in a " genotype-first" era
    • Mefford H.C. Genotype to phenotype-discovery and characterization of novel genomic disorders in a " genotype-first" era. Genet Med 2009, 11(12):836-842.
    • (2009) Genet Med , vol.11 , Issue.12 , pp. 836-842
    • Mefford, H.C.1
  • 23
    • 80052612988 scopus 로고    scopus 로고
    • Extended family impact of genetic testing: the experiences of X-linked carrier grandmothers
    • Lehmann A., Speight B.S., Kerzin-Storrar L. Extended family impact of genetic testing: the experiences of X-linked carrier grandmothers. J Genet Couns 2011, 20(4):365-373.
    • (2011) J Genet Couns , vol.20 , Issue.4 , pp. 365-373
    • Lehmann, A.1    Speight, B.S.2    Kerzin-Storrar, L.3
  • 24
    • 34548675362 scopus 로고    scopus 로고
    • Ethical implications of array comparative genomic hybridization in complex phenotypes: points to consider in research
    • Tabor H.K., Cho M.K. Ethical implications of array comparative genomic hybridization in complex phenotypes: points to consider in research. Genet Med 2007, 9(9):626-631.
    • (2007) Genet Med , vol.9 , Issue.9 , pp. 626-631
    • Tabor, H.K.1    Cho, M.K.2
  • 25
    • 79954449180 scopus 로고    scopus 로고
    • Educational paper: screening in cancer predisposition syndromes: guidelines for the general pediatrician
    • Teplick A., Kowalski M., Biegel J.A., et al. Educational paper: screening in cancer predisposition syndromes: guidelines for the general pediatrician. Eur J Pediatr 2011, 170(3):285-294.
    • (2011) Eur J Pediatr , vol.170 , Issue.3 , pp. 285-294
    • Teplick, A.1    Kowalski, M.2    Biegel, J.A.3
  • 26
    • 77249151732 scopus 로고    scopus 로고
    • From genetics to genomics: ethics, policy, and parental decision-making
    • Wilfond B., Ross L.F. From genetics to genomics: ethics, policy, and parental decision-making. J Pediatr Psychol 2009, 34(6):639-647.
    • (2009) J Pediatr Psychol , vol.34 , Issue.6 , pp. 639-647
    • Wilfond, B.1    Ross, L.F.2
  • 27
    • 0038624107 scopus 로고    scopus 로고
    • Ethical issues with genetic testing in pediatrics
    • Nelson R.M., Botkjin J.R., Kodish E.D., et al. Ethical issues with genetic testing in pediatrics. Pediatrics 2001, 107(6):1451-1455.
    • (2001) Pediatrics , vol.107 , Issue.6 , pp. 1451-1455
    • Nelson, R.M.1    Botkjin, J.R.2    Kodish, E.D.3
  • 28
    • 0031289624 scopus 로고    scopus 로고
    • Genetic dilemmas and the child's right to an open future
    • Davis D.S. Genetic dilemmas and the child's right to an open future. Rutgers Law J 1997, 28:549-592.
    • (1997) Rutgers Law J , vol.28 , pp. 549-592
    • Davis, D.S.1
  • 29
    • 0028132846 scopus 로고
    • Genetic testing for children and adolescents. Who decides?
    • Wertz D.C., Fanos J.H., Reilly P.R. Genetic testing for children and adolescents. Who decides?. JAMA 1994, 272(11):875-881.
    • (1994) JAMA , vol.272 , Issue.11 , pp. 875-881
    • Wertz, D.C.1    Fanos, J.H.2    Reilly, P.R.3
  • 30
    • 77953960881 scopus 로고    scopus 로고
    • Effects of genetic risk information on children's psychosocial wellbeing: a systematic review of the literature
    • Wade C.H., Wilfond B.S., McBride C.M. Effects of genetic risk information on children's psychosocial wellbeing: a systematic review of the literature. Genet Med 2010, 12(6):317-326.
    • (2010) Genet Med , vol.12 , Issue.6 , pp. 317-326
    • Wade, C.H.1    Wilfond, B.S.2    McBride, C.M.3
  • 31
    • 80455145013 scopus 로고    scopus 로고
    • Commentary: children and predictive genomic testing: disease prevention, research protection, and our future
    • Tarini B.A., Tercyak K.P., Wilfond B.S. Commentary: children and predictive genomic testing: disease prevention, research protection, and our future. J Pediatr Psychol 2011, 36(10):1113-1121.
    • (2011) J Pediatr Psychol , vol.36 , Issue.10 , pp. 1113-1121
    • Tarini, B.A.1    Tercyak, K.P.2    Wilfond, B.S.3
  • 32
    • 76049086709 scopus 로고    scopus 로고
    • Children as hematopoietic stem cell donors
    • Committee on Bioethics
    • Committee on Bioethics Children as hematopoietic stem cell donors. Pediatrics 2010, 125(2):392-404.
    • (2010) Pediatrics , vol.125 , Issue.2 , pp. 392-404
  • 33
    • 33644692533 scopus 로고    scopus 로고
    • Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors
    • Pulsipher M.A., Nagler A., Iannone R., et al. Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donors. Pediatr Blood Cancer 2006, 46(4):422-433.
    • (2006) Pediatr Blood Cancer , vol.46 , Issue.4 , pp. 422-433
    • Pulsipher, M.A.1    Nagler, A.2    Iannone, R.3
  • 34
    • 84872595929 scopus 로고    scopus 로고
    • Summary PESM, Available at: Accessed April 24, 2012.
    • Summary PESM. 2008. Available at: Accessed April 24, 2012. http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4406s1-01.pdf.
    • (2008)
  • 35
    • 0031661767 scopus 로고    scopus 로고
    • Selective head cooling in newborn infants after perinatal asphyxia: a safety study
    • Gunn A.J., Gluckman P.D., Gunn T.R. Selective head cooling in newborn infants after perinatal asphyxia: a safety study. Pediatrics 1998, 102(4):885-892.
    • (1998) Pediatrics , vol.102 , Issue.4 , pp. 885-892
    • Gunn, A.J.1    Gluckman, P.D.2    Gunn, T.R.3
  • 36
    • 18444406267 scopus 로고    scopus 로고
    • Whole-body hypothermia for neonatal encephalopathy: animal observations as a basis for a randomized, controlled pilot study in term infants
    • Shankaran S., Laptook A., Wright L., et al. Whole-body hypothermia for neonatal encephalopathy: animal observations as a basis for a randomized, controlled pilot study in term infants. Pediatrics 2002, 110(2):377-385.
    • (2002) Pediatrics , vol.110 , Issue.2 , pp. 377-385
    • Shankaran, S.1    Laptook, A.2    Wright, L.3
  • 37
    • 44649200749 scopus 로고    scopus 로고
    • Cooling for newborns with hypoxic ischaemic encephalopathy
    • CD003311
    • Jacobs S., Hunt R., Tarnow-Mordi W., et al. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev 2007, (4). CD003311.
    • (2007) Cochrane Database Syst Rev , Issue.4
    • Jacobs, S.1    Hunt, R.2    Tarnow-Mordi, W.3
  • 38
    • 33645025987 scopus 로고    scopus 로고
    • Hypothermia: a neuroprotective therapy for neonatal hypoxic-ischemic encephalopathy
    • American Academy of Pediatrics Committee on Fetus and Newborn
    • Blackmon L.R., Stark A.R., American Academy of Pediatrics Committee on Fetus and Newborn Hypothermia: a neuroprotective therapy for neonatal hypoxic-ischemic encephalopathy. Pediatrics 2006, 117(3):942-948.
    • (2006) Pediatrics , vol.117 , Issue.3 , pp. 942-948
    • Blackmon, L.R.1    Stark, A.R.2
  • 39
    • 26444594348 scopus 로고    scopus 로고
    • Systemic hypothermia - A " cool" therapy for neonatal hypoxic-ischemic encephalopathy
    • Papile L.A. Systemic hypothermia - A " cool" therapy for neonatal hypoxic-ischemic encephalopathy. N Engl J Med 2005, 353(15):1619-1620.
    • (2005) N Engl J Med , vol.353 , Issue.15 , pp. 1619-1620
    • Papile, L.A.1
  • 40
    • 35448977629 scopus 로고    scopus 로고
    • A systematic review of cooling for neuroprotection in neonates with hypoxic ischemic encephalopathy - are we there yet?
    • Schulzke S., Rao S., Patole S. A systematic review of cooling for neuroprotection in neonates with hypoxic ischemic encephalopathy - are we there yet?. BMC Pediatr 2007, 7(1):30.
    • (2007) BMC Pediatr , vol.7 , Issue.1 , pp. 30
    • Schulzke, S.1    Rao, S.2    Patole, S.3
  • 41
    • 36048971602 scopus 로고    scopus 로고
    • Cooling for neonatal hypoxic ischemic encephalopathy: do we have the answer?
    • Kirpalani H., Barks J., Thorlund K., et al. Cooling for neonatal hypoxic ischemic encephalopathy: do we have the answer?. Pediatrics 2007, 120(5):1126-1130.
    • (2007) Pediatrics , vol.120 , Issue.5 , pp. 1126-1130
    • Kirpalani, H.1    Barks, J.2    Thorlund, K.3
  • 42
    • 33947110331 scopus 로고    scopus 로고
    • Hypothermia: a neuroprotective therapy for neonatal hypoxic-ischemic encephalopathy
    • Wilkinson D., Casalaz D., Watkins A., et al. Hypothermia: a neuroprotective therapy for neonatal hypoxic-ischemic encephalopathy. Pediatrics 2007, 119(2):422-423.
    • (2007) Pediatrics , vol.119 , Issue.2 , pp. 422-423
    • Wilkinson, D.1    Casalaz, D.2    Watkins, A.3
  • 43
    • 40949134703 scopus 로고    scopus 로고
    • Hypothermia: an evolving treatment for neonatal hypoxic ischemic encephalopathy
    • Gunn A., Hoehn T., Hansmann G., et al. Hypothermia: an evolving treatment for neonatal hypoxic ischemic encephalopathy. Pediatrics 2008, 121(3):648-649.
    • (2008) Pediatrics , vol.121 , Issue.3 , pp. 648-649
    • Gunn, A.1    Hoehn, T.2    Hansmann, G.3
  • 44
    • 79956343399 scopus 로고    scopus 로고
    • Neonatal resuscitation: an update
    • Raghuveer T.S., Cox A.J. Neonatal resuscitation: an update. Am Fam Physician 2011, 83(8):911-918.
    • (2011) Am Fam Physician , vol.83 , Issue.8 , pp. 911-918
    • Raghuveer, T.S.1    Cox, A.J.2
  • 45
    • 44649183886 scopus 로고    scopus 로고
    • Therapeutic hypothermia in neonates. Review of current clinical data, ILCOR recommendations and suggestions for implementation in neonatal intensive care units
    • Hoehn T., Hansmann G., Bhrer C., et al. Therapeutic hypothermia in neonates. Review of current clinical data, ILCOR recommendations and suggestions for implementation in neonatal intensive care units. Resuscitation 2008, 78(1):7-12.
    • (2008) Resuscitation , vol.78 , Issue.1 , pp. 7-12
    • Hoehn, T.1    Hansmann, G.2    Bhrer, C.3
  • 46
    • 80052906259 scopus 로고    scopus 로고
    • The 2010 guidelines on neonatal resuscitation (AHA, ERC, ILCOR): similarities and differences - what progress has been made since 2005?
    • Roehr C.C., Hansmann G., Hoehn T., et al. The 2010 guidelines on neonatal resuscitation (AHA, ERC, ILCOR): similarities and differences - what progress has been made since 2005?. Klin Padiatr 2011, 223(5):299-307.
    • (2011) Klin Padiatr , vol.223 , Issue.5 , pp. 299-307
    • Roehr, C.C.1    Hansmann, G.2    Hoehn, T.3
  • 47
    • 56049127696 scopus 로고    scopus 로고
    • Technical aspects of starting a neonatal cooling program
    • Barks J.D. Technical aspects of starting a neonatal cooling program. Clin Perinatol 2008, 35(4):765-775.
    • (2008) Clin Perinatol , vol.35 , Issue.4 , pp. 765-775
    • Barks, J.D.1
  • 48
    • 79961108502 scopus 로고    scopus 로고
    • Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial
    • Jacobs S.E., Morley C.J., Inder T.E., et al. Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial. Arch Pediatr Adolesc Med 2011, 165(8):692-700.
    • (2011) Arch Pediatr Adolesc Med , vol.165 , Issue.8 , pp. 692-700
    • Jacobs, S.E.1    Morley, C.J.2    Inder, T.E.3
  • 49
    • 77956056237 scopus 로고    scopus 로고
    • Ethics and hypothermia treatment
    • Wyatt J.S. Ethics and hypothermia treatment. Semin Fetal Neonatal Med 2010, 15(5):299-304.
    • (2010) Semin Fetal Neonatal Med , vol.15 , Issue.5 , pp. 299-304
    • Wyatt, J.S.1
  • 50
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assmann S.F., Pocock S.J., Enos L.E., et al. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000, 355(9209):1064-1069.
    • (2000) Lancet , vol.355 , Issue.9209 , pp. 1064-1069
    • Assmann, S.F.1    Pocock, S.J.2    Enos, L.E.3


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