메뉴 건너뛰기




Volumn 134, Issue 5, 2014, Pages 1006-1012

When is waiver of consent appropriate in a neonatal clinical trial?

Author keywords

Child; Consent; Equipoise; Ethics; Meconium aspiration; Research

Indexed keywords

AMNION FLUID; ARTIFICIAL VENTILATION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); ENDOTRACHEAL INTUBATION; GESTATIONAL AGE; HUMAN; INCIDENCE; INFORMED CONSENT; MECONIUM ASPIRATION; MEDICAL DECISION MAKING; NOTE; PARENTAL CONSENT; PRENATAL PERIOD; RESUSCITATION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SAFETY; TRACHEOBRONCHIAL TOILET; TRUST; WAIVER OF CONSENT; EMERGENCY HEALTH SERVICE; ETHICS; NEWBORN; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

EID: 84908877180     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2014-0207     Document Type: Note
Times cited : (18)

References (37)
  • 1
    • 70350044199 scopus 로고    scopus 로고
    • Meconium aspiration syndrome (MAS): Where do we go? Research perspectives
    • Kääpä PO. Meconium aspiration syndrome (MAS): where do we go? Research perspectives. Early Hum Dev. 2009;85(10):627-629
    • (2009) Early Hum Dev , vol.85 , Issue.10 , pp. 627-629
    • Kääpä, P.O.1
  • 2
    • 0034770468 scopus 로고    scopus 로고
    • Severe meconium aspiration syndrome is not caused by aspiration of meconium
    • Ghidini A, Spong CY. Severe meconium aspiration syndrome is not caused by aspiration of meconium. Am J Obstet Gynecol. 2001;185(4):931-938
    • (2001) Am J Obstet Gynecol , vol.185 , Issue.4 , pp. 931-938
    • Ghidini, A.1    Spong, C.Y.2
  • 3
    • 70350073846 scopus 로고    scopus 로고
    • What (not) to do at and after delivery? Prevention and management of meconium aspiration syndrome
    • Vain NE, Szyld EG, Prudent LM, Aguilar AM. What (not) to do at and after delivery? Prevention and management of meconium aspiration syndrome. Early Hum Dev. 2009;85(10):621-626
    • (2009) Early Hum Dev , vol.85 , Issue.10 , pp. 621-626
    • Vain, N.E.1    Szyld, E.G.2    Prudent, L.M.3    Aguilar, A.M.4
  • 4
    • 4143095138 scopus 로고    scopus 로고
    • Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: Multicentre, randomised controlled trial
    • Vain NE, Szyld EG, Prudent LM, Wiswell TE, Aguilar AM, Vivas NI. Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicentre, randomised controlled trial. Lancet. 2004;364(9434):597-602
    • (2004) Lancet , vol.364 , Issue.9434 , pp. 597-602
    • Vain, N.E.1    Szyld, E.G.2    Prudent, L.M.3    Wiswell, T.E.4    Aguilar, A.M.5    Vivas, N.I.6
  • 5
    • 0033977150 scopus 로고    scopus 로고
    • Delivery room management of the apparently vigorous meconium-stained neonate: Results of the multicenter, international collaborative trial
    • Wiswell TE, Gannon CM, Jacob J, et al. Delivery room management of the apparently vigorous meconium-stained neonate: results of the multicenter, international collaborative trial. Pediatrics. 2000;105(1 pt 1):1-7
    • (2000) Pediatrics , vol.105 , Issue.1 , pp. 1-7
    • Wiswell, T.E.1    Gannon, C.M.2    Jacob, J.3
  • 6
    • 0034847795 scopus 로고    scopus 로고
    • Handling the meconium-stained infant
    • Wiswell TE. Handling the meconium-stained infant. Semin Neonatol. 2001;6(3):225-231
    • (2001) Semin Neonatol , vol.6 , Issue.3 , pp. 225-231
    • Wiswell, T.E.1
  • 7
    • 17044362679 scopus 로고    scopus 로고
    • Sample size calculations in randomised trials: Mandatory and mystical
    • Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet. 2005;365(9467):1348-1353
    • (2005) Lancet , vol.365 , Issue.9467 , pp. 1348-1353
    • Schulz, K.F.1    Grimes, D.A.2
  • 8
    • 0029586133 scopus 로고
    • Clinical trials and rare diseases: A way out of a conundrum
    • Lilford RJ, Thornton JG, Braunholtz D. Clinical trials and rare diseases: a way out of a conundrum. BMJ. 1995;311(7020):1621-1625
    • (1995) BMJ , vol.311 , Issue.7020 , pp. 1621-1625
    • Lilford, R.J.1    Thornton, J.G.2    Braunholtz, D.3
  • 9
    • 84880922539 scopus 로고    scopus 로고
    • Oronasopharyngeal suction versus wiping of the mouth and nose at birth: A randomised equivalency trial
    • Kelleher J, Bhat R, Salas AA, et al. Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial. Lancet. 2013;382(9889):326-330
    • (2013) Lancet , vol.382 , Issue.9889 , pp. 326-330
    • Kelleher, J.1    Bhat, R.2    Salas, A.A.3
  • 10
    • 80052484532 scopus 로고    scopus 로고
    • The nocebo effect and its relevance for clinical practice
    • Colloca L, Miller FG. The nocebo effect and its relevance for clinical practice. Psychosom Med. 2011;73(7):598-603
    • (2011) Psychosom Med , vol.73 , Issue.7 , pp. 598-603
    • Colloca, L.1    Miller, F.G.2
  • 11
    • 0018783048 scopus 로고
    • Informed consent may be hazardous to your health
    • Loftus EF, Fries JF. Informed consent may be hazardous to your health. Science. 1979;204(4388):11
    • (1979) Science , vol.204 , Issue.4388 , pp. 11
    • Loftus, E.F.1    Fries, J.F.2
  • 12
    • 0018896476 scopus 로고
    • The effect of a supportive companion on perinatal problems, length of labor, and mother-infant interaction
    • Sosa R, Kennell J, Klaus M, Robertson S, Urrutia J. The effect of a supportive companion on perinatal problems, length of labor, and mother-infant interaction. N Engl J Med. 1980;303(11):597-600
    • (1980) N Engl J Med , vol.303 , Issue.11 , pp. 597-600
    • Sosa, R.1    Kennell, J.2    Klaus, M.3    Robertson, S.4    Urrutia, J.5
  • 13
    • 0025832954 scopus 로고
    • Continuous emotional support during labor in a US hospital. A randomized controlled trial
    • Kennell J, Klaus M, McGrath S, Robertson S, Hinkley C. Continuous emotional support during labor in a US hospital. A randomized controlled trial. JAMA. 1991;265(17):2197-2201
    • (1991) JAMA , vol.265 , Issue.17 , pp. 2197-2201
    • Kennell, J.1    Klaus, M.2    McGrath, S.3    Robertson, S.4    Hinkley, C.5
  • 15
    • 0016721799 scopus 로고
    • Maternal psychological stress and fetal asphyxia: A study in the monkey
    • Myers RE. Maternal psychological stress and fetal asphyxia: a study in the monkey. Am J Obstet Gynecol. 1975;122(1):47-59
    • (1975) Am J Obstet Gynecol , vol.122 , Issue.1 , pp. 47-59
    • Myers, R.E.1
  • 16
    • 0038959948 scopus 로고    scopus 로고
    • Available at: Accessed January 7, 2014
    • IRB Guidebook. Available at: www.hhs.gov/ohrp/archive/irb/irb-guidebook.htm. Accessed January 7, 2014
    • IRB Guidebook
  • 17
    • 84908878633 scopus 로고    scopus 로고
    • Available at: Accessed January 7, 2014
    • OHRP public meeting. August 28, 2013. Available at: www.hhs.gov/ohrp/newsroom/rfc. Accessed January 7, 2014
    • OHRP Public Meeting. August 28, 2013
  • 19
    • 84885093304 scopus 로고    scopus 로고
    • Unproven therapies in clinical research and practice: The necessity to change the regulatory paradigm
    • Wootton SH, Evans PW, Tyson JE. Unproven therapies in clinical research and practice: the necessity to change the regulatory paradigm. Pediatrics. 2013;132(4):599-601
    • (2013) Pediatrics , vol.132 , Issue.4 , pp. 599-601
    • Wootton, S.H.1    Evans, P.W.2    Tyson, J.E.3
  • 20
    • 84872415114 scopus 로고    scopus 로고
    • An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics
    • Faden RR, Kass NE, Goodman SN, et al. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep. 2013;(Spec No):S16-S27
    • (2013) Hastings Cent Rep , Issue.SPEC NO , pp. S16-S27
    • Faden, R.R.1    Kass, N.E.2    Goodman, S.N.3
  • 21
    • 84872422585 scopus 로고    scopus 로고
    • The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight
    • Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep. 2013;(Spec No):S4-S15
    • (2013) Hastings Cent Rep , Issue.SPEC NO , pp. S4-S15
    • Kass, N.E.1    Faden, R.R.2    Goodman, S.N.3    Pronovost, P.4    Tunis, S.5    Beauchamp, T.L.6
  • 23
    • 66249085123 scopus 로고    scopus 로고
    • Equipoise and randomization
    • Emanuel EJ, Grady C, Crouch RA, Lie R, Miller F, Wendler D, eds. Oxford, England: Oxford University Press
    • Joffe S, Truog R. Equipoise and randomization. In: Emanuel EJ, Grady C, Crouch RA, Lie R, Miller F, Wendler D, eds. The Oxford Textbook of Clinical Research Ethics. Oxford, England: Oxford University Press; 2008:245-260
    • (2008) The Oxford Textbook of Clinical Research Ethics , pp. 245-260
    • Joffe, S.1    Truog, R.2
  • 24
    • 0035229810 scopus 로고    scopus 로고
    • Endotracheal intubation at birth for preventing morbidity and mortality in vigorous, meconium-stained infants born at term
    • Halliday HL. Endotracheal intubation at birth for preventing morbidity and mortality in vigorous, meconium-stained infants born at term. Cochrane Database Syst Rev. 2001;1(1). doi:10.1002/14651858.CD000500
    • (2001) Cochrane Database Syst Rev , vol.1 , Issue.1
    • Halliday, H.L.1
  • 26
    • 84908868336 scopus 로고    scopus 로고
    • Available at: Accessed January 6, 2013
    • Vermont Oxford Network. Proposal to IRB/HREB. Available at: www.vtoxford.org/research/help/help.aspx. Accessed January 6, 2013
    • Proposal to IRB/HREB
  • 27
    • 33747031390 scopus 로고    scopus 로고
    • Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process
    • Allmark P, Mason S. Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J Med Ethics. 2006;32(8):439-443
    • (2006) J Med Ethics , vol.32 , Issue.8 , pp. 439-443
    • Allmark, P.1    Mason, S.2
  • 28
    • 4043068015 scopus 로고    scopus 로고
    • Neonatal research and the validity of informed consent obtained in the perinatal period
    • Ballard HO, Shook LA, Desai NS, Anand KJS. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004;24(7):409-415
    • (2004) J Perinatol , vol.24 , Issue.7 , pp. 409-415
    • Ballard, H.O.1    Shook, L.A.2    Desai, N.S.3    Anand, K.J.S.4
  • 29
    • 0034676823 scopus 로고    scopus 로고
    • Obtaining informed consent to neonatal randomised controlled trials: Interviews with parents and clinicians in the Euricon study
    • Mason SA, Allmark PJ; Euricon Study Group. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356(9247):2045-2051
    • (2000) Lancet , vol.356 , Issue.9247 , pp. 2045-2051
    • Mason, S.A.1    Allmark, P.J.2
  • 31
    • 34249894738 scopus 로고    scopus 로고
    • Clinical trials in neonates: Ethical issues
    • Allmark P, Spedding M. Clinical trials in neonates: ethical issues. Semin Fetal Neonatal Med. 2007;12(4):318-323
    • (2007) Semin Fetal Neonatal Med , vol.12 , Issue.4 , pp. 318-323
    • Allmark, P.1    Spedding, M.2
  • 32
    • 84877770702 scopus 로고    scopus 로고
    • Risk, consent, and SUPPORT
    • Magnus D, Caplan AL. Risk, consent, and SUPPORT. N Engl J Med. 2013;368(20):1864-1865
    • (2013) N Engl J Med , vol.368 , Issue.20 , pp. 1864-1865
    • Magnus, D.1    Caplan, A.L.2
  • 36
    • 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, Gensler G, Wendler D. 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    Gensler, G.4    Wendler, D.5
  • 37
    • 1242297504 scopus 로고    scopus 로고
    • Tracheal intubation in neonates, infants, and children: Is there a right way?
    • Anand KJS, Suresh S. Tracheal intubation in neonates, infants, and children: is there a right way? Crit Care Med. 2004;32(2):614-616
    • (2004) Crit Care Med , vol.32 , Issue.2 , pp. 614-616
    • Anand, K.J.S.1    Suresh, S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.