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Volumn 99, Issue 10, 2014, Pages 887-891

Guidance on clinical research involving infants, children and young people: An update for researchers and research ethics committees

Author keywords

[No Author keywords available]

Indexed keywords

CHILD; CLINICAL RESEARCH; COMPETENCE; CONFLICT OF INTEREST; HUMAN; HUMAN RIGHTS; INFANT; INFORMED CONSENT; PREGNANT WOMAN; RESEARCH ETHICS; REVIEW; RISK ASSESSMENT; ADOLESCENT; ARTICLE; CHILDREN'S RESEARCH; CHILDREN'S RIGHTS; ETHICS; MEDICAL RESEARCH; PERSONNEL; PRACTICE GUIDELINE; PRESCHOOL CHILD; PROFESSIONAL STANDARD; RESEARCH ETHICS COMMITTEES; RESEARCH REGULATION; BLOOD SAMPLING; BREAST MILK; CHILD SAFETY; COMORBIDITY; COMPENSATION; COMPREHENSION; CREAM; DIAGNOSTIC PROCEDURE; EMERGENCY; EMOTION; EXPERIMENTAL THERAPY; FUNDING; GENERAL PRACTITIONER; GOOD CLINICAL PRACTICE; INCIDENTAL FINDING; MEDICAL DOCUMENTATION; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL STUDENT; METHODOLOGY; MINOR (PERSON); PARENT; PARENTAL CONSENT; PEDIATRICIAN; PHYSICAL CAPACITY; POSTGRADUATE STUDENT; PROTECTION; REIMBURSEMENT; RESPONSIBILITY; RESUSCITATION; REWARD; SCIENTIST; SEDATION; SOCIAL PSYCHOLOGY; UNITED KINGDOM; VULNERABLE POPULATION; WELLBEING;

EID: 84908044326     PISSN: 17430585     EISSN: 17430593     Source Type: Journal    
DOI: 10.1136/archdischild-2014-306444     Document Type: Review
Times cited : (62)

References (38)
  • 5
    • 84908041914 scopus 로고    scopus 로고
    • last accessed 29 Oct 2013
    • Health Research Authority. http://www.hra.nhs.uk/ (last accessed 29 Oct 2013).
  • 8
    • 84871877801 scopus 로고    scopus 로고
    • New treatments compared to established treatments in randomized trials
    • Djulbegovic B, Kumar A, Glasziou PP, et al. New treatments compared to established treatments in randomized trials. Cochrane Database Syst Rev 2012;10:MR000024.
    • (2012) Cochrane Database Syst Rev , vol.10 , pp. MR000024
    • Djulbegovic, B.1    Kumar, A.2    Glasziou, P.P.3
  • 9
    • 84871986848 scopus 로고    scopus 로고
    • A healthy nation: Strengthening child health research in the UK
    • Modi N, Clark H, Wolfe I, et al.; for the writing group of the Royal College of Paediatrics and Child Health Commission on Child Health Research. A healthy nation: strengthening child health research in the UK. Lancet 2013;381:73-87.
    • (2013) Lancet , vol.381 , pp. 73-87
    • Modi, N.1    Clark, H.2    Wolfe, I.3
  • 10
    • 77950583461 scopus 로고    scopus 로고
    • American Academy of pediatrics clinical report - guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
    • Committee on Drugs and Committee on Pediatric Research.
    • Shaddy RE, Denne C; for the Committee on Drugs and Committee on Pediatric Research. American Academy of pediatrics clinical report - guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 2010;125:850-60.
    • (2010) Pediatrics , vol.125 , pp. 850-860
    • Shaddy, R.E.1    Denne, C.F.T.2
  • 11
    • 84908041912 scopus 로고    scopus 로고
    • Gillick v West Norfolk and Wisbech. London: House of Lords, Gillick v West Norfolk and Wisbech AHA (1986) AC 112, [1985] 3 WLR 830, [1985] 3 AII ER 402, HL
    • Gillick v West Norfolk and Wisbech. London: House of Lords, Gillick v West Norfolk and Wisbech AHA (1986) AC 112, [1985] 3 WLR 830, [1985] 3 AII ER 402, HL.
  • 12
    • 66249138394 scopus 로고    scopus 로고
    • Adolescent research and parental permission
    • Kodish E. ed. New York, NY: Oxford University Press
    • Collogan L, Fleshman A. Adolescent research and parental permission. In: Kodish E. ed. Ethics and research with children. New York, NY: Oxford University Press, 2005:77-99.
    • (2005) Ethics and Research with Children , pp. 77-99
    • Collogan, L.1    Fleshman, A.2
  • 13
    • 84908041911 scopus 로고
    • Children Act. last accessed 29 Oct 2013
    • Children Act. 1989. http://www.legislation.gov.uk/ukpga/1989/41/contents (last accessed 29 Oct 2013).
    • (1989)
  • 14
    • 84908041910 scopus 로고    scopus 로고
    • Mental Capacity Act. last accessed 29 Oct 2013
    • Mental Capacity Act. http://www.legislation.gov.uk/ukpga/2005/9/contents (last accessed 29 Oct 2013).
  • 15
    • 80052397325 scopus 로고    scopus 로고
    • Emergency research in children: Options for ethical recruitment
    • Brierley J, Larcher V. Emergency research in children: options for ethical recruitment. J Medical Ethics 2011;37:429-32.
    • (2011) J Medical Ethics , vol.37 , pp. 429-432
    • Brierley, J.1    Larcher, V.2
  • 16
    • 84875398229 scopus 로고    scopus 로고
    • The CRASH-2 trial: A randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients
    • Roberts I, Shakur H, Coats T, et al. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess 2013;17:1-79.
    • (2013) Health Technol Assess , vol.17 , pp. 1-79
    • Roberts, I.1    Shakur, H.2    Coats, T.3
  • 17
    • 79953197966 scopus 로고    scopus 로고
    • Use of deferred consent for severely ill children in a multi-centre phase III trial
    • Maitland K, Molyneux S, Boga M, et al. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials 2011;12:90.
    • (2011) Trials , vol.12 , pp. 90
    • Maitland, K.1    Molyneux, S.2    Boga, M.3
  • 18
    • 84883270575 scopus 로고    scopus 로고
    • Parental perceptions of clinical research in the pediatric emergency department
    • Abernethy LE, Paulsen EL, Monuteaux MC, et al. Parental perceptions of clinical research in the pediatric emergency department. Pediatr Emerg Care 2013;29:897-902.
    • (2013) Pediatr Emerg Care , vol.29 , pp. 897-902
    • Abernethy, L.E.1    Paulsen, E.L.2    Monuteaux, M.C.3
  • 19
    • 84860642785 scopus 로고    scopus 로고
    • What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: Postal survey
    • Gamble C, Nadel S, Snape D, et al. What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey. PLOS One 2012;7:e35982.
    • (2012) PLOS One , vol.7 , pp. e35982
    • Gamble, C.1    Nadel, S.2    Snape, D.3
  • 21
    • 84858115176 scopus 로고    scopus 로고
    • Parents of children with serious illness are more resilient than credited
    • Wolf J. Parents of children with serious illness are more resilient than credited. J Palliat Med 2012;15:258-9.
    • (2012) J Palliat Med , vol.15 , pp. 258-259
    • Wolf, J.1
  • 22
    • 77749304287 scopus 로고    scopus 로고
    • Qualitative bereavement research: Incongruity between the perspectives of participants and research ethics boards
    • Buckle JL, Dwyer SC, Jackson M. Qualitative bereavement research: incongruity between the perspectives of participants and research ethics boards. Int J Soc Res Methodol 2010;13:111-25.
    • (2010) Int J Soc Res Methodol , vol.13 , pp. 111-125
    • Buckle, J.L.1    Dwyer, S.C.2    Jackson, M.3
  • 23
    • 4444270794 scopus 로고    scopus 로고
    • A population-based nationwide study of parents' perceptions of a questionnaire on their child's death due to cancer
    • Kreicbergs U, Valdimarsdóttir U, Steineck G, et al. A population-based nationwide study of parents' perceptions of a questionnaire on their child's death due to cancer. Lancet 2004;364:787-9.
    • (2004) Lancet , vol.364 , pp. 787-789
    • Kreicbergs, U.1    Valdimarsdóttir, U.2    Steineck, G.3
  • 24
    • 33846031958 scopus 로고    scopus 로고
    • Parents' reactions to participating in interviews about end-of-life decision making
    • Michelson KN, Koogler TK, Skipton K, et al. Parents' reactions to participating in interviews about end-of-life decision making. J Palliat Med 2006;9:1329-38.
    • (2006) J Palliat Med , vol.9 , pp. 1329-1338
    • Michelson, K.N.1    Koogler, T.K.2    Skipton, K.3
  • 25
    • 33846018943 scopus 로고    scopus 로고
    • Research with bereaved parents: A question of how not why
    • Hynson JL, Aroni R, Bauld C, et al. Research with bereaved parents: a question of how not why. Palliat Med 2006;20:805-11.
    • (2006) Palliat Med , vol.20 , pp. 805-811
    • Hynson, J.L.1    Aroni, R.2    Bauld, C.3
  • 26
    • 77952624606 scopus 로고    scopus 로고
    • Research with vulnerable families caring for children with life-limiting conditions
    • Stevens MM, Lord BA, Proctor MT, et al. Research with vulnerable families caring for children with life-limiting conditions. Qual Health Res 2010;20:496-505.
    • (2010) Qual Health Res , vol.20 , pp. 496-505
    • Stevens, M.M.1    Lord, B.A.2    Proctor, M.T.3
  • 27
    • 32044459218 scopus 로고    scopus 로고
    • End-Of-Life Care preferences of pediatric patients with cancer
    • Hinds PS, Drew D, Oakes LL, et al. End-Of-Life Care preferences of pediatric patients with cancer. J Clin Oncol 2005;23:9146-5.
    • (2005) J Clin Oncol , vol.23 , pp. 9146-9155
    • Hinds, P.S.1    Drew, D.2    Oakes, L.L.3
  • 28
    • 78649880992 scopus 로고    scopus 로고
    • Need for healthy controls when assessing lung function in infants with respiratory disease
    • Stocks J, Modi N, Tepper R. Need for healthy controls when assessing lung function in infants with respiratory disease. Am J Respir Crit Care Med 2010;182:1340-2.
    • (2010) Am J Respir Crit Care Med , vol.182 , pp. 1340-1342
    • Stocks, J.1    Modi, N.2    Tepper, R.3
  • 29
    • 20944451804 scopus 로고    scopus 로고
    • The management of infants and children for painless imaging
    • Sury MR, Harker H, Begent J, et al. The management of infants and children for painless imaging. Clin Radiol 2005;60:731-41.
    • (2005) Clin Radiol , vol.60 , pp. 731-741
    • Sury, M.R.1    Harker, H.2    Begent, J.3
  • 30
    • 60349105516 scopus 로고    scopus 로고
    • Sedation medication received and adverse events related to sedation for brain MRI in children with and without developmental disabilities
    • Kannikeswaran N, Mahajan PV, Sethuraman U, et al. Sedation medication received and adverse events related to sedation for brain MRI in children with and without developmental disabilities. Paediatr Anaesth 2009;19:250-6.
    • (2009) Paediatr Anaesth , vol.19 , pp. 250-256
    • Kannikeswaran, N.1    Mahajan, P.V.2    Sethuraman, U.3
  • 31
    • 85027928981 scopus 로고    scopus 로고
    • Avoiding sedation in research magnetic resonance imaging and spectroscopy in infants: Our approach, success rate and prevalence of incidental findings
    • Gale C, Jeffries S, Logan KM, et al. Avoiding sedation in research magnetic resonance imaging and spectroscopy in infants: our approach, success rate and prevalence of incidental findings. Arch Dis Child 2013;98:F267-8.
    • (2013) Arch Dis Child , vol.98 , pp. F267-F268
    • Gale, C.1    Jeffries, S.2    Logan, K.M.3
  • 33
    • 84861483083 scopus 로고    scopus 로고
    • Marketing breast milk substitutes: Problems and perils throughout the world
    • Brady JP. Marketing breast milk substitutes: problems and perils throughout the world. Arch Dis Childhood 2012;97:529-32.
    • (2012) Arch Dis Childhood , vol.97 , pp. 529-532
    • Brady, J.P.1
  • 35
    • 84870338544 scopus 로고    scopus 로고
    • Quantitative valuation placed by children and teenagers on participation in two hypothetical research scenarios
    • Funnell D, Fertleman C, Carrey L, et al. Quantitative valuation placed by children and teenagers on participation in two hypothetical research scenarios. J Med Ethics 2012;38:686-91.
    • (2012) J Med Ethics , vol.38 , pp. 686-691
    • Funnell, D.1    Fertleman, C.2    Carrey, L.3
  • 36
    • 84889020698 scopus 로고    scopus 로고
    • last accessed 29 Oct 2013
    • Good Clinical Practice. http://www.crncc.nihr.ac.uk/workforce-development/learning-and-development/gcp (last accessed 29 Oct 2013).
    • Good Clinical Practice
  • 38
    • 84908041909 scopus 로고    scopus 로고
    • last accessed 4 Jan 2013
    • http://www.nuffieldbioethics.org/research-developingcountries/research-developing-countries-summary-and-conclusions (last accessed 4 Jan 2013).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.