Seminars in Fetal & Neonatal Medicine
Volume 12, Issue 4 , Pages 318-323 , August 2007

Clinical trials in neonates: Ethical issues

  • Peter Allmark

      Affiliations

    • Faculty of Health and Wellbeing, Sheffield Hallam University, Collegiate Crescent Campus, Sheffield S1 1WB, UK
    • Corresponding Author InformationCorresponding author Tel.: +44 114 225 5727.
    • ,
  • Michael Spedding

      Affiliations

    • Research Servier, Rue des Moulineaux, 92150 Suresnes, France

References 

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  4. Allmark P. An argument for the use of Aristotelian method in bioethics. Med Health Care Philos. 2006;9(1):69–79
  5. Field D, Davis C, Elbourne D, Grant A, Johnson A, Macrae D. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet. 1996;348(9020):75–82
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  9. Allmark P, Mason S. Improving the quality of consent to randomised controlled trials using continuous consent and clinician training in the consent process. J Med Ethics. 2006;32(8):439–443
  10. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; Responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med. 1997;45(9):1337–1355
  11. Allmark P, Mason S. Should desperate volunteers be included in randomised controlled trials?. J Med Ethics. 2006;32(9):548–553
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  13. Mason SA, Allmark PJ. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356(9247):2045–2051
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  19. Manning DJ. Presumed consent in emergency neonatal research. J Med Ethics. 2000;26(4):249–253
  20. 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
  21. Allmark P. Should Zelen pre-randomised consent designs be used in some neonatal trials?. J Med Ethics. 1999;25(4):325–329
  22. Snowdon C, Elbourne D, Garcia J. Zelen randomization: Attitudes of parents participating in a neonatal clinical trial. Controlled Clin Trials. 1999;20(2):149–171
  23. Zupan V, Gonzalez P, Lacaze-Masmonteil T, Boithias C, d'Allest AM, Dehan M, et al. Periventricular leukomalacia: risk factors revisited. Dev Med Child Neurol. 1996;38(12):1061–1067
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PII: S1744-165X(07)00024-8

doi: 10.1016/j.siny.2007.01.023

Seminars in Fetal & Neonatal Medicine
Volume 12, Issue 4 , Pages 318-323 , August 2007

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