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Ethical considerations of researchers conducting pediatric clinical drug trials : a qualitative survey in two Belgian university children's hospitals

(2018) EUROPEAN JOURNAL OF PEDIATRICS. 177(7). p.1003-1008
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Abstract
There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh ethical principles, assess the risk/benefit balance, estimate patient experience, and experience informed consent procedures in pediatric drug studies. Based on our assessment of the burden and risk versus benefit ratio in 62 pediatric drug research protocols, we selected 21 studies for further study to maximize diversity. Twenty-seven researchers (17 physicians, 10 study nurses) completed a qualitative survey about their study. We compared their responses to our assessments. The risk benefit assessment of our participants about their own research projects resembled our assessment almost perfectly. Assessing burden appeared to be more subjective. The researchers were confident in their ability to obtain valid consent. However, we question whether this confidence is warranted. Conclusion: We argue for constant ethical reflexivity in pediatric clinical trials, because broad ethical principles are not always easy to apply to specific situations.
Keywords
Informed consent, Pediatrics, Ethics, Clinical trials, Risk benefit assessment, RISK

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Chicago
Van Hoof, Wannes, Kevin Meesters, Lien Dossche, Daphné Christiaens, Pauline De Bruyne, and Johan Vande Walle. 2018. “Ethical Considerations of Researchers Conducting Pediatric Clinical Drug Trials : a Qualitative Survey in Two Belgian University Children’s Hospitals.” European Journal of Pediatrics 177 (7): 1003–1008.
APA
Van Hoof, W., Meesters, K., Dossche, L., Christiaens, D., De Bruyne, P., & Vande Walle, J. (2018). Ethical considerations of researchers conducting pediatric clinical drug trials : a qualitative survey in two Belgian university children’s hospitals. EUROPEAN JOURNAL OF PEDIATRICS, 177(7), 1003–1008.
Vancouver
1.
Van Hoof W, Meesters K, Dossche L, Christiaens D, De Bruyne P, Vande Walle J. Ethical considerations of researchers conducting pediatric clinical drug trials : a qualitative survey in two Belgian university children’s hospitals. EUROPEAN JOURNAL OF PEDIATRICS. 2018;177(7):1003–8.
MLA
Van Hoof, Wannes et al. “Ethical Considerations of Researchers Conducting Pediatric Clinical Drug Trials : a Qualitative Survey in Two Belgian University Children’s Hospitals.” EUROPEAN JOURNAL OF PEDIATRICS 177.7 (2018): 1003–1008. Print.
@article{8559812,
  abstract     = {There is a general consensus about the underlying theoretical ethical principles that ground the practice of pediatric clinical trials: scientific necessity, good risk/benefit ratio, minimized burden, and parental consent/child assent. However, these principles are so broadly construed that it is not always clear how they should be applied in clinical practice. We conducted a qualitative study at Ghent University Hospital and the hospital of the Dutch-speaking university of Brussels on how researchers weigh ethical principles, assess the risk/benefit balance, estimate patient experience, and experience informed consent procedures in pediatric drug studies. Based on our assessment of the burden and risk versus benefit ratio in 62 pediatric drug research protocols, we selected 21 studies for further study to maximize diversity. Twenty-seven researchers (17 physicians, 10 study nurses) completed a qualitative survey about their study. We compared their responses to our assessments. The risk benefit assessment of our participants about their own research projects resembled our assessment almost perfectly. Assessing burden appeared to be more subjective. The researchers were confident in their ability to obtain valid consent. However, we question whether this confidence is warranted. 
Conclusion: We argue for constant ethical reflexivity in pediatric clinical trials, because broad ethical principles are not always easy to apply to specific situations.},
  author       = {Van Hoof, Wannes and Meesters, Kevin and Dossche, Lien and Christiaens, Daphn{\'e} and De Bruyne, Pauline and Vande Walle, Johan},
  issn         = {0340-6199},
  journal      = {EUROPEAN JOURNAL OF PEDIATRICS},
  language     = {eng},
  number       = {7},
  pages        = {1003--1008},
  title        = {Ethical considerations of researchers conducting pediatric clinical drug trials : a qualitative survey in two Belgian university children's hospitals},
  url          = {http://dx.doi.org/10.1007/s00431-018-3151-9},
  volume       = {177},
  year         = {2018},
}

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