Scientific Institute Public Health, Brussels, Belgium.
Department of Pediatrics, Ghent University Hospital, Ghent University, Ghent, Belgium.
Eur J Pediatr. 2018 Jul;177(7):1003-1008. doi: 10.1007/s00431-018-3151-9. Epub 2018 Apr 21.
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.
We argue for constant ethical reflexivity in pediatric clinical trials, because broad ethical principles are not always easy to apply to specific situations. What is Known: • Several international guidelines and a large body of scientific literature indicate a broad consensus about the basic ethical framework for pediatric clinical trials, based on risk benefit assessment and respect for autonomy. • Little is known about how researchers implement these broad principles in practice. What is New: • Researchers' risk/benefit assessments about their own studies resembled the assessment of neutral peers, assessing burden was more subjective. • Researchers were very confident in their ability to obtain valid informed consent.
本研究旨在探讨研究者在儿科药物研究中如何权衡伦理原则、评估风险/效益比、评估患者体验并进行知情同意程序，以了解这些原则在实践中的具体应用。
我们在根特大学医院和布鲁塞尔荷兰语大学医院进行了一项定性研究，对 62 项儿科药物研究方案的负担和风险/效益比进行评估后，选择了 21 项研究进行进一步研究，以最大限度地提高多样性。27 名研究人员（17 名医生，10 名研究护士）完成了一份关于其研究的定性调查。我们比较了他们的回答和我们的评估。
参与者对自己研究项目的风险/效益评估几乎与我们的评估完全一致。评估负担似乎更加主观。研究人员对自己获得有效同意的能力充满信心，但我们质疑这种信心是否合理。
我们主张在儿科临床试验中进行持续的伦理反思，因为广泛的伦理原则并不总是容易应用于具体情况。
