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.
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. |
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Acknowledgements
We acknowledge the SAFEPEDRUG consortium for their progressive attitude towards pediatric clinical trials.
Funding
This study was supported by the “Agency for Innovation by Science and Technology in Flanders (IWT)” through the SAFEPEDRUG project (IWT/SBO 130033).
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PDB and JVdW wrote the grant proposal; WVH, KM, LD, and DC gathered the data; WVH, KM, and LD analyzed the data; WVH drafted the text; and all authors revised the text.
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The authors declare that they have no conflict of interest.
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Communicated by Mario Bianchetti
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Van Hoof, W., Meesters, K., Dossche, L. et al. Ethical considerations of researchers conducting pediatric clinical drug trials: a qualitative survey in two Belgian university children’s hospitals. Eur J Pediatr 177, 1003–1008 (2018). https://doi.org/10.1007/s00431-018-3151-9
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DOI: https://doi.org/10.1007/s00431-018-3151-9