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Original article

Vol. 150 No. 2526 (2020)

Deficiencies in paediatric research applications delaying ethics committee approval

DOI
https://doi.org/10.4414/smw.2020.20267
Cite this as:
Swiss Med Wkly. 2020;150:w20267
Published
19.06.2020

Summary

BACKGROUND

A clinical research application must be submitted for approval by a competent ethics committee (EC) before a study can be executed. There is very limited information on how such submissions could be optimised, especially regarding research in children and adolescents, which requires particular caution and age-adapted patient information.

METHODS

We assessed all research applications from the University Children’s Hospital Zurich submitted to the EC of the Canton of Zurich in 2014–2015, i.e., in the first two years after Switzerland’s new Human Research Act came into effect. Moreover, we validated our findings by assessing a randomly selected sample of applications from the same hospital in 2018–2019.

RESULTS

We assessed a total of 86 applications from 2014–2015, originating from 29 departments and sub-specialties. The EC judged that it was not responsible for three applications and declined an assessment for another three because the studies had already been conducted. Thus, we included 80 applications in the present analysis (18 clinical trials, 52 research projects, 10 further use projects). Applicants withdrew four applications before the EC’s final decision and the EC rejected two after assessment. The EC had objections in 46 (62%) of the remaining 74 applications. Formal, including formal legal, objections (n = 503) and legal objections (n = 287) accounted for the vast majority of objections. There were also 71 ethical and 82 scientific objections. The most frequent formal and formal legal objections were incomplete or missing age-adapted patient information (49%) and incorrect templates for informed consent and signature forms (46%). A review of the 20 randomly selected applications from 2018–2019 confirmed that four out of the five most frequent deficiencies relating to informed consent were identical to those observed in the 2014–2015 applications.

CONCLUSIONS

Careful preparation of submission documents by the investigators and close adherence to formal and legal requirements have the potential to considerably optimise and expedite the EC review process, and thus the commencement of the clinical research.

References

  1. Swiss Academy of Medical Sciences (SAMS). Research with human subjects. Berne: SAMS; 2015.
  2. Hartling L, Wittmeier KD, Caldwell P, van der Lee H, Klassen TP, Craig JC, et al.; StaR Child Health Group. StaR child health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials. Pediatrics. 2012;129(Suppl 3):S112–7. doi:.https://doi.org/10.1542/peds.2012-0055C
  3. Federal Act on Research Involving Human Beings, 810.30. 2014
  4. Ordinance on Clinical Trials in Human Research, 810.305. 2014
  5. Ordinance on Human Research with the Exception of Clinical Trials, 810.301. 2014
  6. Wittmeier KD, Craig J, Klassen TP, Offringa M. The mission of StaR Child Health is to improve the quality of the design, conduct, and reporting of pediatric clinical research by promoting the use of modern research standards. Introduction. Pediatrics. 2012;129(Suppl 3):S111. doi:.https://doi.org/10.1542/peds.2012-0055B
  7. Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011;6(1):3–19. doi:.https://doi.org/10.1525/jer.2011.6.1.3
  8. Hearnshaw H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ. 2004;328(7432):140–1. doi:.https://doi.org/10.1136/bmj.328.7432.140
  9. Lenk C, Radenbach K, Dahl M, Wiesemann C. Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide? J Med Ethics. 2004;30(1):85–7. doi:.https://doi.org/10.1136/jme.2003.005900
  10. Nicholls SG, Hayes TP, Brehaut JC, McDonald M, Weijer C, Saginur R, et al. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review. PLoS One. 2015;10(7):e0133639. doi:.https://doi.org/10.1371/journal.pone.0133639
  11. Silberman G, Kahn KL. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q. 2011;89(4):599–627. doi:.https://doi.org/10.1111/j.1468-0009.2011.00644.x
  12. Paris A, Deygas B, Cornu C, Thalamas C, Maison P, Duale C, et al. Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol. 2015;80(5):1010–20. doi:.https://doi.org/10.1111/bcp.12716

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