Abstract
Background
Inherent to clinical research is the informed consent process, with the informed consent form (ICF), a key component of human participant protections. We wished to examine whether a shortened and simplified ICF, accompanied by an appendix, improved participant understanding of a study compared with a conventional ICF.
Methods
A shortened ICF was developed from an existing conventional ICF for a neonatal study. Either the shortened or conventional ICF was randomly distributed to members of two parental advocacy groups. Participants answered survey questions about the form they received.
Results
Thirty-one out of forty-one (76%) parents in the shortened ICF and 28/41 (68%) in the conventional ICF group responded. Significantly more parents in the shortened ICF group found their form “short and to the point”. Although they also stated that the shortened ICF did not provide enough information, there were no significant differences between groups measuring the understanding of key study components.
Conclusion
A shortened ICF did not impact the understanding of the clinical trial. It will be important to compare the shortened and conventional forms in actual clinical trials.
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Acknowledgements
The authors wish to thank Lynn Hudson from the Critical Path Institute, as well as the leadership and members from the Preemie Parent Alliance and the International Children’s Advisory Network for their assistance with this project. This study was supported in part by the Clinical and Translational Science Award (CTSA) program from the National Center for Advancing Translational Sciences (NCATS) to Tufts University (UL1TR001064) and Harvard University (UL1 TR001102) and a grant from the FDA Office of Orphan Products Development R01 FD003899.
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Murray, P.D., Bierer, B.E., Hirschfeld, S. et al. Assessment of a shortened informed consent form for pediatric research: a pilot study. Pediatr Res 84, 516–519 (2018). https://doi.org/10.1038/s41390-018-0043-7
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DOI: https://doi.org/10.1038/s41390-018-0043-7
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