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Caregivers’ Understanding of Informed Consent in a Randomized Control Trial

Journal of Bioethical Inquiry volume 18, pages 141–150 (2021)Cite this article

Abstract

There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent.

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Acknowledgments

This study was funded by Lottery Health and supported by 3M. We are grateful to the Northland District Health for supporting the study, to the research assistant Carleen Davis, and to the dental therapists, children, and their families who took part.

Author information

Affiliations

  1. Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand

    Dorothy Helen Boyd

  2. Stratford Dental, 82 Miranda Street, Taranaki, Stratford District, 4332, New Zealand

    Yinan Zhang

  3. Wellington Institute of Technology, Private Bag 39803, Wellington Mail Centre, Lower Hutt, 5045, New Zealand

    Lee Smith

  4. Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand

    Lee Adam, L. Foster Page & W. M. Thomson

Authors
  1. Dorothy Helen Boyd
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  2. Yinan Zhang
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  3. Lee Smith
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  4. Lee Adam
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  5. L. Foster Page
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  6. W. M. Thomson
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Contributions

DHB designed the study with guidance from WMT and LFP; YZ conducted and transcribed the telephone interviews; DHB, YZ, LS, and LA analysed the transcripts; DHB drafted the manuscript, and all authors critically appraised and revised the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Dorothy Helen Boyd.

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Competing interests

This study was funded by a grant from the Lottery Health, New Zealand and supported by 3M.

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Boyd, D.H., Zhang, Y., Smith, L. et al. Caregivers’ Understanding of Informed Consent in a Randomized Control Trial. Bioethical Inquiry 18, 141–150 (2021). https://doi.org/10.1007/s11673-020-10085-w

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  • DOI: https://doi.org/10.1007/s11673-020-10085-w

Keywords

  • Informed consent
  • Clinical research
  • Health literacy
  • Children
  • Bioethics