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Caregivers’ Understanding of Informed Consent in a Randomized Control Trial

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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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References

  • Alaei, M., A. Pourshams, N. Altaha, G. Golgani, and E. Jafari. 2013. Obtaining informed consent in an illiterate population. Middle East Journal of Digestive Diseases 5: 37-40.

    PubMed  PubMed Central  Google Scholar 

  • Armfield, J.M., M. Ketting, S. Chrisopoulos, and S.R. Baker. 2016. Do people trust dentists? Development of the Dentist Trust Scale. Australian Dental Journal 62: 355-362.

    Article  Google Scholar 

  • Berman, G., J. Hart, D. O’Mathúna, et al. 2016. What we know about ethical research involving childrenin humanitarian settings: An overview of principles, the literature and case studies. Innocenti Working Paper No. 2016-18, UNICEF Office of Research, Florence.

  • Benatar, J.R., P. McKibbin, and R. Stewart. 2012. Improving the informed consent process—A booklet on participants’ rights in medical research. The New Zealand Medical Journal 125: 36-46.

    PubMed  Google Scholar 

  • Boyd, D.H., L.A. Foster Page, W.M. Thomson, N.P. Innes, and D. Marshall. 2017. A feasibility study of stainless steel crowns placed with the Hall Technique for primary molar carious lesion management in New Zealand primary oral health care. New Zealand Dental Journal 113: 14-21.

    Google Scholar 

  • Boyd, D.H., L.A. Foster Page, and W.M. Thomson. 2018. The Hall Technique and conventional restorative treatment in New Zealand children’s primary oral healthcare—Clinical outcomes at two years. International Journal of Paediatric Dentistry 28: 180-188.

    Article  PubMed  Google Scholar 

  • Brainard, J., S.H. Wilsher, C. Salter, and Y.K. Loke. 2016. Methodological review: Quality of randomized controlled trials in health literacy. BMC Health Services Research 16(1): 246.

    Article  PubMed  PubMed Central  Google Scholar 

  • Carvalho A.A. and L.R. Costa. 2013. Mothers’ perceptions of their child’s enrollment in a randomized clinical trial: Poor understanding, vulnerability and contradictory feelings. BMC Medical Ethics 14(1): 52.

    Article  PubMed  PubMed Central  Google Scholar 

  • Cram, F., L. Smith, and W. Johnston. 2003. Mapping the themes of Māori talk about health. The New Zealand Medical Journal 116: 1170-1177.

    Google Scholar 

  • Durie, M. 1998. Whaiora: Māori health development, 2nd ed. Auckland: Oxford University Press.

    Google Scholar 

  • Erb, T.O., S.R. Schulman, and J. Sugarman. 2002. Permission and assent for clinical research in pediatric anesthesia. Anesthesia and Analgesia 94(5): 1155-1160.

    Article  PubMed  Google Scholar 

  • Gowda, S., W.M. Thomson, L.A. Foster Page, and N.A. Croucher. 2009. Dental caries experience of children in Northland/Te Tai Tokerau. New Zealand Dental Journal 105(4): 116-120.

    CAS  Google Scholar 

  • Grover, S. 2003. On the limits of parental proxy consent: Children’s right to non-participation in non-therapeutic research. Journal of Academic Ethics 1(4): 349-383.

    Article  Google Scholar 

  • Gupta, U.C. 2013. Informed consent in clinical research: Revisiting few concepts and areas. Perspectives in Clinical Research 4(1): 26-32.

    Article  PubMed  PubMed Central  Google Scholar 

  • Harth, S.C., and Y.H. Thong. 1995. Parental perceptions and attitudes about informed consent in clinical research involving children. Social Science and Medicine 40(11): 1573-1577.

    Article  CAS  PubMed  Google Scholar 

  • Health and Disability Commissioner. 1996. Code of Health and Disability Services Consumers’ Rights. https://www.hdc.org.nz/your-rights/about-the-code/code-of-health-and-disability-services-consumers-rights. Accessed April 3, 2019.

  • Innes, N.P., D.J.P. Evans, and D.R. Stirrups. 2007. The Hall Technique; A randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health 7(1): 18.

    Article  PubMed  PubMed Central  Google Scholar 

  • Innes, N.P., D.J.P Evans, and D.R. Stirrups. 2011. Sealing caries in primary molars: Randomized control trial, 5-year results. Journal of Dental Research 90: 1405-1410.

  • Kadam, R.A. 2017. Informed consent process: A step further towards making it meaningful! Perspectives in Clinical Research 8(3): 107-112.

    PubMed  PubMed Central  Google Scholar 

  • Kickbusch I, S. Wait, and D. Maag. 2005. Navigating health: The role of health literacy. https://ilcuk.org.uk/navigating-health-the-role-of-health-literacy/. Accessed April 3, 2019.

  • Kouame, B. J. 2010. Using readability tests to improve the accuracy of evaluation documents intended for low-literate participants. Journal of MultiDisciplinary Evaluation 6(14): 132-139.

    Google Scholar 

  • Kripalani, S., R. Bengtzen, L.E. Henderson, and T.A. Jacobson. 2008. Clinical research in low-literacy populations: Using teach-back to assess comprehension of informed consent and privacy information. IRB: Ethics & Human Research 30(2): 13-29.

    Google Scholar 

  • Mailloux, S.L., M.E. Johnson, D.G. Fisher, and T.J. Pettibone. 1995. How reliable is computerized assessment of readability? Computers in Nursing 13(5): 221-225.

    CAS  PubMed  Google Scholar 

  • Marcus, E.N. 2006. The silent epidemic—The health effects of illiteracy. New England Journal of Medicine 355(4): 339-341.

    Article  CAS  Google Scholar 

  • Marshman, Z., and M.J. Hall. 2008. Oral health research with children. International Journal of Paediatric Dentistry 18(4): 235-316.

    Article  PubMed  Google Scholar 

  • Meneguin, S., and J.A. Ayers. 2014. Perception of the informed consent form by participants in clinical trials. Investigacion y Educacion en Enfermeria 32(1): 95-102.

    Google Scholar 

  • Miller, C.K., D.C. O’Donnell, H.R. Searight, and R.A. Barbarash. 1996. The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 16(5): 872-878.

    CAS  Google Scholar 

  • Miller, V.A., D. Drota, C. Burant, and E. Kodish. 2005. Clinician–parent communication during informed consent for pediatric leukemia trials. Journal of Pediatric Psychology 30(3): 219–229.

    Article  PubMed  Google Scholar 

  • Ministry of Health. 2010. Kōrero Mārama: Health Literacy and Māori Results from the 2006 Adult Literacy and Life Skills Survey. Wellington: Ministry of Health.

    Google Scholar 

  • National Ethics Advisory Committee. 2019. National ethical standards for health and disability research and quality improvement. Wellington. Ministry of Health.

    Google Scholar 

  • Nijhawan, P., M.D. Janodia, B.S. Muddukrishna, et al., 2013. Informed consent: Issues and challenges. Journal of Advanced Pharmaceutical Technology & Research 4(3): 134-140.

    Article  Google Scholar 

  • Ownby, R.L., A. Acevodo, K. Goodman, J. Caballero, and D. Waldrop-Valverde. 2015. Health literacy predicts participant understanding of orally-presented informed consent. Clinical Research Trials 1(1): 15–19.

    PubMed  Google Scholar 

  • Paasche-Orlow, M.K., H.A. Taylor and F.L. Brancati. 2003. Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine 348(8): 721-772.

    Article  Google Scholar 

  • Pearson, S.D., and L.H. Raeke. 2000. Patients’ trust in physicians: Many theories, few measures, and little data. Journal of General Internal Medicine 15(7): 509-513.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Pletsch, P.K., and P.E. Stevens. 2001. Children in research: Informed consent and critical factors affecting mothers. Journal of Family Nursing 7(1): 50-70.

    Article  Google Scholar 

  • Rowe, R., and M. Calnan. 2006. Trust relations in health care—The new agenda. European Journal of Public Health 16(1): 4–6.

    Article  PubMed  Google Scholar 

  • Sachdev, P. 1990. Whakamā: Culturally determined behaviour in the New Zealand Māori. Psychologial Medicine 20(2): 433-444.

    Article  CAS  Google Scholar 

  • Sanders, L.M., V.T. Thompson, and J.D. Wilkinson. 2007. Caregiver health literacy and the use of child health services. Pediatrics 119(1): e86.

    Article  PubMed  Google Scholar 

  • Santamaria R.M., N.P. Innes, V. Machiulskiene, D.J. Evans, M. Alkilzy, and C. Spleith. 2015. Acceptability of different caries management methods for primary molars in a RCT. International Journal of Paediatric Dentistry 25(1): 9-17.

    Article  PubMed  Google Scholar 

  • Saunders, B., J. Sim, T. Kingstone, et al. 2018. Saturation in qualitative research: Exploring its conceptualization and operationalization. Quality and Quantity 52: 1893–1907.

  • Seldon, C.R., M. Zorn, S. Ratzan, and R. M. Parker. compilers. (2020) Health literacy [bibliography online]. Bethesda (MD): National Library of Medicine; 2000 Feb (Current bibliographies in medicine; no.2000-1). http://www.nlm.nih.gov/pubs/cbm/hliteracy.html. Accessed December 29, 2020.

  • Smith, L., E. Tumilty, L.A. Foster Page, W.M. Thomson, and B. Gibson. 2018. Children’s rights in their oral health care: How responsive are oral health professionals to children’s rights. The International Journal of Children’s Rights 26(2): 354-378.

    Article  Google Scholar 

  • Smith-Tyler, J. 2007. Informed consent, confidentiality, and subject rights in clinical trials. Proceedings of the American Thoracic Society 4(2): 189-193.

    Article  PubMed  Google Scholar 

  • Statistics New Zealand. 2017. Labour market statistics: September 2017 quarter. http://archive.stats.govt.nz/browse_for_stats/income-and-work/employment_and_unemployment/LabourMarketStatistics_HOTPSep17qtr.aspx. Accessed February 27, 2018.

  • Tait, A.R., T. Voepel-Lewis, and S. Malviya. 2003a. Do they understand? Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology 98(3): 603-608.

    Article  PubMed  Google Scholar 

  • Tait, A.R., T. Voepel-Lewis, and S. Malviya. 2003b. Participation of children in clinical research: Factors that influence parent’s decision to consent, Anesthesiology 99(3): 603-608.

    Article  Google Scholar 

  • Tait, A.R., T. Voepel-Lewis, and S. Malviya. 2004. Factors that influence parents’ assessments of the risks and benefits of research involving their children. Pediatrics 113(4): 727-732.

    Article  PubMed  Google Scholar 

  • Tait, A.R., T. Voepel-Lewis, S. Malviya, and S.J. Philipson. 2005. Improving the readability and processability of a pediatric informed consent document: Effects on parents’ understanding. Archives of Pediatrics & Adolescent Medicine 159(4): 819-825.

    Article  Google Scholar 

  • Tamariz, M.D., A. Palacio, M. Robert, and E.N. Marxus. 2012. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of Internal Medicine 28(1): 121-126.

    Google Scholar 

  • Thomas, D.R. 2006. A general inductive approach for analyzing qualitative evaluation data. American Journal of Evaluation 27(2): 237-246.

    Article  Google Scholar 

  • van Stuijvenberg M., M.H. Suur, S. de Vos, et al. 1998. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Archives of Disease in Childhood 79(2): 120–125.

    Article  PubMed  PubMed Central  Google Scholar 

  • Weintraub, J.A., and C.E. Breland. 2015. Challenges, benefits, and factors to enhance recruitment and inclusion of children in pediatric dental research. International Journal of Paediatric Dentistry 25(5): 310-316.

    Article  PubMed  PubMed Central  Google Scholar 

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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.

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Authors and 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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  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.

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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

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