Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Facilitators and barriers for parental consent to pediatric emergency research

Abstract

Background

Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies.

Methods

This was a cross-sectional survey assessing parents’ willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision.

Results

Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited “benefits that research would provide to future children” most strongly influenced their decision to agree.

Conclusions

ED investigators should highlight the benefits for future children and inquire about parents’ previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated.

Impact

  • Obtaining consent for pediatric emergency research is challenging and this study identified factors influencing parental consent for research in EDs.

  • Benefits for future children and parents’ previous research experience were two of the most influential factors in parents’ willingness to consent to ED research studies.

  • These findings will help to improve enrollment in ED research studies and better our understanding of how to promote the health and well-being of pediatric patients.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

Fig. 1: Study procedures flowchart.

References

  1. 1.

    Abernethy, L. E., Paulsen, E. L., Monuteaux, M. C., Berry, M. P. & Neuman, M. I. Parental perceptions of clinical research in the pediatric emergency department. Pediatr. Emerg. Care 29, 897–902 (2013).

    Article  Google Scholar 

  2. 2.

    Bourgeois, F. T. et al. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics 130, 285–292 (2012).

    Article  Google Scholar 

  3. 3.

    Morris, M. C., Besner, D., Vazquez, H., Nelson, R. M. & Fischbach, R. L. Parental opinions about clinical research. J. Pediatr. 151, 532–537 (2007).

    Article  Google Scholar 

  4. 4.

    Sammons, H. M., Atkinson, M., Choonara, I. & Stephenson, T. What motivates British parents to consent for research? A questionnaire study. BMC Pediatr. 7, 12 (2007).

    Article  Google Scholar 

  5. 5.

    Wendler, D., Abdoler, E., Wiener, L. & Grady, C. Views of adolescents and parents on pediatric research without the potential for clinical benefit. Pediatrics 130, 692–699 (2012).

    Article  Google Scholar 

  6. 6.

    Caldwell, P. H. Y., Butow, P. N. & Craig, J. C. Parents’ attitudes to children’s participation in randomized controlled trials. J. Pediatr. 142, 554–559 (2003).

    Article  Google Scholar 

  7. 7.

    Stenson, B. J., Becher, J. C. & McIntosh, N. Neonatal research: the parental perspective. Arch. Dis. Child. Fetal Neonatal Ed. 89, F321–F324 (2004).

    CAS  Article  Google Scholar 

  8. 8.

    Ruccione, K., Kramer, R. F., Moore, I. K. & Perin, G. Informed consent for treatment of childhood cancer: factors affecting parents’ decision making. J. Pediatr. Oncol. Nurs. 8, 112–121 (1991).

    CAS  Article  Google Scholar 

  9. 9.

    van Stuijvenberg, M. et al. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Arch. Dis. Child. 79, 120–125 (1998).

    Article  Google Scholar 

  10. 10.

    Eder, M. L., Yamokoski, A. D., Wittmann, P. W. & Kodish, E. D. Improving informed consent: suggestions from parents of children with leukemia. Pediatrics 119, e849–e859 (2007).

    Article  Google Scholar 

  11. 11.

    Natale, J. E. et al. Racial and ethnic disparities in parental refusal of consent in a large, multisite pediatric critical care clinical trial. J. Pediatr. 184, 204–208 (2017).

    Article  Google Scholar 

  12. 12.

    Chamberlain, J. M. et al. Perceived challenges to obtaining informed consent for a time‐sensitive emergency department study of pediatric status epilepticus: results of two focus groups. Acad. Emerg. Med. 16, 763–770 (2009).

    Article  Google Scholar 

  13. 13.

    Heilbrunn, B. R. et al. Reducing anxiety in the pediatric emergency department: a comparative trial. J. Emerg. Med. 47, 623–631 (2014).

    Article  Google Scholar 

  14. 14.

    Holm, L. & Fitzmaurice, L. Factors influencing parent anxiety levels in a pediatric emergency department waiting area. Pediatr. Res. 56, 672 (2004).

    Article  Google Scholar 

  15. 15.

    Woolfall, K. et al. Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting. BMJ Open 4, e005045 (2014).

  16. 16.

    Woolfall, K. et al. Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials. Arch. Dis. Child. Educ. Pract. Ed. 101, 49–53 (2016).

    Article  Google Scholar 

  17. 17.

    Rabow, M. W., Hauser, J. M. & Adams, J. Supporting family caregivers at the end of life: they don’t know what they don’t know. JAMA 291, 483–491 (2004).

    CAS  Article  Google Scholar 

  18. 18.

    Greenberg, R. G. et al. Parents’ perceived obstacles to pediatric clinical trial participation: findings from the clinical trials transformation initiative. Contemp. Clin. Trials Commun. 9, 33–39 (2018).

    Article  Google Scholar 

  19. 19.

    Molyneux, S. et al. ‘The words will pass with the blowing wind’: staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals. PLoS ONE 8, e54894 (2013).

    CAS  Article  Google Scholar 

  20. 20.

    Glickman, S. W. et al. Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research. Ann. Emerg. Med. 51, 775–780 (2008).

    Article  Google Scholar 

  21. 21.

    Kelly, M. L., Ackerman, P. D. & Ross, L. F. The participation of minorities in published pediatric research. J. Natl Med. Assoc. 97, 777 (2005).

    PubMed  PubMed Central  Google Scholar 

  22. 22.

    Stiles, P. G., Epstein, M., Poythress, N. & Edens, J. F. Protecting people who decline to participate in research: an example from a prison setting. IRB-Ethics Hum. Res. 34, 15 (2012).

    Google Scholar 

  23. 23.

    Kim, H.-Y. Statistical notes for clinical researchers: chi-squared test and Fisher’s exact test. Restor. Dent. Endod. 42, 152–155 (2017).

    Article  Google Scholar 

  24. 24.

    Haddad, A. End-of-life decisions: the family’s role. RN 67, 25–28 (2004).

    PubMed  Google Scholar 

  25. 25.

    Allmark, P. & Mason, S. Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process. J. Med. Ethics 32, 439–443 (2006).

    CAS  Article  Google Scholar 

  26. 26.

    Nelson, D. K. et al. Obtaining consent from both parents for pediatric research: what does “reasonably available” mean? Pediatrics 131, e223–e229 (2013).

    Article  Google Scholar 

  27. 27.

    Brandt, A. M. Racism and research: the case of the Tuskegee Syphilis Study. Hastings Cent. Rep. 8, 21–29 (1978).

  28. 28.

    Freimuth, V. S. et al. African Americans’ views on research and the Tuskegee Syphilis Study. Soc. Sci. Med. 52, 797–808 (2001).

    CAS  Article  Google Scholar 

  29. 29.

    Lebet, R., Fineman, L. D., Faustino, E. V. S. & Curley, M. A. Q. Asking for parents’ permission to enroll their child into a clinical trial: best practices. Am. J. Crit. Care 22, 351–356 (2013).

    Article  Google Scholar 

  30. 30.

    Sheidow, A. J., Henry, D. B., Tolan, P. H. & Strachan, M. K. The role of stress exposure and family functioning in internalizing outcomes of urban families. J. Child Fam. Stud. 23, 1351–1365 (2014).

    Article  Google Scholar 

Download references

Acknowledgements

We would like to thank Dr. Daniela Santos for translating the surveys into Spanish and for enrolling patients in the study. We would also like to thank Marissa Garcia, Tate Closson-Niese, Amira Herstic, and Kayla Bell for enrolling patients into this study. Additionally, this study could not have been conducted without the help of Mimi Goodwin and Kathleen Grice. There was no external funding for this manuscript and all authors have indicated they have no financial relationships relevant to this article to disclose.

Author information

Affiliations

Authors

Contributions

R.L.M. conceptualized and designed the study and data collection instruments, collected data, and initiated and revised the manuscript. R.D.M. and R.D.C. conceptualized and designed the study and data collection instruments, supervised the study, reviewed the manuscript for important intellectual content, and revised the manuscript. R.D.M. provided final approval of the version to be published. L.B. conceptualized the study and reviewed and revised the manuscript. L.P. and J.L. made substantial contributions to the analysis and interpretation of data and helped to revise critical manuscript content. All authors are in agreement with the content of the manuscript.

Corresponding author

Correspondence to Reagan L. Miller.

Ethics declarations

Competing interests

The authors declare no competing interests.

Consent statement

Consent was provided through the completion of the survey.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Miller, R.L., Comstock, R.D., Pierpoint, L. et al. Facilitators and barriers for parental consent to pediatric emergency research. Pediatr Res (2021). https://doi.org/10.1038/s41390-021-01600-9

Download citation

Search

Quick links