Introduction The likelihood of a child participating in a clinical trial is mostly independent of the child’s willingness to participate; children’s lack of autonomy obliges parental involvement, which is concurrently conditional to parental understanding, trust and endorsement of the research study. Objectives To identify potential predictors for allowing children to participate in clinical studies and to evaluate if motivators that promote or prevent parental support of children to participate in clinical studies differed according to racial/ethnic categorization.
Methods A stratified sample of 1,057 caregivers of children 1-18 years old who in 2015 resided in South Florida’s Miami-Dade, Broward, and Palm Beach counties were included in the study. Pediatric research participation was analyzed by exploratory unadjusted weighted multinomial association tests.
Results There were different reasons for which caregivers will allow or reject children participation in clinical research. The sex of the respondent [OR = 2.48 (1.58 - 3.90)], difficulties accessing health care access [OR = 2.77 (1.60 – 4.80)], and child’s underweight status [OR: 3.22 (1.90 – 5.47)] significantly differed between those very likely and unlikely to participate.
Conclusions Caregivers decision to allow children to participate or not in clinical research differ according to race/ethnic classification, gender of caregivers, and weight status of the child.
Key Take Away Points
* In this cross-sectional, stratified sample of 1,057 caregivers of children, sex of responders, those with difficulties accessing health care access, and weight status influence the willingness to participation of children in clinical studies.
* Consideration of the factors including in our models may improve participation in pediatric clinical studies.
José R. Fernández, PhD Professor and Vice Chair for Education, University of Alabama at Birmingham (UAB) Department of Nutrition Sciences Webb 522, 1675 University Boulevard Birmingham, AL 35294-3360. Tel: 205-934-2029 , Fax: 205-975-7049 Email: email@example.com Thomas Taylor, PhD Nicklaus Children’s Research Institute, Nicklaus Children’s Health System, Miami, FL 33155 email: Thomas.Taylor@mch.com Yenni E. Cedillo, PhD Postdoctoral fellow University of Alabama at Birmingham (UAB) Department of Nutrition Sciences Webb 552, 1675 University Blvd 35294-3360 Tel: 205-567-8251 Email: firstname.lastname@example.org Beatriz Maciel, MS University of Alabama at Birmingham (UAB) Department of Nutrition Sciences. School of Health Professions. Webb 552, 1675 University Blvd. Birmingham, Alabama USA. e-mail: email@example.com Daria Salyakina, PhD Head of Research Analytics and Data Nicklaus Children’s Research Institute, Nicklaus Children’s Health System, Miami, FL 33155 email: firstname.lastname@example.org Jennifer McCafferty, PhD Director Research Institute Nicklaus Children’s Research Institute Nicklaus Children’s Health System, Miami, FL 33155 email: Jennifer.McCafferty@mch.com
We thank Rebecca F. Lipscomb, MA, MPPM, Manager Department Research Grants and Training, Nutrition Obesity Research Center, University of Alabama at Birmingham for her assistance with the edits in this manuscript.
Fernández, José R.; Taylor, Thomas; Cedillo, Yenni E.; Maciel, Beatriz; Salyakina, Daria; and McCafferty, Jennifer
"Factors Promoting or Preventing Caregivers from Allowing Pediatric Participation in Research,"
Journal of Applied Research on Children: Informing Policy for Children at Risk: Vol. 11:
1, Article 6.
Available at: https://digitalcommons.library.tmc.edu/childrenatrisk/vol11/iss1/6