Why do children decide not to participate in clinical research: a quantitative and qualitative study

Abstract

Background: More pediatric drug trials are needed, but although specific pediatric regulations warrant safety, recruitment of children for these trials remains one of the main difficulties. Therefore, we investigated potential determining factors of nonparticipation in clinical research, in order to optimize research participation of children by recommending improved recruitment strategies. Methods: Between 1 January 2012 and 1 January 2014, we performed a prospective study among161 pediatric patients, aged 6 to 18 y, who were eligible for clinical research. We quantitatively analyzed the association of potential explanatory variables (e.g., age, cognitive development, experience, ethnicity) with nonparticipation and qualitatively analyzed interviews on reasons for nonparticipation. results: Sixty percent of the children did not participate in the research project on offer (39% decided not to participate, 21% were indecisive). Lower age, less disease experience, and less complex research with lower risk were predictive for not participating. Time constraint and extra burden were expressed as decisive reasons for not participating. conclusions: Strategies to optimize research participation should be aimed at younger children and their families, who are logistically challenged and unfamiliar with health care and research. Recommendations include informing pediatric patients and their families of the value of research; minimizing logistic burdens; and improving accessibility.

Patient and caregiver engagement in research: factors that influence co-enrollment in research

“…Multiple patients and caregivers identified altruism as a major reason they participated in research. These findings are consistent with a study done by Hein et al which reported that children’s decisions to participate in research were positively influenced by the prospect of helping others [15]. Another reason that patients and caregivers cited participating in research was to expand their own knowledge.…”

“…Time commitment and invasiveness of the study were found to be key hindrances to recruitment. Time constraints and direct burden have previously been shown to discourage pediatric research participation when participants are above the age of 9 years [15]. In our interviews, participants also indicated they were less inclined to join drug studies.…”

Researching the Experiences of Children with Cancer: Considerations for Practice

“…Some institutions have advisory boards of child and adolescent participants who can share perspectives about which experiences are burdensome in research [61]. Advisory groups like these can help to raise awareness about what expectations are reasonable for child research participants.…”

“…Advisory groups like these can help to raise awareness about what expectations are reasonable for child research participants. One consideration to make research design more flexible is to consider modifying follow up conversations about study progress through digital outlets, such as phone calls or online platforms [61]. By listening to children’s perspectives on hindrances to participating in research, providers may be able to alter their study designs in ways that accommodate the child’s needs, thus improving adherence to studies overall [20].…”

The challenges of research participation by children

“…In this issue, Hein et al (1) make an important contribution to our understanding of why children may not participate in research. Previously, Hein et al reported that almost 40% of children aged between 6 and 17 y were judged incompetent to give consent, with age a key determining factor (2).…”