“My Parents Decide If I Can. I Decide if I Want to.” Children's Views on Participation in Medical Research

Abstract

The participation of children in medical research raises many ethical issues, in particular regarding assent. However, little is known about children's own views on participation. This study presents results from interviews with children 10-12 years old with and without experience in a large-scale longitudinal screening study. We identified five themes: (1) knowledge about research, (2) a sense of altruism, (3) shared decision-making and right to dissent, (4) notions of integrity, privacy, and access, and (5) understanding of disease risk and personal responsibilities. We conclude that the children feel positive towards medical research, and want to take an active part in decisions and have their integrity respected. However, the study also indicates that children who had participated in longitudinal screening had a limited understanding, suggesting the vital importance of providing information appropriate to their age and maturity. This information should be provided out of respect for the children as persons, but also to promote their willingness to continue participating in longitudinal studies.

Understanding Ethical Issues of Research Participation From the Perspective of Participating Children and Adolescents: A Systematic Review

“…This highlights the need to view assent as an ongoing process to be reaffirmed in studies with research activities at more than one time point (Swartling, Hansson, Ludvigsson, & Nordgren, 2011). In addition, challenges were found in children’s ability to understand clinical trials despite researchers’ explanations; with children’s expectations for clinical improvement as a result of clinical trial participation sometimes being unrealistically high (Unguru et al, 2010; Wagner, Martinez, & Joiner, 2006).…”

“…Specific suggestions from children and adolescents on improving assent processes included: for researchers to speak directly to children about research participation – not simply through their parents, ensuring written materials are written in a way that is appealing and understandable, and providing written information instead of using e-mails or websites (Brawner, Volpe, Stewart, & Gomes, 2013; Burke et al, 2005; Swartling et al, 2011; Swartling et al, 2014; Unguru et al, 2010). Specific tools that were demonstrated to enhance children’s and adolescents’ comprehension of research included an assent quiz, and a specific lesson on research rights (Bruzzese & Fisher, 2003; Chu, DePrince, & Weinzierl, 2008).…”

“…Findings in the sample of articles suggested that children and adolescents are most willing to participate in research when they feel safe (Brawner et al, 2013; O’Reilly, Karim, Taylor, & Dogra, 2012; Swartling et al, 2011; Traube et al, 2013). Most children and adolescents expected that researchers and their parents would protect them during their research participation (Brawner et al, 2013; Woodgate & Edwards, 2010).…”

“…Interestingly, of the few studies that examined factors associated with negative or positive appraisals of research participation, only one found that a demographic variable, namely the child’s level of emotional problems, was associated with their appraisals (i.e. there was a positive association between emotional problems and negative feelings towards research participation) (Cohn et al, 2005; Ellonen & Pösö, 2011; Swartling et al, 2011). No other demographic variables –including age, gender, data collection strategy, type of precipitating event that lead to inclusion in the study (i.e.…”

A randomized study of a method for optimizing adolescent assent to biomedical research

“…Consequently, studies of assent have focused on adolescent autonomy, particularly how adolescents interact with parents and with biomedical researchers to arrive at a mutual research participation decision (Miller, Reynolds, and Nelson 2009, Swartling et al 2011). These studies have raised consistent concerns about minors’ capacities to assent or, more importantly, dissent under social pressure (Abramovitch et al 1995, Baumrind 2005, Brody et al 2003, Brody et al 2005, Brody et al 2006, Brody, Turner, et al 2012, Miller, Reynolds, and Nelson 2009, Swartling et al 2011, Varma, Jenkins, and Wendler 2008). …”