Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols

Abstract

Purpose-Much has been written about conceptual concern for voluntary assent with children and adolescents. However, little empirical data exists examining the frequency with which, or context in which, adolescents and parents disagree on research participation decisions. The purpose of this study was to compare parent and adolescent willingness to participate in minimal and above minimal risk pediatric asthma research protocols.Method-36 adolescents diagnosed with asthma and one of their parents independently rated their willingness to participate in 9 pediatric asthma research protocol vignettes. The selected protocols were chosen by an expert panel as representative of typical minimal and above minimal risk pediatric asthma studies.Results-Parents and adolescents were significantly less likely to agree to enroll in above minimal risk studies. However, this was qualified by a finding that adolescents were significantly more willing than parents to enroll in above minimal risk research. Across all 9 studies, parents and adolescents held concordant views on participation decisions approximately 60% of the time. Perception of potential study benefit was the most frequent reason provided for participation decisions by both parents and adolescents.Conclusion-Parents and their adolescents report a consistent 40% discordance in their views about participating in asthma research across a variety of asthma research protocols, with adolescents more willing than their parents to enroll in above minimal risk studies. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation. The role of the adolescent in research participation decision-making is ambiguous. While federal regulations give parents legal responsibility for providing permission, consensus standards view adolescent assent as a moral and ethical imperative [1][2][3][4], with an adolescent's desire to dissent generally considered binding, particularly for non-therapeutic research. KeywordsSeveral models for adolescent participation in research and treatment decision-making have been proposed [5][6][7][8]. Inherent in the formulation of these models are differing views on the best way to protect the rights and interests of children and adolescents. Autonomy focused models [6,9] propose that adolescents should be approached alone after parental permission has been granted. This procedure highlights concern that adolescents exercise decision-making independently of their parents and treatment providers. Proponents of this model argue there may be competing interests between parents and adolescents in participation decision-making that result in different choices [10][11][12] Recent interview studies of parents and adolescents involved in research find that parents see their role as ensuring their child's best interest is upheld and protecting them from harm [6,17]. Factors that appear salient to parents' attitudes on what constitutes the child's best interest...

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

“…Personal benefit is the most popular reason cited by young people consenting to an actual or hypothetical trial; the desire to help others is significantly less influential in young people's decisions than perception of personal benefit, [84][85][86] as it also is for their parents, 87 although occasionally young people cite benefit to others as more important than personal benefit. 88,89 Young people give a number of reasons for declining a trial, including worries about blood or urine samples or the doctor's examination, 89 extra clinic visits, 90 belief that the trial will take up too much time, 88 belief that the 'research methods are too involved or too burdensome' and lack of interest in the research topic.…”

“…Some researchers have argued that while young people's dissent should be respected, they are not in a position to make a decision on trial entry without significant guidance from their parents, 97,98 and that, while it is important that they are consulted, they should be protected from decisions that they are unwilling, or unable, to make. 99 A key complexity in considering research in this area is that much of it has investigated young people's decision-making about entry into hypothetical trials or non-therapeutic clinical research, 87,[100][101][102][103][104][105] rather than focusing on young people who have been approached about a 'real' clinical trial. Moreover, some research in this area has been conducted with samples of healthy children, rather than children who have recent experience of illness.…”

“…76 Interestingly, evidence provides some support for this legislation. Young people are more willing to take part in above-minimalrisk hypothetical studies than their parents, 87 and adolescents are particularly more likely to 'consent' than parents. 87 If they are less risk averse than their parents in actual clinical trials, parental consent may serve a valuable function in helping to protect young people from accepting inappropriate research risks.…”

Determinants of decision-making and patient participation in paediatric clinical trials: A literature review

“…When asked about reasons for participating in a trial, children, particular those suffering from severe illnesses like cancer, often report motivations such as "To get help for my problem", "To find out what is bothering me" [18, 51,60,62]. Other reasons for participation which were less frequent were: "To help other people with problems" [51,56,60], "My doctor told me to be in the study" [51,60], or "My parents told me to be in the study" [60].…”

“…Also relevant were organisational reasons such as the existence of appointments which were made for the initial medical therapy so that participation won't take much effort or the location of the clinic [42,51,56,61,62].…”