"...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials – assessment of understanding, appreciation and reasoning

Abstract

BackgroundThe aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined.MethodsUsing the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR.ResultsFacts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school.ConclusionLegal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships.

“I Won’t Out Myself Just to Do a Survey”: Sexual and Gender Minority Adolescents’ Perspectives on the Risks and Benefits of Sex Research

“…Although adolescents may tend to take more risks with their health behavior than adults (Steinberg, 2008), this does not necessarily mean that they are inclined to make risky or impulsive decisions when deciding to participate in research. By age 14, adolescents’ understanding of the nature of health research and participant rights in general are similar to those of adults (e.g., Bruzzese & Fisher, 2003; Gibson, Stasiulis, Gutfreund, McDonald, & Dade, 2011; Koelch et al, 2009; Masty & Fisher, 2008; Miller, Drotar, & Kodish, 2004; Santelli et al, 2003); consistent with these studies, our work has shown that SGM adolescents can adequately understand and self-consent to sexual health research (Fisher et al, 2016). Many states have minor consent laws that recognize this autonomy and permit adolescents as young as 12 to independently consent to sexual and reproductive healthcare (Guttmacher Institute, 2015).…”

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

“…Studies show that this process has been insufficient to achieve its ethical goal, since children and adolescents do not understand a great deal of the information about the research in which they are involved 4,[12][13][14][15] . In this sense, obtaining the FPIC from these participants may represent failure of the principle of respect for people 16 , because it only formally fulfills the ethical determination to provide participants with information and clarification about the study.…”

Acceptance and insight: incapacity to give informed consent

“…For example, a person may deliberately choose not to understand, or reason about or appreciate the ins and outs of the proposed intervention, for they may find it too upsetting, too grisly, too threatening or even too boring as indeed some research participants suggested [6]. Another example would be that a person might legitimately prefer to trust blindly.…”

“…In the research context, the need for more formal assessments becomes eminent in protection of potential research participants who, by virtue of being incapable of giving informed consent, are at risk of exploitation or harm [1, 5,6,7]. Some ethics review committees, for example, now require explicit assessment of research participants' capacity for those research protocols that involve more than minimal risk in populations who are considered to be at risk of impaired decisional capacity [4,8].…”