Assessing and Enhancing the Research Consent Capacity of Children and Youth

NorthBEAT’s Capacity-to-Consent Protocol for Obtaining Informed Consent from Youth Evaluation Participants: An Alternative to Parental Consent

“…For example, evaluators may be reluctant to include youth in their studies due to practical concerns about getting parental consent and legal concerns about not getting such consent (Bruzzese & Fisher, 2003;Fisher & Wallace, 2000; Heath et al, 2007; Hester, 2004;Rew, Taylor-Seehafer, & Thomas, 2000). Especially for sensitive topics, youth may be unwilling to seek parental permission, or parents may be unwilling to give it (Flicker & Guta, 2008; Hester, 2004;Mustanski, 2011).…”

Ethical Review and Children's Research in Ireland

“…Generally, there is significant evidence that children much younger than the age of maturity can have a good understanding of complex medical treatment and make competent decisions on research participation. Evidence indicates that children over the age of 14 are virtually indistinguishable from adults in their decisionmaking capacities; that children in the age range 10-12 years show major similarities with older age groups; and even the decisions of younger children tend to be congruent with decisions of more mature decision-makers, even though they tend to be less able to provide arguments for their decisions (Bruzzese and Fisher, 2003;Burke et al, 2005;Cauffman and Steinberg, 1995;Schlam and Wood, 2000;Weithorn, 1983;Weithorn and Campbell, 1982). These findings are also compatible with findings that even comparatively young children who have extensive experience of participating in research have a highly sophisticated understanding of ethical concerns, if their views are elicited in relation to their concrete experience of research rather than through more abstract questioning .…”

“…Much attention has been paid to the adequate presentation of informed consent materials, in particular the information sheet and informed consent forms (Burke et al, 2005;Tait et al, 2005 and. Some commentators, while not denying the need for suitable written information material, highlight the importance of the use of additional methods in order to be able to assess and improve children's understanding (Bray, 2007;Bruzzese and Fisher, 2003;Frader, 2003). In order to be able to develop age-appropriate information materials and to present them adequately to children, the researcher in charge of the information process needs to be familiar with the needs and characteristics of children of different age groups, and especially of the particular population to be included in the research holaday et al, 2007).…”

“…a general concern in this context is that not just investigators (Lederer and Grodin, 1994) but also parents might exert undue explicit or implicit pressure on their children to conform to their wishes, rather than allowing them to make up their own minds about research participation (Scherer, 1991). adult authority has been shown to be a potentially significant factor in children's decision-making about participation in research and it can have a significant influence on decisions for uptake or continuation of research, regardless of the children's cognitive level of understanding (abramovitch et al, 1995;Broome, 1999;Bruzzese and Fisher, 2003;Fisher, 2003b;McCabe, 1996;Scherer, 1991). The importance of social factors that might increase the perception of inequalities between researchers and participants has been pointed out (McDowell, 2001).…”

“…This general rule applies to children and adolescents of all ages; however, there is some evidence that they may have little awareness of their right to refuse participation. Thus, sufficiently comprehensive assent procedures need to be in place to ensure children's awareness of their rights (Broome, 1999;Bruzzese and Fisher, 2003;Fisher, 2003b). however, when asked, children frequently seem to express the view that as participants they should have significant decision-making authority on participation Geller et al, 2003).…”