2006
DOI: 10.1016/j.jpeds.2006.08.027
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Involving children with cancer in decision-making about research participation

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Cited by 78 publications
(65 citation statements)
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References 27 publications
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“…2 In this study, children under the age of 9 performed poorly compared to their older counterparts. At age 7, 19% of the children taking the Standard test had a perfect score, while 6% of the children taking the Booklet test had a perfect score.…”
Section: Discussionmentioning
confidence: 67%
See 1 more Smart Citation
“…2 In this study, children under the age of 9 performed poorly compared to their older counterparts. At age 7, 19% of the children taking the Standard test had a perfect score, while 6% of the children taking the Booklet test had a perfect score.…”
Section: Discussionmentioning
confidence: 67%
“…1 There are no templates provided by the governmental agencies that can be used to develop an appropriate assent document, and the IRB is allowed discretion as to the requirements for obtaining and documenting assent. 2 Data suggest that providing written as well as verbal information to children may enhance their understanding of research participation. 3 In a pediatric setting, this is usually accomplished by having the investigator talk with the study participant and giving the subject a simple handout that explains the study in a language that a child can understand.…”
Section: Introductionmentioning
confidence: 99%
“…16 Similarly, Joffe et al claimed that US federal regulations governing paediatric research (1) fail to provide guidelines on what constitutes meaningful assent and dissent, (2) do not require developmentally appropriate information in the assessment of decisional capacity, and (3) fall short in considering the complexity of the research project (e.g., whether the study involves healthy, acutely ill, or chronically ill children). 17 Our REB submission outlined the benefits that could be derived from investigating the therapeutic procedures (i.e., single-casting vs. serial-casting protocols) in terms of enhancing mobility of children with CP and established that risks would be minimized and that the potential benefits outweighed the risks. To verify the clinical equipoise of the protocols, we conducted a systematic review of the literature; 18 we concluded that while both single and serial casting procedures appear to be effective, their relative effectiveness has not been established.…”
Section: The Role Of the Reb As Enforcermentioning
confidence: 99%
“…Ford et al 20 described a process whereby 6-to 12-year-old children were invited to participate in decision making about the content and language of the research information sheet and assent form. In support of the second option, Joffe et al 17 claimed that an assent discussion with written documentation is preferable to a signed assent form because a spoken exchange provides more flexibility to particular circumstances and eliminates the need for the child's signature, which may be neither appropriate nor possible. 17 Ultimately, we chose to provide the REB with details of an assent process designed to be both interactive and iterative, guided by each child's level of comprehension and cognitive/emotional abilities.…”
Section: The Role Of the Reb As Enforcermentioning
confidence: 99%
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