Practical approaches to seeking assent from children

Kumpunen, Stephanie; Shipway, Lisa; Taylor, Rachel; Aldiss, Susie

doi:10.7748/nr2012.01.19.2.23.c8905

Cited by 24 publications

(19 citation statements)

References 11 publications

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“…However, children and adolescents have a normative subservient role in family settings and experience significant power differentials in their relationships with adults and in most institutional settings, especially medical settings, where they likely perceive less decision-making autonomy. Moreover, parents and healthcare professionals often have ambivalence about child and adolescent rights to make healthcare and medical research decisions and omit them from participation discussions (Cox, Smith and Brown 2007; Swartling et al 2009; Kumpunen et al 2011; Varma, Jenkins, and Wendler 2008). The voluminous psychological literature on autonomy and social influence indicates that even adults are quite conforming in the face of social pressure and compliant to authority (Cialdini 2001).…”

Section: The Empirical Evidence Regarding Assent To Pediatric Researchmentioning

confidence: 99%

“…The challenge for assent researchers, ethicists, and pediatric researchers is, in the face of unbounded contextual and developmental variability, to define an assent process that can be adapted for general use in pediatric biomedical research (Gibson, et al 2011, Masty & Fisher, 2008, Kumpunen, et al 2011). In fact, given the variability in adolescent maturity, the diversity of family decision-making styles, and the logistics of seeking adolescent assent and parent permission, investigators need to use flexibility in designing an assent process.…”

Section: Future Directions For the Study And Practice Of Assent To Rementioning

confidence: 99%

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Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Scherer

Brody

Annett

et al. 2013

AJOB Primary Research

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Background There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent. Methods The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors. Results Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time accord adolescents appropriate decision-making autonomy. Conclusions Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.

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Section: The Empirical Evidence Regarding Assent To Pediatric Researchmentioning

confidence: 99%

Section: Future Directions For the Study And Practice Of Assent To Rementioning

confidence: 99%

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Scherer

Brody

Annett

et al. 2013

AJOB Primary Research

View full text Add to dashboard Cite

show abstract

“…The challenge is to define an assent process that can be adapted for general use in pediatric biomedical research and that takes into account how social context affects autonomy, particularly with adolescents with varied competencies (Gibson et al 2011, Kumpunen et al 2011, Masty and Fisher 2008). Brody and colleagues (Brody et al 2003, Brody et al 2005) have examined parent and adolescent participation decision-making in simulated biomedical research participation decisions.…”

Section: Introductionmentioning

confidence: 99%

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

Annett

Brody

Scherer

et al. 2016

AJOB Empirical Bioethics

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Purpose Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Methods Families were randomly assigned to remain together or separated during a consent/assent process, the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Results 64 adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. Conclusions The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent’s informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a “diffusion of responsibility” effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

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“…Although participatory approaches exist such as activity boards (Bray ; Kumpunen et al . ) and written, computer‐assisted (Schmidt & Barfield ; O'Lonergan & Forster‐Harwood ) audio–visual and visual information (O'Lonergan & Forster‐Harwood ), it is unclear how widely such methods are used in therapeutic and non‐therapeutic research, and if used how successful they are. We share with others the notion that engagement with the child is crucial, so that the process and content of assent are adjusted to the individual child and study (Giesbertz et al .…”

Section: Resultsmentioning

confidence: 99%

Assent for children's participation in research: why it matters and making it meaningful

Oulton¹,

Sell²,

Williams³

et al. 2016

Child

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Practical approaches to seeking assent from children

Abstract: Researchers can be confident in gaining assent from children as young as five years.

Cited by 24 publications

References 11 publications

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

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

Assent for children's participation in research: why it matters and making it meaningful

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