Abstract
BackgroundThere is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.MethodsBased on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.ResultsConsensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.ConclusionsIt is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.
Highlights
There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research
Operational definition Preliminary definition Based on our synthesis of the current definitions of assent we formulated a preliminary definition of assent retaining some core elements from 45CFR46 [1] as follows: “An interactive process between a researcher and child participant involving developmentally appropriate disclosure, discussion, and understanding wherein the child freely affirms their agreement to participate in a proposed research study but has insufficient maturity or lack of legal authority to meet the formal and legal expectations of informed consent
While we fully acknowledge that the information in our operational definition is not necessarily novel in that it can be sourced from a review of the extant literature, our aim was to provide a single concise statement that incorporated the important elements of the assent process not addressed in the current definitions
Summary
There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. Development of a standardized operational definition of assent would be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research. Tait and Geisser BMC Medical Ethics (2017) 18:41 for assent (e.g., how capacity for assent should be assessed, what information children want, and what should be disclosed) are often construed in different ways, institutionally disparate, and often inappropriately conflated with those of parental consent [5, 6]. Because not all children are little adults, one cannot hold them to the same standards as those of their parents and, as such the requirements for assent must be viewed independently from consent
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