PAeDS-MoRe: A framework for the development and review of research assent protocols involving children and adolescents

Abstract

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. No articles provided a single, comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child's readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child's role as a research participant.The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent.

Assent in Pediatric Patients

“…Researchers are developing instruments that have been rigorously tested for their use in the assent process, including forms (Dockett et al, ), storyboards, word searches (Kumpunen et al ), interactive web‐based programs (Blake et al., ), and multimedia presentations (O'Lonergan & Forster‐Harwood, ). Notably, Constand, Tanel, and Ryan () developed a six‐step framework with checkpoints that researchers can utilize to ensure that their methods for obtaining assent are ethically sound and developmentally appropriate. These steps are as follows: (1) prepare for assent, (2) assess readiness, (3) discuss study, (4) seek decision, (5) monitor decision, and (6) respect role (Constand et al., ).…”

“…Notably, Constand, Tanel, and Ryan () developed a six‐step framework with checkpoints that researchers can utilize to ensure that their methods for obtaining assent are ethically sound and developmentally appropriate. These steps are as follows: (1) prepare for assent, (2) assess readiness, (3) discuss study, (4) seek decision, (5) monitor decision, and (6) respect role (Constand et al., ). These steps and their associated checkpoints provide a practical guide for researchers attempting to obtain assent (Constand et al., ).…”

“…These steps are as follows: (1) prepare for assent, (2) assess readiness, (3) discuss study, (4) seek decision, (5) monitor decision, and (6) respect role (Constand et al., ). These steps and their associated checkpoints provide a practical guide for researchers attempting to obtain assent (Constand et al., ).…”

Ethics in Pharmacologic Research in the Child with a Disability

“…In concert with calls for the inclusion of children (with disabilities) in research, however, we have seen increasing emphasis on the importance of assent by children to research participation [29][30][31], analysis of the conditions of valid consent [30,31], as well as the development of novel assent procedures [32][33][34][35][36]. For example, Constand and colleagues [32] developed a six-step framework that provides guidance on, among other things, the preparation of children for the assent process, assessment of the child's readiness to engage in decision making, seeking and monitoring assent, or recognizing dissent.…”

“…For example, proposed recruitment activities may include plans to prepare children for the consent discussion. Strategies may include enlisting the support of parents to discuss elements of consent with the child and other family members before meeting with the research team [32].…”