The combination of parental permission and children's assent for research participation is commonly seen as a practical ethical equivalent of informed consent in adults. The federal regulations give much latitude to organizations and researchers in specifying the details of these events. There has been extensive debate within the pediatric bioethics and human subjects protection communities about the most appropriate implementation of these requirements. While valuable research on parental permission and assent (PPA) has been done, much of that research has been specific to clinical trials in pediatric oncology and the measures used have not been thoroughly validated. Hence, there is a need for the development and validation of psychometrically sound measures with broad utility in pediatric research contexts. The availability of well-validated measures could facilitate further research that could yield a more general understanding of the variables affecting the quality of the PPA process and that could permit comparison of PPA studies conducted in varied settings. We have submitted two parallel applications to achieve this in simulated and naturalistic research contexts, respectively. The study proposed in this application will be done in the context of a simulated clinical trial with a sample of 60 parent-child dyads.
Three specific aims will guide the proposed study.
Specific Aim 1 will evaluate the feasibility of conducting research on the PPA process in the context of a simulated pediatric clinical trial.
Specific Aim 2 will evaluate the psychometric properties of several assessment methods developed for quantifying specific behaviors of parents, children and researchers (i.e. comprehension, satisfaction, decision-making) that reflect the quality of the PPA process. These measures will include a structured interview that quantifies key dimensions of parent-child-researcher interaction during the PPA encounter, a direct observation coding system for quantifying selected behaviors of parents, children and researchers during audio-recorded PPA interactions and a structured interview to assess satisfaction with the PPA process among parents and youths.
Specific Aim 3 will illustrate the utility of the simulation study approach with a pilot trial of the effects of researchers'verification of children's comprehension of the elements of research participation during the PPA encounter on participants'comprehension, satisfaction and decisionmaking. The study will provide normative data on the sequence in which children develop the capacity to comprehend the various elements of human research protections and provide extensive psychometric data on the new measures, including internal consistency, inter-rater agreement and sensitivity to intervention effects. Audio recordings of PPA interactions will be retained, permitting iterative refinement of the observational coding system. The fulfillment of the specific aims will facilitate further research on the human subjects protection process and provide empirical support for incorporation of selected elements into a model parental permission and children's assent process that could be tested in a future randomized controlled trial.
Parental permission combined with children's assent (PPA) represents the pediatric equivalent to adult informed consent for research participation. Previous research has answered some questions about the PPA process, but many important questions remain and there is a need for well-validated measurement tools with broad utility for this type of research. The proposed PPA simulation study will develop, refine and validate a collection of pertinent interviews, questionnaires and direct observation methods for use in future studies of the PPA process and outcome, while also providing important preliminary data on variables affecting the quality of the PPA process.
