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 human subjects protection community about the optimal implementation of these requirements. While valuable research on parental permission and assent (PPA) has been done, much of it has been specific to pediatric oncology trials and the measures used have not been well-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 reliable and valid measurement tools could facilitate empirical research toward a better understanding of the variables affecting the quality of the PPA process and this could permit comparisons among PPA studies. We have submitted two parallel applications to achieve this in naturalistic and simulated research contexts, respectively. The study proposed in this application will be done in tandem with actual longitudinal pediatric studies.
Specific Aim 1 will evaluate the feasibility of naturalistic research on the PPA process in the context of actual pediatric clinical trials. A sample of 50 parent-child dyads considering enrollment in a pediatric clinical trial will be recruited for participation in ancillary study about the PPA process.
Specific Aim 2 will evaluate the psychometric properties of several assessment methods developed for quantifying 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 questionnaire to measure events occurring prior to the PPA interaction that may influence the research participation decision, 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. Internal consistency, test-retest reliability, inter-rater agreement and predictive validity will be evaluated.
Specific Aim 3 will evaluate predictors of longitudinal change in participants' comprehension, satisfaction and maintenance of research participation. 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 validate the observational coding system for quantifying targeted behaviors of parents, children and researchers. Audio recordings of PPA interactions will be retained, permitting iterative refinement of the observational coding system. The fulfillment of the three specific aims will facilitate further research on the PPA 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. There are many important questions about the PPA process that could be investigated, but there is a need for well-validated measurement tools with broad utility for this type of research. The proposed 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. ? ? ? ?
