Naturalistic Studies of Parental Permission and Children?s Assent for Research

描述（由申请人提供）：父母许可和儿童同意参与研究的组合通常被视为成人知情同意的实际伦理等同物。联邦法规给了组织和研究人员很大的自由来详细说明这些事件的细节。在人类受试者保护界，关于这些要求的最佳实施方式存在广泛的争论。虽然已经完成了关于父母许可和同意（PPA）的有价值的研究，但其中大部分都是针对儿科肿瘤学试验的，并且所使用的措施尚未得到充分验证。因此，有必要在儿科研究背景下，具有广泛实用性的心理测量健全的措施的发展和验证。可靠和有效的测量工具的可用性可以促进实证研究，更好地了解影响PPA过程质量的变量，这可以允许PPA研究之间的比较。我们已经提交了两个平行的应用程序，以实现这一目标，在自然和模拟的研究背景下，分别。本申请中拟定的研究将与实际纵向儿科研究同步进行。具体目标1将评估在实际儿科临床试验背景下对PPA过程进行自然主义研究的可行性。将招募考虑入组儿科临床试验的50对父母-子女样本，参与关于PPA过程的辅助研究。具体目标2将评估为量化父母、儿童和研究人员的行为（即理解、满意度、决策）而开发的几种评估方法的心理测量特性，这些评估方法反映了PPA过程的质量。这些措施将包括一份问卷，以衡量可能影响研究参与决策的PPA互动之前发生的事件，一个结构化的访谈，量化PPA遭遇期间父母-子女-研究人员互动的关键维度，一个直接观察编码系统，用于量化父母的选定行为，儿童和研究人员在录音PPA互动和结构化的采访，以评估家长和青少年的PPA过程的满意度。将评估内部一致性、重测信度、评分者间一致性和预测效度。具体目标3将评估参与者对研究参与的理解、满意度和维持的纵向变化的预测因素。该研究将提供关于儿童发展理解人类研究保护的各种要素的能力的顺序的规范性数据，并验证用于量化父母，儿童和研究人员的目标行为的观察编码系统。PPA相互作用的录音将被保留，允许反复完善观察编码系统。这三个具体目标的实现将有助于进一步研究的PPA过程中，并提供实证支持纳入一个模型的父母许可和儿童的同意过程中，可以在未来的随机对照试验进行测试的选定元素。 公共卫生相关性父母许可与儿童同意（PPA）相结合代表儿科相当于成人参与研究的知情同意。关于PPA过程有许多重要的问题可以研究，但需要经过充分验证的测量工具，这些工具对这类研究具有广泛的实用性。拟议的研究将开发、完善和验证一系列相关的访谈、问卷和直接观察方法，供今后对项目行动计划过程和结果进行研究时使用，同时还将提供关于影响项目行动计划过程质量的变量的重要初步数据。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE 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.