Simulation Studies of Parental Permission and Childrens Assent for Research

描述（由申请人提供）：父母同意和儿童同意的结合通常被视为成人知情同意的实际伦理等价物。联邦法规给了组织和研究人员很大的自由，可以详细说明这些事件的细节。在儿科生物伦理学和人类受试者保护社区中，关于这些要求的最适当实施存在广泛的争论。虽然对父母许可和同意（PPA）进行了有价值的研究，但其中大部分研究都是针对儿科肿瘤学的临床试验，所使用的措施尚未得到彻底验证。因此，有必要开发和验证心理测量学上健全的措施，在儿科研究背景下具有广泛的效用。有效措施的可用性可以促进进一步的研究，从而对影响PPA过程质量的变量有更普遍的了解，并可以对在不同环境下进行的PPA研究进行比较。我们已经提交了两个并行的应用程序，分别在模拟和自然的研究背景下实现这一目标。在本申请中提出的研究将在模拟临床试验的背景下进行，其中有60对亲子二联体的样本。三个具体目标将指导拟议的研究。具体目标1将评估在模拟儿科临床试验的背景下进行PPA过程研究的可行性。具体目标2将评估几种评估方法的心理测量特性，这些方法用于量化家长、儿童和研究人员的特定行为（即理解、满意度、决策），这些行为反映了PPA过程的质量。这些措施将包括一个结构化访谈，用于量化PPA接触过程中父母-孩子-研究者互动的关键维度；一个直接观察编码系统，用于量化父母、孩子和研究者在PPA互动录音过程中的选定行为；以及一个结构化访谈，以评估父母和青少年对PPA过程的满意度。具体目标3将说明模拟研究方法的效用，通过一个试点试验，研究人员验证儿童在PPA遭遇期间对研究参与要素的理解对参与者的理解、满意度和决策的影响。这项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，并提供关于新措施的广泛心理测量数据，包括内部一致性，评分者之间的一致性和对干预效果的敏感性。PPA相互作用的音频记录将被保留，允许观测编码系统的迭代改进。具体目标的实现将促进对人类受试者保护过程的进一步研究，并为将选定的要素纳入父母许可和儿童同意过程模型提供实证支持，该模型可在未来的随机对照试验中进行测试。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。先前的研究已经回答了关于PPA过程的一些问题，但许多重要的问题仍然存在，并且需要对这类研究具有广泛效用的经过良好验证的测量工具。拟议的PPA模拟研究将开发、完善和验证一系列相关访谈、问卷调查和直接观察方法，用于PPA过程和结果的未来研究，同时也提供影响PPA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 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. PUBLIC HEALTH RELEVANCE: 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.