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相结合的研究参与通常被视为成年人知情同意的实际伦理等价物。联邦法规在具体说明这些事件的细节方面给予组织和研究人员很大的自由度。儿科生物伦理学和人类受试者保护界就如何最适当地实施这些要求进行了广泛的辩论。虽然关于父母许可和同意(PPA)的有价值的研究已经完成，但这些研究大多是针对儿童肿瘤学的临床试验，所使用的措施尚未得到彻底验证。因此，有必要开发和验证在儿科研究背景下具有广泛实用价值的心理测量学测量方法。提供经过充分验证的措施有助于进一步开展研究，以便对影响方案执行进程质量的变量有更全面的了解，并能够对在不同环境下进行的方案执行情况研究进行比较。我们已经提交了两个平行的申请，分别在模拟和自然研究背景下实现这一点。本申请中提出的研究将在模拟临床试验的背景下进行，样本为60个亲子双亲。三个具体目标将指导拟议的研究。具体目标1将在模拟的儿科临床试验的背景下评估对PPA过程进行研究的可行性。具体目标2将评估为量化父母、儿童和研究人员的具体行为(即理解、满意、决策)而开发的几种评估方法的心理测量学特性，这些方法反映了PPA过程的质量。这些措施将包括一次结构化访谈，它量化了在PPA接触期间父母-孩子-研究人员互动的关键维度；一个直接观察编码系统，用于量化录音PPA互动期间父母、儿童和研究人员的选定行为；以及一次结构化访谈，以评估父母和青少年对PPA过程的满意度。具体目标3将通过一个先导性试验来说明模拟研究方法的效用，即研究人员在PPA相遇期间验证儿童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理解人类研究保护的各种要素的能力发展顺序的标准数据，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相互作用的录音将被保留，允许对观测编码系统进行迭代改进。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可在未来的随机对照试验中测试的父母许可和子女同意过程模型提供经验支持。公共卫生相关性：父母许可和儿童同意(PPA)代表了儿科参与研究的等同于成人知情同意。以前的研究已经回答了一些关于PPA过程的问题，但许多重要的问题仍然存在，需要经过充分验证的、具有广泛实用性的测量工具来进行这类研究。拟议的方案规划模拟研究将制定、完善和验证一系列相关的访谈、问卷和直接观察方法，以便在今后对方案规划进程和结果进行研究时使用，同时还将提供关于影响方案规划进程质量的各种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.