Simulation Studies of Parental Permission and Childrens Assent for Research

父母许可和儿童同意研究的模拟研究

• 批准号: 7642449
• 负责人: Holly Antal
• 金额: $ 6.38万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7642449
• 关键词: Address; Adult; Affect; Agreement; Authorization documentation; Behavior Therapy; Bioethics; Child; Childhood; Clinical Trials; Code; Collection; Communities; Comprehension; Data; Decision Making; Development; Dimensions; Elements; Empirical Research; Enrollment; Ethical Issues; Ethics; Event; Foundations; Future; Human; Human Subject Research; Informed Consent; Interview; Knowledge; Measurement; Measures; Methods; Modeling; NIH Program Announcements; Outcome; Parenting behavior; Parents; Participant; Pediatric Oncology; Pediatric Research; Process; Property; Psychometrics; Questionnaires; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regulation; Research; Research Personnel; Rights; Sampling; Simulate; Specific qualifier value; Structure; Testing; Validation; Work; Youth; base; human subject protection; improved; intervention effect; pilot trial; public health relevance; response; satisfaction; simulation; sound; tool; volunteer

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.

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。在儿科生物伦理学和人类受试者保护界，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，但大部分研究都是针对儿科肿瘤学的临床试验，并且所使用的措施尚未得到彻底验证。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。有效的措施的可用性可以促进进一步的研究，可以产生一个更普遍的了解的变量影响的PPA过程的质量，并可以允许比较PPA的研究在不同的设置。我们已经提交了两个平行的应用程序，以实现这一目标，分别在模拟和自然的研究背景下。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对父母-子女。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背景下对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。这些措施将包括一个结构化的采访，量化的主要方面的家长，孩子，研究人员的互动过程中遇到的PPA，一个直接观察编码系统，量化的选择行为的家长，儿童和研究人员在录音PPA的互动和结构化的采访，以评估满意度与家长和青少年的PPA过程。具体目标3将说明模拟研究方法的实用性与研究人员的验证儿童的理解的研究参与的元素在PPA遇到参与者的理解，满意度和决策的影响进行了试点试验。这项研究将提供规范性数据的顺序，儿童发展的能力，理解人类研究保护的各种元素，并提供广泛的心理测量数据的新措施，包括内部一致性，评分员之间的协议和干预效果的敏感性。PPA相互作用的录音将被保留，允许反复完善观察编码系统。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，并为将选定的元素纳入模型父母许可和儿童同意过程提供实证支持，该模型可以在未来的随机对照试验中进行测试。公共卫生关系：父母许可与儿童同意（PPA）相结合代表了儿科参与研究的成人知情同意书。以前的研究已经回答了一些关于PPA过程的问题，但仍然存在许多重要的问题，需要有经过充分验证的测量工具，具有广泛的实用性，用于这类研究。拟议的购股权计划模拟研究将开发、完善和验证一系列相关的访谈、问卷和直接观察方法，供今后对购股权计划过程和结果进行研究时使用，同时还将提供关于影响购股权计划过程质量的变量的重要初步数据。