Naturalistic Studies of Parental Permission and Children?s 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。人类主体保护界就如何最有效地执行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，但大部分研究是专门针对儿童肿瘤学试验的，所使用的措施尚未得到很好的验证。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。可靠和有效的衡量工具的可获得性有助于开展实证研究，以便更好地了解影响购买力评价过程质量的变量，从而能够对购买力评价研究进行比较。我们已经提交了两个平行的申请，分别在自然主义和模拟的研究背景下实现这一点。在这项申请中提出的研究将与实际的纵向儿科研究同步进行。具体目标1将在实际儿科临床试验的背景下评估对PPA过程进行自然主义研究的可行性。考虑参加儿科临床试验的50名亲子二人组样本将被招募参加关于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、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。这些措施将包括一份问卷，以衡量在PPA互动之前发生的可能影响研究参与决定的事件，一次结构化访谈，量化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。将评估内部一致性、重测信度、评分者之间的一致性和预测效度。具体目标3将评估参与者对研究参与的理解、满意和维持的纵向变化的预测因子。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化数据，并验证用于量化父母、儿童和研究人员目标行为的观察编码系统。PPA相互作用的录音将被保留，允许对观测编码系统进行迭代改进。三个具体目标的实现将促进对PPA过程的进一步研究，并为将选定的要素纳入可在未来随机对照试验中测试的父母许可和子女同意过程模式提供经验支持。与公共健康相关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。关于PPA过程有许多重要的问题可以研究，但对于这类研究，需要经过充分验证的、具有广泛实用性的测量工具。拟议的研究将发展、完善和验证一系列相关的访谈、问卷和直接观察方法，以便在今后对方案执行进程和结果的研究中使用，同时还提供关于影响方案执行进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.