Examining how children benefit from the assent process for research decisions

描述（由申请人提供）：关于儿童同意参与研究的意义和要求的争论渗透到生物伦理学，医学和心理学文献中，但这一领域的实证研究尚处于起步阶段。同意过程很重要 以符合研究规定，但也可以用来提高儿童的自我效能感，在卫生保健设置。优化儿童在研究决策中的角色至关重要，特别是在青春期前和青春期，儿童开始争取并获得更多的决策独立性。以前的研究儿童同意一直基于一个模型，专注于认知能力，本研究探讨儿童的理解的研究和影响他们的理解的因素的要素。第二个模型的儿童同意侧重于儿童的决策关系的背景。这种模式认识到，决策通常发生在家庭环境中，并注意到协作决策在规范发展中的作用。关系模式关注的不是谁做决定，而是父母和孩子如何谈论这个问题，它反映了这样一种观点，即孩子可以以各种方式参与决定，父母在孩子的发展过程中发挥着重要的支持和建议的作用。本研究的主要目的是研究儿童参与临床试验入组决策的益处，以及这些益处是否因儿童人口统计学和心理社会特征而异。换句话说，是否有些孩子从参与中受益更多？在本研究中，同意的潜在益处包括儿童对决策过程公平性的感知和自我效能感。建议的研究的假设是，成人和儿童如何互动的研究决策是更相关的儿童的自我效能比谁最终作出决定。这项创新的研究将在10天内对家庭进行评估，这些家庭实际决定参加治疗儿童慢性疾病的临床试验。研究 小组将测试儿童参与研究决策与公平感和自我效能感之间的关系（目标1），确定儿童参与与儿童同意的益处之间的关系是否取决于儿童的人口统计学和心理社会特征，如年龄和感知压力（目标2），并测试儿童参与研究决策与研究特征之间的关系，包括感知的风险和收益以及研究人员的行为（目标3）。这项研究将提供有关儿童实际参与研究决策的数据，以及使他们的参与或多或少有益的因素。该项目的数据对儿童同意相关的伦理问题有影响，并将导致制定干预措施和指导方针，以加强儿童参与研究决策。

DESCRIPTION (provided by applicant): Debates about the meaning and requirements for child assent to research participation permeate the bioethics, medical, and psychology literatures, but empirical research in this area is in its infancy. The assent process is important for conforming to research regulations but can also be used to enhance children's sense of self- efficacy in health care settings. Optimizing children's roles in research decision making is critical, especially during pre-adolescence and adolescence, when children begin to strive for and acquire more decision making independence. Prior research on child assent has been based on a model that focuses on cognitive capabilities; this research examines children's understanding of the elements of research and the factors that influence their understanding. A second model of child assent focuses on the relational context of children's decision making. This model recognizes that decision making typically occurs in a family context and attends to the role of collaborative decision making in normative development. The relational model focuses not on who makes the decision, but on how parents and children talk about it. It reflects the view that children can be involved in decisions in various ways and that parents play an important role as sources of support and advice across the child's development. The primary objective of this research is to examine the benefits of children's involvement in decisions about clinical trial enrollment and whether these benefits vary based on child demographic and psychosocial characteristics. In other words, do some children benefit more from involvement than others? For the purpose of this research, the potential benefits of assent include children's perceptions of the fairness of the decision making process and their sense of self-efficacy. The assumption of the proposed research is that how adults and children interact about the research decision is more relevant for children's self-efficacy than who ultimately makes the decision. This innovative study will assess families within 10 days of having made an actual decision about clinical trial enrollment for the treatment of a chronic condition in the child. The research team will test the relationship between child involvement in the research decision and perception of fairness and self-efficacy (Aim 1), determine if the relationship between child involvement and the benefits of child assent depends on child demographic and psychosocial characteristics, such as age and perceived stress (Aim 2), and test the relationship between child involvement in the research decision and characteristics of the research, including perceived risks and benefits and research personnel behaviors (Aim 3). This research will provide data about children's actual involvement in research decisions and the factors that make their involvement more or less beneficial. Data from this project has implications for ethical questions related to child assent and will lead to the development of interventions and guidelines to enhance child involvement in research decision making.