Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation, Children's Mercy, 2401 Gillham Rd., POB 2.M02.47, Kansas City, MO, 64108, USA.
Department of Pediatrics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
Paediatr Drugs. 2019 Aug;21(4):205-214. doi: 10.1007/s40272-019-00347-5.
Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.
研究对象无论年龄大小，在参与人体研究之前都必须充分了解研究内容，并且在决策之前，研究人员必须确保他们完全理解相关信息。然而，不断发展的监管和机构要求导致许可/同意/同意（PAC）表格变得过于复杂，这只会加剧向潜在参与者传达这一重要信息所面临的挑战。风险最大的是儿童和其他文化程度低、英语水平有限、认知能力下降的人群，而这些人群在临床研究中往往被忽视。本文探讨了为促进知情 PAC 而评估的各种策略，借鉴了广泛人群的经验，这些人群的需求与儿童的需求重叠。这些策略包括简化 PAC 表格以提高可读性和创建多媒体 PAC 交付工具，以及通过测试、奖励和第三方通信来积极参与参与者对 PAC 要素的理解。值得注意的是，在多个环境中探索的策略的发现在提高理解能力方面的效果不一致，这突显了在设计、实施和客观评估旨在促进知情 PAC 的策略方面仍然存在挑战。然而，这些研究确实强调了可能减轻 PAC 过程中的焦虑并提高参与者满意度的努力。最终，为了满足多样化的参与者群体的需求，需要考虑并不断改进各种 PAC 策略，并让熟悉这些人群的团队成员参与进来。
