ENHANCING THE BIOBANKING INFORMED CONSENT PROCESS TO IMPROVE COMPREHENSION

描述(由申请者提供)：为收集和储存生物标本和数据以供未来未指明的研究用途而获得有效同意仍然是一项重大挑战。许多研究证明，在各种环境中的研究参与者--包括生物库--不了解他们同意的研究的重要方面。要纠正这个问题，必须克服两大挑战。首先，在生物库同意中，什么是“充分的”理解没有达成共识，造成了何时获得有效同意的不确定性，并阻碍了设计和评估提高理解能力的干预措施的努力。第二，关于加强理解的干预效果的证据的整体质量很差。以前的研究存在样本量小、非随机设计、与研究人群的特征有关的局限性、如何定义和衡量“理解”的问题，以及仅关注同意过程中选定的因素。鉴于生物库研究无处不在，迫切需要克服这些挑战，界定提供真正知情同意所需的知识门槛，并制定和严格研究干预措施，以促进在完整的知情同意过程中的理解。我们这项申请的目标是开发和评估生物银行的知情同意程序，其中包括简化的同意书和交互式测试/反馈程序，以增强理解。为了实现这一目标，我们将追求以下目标：(1)系统地确定证明充分的生物银行同意理解所需的知识阈值；(2)完善回授工具以提高生物银行同意过程中的理解；(3)进行全国性、多点、随机试验，以确定生物银行同意中回教干预和简化同意书对理解的单独和组合影响；(4)探索回教干预和简化同意书对二次同意过程结果的单独和联合影响。预期成果包括系统制定的“充分”理解的定义和高质量的数据，说明改进形式和流程对生物库同意理解的影响，以及示范同意书、回授工具和可随时适应任何生物库环境使用的措施。

DESCRIPTION (provided by applicant): Obtaining valid consent for the collection and storage of biospecimens and data for future, unspecified research use remains a significant challenge. Numerous studies have documented that research participants in a variety of settings-including biobanking-do not understand important aspects of the research to which they consented. To correct this problem, two major challenges must be overcome. First, there is no consensus on what constitutes 'adequate' understanding in biobanking consent, creating uncertainty about when valid consent has been obtained and hampering efforts to devise and assess interventions to improve comprehension. Second, the overall quality of the evidence concerning the effects of interventions to enhance comprehension is poor. Prior studies have suffered from small sample sizes, non-randomized designs, limitations related to the characteristics of the study population, questions about how 'comprehension' was defined and measured, and a narrow focus on only selected elements of the consent process. Given the ubiquity of biobanking research, there is a critical need to overcome these challenges by defining the threshold of knowledge needed to provide truly informed consent, and developing and rigorously studying interventions to promote comprehension in the context of a complete informed consent process. Our objective for this application is to develop and assess an informed consent process for biobanking that involves a simplified consent form and an interactive test/feedback procedure to enhance comprehension. To achieve this objective, we will pursue the following aims: (1) Systematically determine the threshold of knowledge needed to demonstrate adequate biobanking consent comprehension; (2) Refine a teach-back tool to improve comprehension during the biobanking consent process; (3) Conduct a national, multisite, randomized trial to determine the individual and combined effects of a teach-back intervention and a simplified consent form on comprehension in biobanking consent; (4) Explore the individual and combined effects of a teach-back intervention and a simplified consent form on secondary consent process outcomes. The expected outcomes include a systematically-developed definition of 'adequate' understanding and high quality data demonstrating the effect of improvements to forms and processes on biobanking consent comprehension, as well as model consent forms, teach-back tools, and measures that could be readily adapted for use in any biobanking context.