ENHANCING THE BIOBANKING INFORMED CONSENT PROCESS TO IMPROVE COMPREHENSION

描述（由申请人提供）：获得收集和存储生物标本和数据的有效同意，用于未来，未指定的研究使用仍然是一个重大挑战。大量的研究已经证明，各种环境下的研究参与者——包括生物银行——并不了解他们同意的研究的重要方面。要解决这个问题，必须克服两大挑战。首先，对于什么构成对生物银行同意的“充分”理解没有达成共识，这就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干预措施以提高理解的努力。第二，有关提高理解的干预措施效果的证据的总体质量较差。先前的研究存在样本量小、非随机设计、与研究人群特征相关的局限性、关于如何定义和衡量“理解”的问题，以及只关注同意过程中选定的要素的狭隘关注。鉴于生物银行研究的普遍性，迫切需要通过定义提供真正知情同意所需的知识门槛来克服这些挑战，并制定和严格研究干预措施，以促进在完整知情同意过程背景下的理解。我们的目标是开发和评估生物银行的知情同意流程，包括简化的同意表格和交互式测试/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库同意理解所需的知识门槛；(2)完善教学反馈工具，以提高对生物库同意过程的理解；(3)开展一项全国性、多地点、随机试验，以确定教学干预和简化同意书对理解生物库同意书的个人和综合影响；(4)探讨反教干预和简化同意表格对二次同意过程结果的个人和综合影响。预期的结果包括系统地开发“充分”理解的定义和高质量的数据，证明对生物银行同意理解的形式和过程的改进的效果，以及模型同意书，教学工具和措施，可以很容易地适用于任何生物银行环境。

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.