ENHANCING THE BIOBANKING INFORMED CONSENT PROCESS TO IMPROVE COMPREHENSION

描述（由申请人提供）：为未来未指明的研究用途获取生物标本和数据的采集和储存的有效同意书仍然是一项重大挑战。许多研究已经证明，包括生物库在内的各种环境中的研究参与者并不了解他们同意的研究的重要方面。要纠正这一问题，必须克服两大挑战。首先，对于什么是生物库同意的“充分”理解没有达成共识，这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，关于干预措施对提高理解的效果的证据的总体质量很差。先前的研究受到样本量小，非随机设计，与研究人群特征相关的限制，关于如何定义和测量“理解”的问题，以及仅关注同意过程中的选定元素。鉴于生物库研究的普遍性，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，以促进在完整的知情同意过程中的理解。本申请的目的是开发和评估生物库的知情同意过程，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库同意理解所需的知识阈值;（2）完善反馈工具，以提高生物库同意过程中的理解;（3）进行一次全国性的、多地点的、随机试验，以确定反馈干预和简化同意书对生物库同意书理解的单独和联合影响;（4）探索反馈干预和简化同意书对二级同意过程结果的单独和综合影响。预期成果包括系统开发的“充分”理解定义和高质量数据，证明表格和流程改进对生物库同意理解的影响，以及可随时适用于任何生物库背景的示范同意书、反馈工具和措施。

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.